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Roferon-A (Interferon Alfa-2A (Recombinant)) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Roferon-A has not been tested for its carcinogenic potential.

Mutagenesis

A. Internal Studies — Ames tests using six different tester strains, with and without metabolic activation, were performed with Roferon-A up to a concentration of 1920 µg/plate. There was no evidence of mutagenicity.

Human lymphocyte cultures were treated in vitro with Roferon-A at noncytotoxic concentrations. No increase in the incidence of chromosomal damage was noted.

B. Published Studies — There are no published studies on the mutagenic potential of Roferon-A. However, a number of studies on the genotoxicity of human leukocyte interferon have been reported.

A chromosomal defect following the addition of human leukocyte interferon to lymphocyte cultures from a patient suffering from a lymphoproliferative disorder has been reported.

In contrast, other studies have failed to detect chromosomal abnormalities following treatment of lymphocyte cultures from healthy volunteers with human leukocyte interferon.

It has also been shown that human leukocyte interferon protects primary chick embryo fibroblasts from chromosomal aberrations produced by gamma rays.

Impairment of Fertility

Roferon-A has been studied for its effect on fertility in Macaca mulatta (rhesus monkeys). Nonpregnant rhesus females treated with Roferon-A at doses of 5 and 25 MIU/kg/day have shown menstrual cycle irregularities, including prolonged or shortened menstrual periods and erratic bleeding; these cycles were considered to be anovulatory on the basis that reduced progesterone levels were noted and that expected increases in preovulatory estrogen and luteinizing hormones were not observed. These monkeys returned to a normal menstrual rhythm following discontinuation of treatment.

OVERDOSAGE

There are no reports of overdosage, but repeated large doses of interferon can be associated with profound lethargy, fatigue, prostration, and coma. Such patients should be hospitalized for observation and appropriate supportive treatment given.

CONTRAINDICATIONS

Roferon-A is contraindicated in patients with:

  • Hypersensitivity to Roferon-A or any of its components
  • Autoimmune hepatitis
  • Hepatic decompensation (Child-Pugh class B and C) before or during treatment

Roferon-A is contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurologic and other complications in neonates and infants, which are sometimes fatal.

REFERENCES

  1. Trown PW, et al. Cancer. 1986; 57(suppl):1648-1656.
  2. Itri LM, et al. Cancer. 1987; 59:668-674.
  3. Jones GJ, Itri LM. Cancer. 1986; 57(suppl):1709-1715.
  4. Foon KA, et al. Blood. 1984; 64(suppl 1):164a.
  5. Quesada Jr, et al. Cancer. 1986; 57(suppl):1678-1680.
  6. The Italian Cooperative Study Group on CML. N Engl J Med. 1994; 330:820-825.
  7. Sokal JE, et al. Blood. 1984; 63(4):789-799.
  8. Dow LW, et al. Cancer. 1991; 68:1678-1684.
  9. Krown SE, et al. Proc Am Soc Clin Oncol. 1988; 7:1.
  10. Williams SJ, et al. Lancet. 1987; 2:939-941.
  11. Jonkman JHG, et al. Br J Clin Pharmacol. 1989; 2(27):795-802.
  12. Maybee D, et al. Proc Annu Meet Am Soc Clin Oncol. 1992; 11:A950.

Revised: January 2008

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