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interferon [IFN]-alfa 2a (Roferon-A)
Tradename: Roferon-A.
Indications:
- hairy cell leukemia
- AIDS-related Kaposi's sarcoma
- chronic phase of Philadelpha chromosome positive CML
- bladder cancer [3]
- mycosis fungoides Sezary syndrome
- cutaneous T-cell lymphoma
- multiple myeloma
- carcinoid syndrome [3]
- chronic hepatitis B, chronic hepatitis C [3]
- pulmonary capillary hemangiomatosis [3]
- hemangioma [3]
Contraindications:
Warnings:
1) use with caution in patients with:
a) seizure disorders
b) compromised CNS dysfunction
c) pre-existing cardiac disease
d) severe hepatic or renal insufficiency
e) myelosuppression
2) safety & efficacy in children < 18 years of age is not established
3) mental status changes may occur while on therapy
Pregnancy category C
Safety in lactation ?
Dosage:
1) refer to individual protocols
2) stable for 24 hours under refrigeration after reconstitution with sterile water
3) solution reconstituted with diluent is stable for one month when refrigerated
4) do not change brands as changes in dosage may result
Injection:
1) 3 million units/mL (1 mL)
2) 6 million units/mL (3 mL)
3) 9 million units/mL (0.9 mL)
4) 36 million units/mL (1 mL)
Powder for injection: 6 million units/mL when reconstituted
Pharmacokinetics:
1) bioavailability 90% SC
2) peak serum concentration in 6-8 hours SC
3) elimination 1/2life of 4-8 hours
4) filtered by renal tubules
5) volume of distribution 31 L (320-720 L in leukemia patients receiving infusions)
6) proteolytic degradation during renal tubular reabsorption
Monitor:
1) complete blood count (CBC)
2) electrolytes, BUN & creatinine
3) liver function tests
4) electrocardiogram in patients with cardiac disease or in advanced stage of cancer
5) baseline chest x-ray
Adverse effects:
1) not common (1-10%)
- hepatotoxicity, dry skin, diaphoresis, leg cramps, blurred vision, neurotoxicity, peripheral neuropathy, stomatitis, alopecia
2) uncommon (< 10%)
- cardiotoxicity, hypothyroidism, weight loss, arrhythmias, hypotension, nasal congestion, edema, ECG abnormalities, confusion, sensory neuropathy, fever/chills/rigors, headache, anemia, thrombocytopenia, increased serum transaminases, myalgias, arthralgias, proteinuria, hyperuricemia, renal insufficiency, cough, chest pain, neutralizing antibodies
Drug interactions:
1) acyclovir: possible synergistic effect
2) zidovudine (AZT): possible additive myelosuppression
3) theophylline clearance may be decreased
4) vinblastine
a) possible increased interferon toxicity
b) increased incidence of paresthesias
5) vidarabine may increase neurotoxicity
Specific
peginterferon alfa 2a (Pegasys)
General
biological response modifier; immune factor; immunomodulator; biomodulator
interferon-alfa
References
- Kaiser Permanente Northern California Regional Drug
Formulary, 1998
- Geriatric Dosage Handbook, 6th edition, Selma et al eds,
Lexi-Comp, Cleveland, 2001
- Deprecated Reference