Belzutifan Pregnancy and Breastfeeding Warnings

Brand names: Welireg

Medically reviewed by Drugs.com. Last updated on Nov 6, 2023.

Belzutifan Pregnancy Warnings

Safety has not been established during pregnancy. Use should be avoided.

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

Risk summary: This drug may cause fetal harm when administered to a pregnant woman.

Comments:
-Based on animal studies, this drug can cause embryo-fetal harm, including fetal loss when administered during pregnancy.
- There are no available data on the use of this drug in pregnant women to evaluate a drug-associated risk.
-Adequate methods of contraception should be encouraged.
-Females of reproductive potential should use effective nonhormonal contraception during therapy and for one week after the last dose. If patients are using hormonal contraceptives, a non-hormonal or barrier method of contraception is recommended due to the potential of this drug to reduce the efficacy of hormonal contraceptives.
-Male patients with female partners of reproductive potential should use effective contraception during therapy and for one week after the last dose.
-Negative pregnancy status in females of reproductive potential is recommended prior to initiating therapy.

Animal studies have revealed evidence of developmental toxicity. In pregnant rats given this drug during organogenesis, embryo-fetal lethality, reduced fetal body weight, and fetal skeletal malformations were observed. Testicular atrophy and hypospermia associated with decreased sperm count, and abnormal sperm morphology were observed in general toxicology studies in rats. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to
have caused, or may be expected to cause, an increased incidence of human fetal
malformations or irreversible damage. These drugs may also have adverse
pharmacological effects. Accompanying texts should be consulted for further
details

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 healthcare 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

Belzutifan Breastfeeding Warnings

Breastfeeding is not recommended during the use of this drug

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects on the nursing infant or milk production are unknown.
-Breastfeeding is not recommended during treatment with this drug and for one week after the last dose due to the potential for serious adverse reactions in breastfed children.

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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