Label Changes for:

PegIntron (peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use

May 2009

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2009

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

ADVERSE REACTIONS

Clinical Trials Experience section

  • Adults: Added all the study information
  • Laboratory Values: Decreases in hemoglobin, neutrophils, and platelets may require dose reduction or permanent discontinuation from therapy
  • Added Table 9 (Summary of Treatment Related Emergent Adverse Reactions

Postmarketing Experience

  • The following adverse reactions have been identified during post-approval use of PegIntron therapy.  Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    Blood and Lymphatic System Disorders- pure red cell aplasia, thrombotic thrombocytopenic purpura

    Cardiac Disorders- palpitations

    Ear and Labyrinth Disorders- hearing loss, vertigo, hearing impairment

    Eye Disorders- Vogt-Koyanagi-Harada syndrome

    Gastrointestinal Disorders- aphthous stomatitis

    General Disorders and Administration Site Conditions- asthenic conditions (including asthenia, malaise, fatigue)

    Immune System Disorders- cases of acute hypersensitivity reactions (including anaphylaxis, angioedema, urticaria); Stevens Johnson syndrome, toxic epidermal necrolysis, systemic lupus erythematosus, erythema multiforme

    Infections and Infestations- bacterial infection including sepsis

    Metabolism and Nutrition Disorders- dehydration

    Musculoskeletal and Connective Tissue Disorders- rhabdomyolysis, myositis

    Nervous System Disorders- seizures, memory loss, peripheral neuropathy, paraesthesia, migraine headache

    Psychiatric Disorders- homicidal ideation

    Renal and Urinary Disorders- renal failure, renal insufficiency

    Skin and Subcutaneous Tissue Disorders- psoriasis

    Vascular Disorders- hypertension, hypotension

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