HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use INFERGEN® safely and effectively. See Full Prescribing Information for INFERGEN®.

INFERGEN® (interferon alfacon-1)
injection for subcutaneous use
Initial U.S. Approval: 1997

WARNING: FATAL OR LIFE-THREATENING 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. (5.2)

Use with Ribavirin

  • Ribavirin may cause birth defects and fetal death; avoid pregnancy in female patients and female partners of male patients. (5.1)
  • Ribavirin causes hemolytic anemia which may exacerbate cardiac disease (5.1)

Ribavirin is a potential carcinogen. (13.1)

RECENT MAJOR CHANGES

Boxed Warning 07/2010
Indications and Usage (1) 07/2010
Dosage and Administration (2.2) (2.3) 07/2010
Contraindications (4) 07/2010
Warnings and Precautions (5.1) (5.2) (5.3) (5.6) (5.8) (5.12) 07/2010

INDICATIONS AND USAGE

  • INFERGEN® (interferon alfacon-1) is indicated for treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease. This indication is based on clinical trials conducted using INFERGEN® alone at a time before combination treatment of chronic hepatitis C became the standard of care, and on a single trial evaluating INFERGEN® in combination with ribavirin in patients who failed to respond to previous treatment with a pegylated interferon and ribavirin. Use of monotherapy with an interferon such as INFERGEN® for the treatment of hepatitis C is not recommended unless a patient is unable to take ribavirin.
  • The safety and efficacy of the combination of INFERGEN®/ribavirin in treatment-naïve patients or in patients co-infected with HBV or HIV-1 have not been evaluated.
  • Patients with the following characteristics are less likely to benefit from retreatment with INFERGEN®/ribavirin combination therapy: response of <1 log10 drop HCV RNA on previous treatment, Genotype 1, high viral load (≥ 850,000 IU/mL), African American race, and/or presence of cirrhosis.

DOSAGE AND ADMINISTRATION

  • INFERGEN® is administered by subcutaneous injection.
  • Monotherapy: INFERGEN® 9 mcg three times weekly for 24 weeks (as initial treatment) or 15 mcg three times weekly for up to 48 weeks (as retreatment). (2.1)
  • Combination treatment: INFERGEN® 15 mcg daily with ribavirin 1,000 or 1,200 mg (for body weight < 75 kg and ≥ 75 kg) daily for up to 48 weeks (as retreatment). (2.2)
  • Dose reduction is recommended in patients experiencing serious adverse reactions. (2.3)

DOSAGE FORMS AND STRENGTHS

  • 9 mcg/0.3 mL INFERGEN® in sterile, colorless liquid (3)
  • 15 mcg/0.5 mL INFERGEN® in sterile, colorless liquid (3)

CONTRAINDICATIONS

  • hepatic decompensation (Child-Pugh score > 6 [class B and C])
  • autoimmune hepatitis
  • known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, anaphylaxis to interferon alphas or to any component of the product

Additional contraindications for combination therapy with ribavirin:

  • women who are pregnant
  • men whose female partners are pregnant
  • patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
  • patients with creatinine clearance < 50 mL/min

WARNINGS AND PRECAUTIONS

  • Birth defects and fetal death with ribavirin: Female patients must have a negative pregnancy test prior to therapy, use at least 2 forms of contraception, and undergo monthly pregnancy tests. (5.1)

Patients exhibiting any of the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy:

  • Use with ribavirin (5.1)
  • Neuropsychiatric Disorders (5.2)
  • Cardiovascular Events (5.3)
  • Pulmonary Disorders (5.4)
  • Hepatic Failure(5.5)
  • Renal Insufficiency (5.6)
  • Cerebrovascular Disorders (5.7)
  • Bone Marrow Toxicity (5.8)
  • Colitis (5.9)
  • Pancreatitis (5.10)
  • Hypersensitivity (5.11)
  • Autoimmune Disorders (5.12)
  • Ophthalmologic Disorders (5.13)
  • Peripheral Neuropathy (5.14)
  • Endocrine Disorders (5.15)
  • Laboratory Tests (5.16)

ADVERSE REACTIONS

Most common adverse reactions (incidence > 40%) are fatigue, fever, rigors, body pain, headache, abdominal pain, nausea, granulocytopenia, arthralgia, myalgia, back pain, neutropenia, and influenza-like illness. (6.1) (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Three Rivers Pharmaceuticals at 1-877-377-7862 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Myelosuppressive drugs: Monitor closely for toxicity. (7.1)

Check for drug interactions known to occur with use of ribavirin.

USE IN SPECIFIC POPULATIONS

  • Ribavirin Pregnancy Registry 1-800-593-2214 (8.1)
  • Nursing mothers (8.3)
  • Pediatrics: safety and efficacy have not been established (8.4)
  • Geriatrics: neuropsychiatric, cardiac, pulmonary, GI, and systemic (flu-like) adverse reactions may be more severe (8.5)
  • Hepatic Impairment: safety and efficacy have not been studied (8.6)
  • Renal Impairment: safety and efficacy have not been studied (8.7)
  • Organ transplant: safety and efficacy have not been studied (8.8)
  • HIV or HBV coinfection: safety and efficacy have not been studied (8.9)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 07/2010