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DRUG INTERACTIONS Drug Interactions
No formal drug interaction studies have been conducted with INFERGEN. INFERGEN should be used cautiously in patients who are receiving agents that are known to cause myelosuppression or with agents known to be metabolized via the cytochrome P-450 pathway.9 Patients taking drugs that are metabolized by this pathway should be monitored closely for changes in the therapeutic and/or toxic levels of concomitant drugs.
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OVERDOSAGE
In INFERGEN trials, the maximum overdose reported was a dose of 150 mcg INFERGEN administered SC in a patient enrolled in a phase 1 advanced malignancy trial. The patient received 10 times the prescribed dosage for 3 days. The patient experienced a mild increase in anorexia, chills, fever, and myalgia. Increases in ALT (15 to 127 IU/L), aspartate transaminase (AST) (15 to 164 IU/L), and lactic dehydrogenase (LDH) (183 to 281 IU/L) were reported. These laboratory values returned to normal or to the patient’s baseline values within 30 days.
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CONTRAINDICATIONS
INFERGEN is contraindicated in patients with
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REFERENCES
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Alton K, Stabinsky Y, Richards R, et al. Production, characterization and biological effects of recombinant DNA derived human IFN-α and IFN-γ analogs. In: De Maeyer E, Schellekens H, eds. The Biology of the Interferon System 1983. Elsevier Science Publishers: Amsterdam. 1983;119-128.
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Blatt LM, Davis J, Klein SB, Taylor MW. The biologic activity and molecular characterization of a novel synthetic interferon-alpha species, consensus interferon. J Interferon Cytokine Res. 1996;16:489-499.
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Fish EN, Banerjee K, Levine HL, Stebbing N. Antiherpetic effects of a human alpha interferon analog, IFN-alpha Con1, in hamsters. Antimicrob Agents Chemother. 1986;30:52-56.
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Trown PW, Willis RJ, Kamm JJ. The preclinical development of Roferon®-A. Cancer. 1986;57 (8 Suppl.):1648-1656.
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Tong MJ, Reddy KR, Lee WM, Consensus Interferon Study Group, et al. Treatment of chronic hepatitis C with consensus interferon: a multicenter, randomized, controlled trial. Hepatology. 1997;26:747-754.
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Knodell RG, Ishak KG, Black WC, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology. 1981;1:431-435.
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Heathcote E, Keeffe E, Lee S, et al. Retreatment of chronic hepatitis C with consensus interferon. Hepatology. 1998;27:1136-1143.
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Vial T, Descotes J. Clinical toxicity of interferons. Drug Safety. 1994;10: 115-150.
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Horsmans Y, Brenard R, Geubel AP. Short report: interferon-α decreases 14C- aminopyrine breath test values in patients with chronic hepatitis C. Aliment Pharmacol Ther. 1994;8:353-355.
This product and its use are covered by the following US Patent Nos.: 5,372,808; 5,541,293; 5,980,884.
U.S. License number 1735
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