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Interferon alfacon-1 Pregnancy and Breastfeeding Warnings

Interferon alfacon-1 is also known as: Infergen

Interferon alfacon-1 Pregnancy Warnings

Interferon alfacon-1 has been assigned to pregnancy category C by the FDA. When used with ribavirin, the combination therapy has been assigned to pregnancy category X by the FDA. Animal studies have revealed evidence of embryolethality and abortifacient properties in cynomolgus and rhesus monkeys at 9 to 81 times the human dose (based on body surface area) of interferon alfacon-1. Animal studies have revealed evidence of significant teratogenicity and/or embryocidal effects in all species exposed to ribavirin. There are no controlled data in human pregnancy. The manufacturer recommends interferon alfacon-1 should not be given during pregnancy. Interferon alfacon-1 plus ribavirin combination therapy is contraindicated in pregnant women and in men whose female partners are pregnant.

Males and females treated with interferon alfacon-1 should be advised to use effective contraception. If a woman becomes pregnant or plans to become pregnant while taking interferon alfacon-1, she should be advised of the possible risks to the fetus. Ribavirin may cause birth defects and/or death of the unborn infant. Extreme care must be observed to avoid pregnancy in female patients and in female partners of male patients. Ribavirin should not be initiated until a negative pregnancy test has been obtained immediately prior to the planned start of therapy. The manufacturer recommends that patients undergo pregnancy tests prior to therapy, then monthly during treatment, and for 6 months following treatment cessation. Patients should use at least 2 effective forms of birth control simultaneously. If ribavirin is used during pregnancy or if the patient becomes pregnant while taking ribavirin, the possible risk to the fetus should be discussed with the patient. If pregnancy occurs in a patient or partner of a patient during interferon alfacon-1 plus ribavirin combination therapy or during the 6 months after treatment, physicians should report such cases by calling the Ribavirin Pregnancy Registry at 1-800-593-2214 (USA).

Interferon alfacon-1 Breastfeeding Warnings

There are no data on the excretion of interferon alfacon-1 or ribavirin into human milk. Because many drugs are excreted into human milk, the manufacturer recommends that caution be used when administering interferon alfacon-1 to nursing women. The manufacturer also recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or to delay or discontinue ribavirin, taking into account the importance of interferon alfacon-1 plus ribavirin combination therapy to the mother.

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