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

pharmaand gmbh - peginterferon alfa-2a (unii: q46947fe7k) (peginterferon alfa-2a - unii:q46947fe7k) - adult patients: pegasys, as part of a combination regimen with other hepatitis c virus (hcv) antiviral drugs, is indicated for the treatment of adults with chc and compensated liver disease. for information about the safe and effective use of other hcv antiviral drugs to be used in combination with pegasys, refer to their prescribing information. pegasys monotherapy is only indicated for the treatment of patients with chc and compensated liver disease if there are contraindications or significant intolerance to other hcv antiviral drugs. pediatric patients: pegasys in combination with ribavirin is indicated for the treatment of pediatric patients 5 years of age and older with chc and compensated liver disease. limitations of use : - pegasys alone or in combination with ribavirin without additional hcv antiviral drugs is not recommended for treatment of patients with chc who previously failed therapy with an interferon-alfa. - pegasys is not recommended for treatment of patients with chc who have had solid organ transplantation [see use in specific populations (8.8)] . adult patients: pegasys is indicated for the treatment of adults with hbeag-positive and hbeag-negative chb infection who have compensated liver disease and evidence of viral replication and liver inflammation. pediatric patients: pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic pediatric patients 3 years of age and older with evidence of viral replication and elevations in serum alanine aminotransferase (alt). pegasys is contraindicated in patients with: - known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, anaphylaxis, or stevens-johnson syndrome to alpha interferons, including pegasys, or any of its components. - autoimmune hepatitis - hepatic decompensation (child-pugh score greater than 6 [class b and c]) in cirrhotic patients before treatment - hepatic decompensation with child-pugh score greater than or equal to 6 in cirrhotic chc patients coinfected with hiv before treatment pegasys is contraindicated in neonates and infants because it contains benzyl alcohol. benzyl alcohol is associated with an increased incidence of neurologic and other complications which are sometimes fatal in neonates and infants. when pegasys is used in combination with other hcv antiviral drugs, the contraindications applicable to those agents are applicable to combination therapies. pegasys combination treatment with ribavirin is contraindicated in women who are pregnant and men whose female partners are pregnant [see warnings and precautions (5.1)and use in specific populations (8.1)]. refer to the prescribing information of the other hcv antiviral drugs, including ribavirin, for a list of their contraindications. pregnancy exposure registry – use with ribavirin a ribavirin pregnancy registry has been established to monitor maternal and fetal outcomes of pregnancies of female patients and female partners of male patients exposed to ribavirin during pregnancy or who become pregnant within 6 months following cessation of treatment with ribavirin. healthcare providers and patients are encouraged to report such cases by calling 1-800-593-2214. risk summary there are no adequate and well-controlled studies of pegasys in pregnant women to inform a drug-associated risk. based on animal reproduction studies, pegasys can cause fetal harm and should be assumed to have abortifacient potential. non-pegylated interferon alfa-2a treatment caused abortion when given to pregnant rhesus monkeys (see data). the background risk of major birth defects and miscarriage in the indicated population is 3% and 4-22%, respectively. in the u.s. general population, the estimated background risk for major birth defects and miscarriage in the clinically recognized pregnancies is 2-4% and 15-20%, respectively. pegasys combination treatment with ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant [see contraindications (4), warnings and precautions (5.1), and ribavirin labeling] . significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin [see ribavirin labeling]. data animal data – groups of 8 or 9 pregnant rhesus monkeys were given non-pegylated interferon alfa-2a by daily intramuscular injection over days 22 to 70 of gestation at doses of 1, 5 and 25 million iu/day. two, 3 and 6 monkeys aborted in the low, mid and high dose groups compared with 1 in the control group. maternal toxicity, characterized by transient body weight loss, was seen at all dose levels. there were too few remaining pregnancies to assess teratogenic potential but no developmental abnormalities were observed in surviving fetuses. there is no information regarding the presence of peginterferon alfa-2a in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for adverse reactions from the drugs in nursing infants, a decision must be made whether to discontinue nursing or discontinue pegasys. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for pegasys and any potential adverse effects on the breastfed child from pegasys or from the underlying maternal condition. the centers for disease control and prevention recommends that hiv-infected mothers not breastfeed their infants to avoid potential transmission of hiv; therefore, chc- and chb-infected mothers coinfected with hiv should not breastfeed their infants. pregnancy testing females of reproductive potential must undergo pregnancy testing before initiation of treatment with pegasys or with pegasys in combination with ribavirin or with other hcv drugs [see warnings and precautions (5.17)] . females of reproductive potential receiving pegasys in combination with ribavirin must have a routine pregnancy test performed monthly during treatment and for at least 6 months following treatment. female partners of male patients receiving pegasys in combination with ribavirin must have a routine pregnancy test performed monthly during treatment and for at least 6 months posttherapy [see warnings and precautions (5.17), ribavirin prescribing information] . contraception females because of the abortifacient potential of pegasys, females of reproductive potential should be advised to use effective contraception during therapy [see warnings and precautions (5.17)] . however, when receiving pegasys in combination with ribavirin, women of reproductive potential and their partners must use effective contraception during treatment and for at least 6 months after the last dose [see ribavirin prescribing information] . infertility females based on its mechanism of action and studies in female monkeys, pegasys can cause disruption of the menstrual cycle [see nonclinical toxicology (13.1)] . no female fertility study has been performed. pegasys is indicated for the treatment of chc in pediatric patients 5 to 17 years of age and for the treatment of chb in pediatric patients 3 to 17 years of age [see indications and usage (1.1), (1.2), dosage and administration (2.3), (2.5), clinical studies (14.1), (14.4)]. the use of pegasys for the treatment of pediatric patients 5 to 17 years of age with chc is based on one clinical trial in 114 previously untreated chc subjects 5 to 17 years of age with compensated liver disease and detectable hcv rna [see clinical trials experience (6.1), clinical studies (14.1)] . the safety and efficacy of pegasys in pediatric patients with chc below the age of 5 years have not been established. the use of pegasys for the treatment of pediatric patients 3 to 17 years of age with chb is based on one clinical trial in 161 previously untreated chb subjects 3 to 17 years of age of whom 111 were assigned to treatment with pegasys [ see clinical trials experience (6.1) , clinical studies (14.4)] . pegasys has not been studied in pediatric chb patients with liver cirrhosis and the safety and efficacy of pegasys in pediatric patients with chb below the age of 3 years have not been established. pegasys contains benzyl alcohol. in neonates and infants, benzyl alcohol has been reported to be associated with an increased incidence of neurological and other complications which are sometimes fatal in neonates and infants [see contraindications (4)] . younger patients have higher virologic response rates than older patients. clinical studies of pegasys alone or in combination with ribavirin did not include sufficient numbers of subjects aged 65 or over to determine whether they respond differently from younger subjects. adverse reactions related to alpha interferons, such as cns, cardiac, and systemic (e.g., flu-like) effects may be more severe in the elderly and caution should be exercised in the use of pegasys in this population. pegasys is excreted by the kidney, and the risk of toxic reactions to this therapy may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function. pegasys should be used with caution in patients with creatinine clearance less than or equal to 50 ml/min. the dose of pegasys should be reduced for patients with creatinine clearance less than 30 ml/min [see dosage and administration (2.6)and use in specific populations (8.7)] . chc patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including pegasys. during treatment, patients' clinical status and hepatic function should be closely monitored, and pegasys treatment should be immediately discontinued if decompensation (child-pugh score greater than or equal to 6) is observed [see contraindications (4)] . chronic hepatitis b subjects experienced transient acute exacerbations (flares) of hepatitis b (alt elevation greater than 10-fold higher than the upper limit of normal) during pegasys treatment (12% and 18%) and post-treatment (7% and 12%) in hbeag-negative and hbeag-positive subjects, respectively. renal function should be evaluated in all patients prior to initiation of pegasys by estimating the patient's creatinine clearance. a clinical trial evaluated treatment with pegasys and ribavirin in 50 chc subjects with moderate (creatinine clearance 30 – 50 ml/min) or severe (creatinine clearance less than 30 ml/min) renal impairment or end stage renal disease (esrd) requiring chronic hemodialysis (hd). in 18 subjects with esrd receiving chronic hd, pegasys was administered at a dose of 135 mcg once weekly. dose reductions and temporary interruptions of pegasys (due to pegasys-related adverse reactions, mainly anemia) were observed in up to 22% esrd/hd subjects during treatment; and 17% of these subjects discontinued pegasys due to pegasys-related adverse reactions. only one-third of esrd/hd subjects received pegasys for 48 weeks. subjects with severe (n=14) or moderate (n=17) renal impairment received pegasys 180 mcg once weekly. pegasys discontinuation rates were 36% and 0% in subjects with severe and moderate renal impairment, respectively, compared to 0% discontinuation rate in subjects with normal renal function. based on the pharmacokinetic and safety results from this trial, patients with creatinine clearance less than 30 ml/min should receive a reduced dose of pegasys. in addition, patients with any degree of renal impairment should be carefully monitored for laboratory abnormalities (especially decreased hemoglobin) and adverse reactions, and should undergo careful monitoring of creatinine clearance. patients with clinically significant laboratory abnormalities or adverse reactions which are persistently severe or worsening should have therapy withdrawn [see dosage and administration (2.6), clinical pharmacology (12.3)] . refer to the prescribing information for specific hcv antiviral drugs used in combination with pegasys for information on use in patients with renal impairment. the safety and efficacy of pegasys treatment have not been established in patients with liver and other transplantations. as with other alpha interferons, liver and renal graft rejections have been reported on pegasys. the safety and efficacy of pegasys have not been established in: - hepatitis b patients coinfected with hcv or hiv - hepatitis c patients coinfected with hbv or coinfected with hiv with a cd4+ cell count less than 100 cells/mm 3 first read the medication guide that comes with pegasys for the most important information you need to know about pegasys. be sure that you read, understand and follow these instructions for use before injecting pegasys. your healthcare provider should show you how to prepare, measure and inject pegasys properly before you use it for the first time. ask your healthcare provider if you have any questions. pegasys prefilled syringes come in a monthly convenience pack that contains 4 prefilled syringes of pegasys in a box with 4 needles. each needle has a needle-stick protection device. before starting, collect all of the supplies that you will need to use for preparing and injecting pegasys. you will need the following supplies: - 1 single-dose disposable prefilled syringe of pegasys - 1 needle with needle-stick protection device - several alcohol pads - you will also need a puncture-resistant disposable container to throw away used prefilled syringes and needles as soon as you finish your injection. see " how should i dispose of used syringes and needles? " important: - never reuse disposable prefilled syringes and needles. - throw away the prefilled syringe of pegasys after you use it 1 time, even if there is any medicine left in it. - do not shake pegasys. if shaken, pegasys may not work properly. how should i prepare a dose of pegasys? - find a well-lit, clean, flat surface such as a table. - take a carton containing pegasys out of the refrigerator. check the date on the carton the pegasys comes in. make sure the expiration date has not passed. do not use if the expiration date has passed (see figure a). - figure a: - - remove the prefilled syringe of pegasys from the carton. look at the prefilled syringe of pegasys. the solution should be clear and colorless to slightly yellowish, without particles (see figure b). if there is foam in the solution, put it back in the refrigerator for use at a later time and use another syringe. - figure b: - - do not use the prefilled syringe of pegasys if: the medicine remains cloudy after a few minutes at room temperature has particles the medicine is not colorless to slightly yellowish the expiration date has passed (see figure c). - the medicine remains cloudy after a few minutes at room temperature - has particles - the medicine is not colorless to slightly yellowish - the expiration date has passed (see figure c). - figure c: - - wash your hands well with soap and warm water. keep your work area, your hands, and injection site clean to decrease the risk of infection. - lay the syringe on a flat clean surface and wait a few minutes until it reaches room temperature. if you notice condensation water on the outside of the syringe, wait another few minutes until it disappears. how do i attach the needle to the pegasys prefilled syringe? - remove the needle from its package. do not remove the needle shield yet. keep the needle covered until just before you give the injection (see figure d). - figure d: - - remove and throw away the rubber cap from the tip of the syringe barrel (see figure e). - figure e: - - with one hand, hold the syringe by the barrel. with your other hand, hold the needle close to the hub where the green needle cover connects to the syringe (see figure f). - figure f: - - push the needle onto the syringe and tighten by using an easy twisting motion in the direction of the arrow (see figure g). - figure g: - - here is a picture of what the syringe will look like after you finish attaching the needle (see figure h). - figure h: - - lay the syringe and needle down on your clean work surface. be sure that the plastic needle shield covers the needle. never let the needle touch any surface. how should i choose a site for injection? - you can inject pegasys under the skin on your stomach or thigh (see figure i). avoid your navel and waistline. you should use a different place each time you give yourself an injection. - figure i: - - clean the area using an alcohol pad. let the skin air dry. how do i prepare the pegasys prefilled syringe for injection? - pull the green needle cover back from the needle toward the syringe barrel. the green needle cover will stay in the position you set. do not remove it. this is the needle-stick protection device (see figure j). - figure j: - - hold the syringe and needle tightly at the hub. gently rock the plastic needle shield back and forth to prepare for removal. remove the plastic needle shield by pulling it straight off (see figure k). - figure k: - - remove air bubbles from the syringe. hold the syringe with the needle pointing up to the ceiling. using your thumb and finger, gently tap the syringe to bring air bubbles to the top (see figure l). press the plunger in slightly to push air bubbles out of the syringe. figure l: - hold the syringe with the needle pointing up to the ceiling. - using your thumb and finger, gently tap the syringe to bring air bubbles to the top (see figure l). - press the plunger in slightly to push air bubbles out of the syringe. - figure l: - - depending on the dose of pegasys that your healthcare provider prescribes, you may have to get rid of (discard) some of the medicine from the prefilled syringe before you inject the medicine. the syringe has markings for 180 mcg, 135 mcg, and 90 mcg. your healthcare provider will tell you which mark to use (see figure mand figure n). - figure m: - figure n: - do not decrease or increase your dose of pegasys unless your healthcare provider tells you to. how do i give the injection of pegasys? - position the point of the needle (the bevel) so it is facing up (see figure o). - figure o: - - pinch a fold of skin on your stomach or thigh firmly with your thumb and forefinger (see figure p). - figure p: - - hold the syringe like a pencil at a 45° to 90° angle to your skin. with a quick "dart-like" motion, push the needle into the skin as far as it will go (see figure q). - figure q: - - after the needle is inserted, remove the hand used to pinch the skin and use it to hold the syringe barrel. pull the plunger of the syringe back slightly. if blood comes into the syringe, the needle has entered a blood vessel. do not inject pegasys. withdraw the needle and throw away the syringe and needle in the puncture-resistant container. see “ how should i dispose of used syringes and needles? ” then, repeat steps 1 through 16 with a new prefilled syringe and prepare a new injection site. if no blood is present in the syringe, inject the medicine by gently pressing the plunger all the way down the syringe barrel, until the syringe is empty. - pull the plunger of the syringe back slightly. - if blood comes into the syringe, the needle has entered a blood vessel. do not inject pegasys. withdraw the needle and throw away the syringe and needle in the puncture-resistant container. see “ how should i dispose of used syringes and needles? ” then, repeat steps 1 through 16 with a new prefilled syringe and prepare a new injection site. - do not inject pegasys. withdraw the needle and throw away the syringe and needle in the puncture-resistant container. see “ how should i dispose of used syringes and needles? ” - then, repeat steps 1 through 16 with a new prefilled syringe and prepare a new injection site. - if no blood is present in the syringe, inject the medicine by gently pressing the plunger all the way down the syringe barrel, until the syringe is empty. - when the syringe is empty, pull the needle out of the skin. wipe the area with an alcohol pad. - to prevent needle-stick injuries, before you dispose of the syringe and needle, push the green needle cover toward the needle (see figure r). then place the free end of the green cap on a flat surface and push down with a firm and quick motion until it clicks and covers over the needle (see figure s). - figure r: - figure s: - throw away the used syringe and needle right away as described below. see “ how should i dispose of used syringes and needles? ” how should i dispose of used syringes and needles? - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your 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. - 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. always keep the puncture-resistant container out of the reach of children. how should i store pegasys? - store pegasys prefilled syringes in a refrigerator at 36°f to 46°f (2°c to 8°c). - do not leave pegasys out of the refrigerator for more than 24 hours. - do not freeze or shake pegasys. - protect pegasys from light. this instructions for use has been approved by the u.s. food and drug administration. revised: februaury 2024 pegasys ® is a registered trademark of pharmaand gmbh manufactured by: pharmaand gmbh taborstrasse 1, 1020 wien austria u.s. license no. 2291 distributed by: summit sd, llc. 255 northwest victoria drive, suite a lee’s summit, mo 64086 © 2023 pharmaand gmbh, all rights reserved. first read the medication guide that comes with pegasys for the most important information you need to know about pegasys. be sure that you read, understand and follow these instructions for use before injecting pegasys. your healthcare provider should show you how to prepare, measure, and inject pegasys properly before you use it for the first time. ask your healthcare provider if you have any questions. before starting, collect all of the supplies that you will need to use for preparing and injecting pegasys. you will need the following supplies: - 1 vial of pegasys - 1 single-use disposable syringe and needle - several alcohol pads - you will also need a puncture-resistant disposable container to throw away used syringes, needles, and vials as soon as you finish your injection. see “ how should i dispose of used syringes, needles, and vials? ” follow your healthcare provider's instructions for the type of syringe and needle to use to prepare and inject your dose. if you will be injecting a child with pegasys, you will need a special syringe called a tuberculin syringe, which can measure doses of pegasys that are 1 milliliter (1ml) or less. when you get your prescription from the pharmacy, ask your pharmacist for the syringe and needle that you need to prepare and inject a dose of pegasys from the single-dose vial. important: - never reuse disposable syringes and needles. - throw away the vial of pegasys after you use it 1 time even if there is medicine left in the vial. - do not shake pegasys. if shaken, pegasys may not work properly. how should i prepare a dose of pegasys? - find a well-lit, clean, flat working surface such as a table. - take a carton containing pegasys out of the refrigerator. check the date on the carton the pegasys comes in. make sure the expiration date has not passed. do not use if the expiration date has passed (see figure a). - figure a: - - wash your hands well with soap and warm water. keep your work area, your hands, and injection site clean to decrease the risk of infection. - remove the vial of pegasys from the carton. look at the vial of pegasys. the solution should be clear and colorless to slightly yellowish, without particles (see figure b). - figure b: - - do not use the vial of pegasys if: the medicine is cloudy has particles the medicine is not colorless to slightly yellowish the expiration date has passed (see figure b) - the medicine is cloudy - has particles - the medicine is not colorless to slightly yellowish - the expiration date has passed (see figure b) - warm the refrigerated medicine by gently rolling it in the palms of your hands for about one minute. do not shake pegasys. - remove (flip off) the plastic cap from the top of the pegasys vial (see figure c). clean the rubber stopper on the top of the vial with an alcohol pad (see figure d). - figure c: - figure d: - if you are not sure how much medicine to use or which mark on the syringe to use, stop and call your healthcare provider right away. - open the package for the syringe you are using and if it does not have a needle attached, then attach a new needle to the syringe. - remove the protective cap from the needle on the syringe. never let the needle touch any surface. fill the syringe with air by pulling back on the plunger to the mark on the syringe barrel that matches the dose prescribed by your healthcare provider (see figure e). - figure e: - - hold the vial of pegasys on your flat surface. do not touch the cleaned rubber stopper. - push the needle straight down through the middle of the rubber stopper on the vial. slowly inject all the air from the syringe into the air space above the solution. do not inject air into the fluid (see figure f). - figure f: - - keep the needle in the vial. turn the vial upside down. - make sure the tip of the needle is in the pegasys solution. - slowly pull the plunger back to fill the syringe with pegasys solution to the dose (ml or cc markings on the syringe) that matches the dose prescribed by your healthcare provider (see figure g). - figure g: - - do not remove the needle from the vial. lay the vial and syringe on its side on your flat work surface until you are ready to inject the pegasys solution (see figure h). - figure h: - how should i choose a site for injection? - you can inject pegasys under the skin on your stomach or thigh (see figure i). avoid your navel and waistline. you should use a different place each time you give yourself an injection. - figure i: - - clean the area using an alcohol pad and let the skin air dry. how should i give an injection? - pick up the vial and syringe from your flat work surface. remove the syringe and needle from the vial. hold the syringe in the hand that you will use to inject pegasys. do not touch the needle or allow it to touch the work surface. - hold the syringe in the hand that you will use to inject pegasys. - do not touch the needle or allow it to touch the work surface. - remove air bubbles from the syringe. hold the syringe with the needle pointing up to the ceiling. using your thumb and finger, tap the syringe to bring air bubbles to the top (see figure j). press the plunger in slightly to push air bubbles out of the syringe. figure j: - hold the syringe with the needle pointing up to the ceiling. - using your thumb and finger, tap the syringe to bring air bubbles to the top (see figure j). - press the plunger in slightly to push air bubbles out of the syringe. - figure j: - - position the point of the needle (the bevel) so it is facing up (see figure k). - figure k: - - pinch a fold of skin on your stomach or thigh firmly between your thumb and forefinger (see figure l). - figure l: - - hold the syringe like a pencil at a 45° to 90° angle to your skin. with a quick "dart-like" motion, push the needle into the skin as far as it will go (see figure m). - figure m: - - after the needle is inserted, remove the hand used to pinch the skin and use it to hold the syringe barrel. pull the plunger of the syringe back slightly. if blood comes into the syringe, the needle has entered a blood vessel. do not inject pegasys. withdraw the needle and throw away the syringe, needle, and vial in the puncture-resistant container. see “ how should i dispose of used syringes, needles, and vials? ” then, repeat steps 1 through 19 with a new vial of pegasys and inject the medicine at a new injection site. if no blood is present in the syringe, inject the medicine by gently pressing the plunger all the way down the syringe barrel, until the syringe is empty. - pull the plunger of the syringe back slightly. - if blood comes into the syringe, the needle has entered a blood vessel. do not inject pegasys. withdraw the needle and throw away the syringe, needle, and vial in the puncture-resistant container. see “ how should i dispose of used syringes, needles, and vials? ” then, repeat steps 1 through 19 with a new vial of pegasys and inject the medicine at a new injection site. - do not inject pegasys. withdraw the needle and throw away the syringe, needle, and vial in the puncture-resistant container. see “ how should i dispose of used syringes, needles, and vials? ” - then, repeat steps 1 through 19 with a new vial of pegasys and inject the medicine at a new injection site. - if no blood is present in the syringe, inject the medicine by gently pressing the plunger all the way down the syringe barrel, until the syringe is empty. - when the syringe is empty, pull the needle out of the skin. wipe the area with an alcohol pad. - throw away the used syringe, needle, and vial. see “ how should i dispose of used syringes, needles, and vials? ” how should i dispose of used syringes, needles, and vials? - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your 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. - 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. how should i store pegasys? - store pegasys single-dose vials in a refrigerator at 36°f to 46°f (2°c to 8°c). - do not leave pegasys out of the refrigerator for more than 24 hours. - do not freeze or shake pegasys. - protect pegasys from light. this instructions for use has been approved by the u.s. food and drug administration. revised: february 2024 pegasys ® is a registered trademark of pharmaand gmbh manufactured by: pharmaand gmbh taborstrasse 1, 1020 wien austria u.s. license no. 2291 distributed by: summit sd, llc. 255 northwest victoria drive, suite a lee's summit, mo 64086 © 2023 pharmaand gmbh, all rights reserved.

European Union - English - EMA (European Medicines Agency)

pharmaand gmbh - darifenacin hydrobromide - urinary incontinence, urge; urinary bladder, overactive - urologicals, drugs for urinary frequency and incontinence - symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.

Malta - English - Medicines Authority

pharmaand gmbh taborstrasse 1 1020 vienna , austria - clomipramine hydrochloride - coated tablet - clomipramine hydrochloride 10 mg - psychoanaleptics

Malta - English - Medicines Authority

pharmaand gmbh taborstrasse 1 1020 vienna , austria - clomipramine hydrochloride - coated tablet - clomipramine hydrochloride 25 mg - psychoanaleptics

Malta - English - Medicines Authority

pharmaand gmbh taborstrasse 1 1020 vienna , austria - clomipramine hydrochloride - prolonged-release tablet - clomipramine hydrochloride 75 mg - psychoanaleptics

Canada - English - Health Canada

pharmaand gmbh - peginterferon alfa-2a - solution - 180mcg - peginterferon alfa-2a 180mcg - interferons

European Union - English - EMA (European Medicines Agency)

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1). paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. with respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1). for hepatitis c virus (hcv) genotype specific activity, see sections 4.2 and 5.1. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. when deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case by case basis (see section 4.4).,

European Union - English - EMA (European Medicines Agency)

pharmaand gmbh - panobinostat lactate anhydrous - multiple myeloma - antineoplastic agents - farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.

European Union - English - EMA (European Medicines Agency)

pharmaand gmbh - rucaparib camsylate - ovarian neoplasms - antineoplastic agents - rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

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

pharmaand gmbh - rucaparib camsylate (unii: 41ax9sj8ko) (rucaparib - unii:8237f3u7eh) - rubraca is indicated for the maintenance treatment of adult patients with a deleterious brca mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. rubraca is indicated for the treatment of adult patients with a deleterious brca mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mcrpc) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. select patients for therapy based on an fda-approved companion diagnostic for rubraca [see dosage and administration ( 2.1)]. this indication is approved under accelerated approval based on objective response rate and duration of response [see clinical studies ( 14.2)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. none. risk summary based on findings from animal studies and its mechanism of action, rubraca can cause fetal harm when administered to pregnant women. there are no available data in pregnant women to inform the drug-associated risk. in an animal reproduction study, administration of rucaparib to pregnant rats during organogenesis resulted in embryo-fetal death at maternal exposures that were 0.04 times the auc 0-24h in patients receiving the recommended dose of 600 mg twice daily [see data] . apprise pregnant women of the potential risk to a fetus. 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. data animal data in a dose range-finding embryo-fetal development study, pregnant rats received oral doses of 50, 150, 500, or 1000 mg/kg/day of rucaparib during the period of organogenesis. post-implantation loss (100% early resorptions) was observed in all animals at doses greater than or equal to 50 mg/kg/day (with maternal systemic exposures approximately 0.04 times the human exposure at the recommended dose based on auc 0-24h ). risk summary there is no information regarding the presence of rucaparib in human milk, or on its effects on milk production or the breast-fed child. because of the potential for serious adverse reactions in breast-fed children from rubraca, advise lactating women not to breastfeed during treatment with rubraca and for 2 weeks following the last dose. rubraca can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1)] . pregnancy testing pregnancy testing is recommended for females of reproductive potential prior to initiating rubraca. contraception females advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of rubraca [see use in specific populations ( 8.1)] . males based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of rubraca. advise male patients not to donate sperm during therapy and for 3 months following the last dose of rubraca [see use in specific populations ( 8.1) and nonclinical toxicology ( 13.1)]. the safety and effectiveness of rubraca in pediatric patients have not been established. of the 937 patients with ovarian cancer who received rubraca in clinical trials including ariel3, 41% were age 65 or older and 10% were 75 years or older. no major differences in safety were observed between younger and older patients with ovarian cancer. of the 209 patients with mcrpc who received rubraca in triton2, 77% were age 65 or older and 33% were 75 years or older. no major differences in safety were observed between younger and older patients with mcrpc. no dosage modification is recommended for patients with mild to moderate renal impairment (creatinine clearance [clcr] between 30 and 89 ml/min, as estimated by the cockcroft-gault method) [see clinical pharmacology ( 12.3)]. rubraca has not been studied in patients with clcr < 30 ml/min or patients on dialysis. no dosage modification is recommended for patients with mild to moderate hepatic impairment (total bilirubin ≤ 3 x upper limit of normal [uln] or ast > uln) [see clinical pharmacology ( 12.3)] . rubraca has not been studied in patients with severe hepatic impairment (total bilirubin > 3 x uln and any ast).