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PEGINTERFERON ALFA-2B


DIR Classification


Classification:Less-DIR concern
Severity Score:1

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • 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, pericarditis
  • Ear and Labyrinth Disorders
  • Hearing loss, vertigo, hearing impairment
  • Endocrine Disorders
  • Diabetic ketoacidosis, diabetes
  • Eye Disorders
  • Vogt-Koyanagi-Harada syndrome, serous retinal detachment
  • 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, Hepatitis B virus reactivation in HCV/HBV co-infected patients
  • Metabolism and Nutrition Disorders
  • Dehydration, hypertriglyceridemia
  • Musculoskeletal and Connective Tissue Disorders
  • Rhabdomyolysis, myositis
  • Nervous System Disorders
  • Seizures, memory loss, peripheral neuropathy, paraesthesia, migraine headache
  • Psychiatric Disorders
  • Homicidal ideation
  • Respiratory, Thoracic, and Mediastinal Disorders
  • Pulmonary hypertension, pulmonary fibrosis
  • Renal and Urinary Disorders
  • Renal failure, renal insufficiency
  • Skin and Subcutaneous Tissue Disorders
  • Psoriasis
  • Vascular Disorders
  • Hypertension, hypotension

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
60
42852
Other ADRs
21209
14096070

Odds Ratio = 0.931

Drug Property Information



ATC Code(s):
  • L03AB60 - peginterferon alfa-2b
    • L03AB - Interferons
    • L03A - IMMUNOSTIMULANTS
    • L03 - IMMUNOSTIMULANTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
  • L03AB10 - peginterferon alfa-2b
    • L03AB - Interferons
    • L03A - IMMUNOSTIMULANTS
    • L03 - IMMUNOSTIMULANTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:peginterferon alfa-2b
Active Ingredient UNII:G8RGG88B68
Drugbank ID:DB00022
PubChem Compound:N/A
CAS Number:215647-85-1
Dosage Form(s):kit
Route(s) Of Administrator:
Daily Dose:
  • 0.0075 mg/day L03AB10
Chemical Structure:
SMILE Code:
-

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: Rhabdomyolysis associated with the co-administration of daptomycin and pegylated interferon α-2b and ribavirin in a patient with hepatitis C.

[Colomba Claudia,Rubino Raffaella,Siracusa Lucia,Mazzola Giovanni,Titone Lucina]
J Antimicrob Chemother.2012 Jan;67(1):249-50. doi: 10.1093/jac/dkr398. Epub 2011 Sep 29. PMID: 21965434

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