pegasys
Pegasys (Peginterferon Alfa-2a) is a medication used to treat Brain Neoplasms, Renal Cell Carcinoma, Cryoglobulinemia, Hepatitis D.
Peginterferon Alfa-2a · by Pharmaand Gmbh
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Key facts
- Active ingredient
- Peginterferon Alfa-2a
- Form
- Injectable
- Strength
- Peginterferon ALFA-2A 180U/5ML · Peginterferon ALFA-2A 180UG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- brain neoplasms, renal cell carcinoma, cryoglobulinemia
- Manufacturer
- Pharmaand Gmbh
- FDA application
- BLA103964
- FDA boxed warning
- Yes — see the boxed warning
What is Pegasys?
From the FDA label:Peginterferon alfa-2a, is a covalent conjugate of recombinant alfa-2a interferon (approximate molecular weight [MW] 20,000 daltons) with a single branched bis-monomethoxy polyethylene glycol (PEG) chain (approximate MW 40,000 daltons). The PEG moiety is linked at a single site to the interferon alfa moiety via a stable amide bond to lysine. Peginterferon alfa-2a has an approximate molecular weight of 60,000 daltons. Interferon alfa-2a is produced using recombinant DNA technology in which a cloned human leukocyte interferon gene is inserted into and expressed in Escherichia coli . PEGASYS is a sterile, preservative-free, colorless to slightly yellowish solution available as an injection and is administered subcutaneously. Each vial of 180 mcg/mL peginterferon alfa-2a (expressed as the amount of interferon alfa-2a) also contains acetic acid (0.05 mg), benzyl alcohol (10 mg), polysorbate 80 (0.05 mg), sodium acetate trihydrate (2.62 mg), and sodium chloride (8 mg) at pH 6 ± 0.5. Each prefilled syringe of 180 mcg/0.5 mL peginterferon alfa-2a (expressed as the amount of interferon alfa-2a) also contains acetic acid (0.0231 mg), benzyl alcohol (5 mg), polysorbate 80 (0.025 mg), sodium acetate trihydrate (1.3085 mg), and sodium chloride (4 mg) at pH 6 ± 0.5.
How to use
PEGASYS is administered by subcutaneous injection ( 2 ) In adult patients with CHC, PEGASYS is dosed as 180 mcg per week and the duration of treatment depends on indication, genotype, and whether it is administered with other HCV antiviral drugs ( 2.2 ). In adult patients with CHB, PEGASYS is dosed as 180 mcg per week for 48 weeks ( 2.4 ). In pediatric patients with CHC, PEGASYS is dosed as 180 mcg/1.73 m 2 × BSA per week, in combination with ribavirin, and the duration of treatment depends on genotype ( 2.3 ) In pediatric patients with CHB, PEGASYS is dosed as 180 mcg/1.73 m 2 × BSA per week for 48 weeks ( 2.5 ): Dosage modification is recommended in patients experiencing certain laboratory abnormalities, adverse reactions or renal impairment ( 2.6 , 12.3 ) 2.1 Dosage Overview Administer PEGASYS by subcutaneous injection once weekly in the abdomen or thigh for the treatment of: Adult patients with CHC without or with HIV coinfection [see Dosage and Administration (2.2) ]; Pediatric patients with CHC [see Dosage and Administration (2.3) ] ; Adult patients with CHB [see Dosage and Administration (2.4) ] ; and Pediatric patients with CHB [see Dosage and Administration (2.5) ]. For treatment of CHC, use PEGASYS in combination with other HCV antiviral drugs. For information about the recommended dosage and administration and the safe and effective use of these other HCV antiviral…
Side effects
In clinical trials, a broad variety of serious adverse reactions were observed in 1,010 subjects who received PEGASYS at doses of 180 mcg for 48 weeks, alone or in combination with ribavirin [see Boxed Warning and Warnings and Precautions (5) ] . The most common life-threatening or fatal events induced or aggravated by PEGASYS and ribavirin include depression, suicide, relapse of drug abuse/overdose, and bacterial infections, each occurring at a frequency of less than 1%. Hepatic decompensation occurred in 2% (10/574) of CHC/HIV subjects [see Warnings and Precautions (5.9) ] . Adult subjects: The most common adverse reactions (incidence greater than 40%) are fatigue/asthenia, pyrexia, myalgia, and headache ( 6.1 ) Pediatric subjects: The most common adverse reactions are similar to those seen in adults ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact pharma& agent at 1-888-814-7734 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in clinical practice. Chronic Hepatitis C Adult Subjects In all hepatitis C studies, one or more serious adverse reactions occurred in 10% of CHC…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
RISK OF SERIOUS DISORDERS WARNING: RISK OF SERIOUS DISORDERS See full prescribing information for complete boxed warning. Risk of Serious Disorders May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders ( 5 ) Risk of Serious Disorders Alpha interferons, including PEGASYS (peginterferon alfa-2a), may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy [see Warnings and Precautions (5.2 , 5.5 , 5.8 , 5.11 , 5.14 , 5.16) , Adverse Reactions (6.1) and Nonclinical Toxicology (13.1) ] .
Warnings
Important safety information
Refer to the prescribing information of the other HCV antiviral drugs, including ribavirin, for their Warnings and Precautions. Use with ribavirin Birth defects and fetal death: patients must have a negative pregnancy test prior to therapy, use 2 forms of effective contraception, and have monthly pregnancy tests ( 5.1 ) PEGASYS Clinically Significant Adverse Reactions or Risks Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy: Neuropsychiatric reactions ( 5.2 ) Cardiovascular disorders ( 5.3 ) Bone marrow suppression ( 5.4 ) Autoimmune and endocrine disorders (including thyroid disorders; hyperglycemia) ( 5.5 , 5.6 ) Ophthalmologic disorders ( 5.7 ) Cerebrovascular disorders ( 5.8 ) Hepatic decompensation in cirrhotic patients. Exacerbation of hepatitis during hepatitis B treatment ( 5.9 ) Pulmonary disorders ( 5.10 ) Infections (bacterial, viral, fungal) ( 5.11 ) Colitis and pancreatitis ( 5.12 , 5.13 ) Hypersensitivity and serious skin reactions including Stevens-Johnson syndrome ( 5.14 ) Growth impairment with combination therapy in pediatric patients ( 5.15 ) Peripheral neuropathy when used in combination with telbivudine ( 5.16 ) 5.1 Pregnancy: Use with ribavirin Ribavirin may cause birth defects and/or death of the exposed fetus. Patients must avoid pregnancy (female patients or female partners of male patients) while taking PEGASYS and ribavirin combination therapy. Ribavirin therapy should not be started unless a confirmed negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use two forms of effective contraception during treatment and for at least 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time [see Contraindications (4) , Patient Counseling Information (17) and ribavirin labeling] . 5.2 Neuropsychiatric Reactions Life-threatening or fatal neuropsychiatric reactions may manifest in all patients receiving therapy with PEGASYS and include suicide, suicidal ideation, homicidal ideation, depression, relapse of drug addiction, and drug overdose. These reactions may occur in patients with and without previous psychiatric illness. PEGASYS should be used with extreme caution in all patients who report a history of depression. Neuropsychiatric adverse events observed with alpha interferon treatment include aggressive behavior, psychoses, hallucinations, bipolar disorders, and mania. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. Patients should be advised to report any sign or symptom of depression or suicidal ideation to their prescribing physicians. In severe cases, therapy should be stopped immediately and psychiatric intervention instituted [see Boxed Warning , Adverse Reactions (6.1) and Dosage and Administration (2.6) ] . 5.3 Cardiovascular Disorders Hypertension, supraventricular arrhythmias, chest pain, and myocardial infarction have been observed in patients treated with PEGASYS. PEGASYS should be administered with caution to patients with pre-existing cardiac disease. Because cardiac disease may be worsened by ribavirin-induced anemia, patients with a history of significant or unstable cardiac disease should not receive PEGASYS/ribavirin [see ribavirin prescribing information] . 5.4 Bone Marrow Suppression PEGASYS suppresses bone marrow function and may result in severe cytopenias. Ribavirin may potentiate the neutropenia and lymphopenia induced by alpha interferons including PEGASYS. Very rarely, alpha interferons may be associated with aplastic anemia. It is advised that complete blood counts (CBC) be obtained pre-treatment and monitored routinely during therapy [see ribavirin prescribing information] . PEGASYS/ribavirin should be used with caution in patients with baseline neutrophil counts less than 1,500 cells/mm 3 , with baseline platelet counts less than 90,000 cells/mm 3 or baseline hemoglobin less than 10 g/dL. PEGASYS therapy should be discontinued, at least temporarily, in patients who develop severe decreases in neutrophil and/or platelet counts [see Dosage and Administration (2.6) ] . Severe neutropenia and thrombocytopenia occur with a greater incidence in HIV coinfected patients than monoinfected patients and may result in serious infections or bleeding [see Adverse Reactions (6.1) ] . Pancytopenia (marked decreases in RBCs, neutrophils and platelets) and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the concomitant administration of pegylated interferon/ribavirin and azathioprine. In this limited number of patients (n=8), myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of both HCV antiviral therapy and concomitant azathioprine and did not recur upon reintroduction of either treatment alone. PEGASYS, ribavirin, and azathioprine should be discontinued for pancytopenia, and pegylated interferon/ribavirin should not be re-introduced with concomitant azathioprine. 5.5 Autoimmune Disorders Development or exacerbation of autoimmune disorders including myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, and systemic lupus erythematosus have been reported in patients receiving alpha interferon. PEGASYS should be used with caution in patients with autoimmune disorders [see Boxed Warning ] . 5.6 Endocrine Disorders PEGASYS causes or aggravates hypothyroidism and hyperthyroidism. Hyperglycemia, hypoglycemia, and diabetes mellitus have been observed to develop in patients treated with PEGASYS. Patients with these conditions at baseline who cannot be effectively treated by medication should not begin PEGASYS therapy. Patients who develop these conditions during treatment and cannot be controlled with medication may require discontinuation of PEGASYS therapy. 5.7 Ophthalmologic Disorders Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, papilledema and serous retinal detachment are induced or aggravated by treatment with PEGASYS or other alpha interferons. All patients should receive an eye examination at baseline. Patients with pre-existing ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during interferon alpha treatment. Any patient who develops ocular symptoms should receive a prompt and complete eye examination. PEGASYS treatment should be discontinued in patients who develop new or worsening ophthalmologic disorders. 5.8 Cerebrovascular Disorders Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including PEGASYS. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between interferon alfa-based therapies and these events is difficult to establish [see Boxed Warning ] . 5.9 Hepatic Failure and Hepatitis Exacerbations Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART. In Study 7 [see Clinical Studies (14.3) ] , among 129 CHC/HIV cirrhotic subjects receiving HAART, 14 (11%) of these subjects across all treatment arms developed hepatic decompensation resulting in 6 deaths. All 14 subjects were on NRTIs, including…
Who should not take Pegasys
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. Autoimmune hepatitis ( 4 ) Hepatic decompensation in patients with cirrhosis ( 4 ) Use in neonates/infants ( 4 ) Known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction and anaphylaxis to alpha interferons or any component of the product ( 4 ) Additional contraindications for use with other HCV antiviral drugs: When used in combination with other HCV antiviral drugs, all contraindications also apply to PEGASYS combination therapy ( 4 ) Ribavirin is contraindicated in pregnant women and men whose female partners are pregnant ( 4 , 8.1 )
Overdose — what happens if you take too much
There is limited experience with overdosage. The maximum dose received by any patient was 7 times the intended dose of PEGASYS (180 mcg/day for 7 days). There were no serious reactions attributed to overdosages. Weekly doses of up to 630 mcg have been administered to patients with cancer. Dose-limiting toxicities were fatigue, elevated liver enzymes, neutropenia, and thrombocytopenia. There is no specific antidote for PEGASYS. Hemodialysis and peritoneal dialysis are not effective.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Drugs metabolized by CYP1A2: monitor for increased serum levels of theophylline and adjust dose accordingly ( 7.2 ) Methadone: monitor for signs and symptoms of methadone toxicity ( 7.3 ) Nucleoside analogues: closely monitor for toxicities. Reduce or discontinue the dose of PEGASYS or ribavirin or both should the events worsen ( 7.4 ) Zidovudine: monitor for worsening neutropenia and/or anemia with PEGASYS and/or ribavirin ( 7.4 ) 7.1 Drugs Metabolized by Cytochrome P450 There was no effect on the pharmacokinetics of representative drugs metabolized by CYP 2C9, CYP 2C19, CYP 2D6 or CYP 3A4. Treatment with PEGASYS once weekly for 4 weeks in healthy subjects was associated with an inhibition of P450 1A2 and a 25% increase in theophylline AUC. 7.2 Theophylline Treatment with PEGASYS once weekly for 4 weeks in healthy subjects was associated with an inhibition of P450 1A2 and a 25% increase in theophylline AUC. Theophylline serum levels should be monitored and appropriate dose adjustments considered for patients given both theophylline and PEGASYS. 7.3 Methadone In a PK study of HCV subjects concomitantly receiving methadone, treatment with PEGASYS once weekly for 4 weeks was associated with methadone levels that were 10% to 15% higher than at baseline. The clinical significance of this finding is unknown; however, patients should be monitored for the signs and symptoms of methadone toxicity. The pharmacokinetics of concomitant administration of methadone and PEGASYS were evaluated in 24 PEGASYS naïve CHC subjects (15 male, 9 female) who received 180 mcg PEGASYS subcutaneously weekly. All subjects were on stable methadone maintenance therapy (median dose 95 mg, range 30 mg to 150 mg) prior to receiving PEGASYS. Mean methadone PK parameters were 10% to 15% higher after 4 weeks of PEGASYS treatment as compared to baseline. Methadone did not significantly alter the PK of PEGASYS as compared to a PK study of 6 chronic hepatitis C subjects not receiving methadone. 7.4 Nucleoside Analogues NRTIs In Study 7 among the CHC/HIV coinfected cirrhotic subjects receiving NRTIs cases of hepatic decompensation (some fatal) were observed [see Warnings and Precautions (5.9) ] . Patients receiving PEGASYS/ribavirin in combination with other HCV antiviral drugs and NRTIs should be closely monitored for treatment associated toxicities. Physicians should refer to prescribing information for other HCV antiviral drugs and the respective NRTIs for guidance regarding toxicity management. In addition, dose reduction or discontinuation of PEGASYS, ribavirin or both, should also be considered if worsening toxicities are observed [see Warnings and Precautions (5.3 , 5.9) and Dosage and Administration (2.6) ] . Zidovudine In Study 7, subjects who were administered zidovudine in combination with PEGASYS/ribavirin developed severe neutropenia (ANC less than 500 cells/mm 3 ) and severe anemia (hemoglobin less than 8 g/dL) more frequently than similar subjects not receiving zidovudine (neutropenia 15% vs. 9%) (anemia 5% vs. 1%). Discontinuation of zidovudine should be considered as medically appropriate. Dose reduction or discontinuation of PEGASYS, ribavirin or both should also be considered if worsening clinical toxicities are observed, including hepatic decompensation (e.g., Child-Pugh greater than 6). Refer to the prescribing information for specific HCV antiviral drugs used in combination with PEGASYS for information on drug interaction potential.
Storing Pegasys, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Continue reduced dosing If symptoms improve and are stable for 4 weeks, may resume normal visit schedule.”
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Frequently asked questions
- What does Pegasys treat?
- Pegasys (Peginterferon Alfa-2a) may be used to treat brain neoplasms, renal cell carcinoma, cryoglobulinemia, hepatitis d, hemangioma, hepatocellular carcinoma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Pegasys?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Pegasys. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Pegasys?
- Pegasys is marketed by Pharmaand Gmbh. You can see Pharmaand Gmbh's full profile, rating, and other products on pharmaranks.
- Is Pegasys a brand-name or generic drug?
- Pegasys is a brand-name product with the active ingredient Peginterferon Alfa-2a.
- Is Pegasys available over the counter?
- No. Pegasys is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Pegasys come in?
- Pegasys is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Pegasys FDA-registered?
- Pegasys is on record with the U.S. FDA under application number BLA103964. You can verify this on its official FDA label.
- Is Pegasys safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Pegasys. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Pegasys?
- Pegasys's side effects are taken directly from its FDA label. From the label: In clinical trials, a broad variety of serious adverse reactions were observed in 1,010 subjects who received PEGASYS at doses of 180 mcg for 48 weeks, alone or in combination with ribavirin [see Boxed Warning and Warnings and Precautions (5) ] .… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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