САЩ - английски - NLM (National Library of Medicine)

abbvie inc. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - adalimumab 40 mg in 0.8 ml - humira is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. humira can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards).  humira is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. humira can be used alone or in combination with methotrexate. humira is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. humira can be used alone or in combination with non-biologic dmards. humira is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. humira is indicated for the treatment of moderately to severely active crohn’s disease in adults and pediatric patients 6 years of age and older. humira is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. limitations of use the effectiveness of humira has not been established in patients who have lost response to or were intolerant to tnf blockers [see clinical studies ( 14.7 , 14.8 )] . humira is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. humira should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see warnings and precautions ( 5 ) ] . humira is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. humira is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby humira pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn’s disease (cd). registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data ) . adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant (see clinical considerations ) . in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data ) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester (see data ) . risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to humira in utero  [see use in specific populations ( 8.4 ) ] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with humira, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. the last dose of humira was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 µg/ml in cord blood, 4.28-17.7 µg/ml in infant serum, and 0-16.1 µg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 µg/ml), 7 weeks (1.31 µg/ml), 8 weeks (0.93 µg/ml), and 11 weeks (0.53 µg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for humira and any potential adverse effects on the breastfed child from humira or from the underlying maternal condition. the safety and effectiveness of humira have been established for: - reducing signs and symptoms of moderately to severely active polyarticular jia in pediatric patients 2 years of age and older. - the treatment of moderately to severely active crohn’s disease in pediatric patients 6 years of age and older. - the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. - the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. - the treatment of non-infectious intermediate, posterior, and panuveitis in pediatric patients 2 years of age and older. due to its inhibition of tnfα, humira administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to humira in utero suggest adalimumab crosses the placenta [see use in specific populations ( 8.1 )] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including humira [see warnings and precautions ( 5.2 ) ] . juvenile idiopathic arthritis in study jia-i, humira was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies ( 14.2 ) ] . in study jia-ii, the safety profile for patients 2 to <4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions ( 6.1 ) ] . humira has not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of humira in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions ( 6.1 ) ] . the safety and effectiveness of humira have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn’s disease the safety and effectiveness of humira for the treatment of moderately to severely active crohn’s disease have been established in pediatric patients 6 years of age and older. use of humira for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of humira in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions ( 6.1 ) , clinical pharmacology ( 12.2 , 12.3 ), clinical studies ( 14.6 ) ] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of humira have not been established in pediatric patients with crohn’s disease less than 6 years of age. pediatric ulcerative colitis the safety and effectiveness of humira for the treatment of moderately to severely active ulcerative colitis have been established in pediatric patients 5 years of age and older. use of humira for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of humira in 93 pediatric patients (5 years to 17 years of age) [see adverse reactions ( 6.1 ) , clinical pharmacology ( 12.3 ) , clinical studies ( 14.8 ) ] . the adverse reaction profile in patients 5 years to 17 years of age was similar to adults. the effectiveness of humira has not been established in patients who have lost response or were intolerant to tnf blockers. the safety and effectiveness of humira have not been established in pediatric patients with ulcerative colitis less than 5 years of age. pediatric uveitis the safety and effectiveness of humira for the treatment of non-infectious uveitis have been established in pediatric patients 2 years of age and older. the use of humira is supported by evidence from adequate and well-controlled studies of humira in adults and a 2:1 randomized, controlled clinical study in 90 pediatric patients [see clinical studies ( 14.12 ) ] . the safety and effectiveness of humira have not been established in pediatric patients with uveitis less than 2 years of age. hidradenitis suppurativa use of humira in pediatric patients 12 years of age and older for hs is supported by evidence from adequate and well-controlled studies of humira in adult hs patients. additional population pharmacokinetic modeling and simulation predicted that weight-based dosing of humira in pediatric patients 12 years of age and older can provide generally similar exposure to adult hs patients. the course of hs is sufficiently similar in adult and adolescent patients to allow extrapolation of data from adult to adolescent patients. the recommended dosage in pediatric patients 12 years of age or older is based on body weight [see dosage and administration ( 2.6 ) , clinical pharmacology ( 12.3 ) , and clinical studies ( 14.10 ) ] . the safety and effectiveness of humira have not been established in patients less than 12 years of age with hs. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received humira in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among humira treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of humira in patients 65 years of age and older. in patients treated with humira, closely monitor for the development of infection or malignancy [see warnings and precautions ( 5.1 , 5.2 )] . instructions for use humira ® (hu-mare-ah) (adalimumab) 40 mg/0.8 ml single-dose pen do not try to inject humira yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your doctor decides that you or a caregiver may be able to give your injections of humira at home, you should receive training on the right way to prepare and inject humira. it is important that you read, understand, and follow these instructions so that you inject humira the right way. it is also important to talk to your doctor to be sure you understand your humira dosing instructions. to help you remember when to inject humira, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver have any questions about the right way to inject humira.  important: - do not use humira if frozen, even if it has been thawed. - the humira pen contains glass. do not drop or crush the pen because the glass inside may break. - each humira pen has 2 caps on it. do not remove the gray cap (cap #1) or the plum-colored cap (cap #2) until right before your injection. - when the plum-colored button on the humira pen is pressed to give your dose of humira, you will hear a loud “click” sound. you must practice injecting humira with your doctor or nurse so that you are not startled by this click when you start giving yourself the injections at home. the loud click sound means the start of the injection. you will know that the injection has finished when the yellow indicator appears fully in the window view and stops moving. - you must practice injecting humira with your doctor or nurse so that you are not startled by this click when you start giving yourself the injections at home. - the loud click sound means the start of the injection. - you will know that the injection has finished when the yellow indicator appears fully in the window view and stops moving. see the section below called “prepar ing the humira pen” . gather the supplies for your injection - you will need the following supplies for each injection of humira. find a clean, flat surface to place the supplies on. 1 alcohol swab 1 cotton ball or gauze pad (not included in your humira carton) 1 humira pen (see figure a) puncture-resistant sharps disposal container for humira pen disposal (not included in your humira carton). see the “how should i throw away (dispose of) the used humira pen?” section at the end of this instructions for use. - 1 alcohol swab - 1 cotton ball or gauze pad (not included in your humira carton) - 1 humira pen (see figure a) - puncture-resistant sharps disposal container for humira pen disposal (not included in your humira carton). see the “how should i throw away (dispose of) the used humira pen?” section at the end of this instructions for use. if more comfortable, take your humira pen out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature. do not remove the gray cap (cap #1) or the plum-colored cap (cap #2) while allowing it to reach room temperature. do not warm humira in any other way (for example, do not warm it in a microwave or in hot water). if you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist. the figure below shows what the humira pen looks like. see figure a. figure a check the carton, dose tray, and humira pen . 1. make sure the name humira appears on the carton, dose tray, and humira pen label. 2. do not use and do call your doctor or pharmacist if: - you drop or crush your humira pen. - the seals on the top or bottom of the carton are broken or missing. - the expiration date on the carton, dose tray, and pen has passed. - the humira pen has been frozen or left in direct sunlight. - humira has been kept at room temperature for longer than 14 days or humira has been stored above 77°f (25°c). see the “how should i store humira?” section at the end of this instructions for use. 3. hold the pen with the gray cap (cap # 1) pointed down. 4. make sure the amount of liquid in the pen is at the fill line or close to the fill line seen through the window. this is the full dose of humira that you will inject. see figure b. 5. if the pen does not have the full amount of liquid, do not use that pen . call your pharmacist. figure b 6. turn the pen over and hold the pen with the gray cap (cap # 1) pointed up. see figure c. 7. check the solution through the windows on the side of the pen to make sure the liquid is clear and colorless. do not use your humira pen if the liquid is cloudy, discolored, or if it has flakes or particles in it. call your pharmacist. it is normal to see one or more bubbles in the window. figure c choose the injection site 8. wash and dry your hands well. 9. choose an injection site on: - the front of your thighs or - your lower abdomen (belly). if you choose your abdomen, do not use the area 2 inches around your belly button (navel). see figure d. figure d - choose a different site each time you give yourself an injection. each new injection should be given at least one inch from a site you used before. - do not inject humira into skin that is: sore (tender) bruised red hard scarred or where you have stretch marks - sore (tender) - bruised - red - hard - scarred or where you have stretch marks - if you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. - do not inject through your clothes. prepare the injection site 10. wipe the injection site with an alcohol prep (swab) using a circular motion. - do not touch this area again before giving the injection. allow the skin to dry before injecting. do not fan or blow on the clean area. preparing the humira pen 11. do not remove the gray cap (cap # 1) or the plum-colored cap (cap # 2) until right before your injection. 12. hold the middle of the pen (gray body) with one hand so that you are not touching the gray cap (cap # 1) or the plum-colored cap (cap # 2). turn the pen so that the gray cap (cap # 1) is pointing up. see figure e. figure e 13. with your other hand, pull the gray cap (cap # 1) straight off (do not twist the cap). make sure the small needle cover of the syringe has come off with the gray cap (cap # 1). see figure f. 14. throw away the gray cap (cap # 1). figure f - do not put the gray cap (cap # 1) back on the pen. putting the gray cap (cap # 1) back on may damage the needle. - the white needle sleeve, which covers the needle, can now be seen. - do not touch the needle with your fingers or let the needle touch anything. - you may see a few drops of liquid come out of the needle. this is normal. 15. remove the plum-colored cap (cap # 2) from the bottom of the pen by pulling it straight off (do not twist the cap). the pen is now activated. throw away the plum-colored cap (cap # 2). - do not put the plum-colored cap (cap # 2) back on the pen because it could cause medicine to come out of the syringe. the plum-colored activator button: - turn the pen so the plum-colored activator button is pointed up. see figure g. figure g - do not press the plum-colored activator button until you are ready to inject humira. pressing the plum-colored activator button will release the medicine from the pen. - hold the pen so that you can see the window. see figure h. it is normal to see one or more bubbles in the window. figure h position the pen and inject humira 16. position the pen: - squeeze the area of the cleaned skin and hold it firmly until the injection is complete. see figure i. you will inject into this raised area of skin. figure i 17. place the white end of the pen straight (at a 90º angle ) and flat against the raised area of your skin that you are squeezing. place the pen so that it will not inject the needle into your fingers that are holding the raised skin. see figure j. figure j 18. inject humira - it is important that you firmly push the pen down all the way against the injection site before starting the injection. - keep pushing down to prevent the pen from moving away from the skin during the injection. - press the plum-colored activator button with your thumb to begin the injection. try not to cover the window. see figure k. figure k - you will hear a loud ‘click’ when you press the plum-colored activator button. the loud click means the start of the injection. - keep pressing the plum-colored activator button and continue to push the pen against your squeezed, raised skin until all the medicine is injected. this can take up to 10 seconds, so count slowly to ten. keep pushing the pen against the squeezed, raised skin of your injection site for the whole time so you get the full dose of medicine. - you will know that the injection has finished when the yellow indicator fully appears in the window view and stops moving. see figure l. figure l 19. when the injection is finished, slowly pull the pen from your skin. the white needle sleeve will move to cover the needle tip. see figure m. - do not touch the needle. the white needle sleeve is there to prevent you from touching the needle. figure m - there may be a small amount of liquid on the injection site. this is normal. - press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. do not rub the injection site. you may have slight bleeding. this is normal. 20. throw away (dispose of) your used humira pen in a sharps disposal container right away after use. see the section “how should i dispose of the used humira pen?” 21. keep a record of the dates and location of your injection sites. to help you remember when to take humira, you can mark your calendar ahead of time. how should i throw away ( dispose of ) the used humira pen? - put your pen in a fda-cleared sharps disposal container right away after use. see figure n. do not throw away the pen in your household trash.   - do not try to touch the needle. the white needle sleeve is there to prevent you from touching the needle. figure n - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: ○ made of a heavy-duty plastic, ○ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, ○ upright and stable during use, ○ leak-resistant, and ○ properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - for the safety and health of you and others, never re-use your humira pens. - the used alcohol pads, cotton balls, dose trays and packaging may be placed in your household trash. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container.   - always keep the sharps container out of the reach of children. how should i store humira? - store humira in the refrigerator between 36ºf to 46ºf (2ºc to 8ºc). store humira in the original carton until use to protect it from light. - do not freeze humira. do not use humira if frozen, even if it has been thawed. - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or pen. do not use humira after the expiration date. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. store humira in the original carton until use to protect it from light. - throw away humira if it has been kept at room temperature and not been used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not use a pen if the liquid is cloudy, discolored, or has flakes or particles in it. - do not drop or crush humira. - keep humira, injection supplies, and all other medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: abbvie inc. north chicago, il 60064, u.s.a. us license number 1889 20066944 revised: 02/2021  - liquid is cloudy, discolored, or has flakes or particles in it - expiration date has passed - liquid has been frozen (even if thawed) or left in direct sunlight - the pen has been dropped or crushed - store humira in the refrigerator between 36°f to 46°f (2°c to 8°c). - store humira in the original carton until use to protect it from light. - do not freeze - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or pen. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. - throw away humira if it has been kept at room temperature and not used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not remove the gray cap (cap #1) or plum-colored cap (cap #2) while allowing humira to reach room temperature - do not warm humira in any other way. for example, do not warm it in a microwave or in hot water. - do not use the pen if liquid has been frozen (even if thawed) - 1 single-dose pen and alcohol swab - 1 cotton ball or gauze pad (not included) - puncture-resistant sharps disposal container (not included). see step 9 at the end of this instructions for use for instructions on how to throw away (dispose of) your humira pen - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - different from your last injection site - do not inject through clothes - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques - it is normal to see 1 or more bubbles in the window - make sure the liquid is clear and colorless - do not use the pen if the liquid is cloudy, discolored, or has flakes or particles in it - do not use the pen if it has been dropped or crushed - it is normal to see a few drops of liquid come out of the needle - a loud “click” will signal the start of the injection - keep pushing the pen down firmly against the injection site until the injection is complete - injection is complete when the yellow indicator has stopped moving - a small amount of liquid on the injection site is normal - do not rub - slight bleeding at the injection site is normal - put your used needles, pens, and sharps in a fda cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles, syringes, and the pen in the household trash. - if you do not have a fda cleared sharps disposal container, you may use a household container that is: ○ made of a heavy-duty plastic, ○ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, ○ upright and stable during use, ○ leak-resistant, and ○ properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - call your healthcare provider or 1-800-4humira (1-800-448-6472) or visit www.humira.com if you need help - the yellow indicator has stopped moving. this takes up to 10 seconds.  - call 1-800-4humira (1-800-448-6472) for help - call 1-800-4humira (1-800-448-6472) for a free fda-cleared sharps disposal container - liquid is cloudy, discolored, or has flakes or particles in it - expiration date has passed - liquid has been frozen (even if thawed) or left in direct sunlight - the pen has been dropped or crushed - store humira in the refrigerator between 36°f to 46°f (2°c to 8°c). - store humira in the original carton until use to protect it from light. - do not freeze - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or pen. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. - throw away humira if it has been kept at room temperature and not used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not remove the gray cap (cap #1) or plum-colored cap (cap #2) while allowing humira to reach room temperature - do not warm humira in any other way. for example, do not warm it in a microwave or in hot water - do not use the pen if liquid has been frozen (even if thawed) - 1 single-dose pen and alcohol swab - 1 cotton ball or gauze pad (not included) - puncture-resistant sharps disposal container (not included). see step 9 at the end of this instructions for use for instructions on how to throw away (dispose of) your humira pen - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - different from your last injection site - do not inject through clothes - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques - it is normal to see 1 or more bubbles in the window - make sure the liquid is clear and colorless - do not use the pen if the liquid is cloudy, discolored, or has flakes or particles in it - do not use the pen if it has been dropped or crushed - it is normal to see a few drops of liquid come out of the needle - a loud “click” will signal the start of the injection - keep pushing the pen down firmly against the injection site until the injection is complete - injection is complete when the yellow indicator has stopped moving - a small amount of liquid on the injection site is normal - do not rub - slight bleeding at the injection site is normal - put your used needles, pens, and sharps in a fda cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles, syringes, and the pen in the household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: ○ made of a heavy-duty plastic, ○ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, ○ upright and stable during use, ○ leak-resistant, and ○ properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - call your healthcare provider or 1-800-4humira (1-800-448-6472) or visit www.humira.com if you need help - the yellow indicator has stopped moving. this takes up to 15 seconds.  - call 1-800-4humira (1-800-448-6472) for help - call 1-800-4humira (1-800-448-6472) for a free fda-cleared sharps disposal container instructions for use humira ® (hu-mare-ah) (adalimumab) 40 mg/0.8 ml, 20 mg/0.4 ml and 10 mg/0.2 ml single-dose prefilled syringe do not try to inject humira yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your doctor decides that you or a caregiver may be able to give your injections of humira at home, you should receive training on the right way to prepare and inject humira. it is important that you read, understand, and follow these instructions so that you inject humira the right way. it is also important to talk to your doctor to be sure you understand your humira dosing instructions. to help you remember when to inject humira, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver have any questions about the right way to inject humira. gather the supplies for your injection - you will need the following supplies for each injection of humira. find a clean, flat surface to place the supplies on. ● 1 alcohol swab ● 1 cotton ball or gauze pad (not included in your humira carton) ● 1 humira prefilled syringe (see figure a) ● puncture-resistant sharps disposal container for humira prefilled syringe disposal (not included in your humira carton). see the “how should i throw away (dispose of) the used prefilled syringes and needles?” section at the end of this instructions for use. if more comfortable, take your humira prefilled syringe out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature. do not remove the needle cover while allowing it to reach room temperature. do not warm humira in any other way (for example, do not warm it in a microwave or in hot water). if you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist. the figure below shows what a prefilled syringe looks like. see figure a. figure a check the carton, dose tray, and prefilled syringe 1. make sure the name humira appears on the dose tray and prefilled syringe label. 2. do not use and do call your doctor or pharmacist if: - the seals on top or bottom of the carton are broken or missing. - the humira labeling has an expired date. check the expiration date on your humira carton and do not use if the date has passed. - the prefilled syringe has been frozen or left in direct sunlight. - humira has been kept at room temperature for longer than 14 days or humira has been stored above 77°f (25°c). - the liquid in the prefilled syringe is cloudy, discolored or has flakes or particles in it. make sure the liquid is clear and colorless. see the “how should i store humira?” section at the end of this instructions for use. choose the injection site 3. wash and dry your hands well. 4. choose an injection site on: - the front of your thighs or - your lower abdomen (belly). if you choose your abdomen, do not use the area 2 inches around your belly button (navel). see figure b. figure b - choose a different site each time you give yourself an injection. each new injection should be given at least one inch from a site you used before. - do not inject into skin that is: sore (tender) bruised red hard scarred or where you have stretch marks - sore (tender) - bruised - red - hard - scarred or where you have stretch marks - if you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. - do not inject through your clothes. prepare the injection site 5. wipe the injection site with an alcohol prep (swab) using a circular motion. 6. do not touch this area again before giving the injection. allow the skin to dry before injecting. do not fan or blow on the clean area. prepare the syringe and needle 7. check the fluid level in the syringe: - hold the syringe with the covered needle pointing down. see figure c. figure c - hold the syringe at eye level. look closely to make sure that the amount of liquid in the syringe is the same or close to the: 0.8 ml line for the 40 mg prefilled syringe. see figure d. 0.4 ml line for the 20 mg prefilled syringe. see figure d. 0.2 ml line for the 10 mg prefilled syringe. see figure d. - 0.8 ml line for the 40 mg prefilled syringe. see figure d. - 0.4 ml line for the 20 mg prefilled syringe. see figure d. - 0.2 ml line for the 10 mg prefilled syringe. see figure d. figure d 8. the top of the liquid may be curved. if the syringe does not have the correct amount of liquid, do not use that syringe . call your pharmacist. 9. remove the needle cover: - hold the syringe in one hand. with the other hand gently remove the needle cover. see figure e. - throw away the needle cover. figure e - do not touch the needle with your fingers or let the needle touch anything. 10. turn the syringe so the needle is facing up and hold the syringe at eye level with one hand so you can see the air in the syringe. using your other hand, slowly push the plunger in to push the air out through the needle. see figure f. figure f - you may see a drop of liquid at the end of the needle. this is normal. position the prefilled syringe and inject humira position the syringe 11. hold the body of the prefilled syringe in one hand between the thumb and index finger. hold the syringe in your hand like a pencil. see figure g. figure g - do not pull back on the plunger at any time. - with your other hand, gently squeeze the area of the cleaned skin and hold it firmly. see figure h. figure h inject humira 12. using a quick, dart-like motion, insert the needle into the squeezed skin at about a 45-degree angle . see figure i. figure i - after the needle is in, let go of the skin. pull back gently on the plunger. if blood appears in the syringe: - it means that you have entered a blood vessel. - do not inject humira. - pull the needle out of the skin while keeping the syringe at the same angle. - press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. see figure j. figure j - do not use the same syringe and needle again. throw away the needle and syringe in your sharps container. - do not rub the injection site. you may have slight bleeding. this is normal. - repeat steps 1 through 12 with a new prefilled syringe. if no blood appears in the syringe: - slowly push the plunger all the way in until all the liquid is injected and the syringe is empty. - pull the needle out of the skin while keeping the syringe at the same angle. - press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. do not rub the injection site. you may have slight bleeding. this is normal. 13. throw away the used prefilled syringe and needle in a sharps disposal container right away after use. see “how should i throw away ( dispose of ) used prefilled syringes and needles?” 14. keep a record of the dates and location of your injection sites. to help you remember when to take humira, you can mark your calendar ahead of time. how should i throw away ( dispose of ) used prefilled syringes and needles? - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. see figure k. do not throw away (dispose of) loose needles and syringes in your household trash.   - do not try to touch the needle. figure k - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: ○ made of a heavy-duty plastic, ○ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, ○ upright and stable during use, ○ leak-resistant, and ○ properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - for the safety and health of you and others, needles and used syringes must never be re-used. - the used alcohol pads, cotton balls, dose trays and packaging may be placed in your household trash. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - always keep the sharps container out of the reach of children. how should i store humira? - store humira in the refrigerator between 36ºf to 46ºf (2ºc to 8ºc). store humira in the original carton until use to protect it from light. - do not freeze humira. do not use humira if frozen, even if it has been thawed. - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or prefilled syringe. do not use humira after the expiration date. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. store humira in the original carton until use to protect it from light. - throw away humira if it has been kept at room temperature and not been used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not use a prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it. - do not drop or crush humira. the prefilled syringe is glass. - keep humira, injection supplies, and all other medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: abbvie inc. north chicago, il 60064, u.s.a. us license number 1889 20066947 revised: 02/2021  - liquid is cloudy, discolored, or has flakes or particles in it - expiration date has passed - liquid has been frozen (even if thawed) or left in direct sunlight - the prefilled syringe has been dropped or crushed - store humira in the refrigerator between 36°f to 46°f (2°c to 8°c). - store humira in the original carton until use to protect it from light. - do not freeze - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or prefilled syringe. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. - throw away humira if it has been kept at room temperature and not used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not remove the needle cover while allowing humira to reach room temperature - do not warm humira in any other way. for example, do not warm it in a microwave or in hot water. - do not use the prefilled syringe if liquid has been frozen (even if thawed) - 1 single-dose prefilled syringe and alcohol swab - 1 cotton ball or gauze pad (not included) - puncture-resistant sharps disposal container (not included). see step 9 at the end of this instructions for use for instructions on how to throw away (dispose of) your prefilled syringe - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - different from your last injection site - do not inject through clothes - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques - throw the needle cover away - do not touch the needle with your fingers or let the needle touch anything - hold the prefilled syringe at eye level with one hand so you can see the air in the prefilled syringe - using your other hand, slowly push the plunger in to push the air out through the needle. - you may see a drop of liquid at the end of the needle. this is normal. - after the needle is in, let go of the skin. - do not rub - slight bleeding at the injection site is normal - put your used needles, syringes, and sharps in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in the household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: ○ made of a heavy-duty plastic, ○ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, ○ upright and stable during use, ○ leak-resistant, and ○ properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - call your healthcare provider or 1-800-4humira (1-800-448-6472) or visit www.humira.com if you need help - call 1-800-4humira (1-800-448-6472) for a free fda-cleared sharps disposal container

Австралия - английски - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - ritonavir -

САЩ - английски - NLM (National Library of Medicine)

abbvie inc. - risankizumab (unii: 90zx3q3fr7) (risankizumab - unii:90zx3q3fr7) - skyrizi® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. skyrizi is indicated for the treatment of active psoriatic arthritis in adults. skyrizi is indicated for the treatment of moderately to severely active crohn's disease in adults. skyrizi is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients [see warnings and precautions ( 5.1 )]. pregnancy exposure registry there is a pregnancy exposure registry that monitors outcomes in women who become pregnant while treated with skyrizi. patients should be encouraged to enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com. risk summary available pharmacovigilance and clinical trial data with risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. although there are no data on risankizumab-rzaa, monoclonal antibodies can be actively transported across the placenta, and skyrizi may cause immunosuppression in the in utero- exposed infant. there are adverse pregnancy outcomes in women with inflammatory bowel disease (see clinical considerations) .  in an enhanced pre- and post-natal developmental toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of 5 or 50 mg/kg risankizumab-rzaa once weekly during the period of organogenesis up to parturition. increased fetal/infant loss was noted in pregnant monkeys at the 50 mg/kg dose (see data) . the 50 mg/kg dose in pregnant monkeys resulted in approximately 10 times the exposure (auc) in humans administered the 600 mg induction regimen and 39 times the exposure (auc) to the 360 mg maintenance doses, respectively. no risankizumab-rzaa-related effects on functional or immunological development were observed in infant monkeys from birth through 6 months of age. the clinical significance of these findings for humans is unknown.  all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations  disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions transport of endogenous igg antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. because risankizumab may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to skyrizi in utero. there are insufficient data regarding infant serum levels of risankizumab at birth and the duration of persistence of risankizumab in infant serum after birth. although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, a minimum of 5 months after birth should be considered because of the half-life of the product. data animal data an enhanced pre- and post-natal developmental toxicity study was conducted in cynomolgus monkeys. pregnant cynomolgus monkeys were administered weekly subcutaneous doses of risankizumab-rzaa of 5 or 50 mg/kg from gestation day 20 to parturition, and the cynomolgus monkeys (mother and infants) were monitored for 6 months after delivery. no maternal toxicity was noted in this study. there were no treatment-related effects on growth and development, malformations, developmental immunotoxicology, or neurobehavioral development. however, a dose-dependent increase in fetal/infant loss was noted in the risankizumab-rzaa-treated groups (32% and 43% in the 5 mg/kg and 50 mg/kg groups, respectively) compared with the vehicle control group (19%). the increased fetal/infant loss in the 50 mg/kg group was considered to be related to risankizumab-rzaa treatment. the no observed adverse effect level (noael) for maternal toxicity was identified as 50 mg/kg and the noael for developmental toxicity was identified as 5 mg/kg. on an exposure (auc) basis, the 5 mg/kg dose in pregnant monkeys resulted in approximately 1.24 times the exposure in humans administered the 600 mg induction regimen and 5 times the exposure in humans administered the 360 mg maintenance doses, respectively. in the infants, mean serum concentrations increased in a dose-dependent manner and were approximately 17%-86% of the respective maternal concentrations. following delivery, most adult female cynomolgus monkeys and all infants from the risankizumab-rzaa-treated groups had measurable serum concentrations of risankizumab-rzaa up to 91 days postpartum. serum concentrations were below detectable levels at 180 days postpartum. risk summary there are no data on the presence of risankizumab-rzaa in human milk, the effects on the breastfed infant, or the effects on milk production. endogenous maternal igg and monoclonal antibodies are transferred in human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to risankizumab-rzaa are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for skyrizi and any potential adverse effects on the breastfed infant from skyrizi or from the underlying maternal condition. the safety and effectiveness of skyrizi have not been established in pediatric patients. of the 2234 subjects with plaque psoriasis exposed to skyrizi, 243 subjects were 65 years or older and 24 subjects were 75 years or older. no overall differences in skyrizi exposure, safety, or effectiveness were observed between older and younger subjects who received skyrizi. however, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects. clinical studies of skyrizi for the treatment of crohn’s disease did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects. no clinically meaningful differences in the pharmacokinetics of risankizumab-rzaa were observed in geriatric subjects compared to younger adult subjects with crohn’s disease [see clinical pharmacology ( 12.3 )] . i nstructions for use skyrizi ® (sky-rizz-ee) pen (risankizumab-rzaa) injection, for subcutaneous use read before first use refer to the medication guide for product information. read this instructions for use before using skyrizi pen (risankizumab-rzaa) injection. before using skyrizi, you should receive training from your healthcare provider on how to inject skyrizi. skyrizi single-dose pen    important information - store skyrizi in the refrigerator at 36°f to 46°f (2°c to 8°c). - keep skyrizi in the original carton to protect from light until you are ready to use. - before injecting, take the skyrizi carton out of the refrigerator. leave the carton at room temperature and out of direct sunlight for 30 to 90 minutes. - the liquid in the inspection window should look clear to yellow and may contain tiny white or clear particles. - do not use skyrizi if the liquid is cloudy or contains flakes or large particles . - do not use skyrizi if the expiration date (exp) has passed. - do not use skyrizi if the liquid has been frozen, even if it has been thawed. - do not shake skyrizi. - do not use if the skyrizi pen has been dropped or damaged.   - do not use skyrizi if carton perforations are broken. return product to pharmacy. - do not remove the dark gray cap until right before injection. - skyrizi is not made with natural rubber latex. - do not remove the pen from the carton while allowing skyrizi to reach room temperature. - do not warm skyrizi in any other way. for example, do not warm it in a microwave or in hot water. - do not use the pen if the liquid has been frozen, even if it has been thawed. - 1 single-dose skyrizi pen (included) - 1 alcohol swab (not included) - 1 cotton ball or gauze pad (not included) - fda-cleared sharps disposal container (not included). see “used skyrizi prefilled pen disposal ”  for information on how to throw away (dispose of) used pens. - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - do not touch or blow on the injection site after it is cleaned. allow the skin to dry before injecting.  - do not inject through clothes. - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis. - pull the dark gray cap straight off. - throw  the dark gray cap away. - it is normal to see 1 or more bubbles in the liquid.  - the liquid should look clear to yellow and may contain tiny white or clear particles. - do not use if the liquid is  cloudy or contains flakes or large particles. - the pen will activate only if the white needle sleeve is pressed down against the injection site before pressing the green activator button. - the first loud “click” means the start of the injection. - the pen has made a second “click” or - the yellow indicator has filled the inspection window - do not rub the injection site. - slight bleeding at the injection site is normal. important information - store skyrizi in the refrigerator at 36°f to 46°f (2°c to 8°c). - keep skyrizi in the original carton to protect from light until you are ready to use. - before injecting , take the skyrizi carton out of the refrigerator. leave the carton at room temperature and out of direct sunlight for 30 to 90 minutes . - the liquid in the inspection window should look clear to yellow and may contain tiny white or clear particles. - do not use skyrizi if the liquid is cloudy or contains flakes or large particles . - do not use skyrizi if the expiration date (exp) has passed. - do not use skyrizi if the liquid has been frozen , even if it has been thawed. - do not shake skyrizi. - do not use if the skyrizi pen has been dropped or damaged . - do not use skyrizi if carton perforations are broken. return product to pharmacy . - do not remove the dark gray cap until right before injection. - skyrizi is not made with natural rubber latex. keep the skyrizi pen and sharps disposal container out of the reach of children. call your healthcare provider or (866) skyrizi or (866) 759-7494  if you need help or do not know how to proceed. questions about using the skyrizi pen q.       what if i need help on how to inject skyrizi? a.       call your healthcare provider or (866) skyrizi or (866) 759-7494   if you need help. q.       i have removed the dark gray cap and pressed the green activator button. why isn’t my injection starting? a.       the green activator button will not start the injection unless the white needle sleeve is pressed firmly against the injection site. q.       how do i know when the injection is complete? a.       the injection is complete if the pen makes a second “click” or the yellow indicator fills the inspection window. this takes up to 15 seconds. q.       what should i do if there are more than a few drops of liquid on the injection site? a.       call (866) skyrizi or (866) 759-7494 for help. q.       what should i do with the used pen after my injection? a.       dispose of the used pen in a sharps disposal container right after use. do not dispose of the used pen in your household trash. you can sign up to receive sharps containers for skyrizi pen disposal at no additional cost by going to www. skyrizi .com or calling (866) skyrizi or (866) 759-7494 . call (866) skyrizi or (866) 759-7494 or go to www. skyrizi .com for help with your injection. keep the skyrizi pen and sharps disposal container out of the reach of children. call your healthcare provider or (866) skyrizi or (866) 759-7494 if you need help or have questions about the use of skyrizi. used skyrizi prefilled pen disposal if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used pens. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: www.fda.gov/safesharpsdisposal. do not recycle your used sharps disposal container. manufactured by: abbvie inc., north chicago, il 60064, u.s.a. us license number 1889 skyrizi® is a registered trademark of abbvie biotechnology ltd. © 2019-2022 abbvie inc. 20071035  this instructions for use has been approved by the u.s. food and drug administration. revised: 01/2022 instructions for use skyrizi ® (sky-rizz-ee) (risankizumab-rzaa) injection, for subcutaneous use 150 mg/ml prefilled syringe read before first use refer to the medication guide for product information. skyrizi single-dose prefilled syringe important information - keep skyrizi in the original carton to protect from light until time to use. - the liquid should look clear to yellow and may contain tiny white or clear particles. - do not use skyrizi if the liquid is cloudy or contains flakes or large particles . - do not use skyrizi if the expiration date (exp:) shown on the carton and prefilled syringe has passed. - do not use skyrizi if the liquid has been frozen (even if thawed). - do not shake skyrizi. - do not use skyrizi if the prefilled syringe has been dropped or damaged . - do not use skyrizi if carton perforations are broken . return product to the pharmacy . - do not remove the needle cover until right before giving the injection. keep skyrizi and all medicines out of the reach of children. please read complete instructions for use before using skyrizi prefilled syringe before injecting - receive training on how to inject skyrizi before giving injection. call your healthcare provider or (866) skyrizi or (866) 759-7494 if you need help. - mark your calendar ahead of time to remember when to take skyrizi. - leave the carton at room temperature and out of direct sunlight for 15 to 30 minutes to warm. do not remove the syringe from the carton while allowing skyrizi to reach room temperature. do not warm skyrizi in any other way (for example, do not warm it in a microwave or in hot water). - do not remove the syringe from the carton while allowing skyrizi to reach room temperature. - do not warm skyrizi in any other way (for example, do not warm it in a microwave or in hot water). important information - the liquid should look clear to yellow and may contain tiny white or clear particles. - do not use skyrizi if the liquid is cloudy or contains flakes or large particles . - do not use skyrizi if the expiration date (exp:) shown on the carton and prefilled syringe has passed. - do not use skyrizi if the syringe has been dropped or damaged . - do not use skyrizi if carton perforations are broken . return product to the pharmacy . storage information - store skyrizi in the refrigerator between 36°f to 46°f (2°c to 8°c). - do not shake skyrizi. - keep skyrizi in the original carton to protect from light until time to use. - skyrizi is not made with natural rubber latex. - do not use if the liquid has been frozen (even if thawed). keep skyrizi and all medicines out of the reach of children. call your healthcare provider or (866) skyrizi or (866) 759-7494 if you need help or do not know how to proceed. - do not hold or pull the plunger rod when removing the prefilled syringe from the sleeve. - 1 prefilled syringe (included) - 1 alcohol swab   (not included)  - 1 cotton ball or gauze pad (not included)  - fda-cleared sharps disposal container  (not included). see “used skyrizi prefilled syringe disposal ” for information on how to throw away (dispose of) used prefilled syringes. - front of left thigh or right thigh - your abdomen (belly) at least 2 inches from your navel (belly button) - do not touch or blow on the injection site after it is cleaned. allow the skin to dry before injecting. - do not inject through clothes. - do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks, or into areas affected by psoriasis. - it is normal to see 1 or more bubbles in the window. - the liquid should look clear to yellow and may contain tiny white or clear particles. - do not use the prefilled syringe if the liquid is cloudy or contains flakes or large particles . - hold the prefilled syringe in 1 hand between the finger grip and needle cover. - with the other hand, gently pull the needle cover straight off. - do not hold or pull the plunger rod when removing the needle cover. - you may see a drop of liquid at the end of the needle. this is normal. - throw away the needle cover. - do not touch the needle with your fingers or let the needle touch anything. - press a cotton ball or gauze pad over the injection site and hold for 10 seconds. - do not rub the injection site. you may have slight bleeding. this is normal. - do not throw away (dispose of) the used prefilled syringe in the household trash. questions about using skyrizi used skyrizi prefilled syringe disposal if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: www.fda.gov/safesharpsdisposal. do not recycle your used sharps disposal container. manufactured by: abbvie inc., north chicago, il 60064, u.s.a. us license number 1889 skyrizi® is a registered trademark of abbvie biotechnology ltd. © 2019-2022 abbvie inc. 20071033 r1 this instructions for use has been approved by the u.s. food and drug administration. revised: 03/2022  instructions for use skyrizi ® (sky-rizz-ee) (risankizumab-rzaa) injection, for subcutaneous use 2 x 90 mg/ml single-dose prefilled syringes for a total 180 mg/2 ml dose read before first use refer to the medication guide for product information. skyrizi single-dose prefilled syringe keep skyrizi and all medicines out of the reach of children. important information: - keep skyrizi in the original carton to protect from light until time to use. - the liquid should look clear to slightly yellow and may contain tiny white or clear particles. - do not use skyrizi if the liquid is discolored , cloudy or contains flakes or large particles . return product to pharmacy. - do not use skyrizi if the expiration date (exp:) shown on the carton and prefilled syringe has passed. return product to pharmacy. - do not use skyrizi if the liquid has been frozen (even if thawed). - do not shake the syringe. - do not use skyrizi if the prefilled syringe has been dropped or damaged . return product to pharmacy. - do not use skyrizi if carton perforations are broken . return product to the pharmacy . - do not remove the needle cover until right before giving the injections. - skyrizi is not made with natural rubber latex. please read complete instructions for use before using skyrizi prefilled syringe before injecting: - receive training on how to inject skyrizi before giving injections. call your healthcare provider or (866)  skyrizi  or (866) 759-7494 if you need help. - mark your calendar ahead of time to remember when to take skyrizi. - leave the carton at room temperature and out of direct sunlight for 15 to 30 minutes to warm. do not remove the prefilled syringes from the carton while allowing skyrizi to reach room temperature. do not warm skyrizi in any other way (for example, do not warm it in a microwave or in hot water). - do not remove the prefilled syringes from the carton while allowing skyrizi to reach room temperature. - do not warm skyrizi in any other way (for example, do not warm it in a microwave or in hot water). important  information : - the liquid should look clear to slightly yellow and may contain tiny white or clear particles. - do not use skyrizi if the liquid is discolored , cloudy or contains flakes  or large  particles . return  product to pharmacy. - do not use skyrizi if the expiration  date  (exp:) shown on the carton and prefilled syringe has passed. return  product to pharmacy. - do  not use skyrizi if the prefilled syringe has been dropped  or  damaged . return  product to pharmacy. - do  not use skyrizi if carton perforations are broken . return  product to pharmacy. storage information: - store skyrizi in the refrigerator between 36°f to 46°f (2°c to 8°c). - do not shake skyrizi. - keep skyrizi in the original carton to protect from light until time to use. - skyrizi is not made with natural rubber latex. - do not use if liquid has been frozen (even if thawed). keep skyrizi and all medicines out of the reach of children. call your healthcare provider or (866)  skyrizi or (866) 759-7494 if you need help or do not know how to proceed. - 2 prefilled syringes - 2 alcohol swabs and 2 cotton balls or gauze pads (not included) - fda-cleared sharps disposal container (not included) see “used skyrizi prefilled syringe disposal ”  for information on how to throw away (dispose of) used prefilled syringes. - front of left thigh or right thigh - your abdomen (belly) at least 2 inches from your navel (belly button) - do not touch or blow on the injection site after it is cleaned. allow the skin to dry before injecting. - do not inject through clothes. - do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks. - it is normal to see one or more bubbles in the window. - the liquid should look clear to slightly yellow and may contain tiny white or clear particles. - do not use the prefilled syringe if liquid is discolored , cloudy or contains flakes or large particles . - do not hold or pull plunger rod when removing the needle cover. - hold the syringe in 1 hand between the finger grip and needle cover. - with the other hand, carefully pull the needle cover straight off. - you may see a drop of liquid at the end of the needle. this is normal. - throw away the needle cover. - do not touch the needle with your fingers or let the needle touch anything. - allow the prefilled syringe to move up until the entire needle is covered by the needle guard. - press a cotton ball or gauze pad over the injection site and hold for 10 seconds. - do not rub the injection site. you may have slight bleeding. this is normal. - use the 2nd prefilled syringe right after using the 1st syringe. - do not throw away (dispose of) used prefilled syringes in the household trash. questions about using the skyrizi syringe q.  what if i have not received in-person training from a healthcare professional? a. call your healthcare provider or (866) skyrizi or (866) 759-7494 if you need help. receive training on how to inject skyrizi before giving injections. q. what should i do with both used prefilled syringes after my injections? a. throw away (dispose of) both used prefilled syringes in a sharps disposal container. do not put in household trash. for more information, see “used skyrizi prefilled syringe disposal ” section. you can sign up to receive sharps containers for skyrizi prefilled syringe disposal at no additional cost by going to www.skyrizi.com or calling (866) 759-7494 q. how do i know when the injection is complete? a. the injection is complete when the prefilled syringe is empty, the plunger rod is pushed all the way in, and the syringe needle guard is activated. used skyrizi prefilled syringe disposal throw away (dispose of) both used prefilled syringes in a sharps disposal container. do not put in household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that: - is made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - stays upright and stable during use, - is leak-resistant, and - has been properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: www.fda.gov/safesharpsdisposal. do not recycle your used sharps disposal container. manufactured by: abbvie inc., north chicago, il 60064, u.s.a. us license number 1889 skyrizi® is a trademark of abbvie biotechnology ltd. © 2019-2024 abbvie inc. 20078139 this instructions for use have been approved by the u.s. food and drug administration. revised: 3/2024 instructions for use skyrizi ® (sky-rizz-ee) (risankizumab-rzaa) injection, for subcutaneous use 4 x 90 mg/ml single-dose prefilled syringes for a total 360 mg/4 ml dose read before first use refer to the medication guide for product information. skyrizi single-dose prefilled syringe keep skyrizi and all medicines out of the reach of children. important information: - keep skyrizi in the original carton to protect from light until time to use. - the liquid should look clear to slightly yellow and may contain tiny white or clear particles. - do not use skyrizi if the liquid is discolored , cloudy or contains flakes or large particles . return product to pharmacy. - do not use skyrizi if the expiration date (exp:) shown on the carton and prefilled syringe has passed. return product to pharmacy. - do not use skyrizi if the liquid has been frozen (even if thawed). - do not shake the syringe. - do not use skyrizi if the prefilled syringe has been dropped or damaged . return product to pharmacy. - do not use skyrizi if carton perforations are broken . return product to the pharmacy . - do not remove the needle cover until right before giving the injections. - skyrizi is not made with natural rubber latex. please read complete instructions for use before using skyrizi prefilled syringe before injecting: - receive training on how to inject skyrizi before giving injections. call your healthcare provider or (866)  skyrizi  or (866) 759-7494 if you need help. - mark your calendar ahead of time to remember when to take skyrizi. - leave the carton at room temperature and out of direct sunlight for 15 to 30 minutes to warm. do not remove the prefilled syringes from the carton while allowing skyrizi to reach room temperature. do not warm skyrizi in any other way (for example, do not warm it in a microwave or in hot water). - do not remove the prefilled syringes from the carton while allowing skyrizi to reach room temperature. - do not warm skyrizi in any other way (for example, do not warm it in a microwave or in hot water). important  information : - the liquid should look clear to slightly yellow and may contain tiny white or clear particles. - do not use skyrizi if the liquid is discolored , cloudy or contains flakes  or large  particles . return  product to pharmacy. - do not use skyrizi if the expiration  date  (exp:) shown on the carton and prefilled syringe has passed. return  product to pharmacy. - do  not use skyrizi if the prefilled syringe has been dropped  or  damaged . return  product to pharmacy. - do  not use skyrizi if carton perforations are broken . return  product to pharmacy. storage information: - store skyrizi in the refrigerator between 36°f to 46°f (2°c to 8°c). - do not shake skyrizi. - keep skyrizi in the original carton to protect from light until time to use. - skyrizi is not made with natural rubber latex. - do not use if liquid has been frozen (even if thawed). keep skyrizi and all medicines out of the reach of children. call your healthcare provider or (866)  skyrizi or (866) 759-7494 if you need help or do not know how to proceed. - 4 prefilled syringes - 4 alcohol swabs and 4 cotton balls or gauze pads (not included) - fda-cleared sharps disposal container (not included) see “used skyrizi prefilled syringe disposal ”  for information on how to throw away (dispose of) used prefilled syringes. - front of left thigh or right thigh - your abdomen (belly) at least 2 inches from your navel (belly button) - do not touch or blow on the injection site after it is cleaned. allow the skin to dry before injecting. - do not inject through clothes. - do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks. - it is normal to see one or more bubbles in the window. - the liquid should look clear to slightly yellow and may contain tiny white or clear particles. - do not use the prefilled syringe if liquid is discolored , cloudy or contains flakes or large  particles . - do not hold or pull plunger rod when removing the needle cover. - hold the syringe in 1 hand between the finger grip and needle cover. - with the other hand, carefully pull the needle cover straight off. - you may see a drop of liquid at the end of the needle. this is normal. - throw away the needle cover. - do not touch the needle with your fingers or let the needle touch anything. - allow the prefilled syringe to move up until the entire needle is covered by the needle guard. - press a cotton ball or gauze pad over the injection site and hold for 10 seconds. - do not rub the injection site. you may have slight bleeding. this is normal. - use the 2nd, 3rd, and 4th prefilled syringe right after using the 1st syringe. - do not throw away (dispose of) used prefilled syringes in the household trash. questions about using the skyrizi syringe q.  what if i have not received in-person training from a healthcare professional? a. call your healthcare provider or (866) skyrizi or (866) 759-7494 if you need help. receive training on how to inject skyrizi before giving injections. q. what should i do with all four used prefilled syringes after my injections? a. throw away (dispose of) all 4 used prefilled syringes in a sharps disposal container. do not put in household trash. for more information, see “used skyrizi prefilled syringe disposal” section. you can sign up to receive sharps containers for skyrizi prefilled syringe disposal at no additional cost by going to www.skyrizi.com or calling (866) 759-7494 q. how do i know when the injection is complete? a. the injection is complete when the prefilled syringe is empty, the plunger rod is pushed all the way in, and the syringe needle guard is activated. used skyrizi prefilled syringe disposal throw away (dispose of) all four used prefilled syringes in a sharps disposal container. do not put in household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that: - is made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - stays upright and stable during use, - is leak-resistant, and - has been properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: www.fda.gov/safesharpsdisposal. do not recycle your used sharps disposal container. manufactured by: abbvie inc., north chicago, il 60064, u.s.a. us license number 1889 skyrizi® is a trademark of abbvie biotechnology ltd. © 2019-2024 abbvie inc. 20078144 this instructions for use have been approved by the u.s. food and drug administration. revised: 3/2024 instructions for use skyrizi ® (sky-rizz-ee)  on-body injector risankizumab-rzaa injection, for subcutaneous use only on-body injector and 180 mg/1.2 ml prefilled cartridge, on-body injector and 360 mg/2.4 ml prefilled cartridge read this instructions for use before you start using skyrizi and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. refer to the medication guide for skyrizi product information. call your healthcare provider, call (866) skyrizi or (866) 759-7494 or go to skyrizi.com  if you need help. important information you need to know before injecting skyrizi - receive training on how to inject skyrizi before giving an injection. - do not shake the skyrizi carton, on-body injector or prefilled cartridge. - do not remove the on-body injector or prefilled cartridge from the carton until you are ready to inject. - inject the medicine within 5 minutes after loading the cleaned prefilled cartridge into the on-body injector. waiting will dry out the medicine and the on-body injector will not work afterwards. - do not touch the start button until you place the on-body injector loaded with the prefilled cartridge onto your skin and are ready to inject. ◦ you can only press the start button 1-time. - do not use on-body injector or prefilled cartridge if either has been dropped or damaged. - do not reuse on-body injector or prefilled cartridge. the on-body injector and prefilled cartridge are for 1-time (single-dose) use only. - do not let the on-body injector get wet with water or any other liquids. - this single-dose on-body injector is designed for use with skyrizi prefilled cartridge only. - physical activity should be limited during the injection process. moderate physical activities can be done, such as walking, reaching and bending. - do not use skyrizi if the expiration date (exp:) has passed. - do not use the prefilled cartridge if the liquid is cloudy or contains flakes or large particles. the liquid should look clear to yellow and may contain tiny white or clear particles.  - the on-body injector and the prefilled cartridge are not made with natural rubber latex. - keep skyrizi and all medicines out of the reach of children. storage and preparation for use - keep skyrizi in the original carton to protect from light and physical damage until time to use. - store skyrizi in your refrigerator between 36°f to 46°f (2°c to 8°c). - when ready to use, take the carton out of the refrigerator and leave it at room temperature for at least 45 minutes up to 90 minutes  to allow skyrizi to warm. - do not leave out in direct sunlight. - do not remove the on-body injector or prefilled cartridge from the carton while allowing skyrizi to reach room temperature. - do not warm skyrizi in any other way. for example, do not warm it in a microwave or in hot water. - do not use if liquid has been frozen (even if thawed). - do not use skyrizi if carton perforations are broken. return product to the pharmacy.  - do not use the on-body injector and prefilled cartridge if the white paper tray seal is missing or damaged and return the carton to the pharmacy. get to know your skyrizi on-body injector and prefilled cartridge please read complete instructions for use before using skyrizi. call your healthcare provider or (866) skyrizi or (866) 759-7494 or go to www.skyrizi.com if you need help or if you do not know how to proceed. - remove the carton  from the refrigerator. - check expiration date (exp:) on the carton. - do not use skyrizi if the expiration date (exp:)  has passed. - leave unopened carton at room temperature to warm. - keep out of direct sunlight. - wait at least 45 minutes up to a maximum of 90 minutes  to allow skyrizi to warm. - do not warm skyrizi in any other way (for example, do not warm it in a microwave or in hot water). - lift up  the flap on the side of the carton. - take out  the plastic tray. - place the following on a clean surface: ◦ plastic tray containing the on-body injector and prefilled cartridge (included) ◦ 2 alcohol wipes (not included) ◦ cotton ball or gauze pad (not included) ◦ sharps disposal container (not included) (see “disposing of skyrizi”) - wash and dry your hands. - locate  the black arrow. - peel away  the white paper tray seal from the plastic tray. - do not use the on-body injector and prefilled cartridge if the white paper tray seal is missing or damaged and return the carton to the pharmacy.  - locate  the  rounded opening on the top cover. - insert your pointer finger in the opening and place your thumb on the opposite side. - lift the cover  to remove and set aside. - check  that the on-body injector is intact and undamaged. - do not close the gray door before the prefilled cartridge is loaded. - the gray door should be slightly open. - if the gray door does not open, press in firmly  on the gray door ridges (left side of door) and swing open the door. - do not use on-body injector if you drop it, discover missing pieces, or it is damaged. - do not let the on-body injector get wet with water or any other liquids. - do not touch the needle cover or the needle. - proceed to set up on-body injector. - swing the gray door  all the way to the right to open it. - if the gray door does not open, press in firmly  on the gray door ridges (left side of door) and swing open the door. - do not close the gray door before the prefilled cartridge is loaded. - do not touch the needle cover or needle. - put the on-body injector aside. - carefully remove the prefilled cartridge from the plastic tray. - do not twist or remove cartridge top. - check the prefilled cartridge to make sure: ◦ the expiration date  (exp:)  has not passed. ◦ the liquid should look clear to yellow and may contain tiny white or clear particles. it is normal to see one or more bubbles. ◦ the prefilled cartridge parts appear intact, and the clear plastic is not cracked or broken. - do not use if the expiration date  (exp:)  has passed. - do not use if the liquid is cloudy, discolored, or contains flakes or large particles. - do not use if the liquid has been frozen  (even if thawed). - do not use the prefilled cartridge if you drop it, discover missing pieces, or it is damaged. - locate  the smaller bottom tip of the prefilled cartridge. - clean the smaller bottom tip of the prefilled cartridge with an alcohol wipe. make sure to use the alcohol wipe to clean the center of the smaller bottom tip  of the prefilled cartridge. - do not touch the smaller bottom tip of the prefilled cartridge after cleaning. - do not twist or remove the prefilled cartridge top. - insert the  smaller bottom tip of the prefilled cartridge into the on-body injector first. - firmly push down on the prefilled cartridge top until you hear a “click”.  - after loading the prefilled cartridge, you may see a few drops of medicine on the back of the on-body injector. this is normal. - make sure that you start the injection within 5 minutes after inserting the prefilled cartridge into the on-body injector. waiting will dry out the medicine. - swing the gray door to the left, then squeeze firmly  and listen for the gray door to "snap" shut. - the gray door should stay locked after loading the prefilled cartridge. - do not close the gray door if the prefilled cartridge is not fully inserted or is missing. - proceed without delay to prepare to inject - your abdomen  (belly) at least 2 inches from your navel (belly button). - the front of your left thigh or your right thigh. - do not inject into areas of the skin  that naturally fold or bulge  because the on-body injector could fall off during wear. - do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks, moles or excessive hair. you can trim the excessive hair from the injection area. - clean  injection area with an alcohol wipe. - allow the injection area to completely dry. - do not touch cleaned injection area before placing the on-body injector on the skin. - turn the on-body injector over  to find both green pull tabs. - peel  away the large section  using the green pull tab to expose the adhesive. - peel  away the small section  using the green pull tab to expose the adhesive. this will remove the clear plastic strip, activating the on-body injector. - do not pull the adhesive material off the on-body injector or allow the sticky side to fold and stick to itself. - check the status light  when the on-body injector beeps. - the status light will flash blue  when the on-body injector is activated. - if the status light does not flash blue, call (866) skyrizi or (866) 759-7494. - do not press the gray start button yet. - do not touch the needle cover or the needle. - for the abdomen  (belly), move and hold the skin to create a firm, flat surface for injection at least 2 inches from your navel  (belly button). make sure to adjust your posture (sit up straight) to avoid skin folds and bulges. - you do not need to pull the skin flat for the front of left thigh or right thigh. - make sure to position the on-body injector so that you can see the blue status light. - when the blue light flashes, the on-body injector is ready. place  the on-body injector onto the cleaned skin with the status light visible. - do not place the on-body injector on clothes. only place on bare skin. - run your finger around the adhesive material to secure it. make sure all of the adhesive is attached to your skin. - do not move or adjust the on-body injector after it has been placed on your skin. - when the on-body injector is on your skin, proceed to inject medicine - firmly press  the gray start button until you hear a click. then release the gray start button. - do not touch the gray start button until you place the on-body injector loaded with the prefilled cartridge onto your skin and are ready to inject. you can only press the start button 1 time. - you may feel a needle pinch. - check the status light  when the on-body injector beeps. - after starting the injection, the status light will continuously flash green. - you will hear pumping  sounds as the on-body injector delivers the medicine. - do not continue to use the on-body injector if status light flashes red and beeps. carefully remove from skin if the status light flashes red. call (866) skyrizi or (866) 759-7494. - it may take up to 5 minutes  to complete full dose of medicine. the on-body injector will automatically stop when the injection is finished. - do not continue to use the on-body injector if the status light flashes red and beeps. carefully remove it from the skin if the status light flashes red and beeps. call (866) skyrizi or (866) 759-7494. - the on-body injector will stop on its own. - after the injection is finished, you will hear beeps and the status light will change to solid green. check the status light. if it has changed to solid green, this means that the injection is finished. - when the injection is finished, proceed to next step. - do not   put your fingers on the back side of the on-body injector when removing it from your skin. - when the injection is done, grab the corner of the adhesive to carefully peel the on-body injector from the skin. - after removing the on-body injector, you will hear several beeps  and the status light will turn off. - the needle cover will cover the needle when the on-body injector is removed from the skin. - it is normal to see a few small drops of liquid on your skin after removing the on-body injector. if you see more than a few small drops of liquid left on your skin, call (866) skyrizi or (866) 759-7494. - press a cotton ball or gauze pad over the injection site on your skin and hold for 10 seconds. - do not rub the injection site. - slight bleeding at the injection site is normal. - proceed to confirm and dispose - inspect the medicine window and status light. - check to see that the used white plunger fills the medicine window and the solid green light turns off, letting you know that all the medicine has been injected. - leave the prefilled cartridge in the on-body injector. - do not throw away (dispose of) the used on-body injector in your household trash. - for more information, see “disposing of skyrizi” section. please read complete instructions for use before using skyrizi. call your healthcare provider or (866) skyrizi or (866) 759-7494 or go to www.skyrizi.com if you need help or if you do not know how to proceed. commonly asked questions   q.   what if i cannot open the on-body injector door to insert the prefilled cartridge? a.   to open the on-body injector door, press in firmly on the left side of the door to release the door latch. if you are still unable to open the door, call (866) skyrizi or (866) 759-7494. q.   what if i push the gray start button before i place the on-body injector on my skin? a. the gray start button may be pressed just 1 time only. if the gray start button is pressed before placing it on your body, it can no longer be used. call (866) skyrizi or (866) 759-7494. q. what if the on-body injector does not beep and the blue status light does not flash when i remove the green pull tabs? a. peeling off small green pull tab will remove the clear plastic strip, activating the on-body injector. if all of the adhesive paper has been removed and the on-body injector still does not turn on, call (866) skyrizi or (866) 759-7494. q. what if i push the start button as instructed after placing the on-body injector on the skin and the light remains blue? a.   firmly press the gray start button again. if the status light remains blue or flashes red, remove the on-body injector by carefully peeling it away from your skin. do not re-apply the on-body injector. call (866) skyrizi or (866) 759-7494. q.     what if the status light flashes red and beeps while wearing the on-body injector? a.   if the status light continuously flashes red and beeps, do not use the on-body injector. if it is attached to your body, carefully remove it. call (866) skyrizi or (866) 759-7494. q.     what should i do if the on-body injector comes off my body during the injection? a.   the loaded on-body injector can no longer be used. do not re-apply it to your body. call (866) skyrizi or (866) 759-7494. q.     how do i know when the injection is complete? a.   the injection is complete when the on-body injector beeps, the white plunger has completely filled the medicine window, and the status light turns from flashing green to solid green. q.    what should i do if there are more than a few drops of liquid on the injection area? a.   call (866) skyrizi or (866) 759-7494  for help. q. what should i do with the used on-body injector after my injection? a.   throw away (dispose of) used on-body injector in a fda-cleared sharps disposal container and not your household trash. you can receive a sharps container for skyrizi disposal at no additional cost by going to www.skyrizi.com or by calling (866) skyrizi or (866) 759-7494. q.     what if i have not received in-person training from a healthcare professional? a.   call your healthcare provider or (866) skyrizi or (866) 759-7494 if you need help. disposing of skyrizi - put skyrizi in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) skyrizi in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: ◦ made of a heavy-duty plastic, ◦ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, ◦ upright and stable during use, ◦ leak-resistant, and ◦ properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal in the state that you live in, go to the fda’s website at: www.fda.gov/safesharpsdisposal. do not recycle your used sharps disposal container. additional information ● type bf applied part. ● on-body injector sterilized using ethylene oxide. ● altitude range is -1,312 feet to 10,499 feet (-400 meters to 3,200 meters). electromagnetic compatibility (emc) of the on-body injector the on-body injector is intended for home use or use in a professional healthcare environment and complies with iso 11608-1:2014 and iec 60601-1-2:2014. care should be taken to use the on-body injector within the following specific limits and environments to avoid adversely impacting the performance (missed or incomplete skyrizi dose). - keep electronic devices including cell phones at least 12 inches (30 cm) from the on-body injector until injection is complete. the potential impact of electronic interference is unknown when the on-body injector is operated within 12 inches (30 cm). - do not expose the on-body injector to magnetic resonance (mr) environment (e.g., mri). - if it is used adjacent to other electrical equipment, observe the on-body injector and other equipment to ensure it is operating normally. emissions electromagnetic immunity the enclosure port immunity to rf wireless communications equipment complies with iec 60601-1-2:2014.     glossary of symbols manufactured by: abbvie inc., north chicago, il 60064, u.s.a. us license number 1889 skyrizi® is a registered trademark of abbvie biotechnology ltd. ©2022 abbvie inc. this instructions for use has been approved by the u.s. food and drug administration. approved: 09/2022 20071101

Южна Африка - английски - South African Health Products Regulatory Authority (SAHPRA)

abbvie (pty) ltd - suspension - see ingredients - each 1 ml suspension contains prednisolone acetate 10 mg

Южна Африка - английски - South African Health Products Regulatory Authority (SAHPRA)

abbvie (pty) ltd - suspension - see ingredients - each 1 ml ophthalmic suspension contains fluorometholone 1,1 mg neomycin sulphate equivalent to 3,85 mg/ml neomycin

Южна Африка - английски - South African Health Products Regulatory Authority (SAHPRA)

abbvie (pty) ltd - drops - see ingredients - each 1 ml solution contains ofloxacine 3 mg

Южна Африка - английски - South African Health Products Regulatory Authority (SAHPRA)

abbvie (pty) ltd - solution - see ingredients - each 1,0 ml solution contains epinastine hydrochloride 0,5 mg

Южна Африка - английски - South African Health Products Regulatory Authority (SAHPRA)

abbvie (pty) ltd - solution - see ingredients - each 1,0 ml solution contains brimonidine tartrate 2,0 mg timolol maleate equivalent to timolol 5,0 mg

Южна Африка - английски - South African Health Products Regulatory Authority (SAHPRA)

abbvie (pty) ltd - eyedrops - see ingredients - each 1,0 ml solution contains bimatoprost 0,3 mg timolol maleate equivalent to timolol 5,0 mg

Южна Африка - английски - South African Health Products Regulatory Authority (SAHPRA)

abbvie (pty) ltd - eyedrops - see ingredients - each 1,0 ml solution contains benzalkonium chloride o 0,02 % m/v bimatoprost 0,1 mg