Pregnancy of Ledipasvir and sofosbuvir in details
UK: Use should be avoided. US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: B Comments: -Use of a ribavirin-containing regimen is contraindicated in pregnant women and in the male partners of women who are pregnant; if applicable, the manufacturer product information for ribavirin should be consulted. -Effective contraception is required during ribavirin therapy and for 6 months after the last dose; local protocol should be consulted regarding contraception timing.
Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Pregnancy must be avoided in female patients and female partners of male patients using a ribavirin-containing regimen. Ribavirin is contraindicated in pregnant women and men whose female partners are pregnant; all animal species exposed to ribavirin have shown significant teratogenic and/or embryocidal effects. Females of reproductive potential and their male partners should not receive ribavirin unless they are using effective contraception during therapy and for 6 months after therapy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
See references
Ledipasvir and sofosbuvir breastfeeding
UK: Use is not recommended. US: Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for the drug; potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered. Excreted into human milk: Unknown Excreted into animal milk: Yes (Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)), GS-331007 [main circulating metabolite of Sofosbuvir (Ledipasvir and sofosbuvir)])
See references
References for pregnancy information
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- "Product Information. Harvoni (Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir))-Sofosbuvir (Ledipasvir and sofosbuvir))." Gilead Sciences, Foster City, CA.
References for breastfeeding information
- "Product Information. Harvoni (Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir))-Sofosbuvir (Ledipasvir and sofosbuvir))." Gilead Sciences, Foster City, CA.
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
References
- DailyMed. "LEDIPASVIR; SOFOSBUVIR: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA Pharm Classes. "FDA Pharmacological Classification: FDA published a final rule that amended the requirements for the content and format of approved labeling (prescribing information) for human prescription drug and biological products in January 2006.". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- FDA Orange Book. "LEDIPASVIR; SOFOSBUVIR: The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).". https://www.fda.gov/Drugs/Informatio... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
