Safety

Extavia (interferon beta-1b) for injection, for subcutaneous use

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

May 2016

Summary View

WARNINGS AND PRECAUTIONS

Anaphylaxis and Other Allergic Reactions (addition of paragraph)
  • The removable rubber cap of the diluent (Sodium Chloride, 0.54% Solution) pre-filled syringe contains natural rubber latex, which may cause allergic reactions and should not be handled by latex-sensitive individuals. The safe use of EXTAVIA pre-filled syringe in latex-sensitive individuals has not been studied.
Drug-induced Lupus Erythematosus (addition of section)
  • Cases of drug-induced lupus erythematosus have been reported with some interferon beta products, including EXTAVIA. Signs and symptoms of drug-induced lupus reported in EXTAVIA-treated patients have included rash, serositis, polyarthritis, nephritis, and Raynaud’s phenomenon. Cases have occurred with positive serologic testing (including positive anti-nuclear and/or anti-double-stranded DNA antibody testing). If EXTAVIA-treated patients develop new signs and symptoms characteristic of this syndrome, EXTAVIA therapy should be stopped.

ADVERSE REACTIONS (add)

  • Drug Induced Lupus Erythematosus
Post Marketing Experience (addition to subsection)
  • Musculoskeletal and connective tissue disorders: drug-induced lupus erythematosus

PATIENT COUNSELING INFORMATION

  • Anaphylaxis and Other Allergic Reactions (addition of sentence)
  • Inform latex-sensitive patients that the removable rubber cap of the diluent pre-filled syringe contains natural rubber latex.

 

December 2014

Summary View

WARNINGS AND PRECAUTIONS

Hepatic Injury

*Section added

Anaphylaxis and Other Allergic Reactions

*Section Title changed to add “Other Allergic Reactions”

  • …Discontinue Extavia if anaphylaxis occurs.
Congestive Heart Failure

*Section added

Injection Site Necrosis and Reactions

*Several additions

Leukopenia
  • …Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Flu-like Symptom Complex
  • …Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms associated with Extavia use
Seizures

*Section added

Monitoring for Laboratory Abnormalities

*Section title changed from “Laboratory Tests”

ADVERSE REACTIONS

Clinical Studies Experience

*Several edits to this section

Postmarketing Experience
  • Cardiac disorders: … Palpitations, Tachycardia
  • Gastrointestinal disorders: Diarrhea, Nausea, …
  • Skin and subcutaneous tissue disorders: Alopecia…
  • Musculoskeletal and connective tissue disorders: Arthralgia
  • Reproductive system and breast disorder: Menorrhagia

PATIENT COUNSELING INFORMATION

*Several updates

MEDICATION GUIDE

*Several updates

Page Last Updated: 06/10/2016
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