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Rifapentine Pregnancy and Breastfeeding Warnings

Rifapentine is also known as: Priftin

Medically reviewed on December 11, 2017

Rifapentine Pregnancy Warnings

Animal studies have revealed evidence of embryofetal toxicity and major fetal malformations. Cleft palate, right aortic arch, delayed ossification, and increased numbers of ribs were reported in models given 40 mg/kg/day during organogenesis; decreased pup weights, gestational survival, increased resorptions, post implantation loss, decreased mean fetal weight, increased numbers of stillborn pups, and slightly increased pup mortality during lactation were noted in animal models given doses of 20 mg/kg/day late in gestation. Ovarian agenesis, pes varus, arrhinia, microphthalmia, and ossified facial tissue irregularities occurred at doses of 10 to 40 mg/kg in another animal model. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Comments:
-Treatment with vitamin K in mothers and infants who develop post-natal hemorrhage associated with use during the last few weeks of pregnancy.
-The reliability of oral or other systemic hormonal contraceptives may be affected; adequate methods of alternative contraception should be encouraged.

See references

Rifapentine Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown.
-This drug may produce a red-orange discoloration of breast milk.
-The American Academy of Pediatrics considers rifampin (rifampicin), a closely related agent, compatible with breastfeeding.
-The US Centers for Disease Control and Prevention state that breastfeeding should not be discouraged in patients taking this drug.

Animal models given this drug late in gestation through lactation had a slight increase in pup mortality.

See references

References for pregnancy information

  1. "Product Information. Priftin (rifapentine)." Hoechst Marion-Roussel Inc, Kansas City, MO.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Priftin (rifapentine)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  3. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

Further information

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

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