Safety

  • 3% of patients (8/271) receiving PEGASYS monotherapy discontinued due to adverse reactions1

Important Safety Information in HBeAg-positive patients2

Art image of most common AEs in ≥10% of HBeAg-positive patients with PEGASYS and lamivudine

WARNINGS SPECIFIC TO HEPATITIS B PATIENTS

Exacerbations of hepatitis during hepatitis B therapy are not uncommon and are characterized by transient and potentially severe increases in serum ALT. Patients experiencing ALT flares should receive more frequent monitoring of liver function. PEGASYS dose reduction should be considered in patients experiencing transaminase flares. If ALT increases are progressive despite reduction of PEGASYS dose or are accompanied by increased bilirubin or evidence of hepatic decompensation, PEGASYS should be immediately discontinued.

ADVERSE REACTIONS

Six percent of PEGASYS treated subjects in the hepatitis B studies experienced one or more serious adverse events. The most common or important serious adverse events, all of which occurred at a frequency of less than or equal to 1%, in the hepatitis B studies were infections (sepsis, appendicitis, tuberculosis, influenza), hepatitis B flares, and thrombotic thrombocytopenic purpura.

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Important Informationclose

INDICATIONS AND USAGE

PEGASYS® (peginterferon alfa-2a) is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.

IMPORTANT SAFETY INFORMATION

Boxed WARNINGS

Alpha interferons, including PEGASYS, 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 Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions.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.

DOSE MODIFICATION

If severe adverse reactions or laboratory abnormalities develop during PEGASYS therapy, the dose should be modified until the adverse reactions abate. If intolerance persists after dose adjustment, PEGASYS therapy should be discontinued. Refer to the full prescribing information for guidelines pertaining to dose modifications and discontinuation of PEGASYS based on laboratory abnormalities and patient’s depression status.

In patients with CrCL less than 30 mL/min, including patients with end-stage renal disease requiring hemodialysis, dose reduction to 135 mcg PEGASYS is recommended. Signs and symptoms of interferon toxicity should be closely monitored.

CONTRAINDICATIONS

PEGASYS is contraindicated in:

  • Patients with known hypersensitivity reaction such as urticaria, angioedema, bronchoconstriction, anaphylaxis, or Stevens-Johnson syndrome to alpha interferons, including PEGASYS, or any of its components
  • Patients with autoimmune hepatitis
  • Patients with hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic patients before treatment
  • Neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurologic and other complications in neonates and infants, which are sometimes fatal

WARNINGS AND PRECAUTIONS

Patients should be monitored for the following serious conditions, some of which may become life threatening. Patients with persistently severe or worsening signs or symptoms should have their therapy withdrawn:

  • Neuropsychiatric reactions (suicide, suicidal ideation, homicidal ideation, depression, relapse of drug addiction and drug overdose)
  • Cardiovascular disorders (hypertension, supraventricular arrhythmias, chest pain and myocardial infarction)
  • Bone marrow suppression (severe cytopenias and, rarely, aplastic anemia). Pancytopenia has been reported with concomitant use of azathioprine
  • Autoimmune disorders (including myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, and lupus)
  • Endocrine disorders (hypothyroidism, hyperthyroidism, hyperglycemia, hypoglycemia and diabetes mellitus)
  • 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)
  • Cerebrovascular events (ischemic and hemorrhagic cerebrovascular events)
  • Hepatitis exacerbations (exacerbations of hepatitis during hepatitis B therapy)
  • Pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension and sarcoidosis, some resulting in respiratory failure and/or patient deaths)
  • Infections (bacterial, viral, or fungal), some fatal
  • Colitis (ulcerative and hemorrhagic/ischemic colitis), sometimes fatal
  • Pancreatitis, sometimes fatal
  • Hypersensitivity (eg, urticaria, angioedema, bronchoconstriction, and anaphylaxis) and serious skin reactions, including Stevens-Johnson syndrome
  • Peripheral neuropathy (in combination with telbivudine)

ADVERSE REACTIONS

Chronic Hepatitis B

Six percent of PEGASYS treated subjects in the hepatitis B studies experienced one or more serious adverse events. The most common or important serious adverse events, all of which occurred at a frequency of less than or equal to 1%, in the hepatitis B studies were infections (sepsis, appendicitis, tuberculosis, influenza), hepatitis B flares, and thrombotic thrombocytopenic purpura.

The most commonly observed adverse reactions in patients treated with PEGASYS were pyrexia (54%), headache (27%), fatigue (24%), myalgia (26%), alopecia (18%), and anorexia (16%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see PEGASYS full Prescribing Information for Boxed WARNINGS and additional Important Safety Information.

PEGASYS® is a registered trademark of Hoffmann-La Roche Inc. All other brands for listed products are trademarks or registered trademarks (as indicated) of their respective owners and are not trademarks of Genentech, Inc. or Hoffmann-La Roche Inc.

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(peginterferon alfa-2a) ProClick™ Autoinjector

INDICATIONS AND USAGE

PEGASYS® (peginterferon alfa-2a) is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.

IMPORTANT SAFETY INFORMATION

Boxed WARNINGS

Alpha interferons, including PEGASYS, 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.

DOSE MODIFICATION

If severe adverse reactions or laboratory abnormalities develop during PEGASYS therapy, the dose should be modified until the adverse reactions abate. If intolerance persists after dose adjustment, PEGASYS therapy should be discontinued. Refer to the full prescribing information for guidelines pertaining to dose modifications and discontinuation of PEGASYS based on laboratory abnormalities and patient’s depression status.

In patients with CrCL less than 30 mL/min, including patients with end-stage renal disease requiring hemodialysis, dose reduction to 135 mcg PEGASYS is recommended. Signs and symptoms of interferon toxicity should be closely monitored.

CONTRAINDICATIONS

PEGASYS is contraindicated in:

WARNINGS AND PRECAUTIONS

Patients should be monitored for the following serious conditions, some of which may become life threatening. Patients with persistently severe or worsening signs or symptoms should have their therapy withdrawn:

ADVERSE REACTIONS

Chronic Hepatitis B

Six percent of PEGASYS treated subjects in the hepatitis B studies experienced one or more serious adverse events. The most common or important serious adverse events, all of which occurred at a frequency of less than or equal to 1%, in the hepatitis B studies were infections (sepsis, appendicitis, tuberculosis, influenza), hepatitis B flares, and thrombotic thrombocytopenic purpura.

The most commonly observed adverse reactions in patients treated with PEGASYS were pyrexia (54%), headache (27%), fatigue (24%), myalgia (26%), alopecia (18%), and anorexia (16%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see PEGASYS full Prescribing Information for Boxed WARNINGS and additional Important Safety Information.

PEGASYS® is a registered trademark of Hoffmann-La Roche Inc. All other brands for listed products are trademarks or registered trademarks (as indicated) of their respective owners and are not trademarks of Genentech, Inc. or Hoffmann-La Roche Inc.

References
 
1.
Lau GKK et al. Peginterferon alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med. 2005;352(26):2682-2695.
2.
PEGASYS Prescribing Information. Genentech, Inc. 2011.