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Glecaprevir / pibrentasvir Pregnancy and Breastfeeding Warnings

Glecaprevir / pibrentasvir is also known as: Mavyret

Medically reviewed on August 11, 2017.

Glecaprevir / pibrentasvir Pregnancy Warnings

Animal studies with glecaprevir have failed to reveal evidence of embryofetal toxicity in rats (exposures up to 53 times the exposure in humans at the recommended human dose [RHD]); in rabbits, maternal toxicity (anorexia, lower body weight, lower body weight gain) with some embryofetal toxicity (increased postimplantation loss, increased number of resorptions, decreased fetal body weight) prevented evaluation of glecaprevir at clinical exposures (highest exposure reached in rabbits was 0.07 times the exposure in humans at RHD). Animal studies with pibrentasvir have failed to reveal evidence of embryofetal toxicity in mice and rabbits (exposures up to 51 and 1.5 times the exposure in humans at RHD, respectively). 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.

According to some authorities: As a precaution, use is not recommended.

US FDA pregnancy category: Not assigned.

Risk summary: No adequate data available on use of this drug in pregnant women to inform a drug-related risk.

See references

Glecaprevir / pibrentasvir Breastfeeding Warnings

According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (both components)

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Mavyret (glecaprevir-pibrentasvir)." Abbott Pharmaceutical, Abbott Park, IL.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Mavyret (glecaprevir-pibrentasvir)." Abbott Pharmaceutical, Abbott Park, IL.

Further information

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

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