Macitentan / tadalafil Pregnancy and Breastfeeding Warnings

Brand names: Opsynvi

Medically reviewed by Drugs.com. Last updated on May 20, 2024.

Macitentan / tadalafil Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category: Not assigned

Risk summary:
-Macitentan: Based on findings from animal studies, this component can cause fetal death and fetal harm when administered to a pregnant female patient.
-Tadalafil: Available data on the use of this component in pregnant women have not identified a drug-related risk.

Comments:
-Effective contraception is required during therapy and for 1 month after the last dose.
---Choices include 1 highly effective method (intrauterine devices, contraceptive implants, tubal sterilization) or a combination of methods (hormone and barrier methods or 2 barrier methods); if a partner's vasectomy is the selected form of contraception, a hormone or barrier method is also required.
---Patients should be counseled on pregnancy planning and prevention (including emergency contraception).
-Female patients of reproductive potential must confirm negative pregnancy status with pregnancy testing prior to starting treatment, monthly during treatment, and 1 month after stopping treatment with this drug.
-If pregnancy is suspected or onset of menses is delayed, patients should immediately contact their health care provider for further testing.
-Increased fetal and maternal morbidity and mortality, including heart failure, intrauterine growth restriction, premature labor/preterm birth, spontaneous abortion, and/or stroke have been associated with pulmonary arterial hypertension in pregnancy.
-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.

Animal studies with macitentan have revealed evidence of embryofetal toxicity, including fetolethality and teratogenicity; macitentan was teratogenic in rabbits and rats at all doses tested. Animal studies with tadalafil have failed to reveal evidence of teratogenicity or embryofetal toxicity at exposures up to 7 times the exposure at the maximum recommended human dose (based on AUC); tadalafil and/or its metabolites were shown to cross the placenta in rats, resulting in fetal exposure. There are no controlled data in human pregnancy with this combination drug.

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

Macitentan / tadalafil Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown (macitentan, tadalafil)
Excreted into animal milk: Data not available (macitentan); Yes (tadalafil)

Comments:
-The effects on the nursing infant or milk production are unknown.
-There is the potential for serious adverse reactions in breastfed infants.

See references

Further information

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