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Pemigatinib Pregnancy and Breastfeeding Warnings

Brand names: Pemazyre

Medically reviewed by Drugs.com. Last updated on Aug 1, 2023.

Pemigatinib Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: D
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.
-Women of childbearing potential should avoid becoming pregnant, and men should avoid fathering a child during treatment with this drug.
-Females of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.
-Males with female partners of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.
-The use of barrier methods as a second form of contraception is recommended to avoid 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 have revealed evidence of fetotoxicity and embryofetal death. After once daily oral dosing to pregnant rats during organogenesis, 100% embryofetal mortality was observed due to postimplantation loss; this occurred at doses about 0.6 times the human exposure based on AUC at the clinical dose of 13.5 mg. Fetal survival was unaffected at 0.1 mg/kg/day; however, once daily oral administration at the 0.1 mg/kg dose level (approximately 0.2 times the human exposure based on AUC at the clinical dose of 13.5 mg) resulted in reduced mean fetal body weight and an increase in fetal skeletal and visceral malformations, major blood vessel variations, and reduced ossification. 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 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

Pemigatinib Breastfeeding Warnings

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

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

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. Pemazyre (pemigatinib). Incyte Biosciences UK Ltd. 2023.
  2. Product Information. Pemazyre (pemigatinib). Incyte Corporation. 2022;SUPPL-2.
  3. Product Information. Pemazyre (pemigatinib). Specialised Therapeutics Alim Pty Ltd. 2023;20231019_PEM_AU_PI_S.

References for breastfeeding information

  1. Product Information. Pemazyre (pemigatinib). Incyte Biosciences UK Ltd. 2023.
  2. Bethesda (MD): National Institute of Child Health and Human Development (US). Pemigatinib - Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK591126/ 2023.
  3. Product Information. Pemazyre (pemigatinib). Incyte Corporation. 2022;SUPPL-2.
  4. Product Information. Pemazyre (pemigatinib). Specialised Therapeutics Alim Pty Ltd. 2023;20231019_PEM_AU_PI_S.

Further information

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