Riociguat Pregnancy and Breastfeeding Warnings
Brand names: Adempas
Medically reviewed by Drugs.com. Last updated on Feb 8, 2024.
Riociguat Pregnancy Warnings
Animal studies have revealed evidence of teratogenicity, embryotoxicity, placental transfer, and reproductive toxicity. There are no controlled data in human pregnancy.
AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Use is contraindicated.
AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned
Comments:
-A negative pregnancy test must be obtained prior to initiation, monthly during treatment, and for 1 month after discontinuation.
-Adequate methods of contraception must be used during treatment and for 1 month after discontinuing treatment.
-Patients may choose one highly effective form of contraception (e.g., intrauterine device, contraceptive implants, tubal sterilization) or a combination of methods (e.g., hormone method with barrier method or 2 barrier methods); if a partner's vasectomy is the chosen method, a hormone or barrier method must also be used concurrently.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Riociguat Breastfeeding Warnings
Use is nor recommended. According to some authorities, use is contraindicated.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-The effects in the nursing infant are unknown.
-Hypotension may occur in breasted infants.
See also
References for pregnancy information
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Adempas (riociguat). Bayer Pharmaceutical Inc. 2013.
References for breastfeeding information
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Adempas (riociguat). Bayer Pharmaceutical Inc. 2013.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
