Intron A Rebetol
"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is updating labeling information for the hepatitis C antivirals ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and sofosbuvir (Sovaldi, Gilead Sciences) after th"...
Intron A - Rebetol
In combination REBETOL/ INTRON A clinical trials, the maximum overdose reported was a dose of 39 million units of INTRON A (13 subcutaneous injections of 3 million IU each) taken with 10 g of REBETOL (fifty 200-mg capsules) in an investigator-initiated trial. The patient was observed for 2 days in the emergency room during which time no adverse event from the overdose was noted.
Combination REBETOL/INTRON A therapy must not be used by women who are pregnant or by men whose female partners are pregnant. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients taking combination REBETOL/INTRON A therapy. Combination REBETOL/INTRON A therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the 6 months after treatment has been concluded. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL Capsules. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment s.o.s. physicians are encouraged to report such cases by calling (800) 727-7064. See boxed CONTRAINDICATIONS AND WARNINGS below. See WARNINGS.
REBETOL Capsules in combination with INTRON A Injection is contraindicated in patients with a history of hypersensitivity to ribavirin and/or alpha interferon or any component of the capsule and/or injection.
Patients with autoimmune hepatitis must not be treated with combination REBETOL/INTRON A therapy.
Combination REBETOL/INTRON A therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in female patients, and in female partners of male patients who are taking combination REBETOL/INTRON A therapy. Women of childbearing potential and men must use two reliable forms of effective contraception during treatment and during the 6-month posttreatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species studied. See WARNINGS.
REBETOL monotherapy is not effective for the treatment of chronic hepatitis C and should not be used for this indication. See WARNINGS.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Intron A - Rebetol Information
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