Sofosbuvir warnings and precautions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Warnings And Precautions
Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin
Ribavirin may cause birth defects and/or death of the exposed fetus and animal studies have shown that interferons have abortifacient effects [See Contraindications (4)]. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
When SOVALDI is used in combination with Ribavirin or peginterferon alfa/Ribavirin, women of childbearing potential and their male partners must use two forms of effective contraception during treatment and for at least 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. There are no data on the effectiveness of systemic hormonal contraceptives in women taking SOVALDI, therefore, two non-hormonal methods of contraception should be used during treatment with SOVALDI and concomitant Ribavirin [See Contraindications (4) and Use in Specific Populations (8.1)]. Refer also to the prescribing information for Ribavirin.
Use with Potent P-gp Inducers
Drugs that are potent P-gp inducers in the intestine (e.g., rifampin, St. John's wort) may significantly decrease sofosbuvir plasma concentrations and may lead to a reduced therapeutic effect of SOVALDI. Rifampin and St. John's wort should not be used with SOVALDI [See Drug Interactions (7.2)].[1]
References
- ↑ "SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]". Retrieved 7 January 2014.
Adapted from the FDA Package Insert.