Riociguat Pregnancy and Breastfeeding Warnings

Brand names: Adempas

Medically reviewed by Drugs.com. Last updated on Feb 8, 2024.

Riociguat Pregnancy Warnings

Use is contraindicated during pregnancy.

AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned

Risk summary: Based on findings from animal studies, this drug can cause fetal harm and miscarriage when administered to a pregnant woman.

Comments:
-Obtain a negative pregnancy test prior to starting treatment, monthly during treatment, and for 1 month after discontinuation.
-Reliable methods of contraception must be used during therapy and for 1 month after discontinuation.
-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 should be concurrently used.
-Apprise patients of the potential harm to the fetus if this drug is used during pregnancy, and to contact their healthcare provider if they become or suspect they are pregnant.
-Counsel patients on pregnancy planning and prevention, including emergency contraception, or consult a gynecologist.

Animal studies have revealed evidence of embryotoxicity and teratogenicity. Administration of this drug to pregnant animals during the period of organogenesis resulted in abortions, cardiac malformations, and fetal toxicity at exposures ranging from approximately 2 to 13 times the maximum recommended human dose. 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.

See references

Riociguat Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.
-A decision should be made to discontinue breastfeeding or discontinue/abstain from therapy, taking into account the mother's clinical need for this drug.
-According to some experts, this drug should be absent from breastmilk 3 days after the last dose.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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