AVONEX has a well-understood safety profile1

Contraindications

  • AVONEX is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation
  • The formerly available lyophilized vial formulation of AVONEX is contraindicated in patients with a history of hypersensitivity to albumin (human)
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Warnings and Precautions1

Depression, Suicide, and Psychotic Disorders

Warning

  • Patients treated with AVONEX and their caregivers should be advised to report immediately any symptoms of depression, suicidal ideation, and/or psychosis to their prescribing physician

Details

  • Depression and suicide have been reported to occur with increased frequency in patients receiving AVONEX
  • Additionally, there have been postmarketing reports of depression, suicidal ideation, and/or development of new or worsening of other pre-existing psychiatric disorders, including psychosis

Guidance

  • If a patient develops depression or other severe psychiatric symptoms, cessation of AVONEX therapy should be considered
  • For some of these patients, symptoms of depression improved upon cessation of AVONEX

Hepatic injury

Warning

  • Severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients taking AVONEX

Details

  • Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge with AVONEX
  • In some cases, these events have occurred in the presence of other drugs that have been associated with hepatic injury

Guidance

  • The potential risk of AVONEX used in combination with known hepatotoxic drugs or other products (e.g., alcohol) should be considered prior to starting AVONEX, or before starting hepatotoxic drugs
  • Patients should be monitored for signs of hepatic injury

Anaphylaxis and Other Allergic-Reactions

Warning

  • Anaphylaxis has been reported as a rare complication of AVONEX use

Signs and symptoms

  • Other allergic reactions have included dyspnea, orolingual edema, skin rash, and urticaria

Guidance

  • Discontinue AVONEX if anaphylaxis or other allergic reactions occur

Congestive Heart Failure

Warning

  • Patients with pre-existing congestive heart failure should be monitored for worsening of their cardiac condition during initiation of and continued treatment with AVONEX

Details

  • While beta interferons do not have any known direct cardiac toxicity, during the postmarketing period cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition to these events, and without other etiologies being established

Decreased Peripheral Blood Counts

Warning

  • Decreased peripheral blood counts in all cell lines, including rare pancytopenia and thrombocytopenia, have been reported from postmarketing experience in AVONEX-treated patients

Guidance

  • Patients should be monitored for symptoms or signs of decreased blood counts

Thrombotic Microangiopathy

Warning

  • Case of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported with interferon beta products, including AVONEX

Details

  • Cases have been reported several weeks to years after starting interferon beta products

Guidance

  • Discontinue AVONEX if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated

Seizures

Warning

  • Seizures have been temporally associated with the use of beta interferons in clinical trials and postmarketing safety surveillance

Details

  • It is not known whether these events were related to the effects of multiple sclerosis alone, to AVONEX, or to a combination of both

Autoimmune Disorders

Warning

  • Postmarketing reports of autoimmune disorders of multiple target organs in AVONEX-treated patients included idiopathic thrombocytopenia, hyper- and hypothyroidism, and rare cases of autoimmune hepatitis

Guidance

  • If AVONEX-treated patients develop a new autoimmune disorder, consider stopping the therapy

Laboratory Tests

Guidance

  • In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests, are recommended during AVONEX therapy
  • Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts
  • Thyroid function should be monitored periodically
  • If patients have or develop symptoms of thyroid dysfunction (hypo- or hyperthyroidism), thyroid function tests should be performed according to standard medical practice

No changes to the well-understood safety profile of AVONEX were identified in the CHAMPIONS follow-up study out to 10 years1,2

  • Over the course of the entire 10-year follow-up, there were 34 serious adverse events in 25 patients, including 2 deaths (metastatic breast cancer and an automobile accident)
  • Serious adverse events were similar by treatment group (16 patients in the IT group and 18 patients in the DT group had serious adverse events)

No changes to the well-understood safety profile were identified in the ASSURANCE follow-up study over 15 years of use3

In placebo-controlled studies, adverse reactions observed at an incidence ≥20% on AVONEX and at least 2% more frequently on AVONEX (n=351) than placebo (n=333) were headache (58% vs 55%), flu-like symptoms (49% vs 29%), myalgia (29% vs 22%), asthenia (24% vs 18%), nausea (23% vs 19%), pain (23% vs 21%), and fever (20% vs 9%)1

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