United States - English - NLM (National Library of Medicine)

united therapeutics corporation - dinutuximab (unii: 7sqy4zud30) (dinutuximab - unii:7sqy4zud30) - dinutuximab 3.5 mg in 1 ml - unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (gm-csf), interleukin-2 (il-2), and 13-cis-retinoic acid (ra), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see clinical studies (14)]. unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab. risk summary based on its mechanism of action, unituxin may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no studies in pregnant women and no reproductive studies in animals to inform the drug-associated risk. monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. risk summary there is no information available on the presence of dinutuximab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. however, human igg is present in human milk. because of the potential for serious adverse reactions in a breastfed infant, advise a nursing woman to discontinue breastfeeding during treatment with unituxin. contraception females unituxin may cause fetal harm [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of unituxin. the safety and effectiveness of unituxin as part of multi-agent, multimodality therapy have been established in pediatric patients with high-risk neuroblastoma based on results of an open-label, randomized (1:1) trial conducted in 226 patients aged 11 months to 15 years (median age 3.8 years) (study 1). prior to enrollment, patients achieved at least a partial response to prior first-line therapy for high-risk neuroblastoma consisting of induction combination chemotherapy, maximum feasible surgical resection, myeloablative consolidation chemotherapy followed by autologous stem cell transplant, and received radiation therapy to residual soft tissue disease. patients randomized to the unituxin/13-cis-retinoic acid (ra) arm (unituxin/ra) received up to 5 cycles of unituxin in combination with alternating cycles of granulocyte-macrophage colony-stimulating factor (gm-csf) and interleukin-2 (il-2) plus ra, followed by 1 cycle of ra alone. patients randomized to the ra arm received up to 6 cycles of ra monotherapy. study 1 demonstrated an improvement in event-free survival (efs) and overall survival (os) in patients in the unituxin/ra arm compared to those in the ra arm [see adverse reactions (6), clinical pharmacology (12), and clinical studies (14)] . juvenile animal toxicity data juvenile monkeys (13 to 18 months of age at study start) received dinutuximab daily via intravenous infusion for 4 consecutive days over five 28-day cycles at doses of 1, 3, or 10 mg/kg. monkeys also received morphine during infusion for pain management. at the high dose of 10 mg/kg (approximately equal to the 17.5 mg/m2 clinical dose), mild degeneration of nerve fibers in the brain (medulla oblongata) and moderate degeneration of nerve fibers in the spinal cord (cervical, thoracic, and lumbar) were present. mild neuronal and nerve fiber degeneration were also present in the dorsal root ganglia (cervical, thoracic, and lumbar). nerve fiber degeneration in the spinal cord and neuronal degeneration in dorsal root ganglia persisted 6 months after the end of dosing, though at lower severity. at the 10 mg/kg dose level, nerve conduction velocity (ncv) analysis showed motor and sensory ncv decreases of less than 10% compared to vehicle controls, starting on day 27 and continuing to day 83. sensory ncv decreases were still present at the end of the dosing period but were on a trend towards recovery 6 months after the end of dosing. the safety and effectiveness of unituxin in geriatric patients have not been established. unituxin has not been studied in patients with renal impairment. unituxin has not been studied in patients with hepatic impairment.

European Union - English - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - neuroblastoma - antineoplastic agents - unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (asct). it is administered in combination with granulocyte-macrophage colony-stimulating factor (gm-csf), interleukin-2 (il-2), and isotretinoin.

United States - English - 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

United States - English - NLM (National Library of Medicine)

united airlines - sodium monofluorophosphate (unii: c810jcz56q) (fluoride ion - unii:q80vpu408o) - fluoride ion 7.6 mg in 1 g - anticavity helps protect against cavities

United States - English - NLM (National Library of Medicine)

united laboratories inc. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - anti-microbial hand sanitizer - helps reduce bacteria that potentially can cause disease - helps prevent cross contamination by hand contact - recommended for repeated use

United States - English - NLM (National Library of Medicine)

unique biotech.,co.ltd - silicon dioxide (unii: etj7z6xbu4) (silicon dioxide - unii:etj7z6xbu4), .alpha.-tocopherol acetate (unii: 9e8x80d2l0) (.alpha.-tocopherol - unii:h4n855pnz1) - purpose: antibacterial and anticavity uses: - delivering all features including anti-plague, anti-septic & anti-bacterial properties, gingivitis, cavities reduction and mouth & gums.

United States - English - NLM (National Library of Medicine)

univet holdings limited - isopropyl alcohol (unii: nd2m416302) (isopropyl alcohol - unii:nd2m416302) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - risankizumab - solution for injection - risankizumab 75 mg / 0.83 ml - risankizumab - plaque psoriasisskyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who arecandidates for systemic therapy.psoriatic arthritisskyrizi, alone or in combination with methotrexate (mtx), is indicated for the treatment of activepsoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards).

United States - English - NLM (National Library of Medicine)

star valley research, llc dba united sanitizer - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - risankizumab - solution for injection - risankizumab 150 mg / 1 ml - risankizumab - plaque psoriasisskyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who arecandidates for systemic therapy.psoriatic arthritisskyrizi, alone or in combination with methotrexate (mtx), is indicated for the treatment of activepsoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards).