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Tazemetostat Pregnancy and Breastfeeding Warnings

Brand names: Tazverik

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

Tazemetostat Pregnancy Warnings

Administration in pregnant animals resulted in dose-dependent increases in skeletal developmental abnormalities at maternal exposures approximately 1.5 times the adult human exposure (at the 800 mg orally 2 times a day). Major findings included increased post implantation loss, missing digits, fused vertebrae, domed heads and fused bones of the skull, cleft palate, snout, and reduced fetal body weights. There are no controlled data in human 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 should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action and findings in animal models, this drug can cause fetal harm when administered during pregnancy; no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Pregnancy status of patients of childbearing potential should be verified before starting this drug.
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-This drug can render some hormonal contraceptives ineffective.
-Advise females of reproductive potential to use effective non-hormonal contraception during therapy and for 6 months after.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for at least 3 months after.
-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

Tazemetostat Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 1 week after the final dose.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions.

See references

References for pregnancy information

  1. Product Information. Tazverik (tazemetostat). Epizyme, Inc. 2020.

References for breastfeeding information

  1. Product Information. Tazverik (tazemetostat). Epizyme, Inc. 2020.

Further information

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