interferon alfa 2b (Rx)

>10%

Fatigue (8-96%)

Fever (34-94%)

Neutropenia (92%)

Flu-like syndrome (79%)

Myalgia (28-75%)

Anorexia (1-69%)

Leukopenia (68%)

Nausea (17-66%)

Transaminases increased (13-63%)

Weakness (63%)

Headache (21-62%)

Chills (54%)

Diarrhea (2-45%)

Rigors (42%)

Depression (up to 40% of pts), suicidal ideation/ attempts, suicide

Alopecia (38%)

Dyspnea (34%)

Somnolence (33%)

Vomiting (2-32%)

Anemia (32%)

Cough (31%)

Pharyngitis (31%)

Chest pain (28%)

Xerostomia (28%)

Rash (25%)

Dizziness (24%)

Taste alteration (24%)

Abdominal pain (1-23%)

Irritability (22%)

Sinusitis (21%)

Skeletal pain (21%)

Diaphoresisi (1-21%)

Paresthesias (1-21%)

Arthralgia/back pain (19%)

Pain (18%)

Moniliasis (17%)

Thrombocytopenia (15%)

Amnesia (14%)

Constipation (14%)

Gingivitis (14%)

Impaired concentration (14%)

Malaise (14%)

Weight loss (1-13%)

Amenorrhea (12%)

BUN increased (12%)

Confusion (12%)

Insomnia (12%)

Iruritus (11%)

1-10%

Bronchitis (10%)

Dry skin (10%)

Edema (10%)

Hypoestheisa (10%)

Loose stools (10%)

Nasal congestion (10%)

Polyuria (10%)

Anxiety (9%)

Hypertension (9%)

Dermatitis (8%)

Dyspepsia (8%)

Vertigo (8%)

Agitation (7%)

Infection (7%)

SCr increased (6%)

Herpes virus infections (5%)

UTI (5%)

<1%

Acute hypersensitivity reactions; exacerbation of preexisting psoriasis & sarcoidosis

Myelosuppression, thyroid dysfunction, hepatotox., pulmonary infiltrates, retinal hemorrhage

Severe cytopenias incl aplastic anemia

Autoimmune dz, DM/hyperglycemia (rare)

Posmarketing reports

Pulmonary fibrosis

Hepatitis B virus reactivation in HCV/HBV co-infected patients

Pericarditis

Pancreatitis

Tongue pigmentation

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

Contraindications

Hypersensitivity

Autoimmune hepatitis

Decompensated liver disease (Child-Pugh >6 [class B and C])

Cautions

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

Mechanism of Action

Inhibits HBV replication; immunomodulatory actions; may induce gene transcription; interferes with oncogene expression, may change cell surface antigen expressoin; cytotoxic activity of macrophages increases

Suppresses cell proliferation

Pharmacokinetics

Half-Life: 2-3 hr (IM/SC); 2 hr (IV)

Peak Plasma Time: 3-12 hr (IM/SC); 30 min (IV)

Pharmacogenomics

Polymorphic cytokine genes (encoding IL-10, a Th2 cytokine); Th2 responses are associated with production of large amounts of antibodies

Patients with chronic hepatitis C are 5 times more likely to have a favorable response to interferon alfa if they carried the IL-10 genetic polymorphism that results in low expression of IL-10 than if they did not

IV Preparation

Intron A Solution for Injection not recommended for IV

SC Administration

SC administration is suggested for those who are at risk for bleeding or thrombocytopenic

Rotate SC injection site

Storage

Refrigerate intact vials

Powder & premixed solutions are stable at room temp for 7 d & for 30 d if refrigerated