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Riociguat Pregnancy and Breastfeeding Warnings

Riociguat is also known as: Adempas

Medically reviewed on September 7, 2017

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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated.

AU TGA pregnancy category: X
US FDA pregnancy category: X

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.

See references

Riociguat Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother.
-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 references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Adempas (riociguat)." Bayer Pharmaceutical Inc, West Haven, CT.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Adempas (riociguat)." Bayer Pharmaceutical Inc, West Haven, CT.

Further information

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

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