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Ombitasvir / paritaprevir / ritonavir Pregnancy and Breastfeeding Warnings

Ombitasvir / paritaprevir / ritonavir is also known as: Technivie

Ombitasvir / paritaprevir / ritonavir Pregnancy Warnings

Animal studies have revealed evidence of teratogenicity at exposures higher than the recommended clinical dose. In rabbits, low incidences of malformations (microphthalmia, absent incisors) were seen at ombitasvir exposures 4-fold higher than AUC exposure at recommended clinical dose. In mice, open eyelid occurred at a higher rate in fetuses of dams given ombitasvir (relationship unclear); the major ombitasvir human metabolites (inactive) were not teratogenic in mice at exposures about 26 times higher than in humans at recommended clinical dose. In mice, low incidences of malformations (open eyelids) were seen at paritaprevir/ritonavir exposures 32/8-fold higher than human exposure at recommended clinical dose. In rats, paritaprevir/ritonavir had no effect on embryofetal viability or fertility at exposures 2- to 8-fold higher than human exposure at recommended clinical dose. Minimal transfer of ombitasvir- and paritaprevir-derived materials through the placenta occurred in pregnant rats. There are no controlled data in human pregnancy. Pregnancy must be avoided in female patients and female partners of male patients using a ribavirin-containing regimen. Ribavirin is contraindicated in pregnant women and men whose female partners are pregnant; all animal species exposed to ribavirin have shown significant teratogenic and/or embryocidal effects. Females of reproductive potential and their male partners should not receive ribavirin unless they are using effective contraception during therapy and for 6 months after therapy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

UK: This drug should not be used during pregnancy or in females of reproductive potential not using effective contraception. US: This drug should be used during pregnancy only if clearly needed. US FDA pregnancy category: B Comments: -Coadministration with ethinyl estradiol is contraindicated. -Use of a ribavirin-containing regimen is contraindicated in pregnant women and in the male partners of women who are pregnant; if applicable, the manufacturer product information for ribavirin should be consulted. -Effective contraception is required during ribavirin therapy and for 6 months after the last dose; local protocol should be consulted regarding contraception timing.

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Ombitasvir / paritaprevir / ritonavir Breastfeeding Warnings

According to some experts, 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 (ombitasvir, paritaprevir); Yes (ritonavir) Excreted into animal milk: Yes (ombitasvir, paritaprevir [and its hydrolysis product M13]) Comments: -Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this product. -The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this product or the mother's underlying condition should be considered. -If applicable, the manufacturer product information for ribavirin should be consulted.

RITONAVIR: In 1 study, nursing mothers used ritonavir as part of a clinical trial to evaluate maternal-to-child transmission of HIV infection. Doses, dose regimens, and breast milk collection times were not provided. Ritonavir was not detected in any of 60 breast milk samples. A total of 23 milk samples were obtained (at birth, 1 month, 3 months, and/or 6 months postpartum) from 9 mothers using lopinavir 400 mg plus ritonavir 100 mg twice a day as part of combination antiretroviral therapy. Their breastfed infants had a total of 6 blood samples analyzed at 1 month, 3 months, and/or 6 months postpartum. Milk samples and infant blood samples were collected at about 4.5 hours (range: 3.5 to 6 hours) after the previous maternal dose and about 30 minutes (range: 20 to 60 minutes) after nursing. The ritonavir level in breast milk averaged 79 mcg/L (range: 31 to 193 mcg/L). The ritonavir plasma level in infants averaged 7 mcg/L (range: 0 to 138 mcg/L), which was about 12% (range: 11% to 40%) of the maternal serum level. Starting at delivery, 30 mothers used zidovudine 300 mg, lamivudine 150 mg, lopinavir 400 mg, and ritonavir 100 mg orally twice a day; they were studied at 6, 12, or 24 weeks postpartum (10 at each time). On the study day, breast milk samples and maternal and infant plasma samples were collected before the maternal morning dose (about 14.9 hours after the prior evening dose) and 2, 4, and 6 hours after the maternal dose. Detectable quantities (at least 10 mcg/L) of ritonavir were found in 112 of 121 breast milk samples; breast milk level averaged 79 mcg/L over the 6 hours. Infants could breastfeed freely during the study period. Ritonavir was undetectable (less than 10 mcg/L) in all of the 115 infant plasma samples. Ritonavir was measured in 117 breastfed (90% exclusive) infants whose mothers were using lopinavir plus ritonavir for HIV infection during pregnancy and postpartum. At 8 and 12 weeks postpartum, none of the infants had detectable ritonavir plasma levels. At 12 weeks postpartum, ritonavir was detectable in hair samples of 91% of infants; concentration averaged 0.15 ng/mg of hair (range: 0.03 to 0.42 ng/mg). According to author interpretation, infant exposure to ritonavir during breastfeeding is negligible.

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References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Technivie (ombitasvir/paritaprevir/ritonavir)." AbbVie US LLC, North Chicago, IL.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. 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 -]):
  3. "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprevir/ritonavir)." AbbVie US LLC, North Chicago, IL.
  4. "Product Information. Technivie (ombitasvir/paritaprevir/ritonavir)." AbbVie US LLC, North Chicago, IL.

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