Pegasys 180 injectable solution

Pegasys (Genentech), manufactured drug form of Peginterferon alfa-2a, 180ug/0.5mL peginterferon alfa-2a injectable solution, NDC 0004-0357

Available in:

NDC Product ID:

  • 0004-0357

Manufacturer:

Manufactured drug form

Manufactured form of:

Generic drug:

  • No

Label date:

  • Oct 11, 2011

Label link:

Label sections:

Section name Section URI Prominent warning Highlight text Section LOINC code
  • Warning: Risk Of Serious Disorders And Ribavirin-associated Effects
  • Yes
  • WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS See full prescribing information for complete boxed warning. 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) Use with Ribavirin Ribavirin may cause birth defects and fetal death; avoid pregnancy in female patients and female partners of male patients (5.1, 8.1)
  • 34066-1
  • Recent Major Changes Section
  • No
  • 43683-2
  • 1 Indications And Usage
  • No
  • PEGASYS is an antiviral indicated for: Treatment of Chronic Hepatitis C (CHC) in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, in patients with histological evidence of cirrhosis and compensated liver disease, and in adults with CHC/HIV coinfection and CD4 count greater than 100 cells/mm 3 (1.1) Combination therapy with COPEGUS is recommended unless patient has contraindication to or significant intolerance to COPEGUS (1.1) PEGASYS monotherapy is indicated for: Treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication and liver inflammation (1.2)
  • 34067-9
  • 2 Dosage And Administration
  • No
  • PEGASYS is administered by subcutaneous injection In adult patients with CHC or chronic hepatitis B, PEGASYS is dosed as 180 mcg per week and the duration of treatment depends on indication, genotype, and whether it is administered with COPEGUS (2.2, 2.3, 2.4) In pediatric patients with CHC, PEGASYS is dosed as 180 mcg/1.73 m 2 × BSA per week, in combination with COPEGUS, and the duration of treatment depends on genotype (2.1) Dose reduction is recommended in patients experiencing certain laboratory abnormalities, adverse reactions or renal impairment (2.5, 12.3)
  • 34068-7
  • 3 Dosage Forms And Strengths
  • No
  • 180 mcg/mL Vial for single use (3) 180 mcg/0.5 mL Prefilled Syringe for single use (3) 180 mcg/0.5 mL Autoinjector for single use (3) 135 mcg/0.5 mL Autoinjector for single use (3)
  • 43678-2
  • 4 Contraindications
  • No
  • 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, 5) Additional contraindications for use with ribavirin: Pregnant women and men whose female partners are pregnant (4, 8.1) Hemoglobinopathies (e.g., thalassemia major, sickle cell disease) (4) Coadministration with didanosine
  • 34070-3
  • 5 Warnings And Precautions
  • No
  • Use with Ribavirin Birth defects and fetal death: patients must have a negative pregnancy test prior to therapy, use 2 or more forms of contraception, and have monthly pregnancy tests (5.1) Hemolytic anemia (5.1) History of significant or unstable cardiac disease (5.3) Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy: Neuropsychiatric events (5.2) 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) Bone marrow suppression (5.4) 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)
  • 43685-7
  • 6 Adverse Reactions
  • No
  • The most common adverse reactions (incidence greater than 40%) are fatigue/asthenia, pyrexia, myalgia, and headache. (6.1) The most common adverse reactions in pediatric subjects were similar to those seen in adults. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 34084-4
  • 7 Drug Interactions
  • No
  • 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 COPEGUS or both should the events worsen (7.4) Zidovudine: monitor for worsening neutropenia and/or anemia with PEGASYS/COPEGUS (7.4) Azathioprine (7.4)
  • 34073-7
  • 8 Use In Specific Populations
  • No
  • Ribavirin Pregnancy Registry (8.1) Pediatric patients: Safety and efficacy in pediatric patients less than 5 years old have not been established (8.4) Geriatric patients: Neuropsychiatric, cardiac, and systemic (flu-like) adverse reactions may be more severe (8.5) Patients with hepatic impairment: Clinical status and hepatic function should be closely monitored and treatment should be immediately discontinued if decompensation occurs (8.6) Patients with renal impairment: PEGASYS dose should be reduced in patients with creatinine clearance less than 30 mL/min (2.5, 8.7) Organ transplant recipients: Safety and efficacy have not been studied (8.8) Chronic Hepatitis B: Safety and efficacy have not been established in hepatitis B patients coinfected with HCV or HIV (8.9)
  • 43684-0
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Discontinued:

  • No

Marketing start date:

  • Mar 29, 2011

FDA application number:

  • BLA103964
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