Peg intron 100 mcg/0.5 ml

Peginterferon alfa-2b 100 mcg

Black Box Warnings
Alfa interferons cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders
The risk of serious depression, with suicidal ideation and completed suicides, and other serious neuropsychiatric disorders are increased with alpha interferons
Discontinue drug if persistently severe or worsening signs or symptoms of the above conditions are present; disorders typically resolve after stopping therapy
These disorders may not resolve after the drug is discontinued
Monitored closely with periodic clinical and laboratory evaluations
Combination therapy with ribavirin

  • Ribavirin may cause birth defects and/or fetal death
  • Extreme care must be taken to avoid pregnancy in women taking peginterferon alfa-2a and in female partners of men taking peginterferon alfa-2a
  • Ribavirin causes hemolytic anemia; associated anemia may result in worsening of cardiac disease
  • Because ribavirin is genotoxic and mutagenic, consider it a potential carcinogen
Autoimmune hepatitis
Decompensated liver disease (Child-Pugh >6 [class B and C])
Contraindications for combination therapy with ribavirin:

  • Pregnant women and men whose female partners are pregnant.
  • Hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
  • Creatinine clearance less than 50 mL/min
Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others reported in patients with and without a previous psychiatric disorder during therapy and follow-up; psychoses, hallucinations, bipolar disorders, and mania have been observed in patients treated with interferon alpha should be used with caution in patients with a history of psychiatric disorders; discontinue if severe depression develops
If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation or aggressive behavior towards others identified, discontinue therapy and follow patient closely, with psychiatric intervention as appropriate; narcotics, hypnotics, or sedatives may be used concurrently with caution and patients should be closely monitored until adverse effects resolved
Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, and sarcoidosis, some resulting in respiratory failure or patient deaths, may be induced or aggravated by therapy; recurrence of respiratory failure has been observed with interferon rechallenge; monitor
Development or exacerbation of autoimmune disorders (e.g., thyroiditis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, rheumatoid arthritis, interstitial nephritis, systemic lupus erythematosus, and psoriasis) observed; use with caution in patients with autoimmune disorders
Caution in pre-existing cardiac abnormalities &/or advanced cancer Ischemic and hemorrhagic cerebrovascular events reported
Pancreatitis and ulcerative or hemorrhagic/iscemic colitis may occur
Severe decreases in neutrophil or platelet counts reported
Hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including peginterferon alpha 2b; cirrhotic CHC patients co-infected with HIV receiving highly active antiretroviral therapy (HAART) and alpha interferons with or without ribavirin appear to be at increased risk for development of hepatic decompensation compared to patients not receiving HAART; monitor clinical status and hepatic function during treatment and discontinue immediately if decompensation (Child-Pugh score greater than 6) observed
Monitor patients with impaired renal function, for signs and symptoms of interferon toxicity, including increases in serum creatinine; adjust dose or discontinue therapy accordingly
Serious, acute hypersensitivity reactions and cutaneous eruptions reported
Dental/periodontal disorders reported with combination therapy Hypertriglyceridemia may result in pancreatitis (e.g., triglycerides greater than 1000 mg/dL)
Weight loss and growth inhibition reported during combination therapy in pediatric patients
Long-term growth inhibition (height) reported in some patients
Peripheral neuropathy observed when used in combination with telbivudine
Risk of visual impairment and retinal disorders; discontinue if ophthalmologic problems develop
Use with caution in patients with endocrine disorder: thyroid disease; DM prone to ketoacidosis
Pre-existing cardiac abnormalities &/or advanced cancer
AIDS-related Kaposi's Sarcoma: do not use in patients w/ rapidly progressive disease
Discontinue if acute hypersensitivity occurs
Risk of exacerbation of preexisting psoriasis & sarcoidosis; risk of developing new sarcoidosis
Patients should be well hydrated during initial treatment
If platelets <50,000/mm³, do not administer IM (may admin SC)
Do not use the 18 million IU or 50 million IU powder for injection or the18 million IU multidose vial for condylomata acuminata
Increases risk of hepatic decompensation and death in patients with cirrhosis; any patient developing liver function abnormalities during treatment should be monitored closely and if appropriate, treatment should be discontinued
Numerous cardiotoxicities, including arrhythmias, ischemia, infarction, and cardiomyopathy occur during and immediately after infusion

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