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Dasabuvir / ombitasvir / paritaprevir / ritonavir Pregnancy and Breastfeeding Warnings

Dasabuvir / ombitasvir / paritaprevir / ritonavir is also known as: Viekira Pak, Viekira XR

Dasabuvir / ombitasvir / paritaprevir / ritonavir Pregnancy Warnings

DASABUVIR, OMBITASVIR, PARITAPREVIR/RITONAVIR (in combination): Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. -RITONAVIR (alone): Animal studies with have revealed evidence of developmental toxicity in rats (early resorption, decreased fetal body weight, ossification delays, developmental variations) and rabbits (resorptions, decreased litter size, decreased fetal weights) at maternally toxic doses (75 mg/kg/day and 110 mg/kg/day, respectively). In rats given 35 mg/kg/day, the incidence of cryptorchidism was slightly increased. There are no controlled data in human pregnancy; no developmental effects identified in humans exposed to ritonavir during pregnancy and no association with cryptorchidism. To monitor maternal-fetal outcomes of hepatitis C virus/HIV-1 coinfected pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. 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.

This product should be used during pregnancy only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: B3 US FDA pregnancy category: B Comments: -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.

See references

Dasabuvir / ombitasvir / paritaprevir / ritonavir Breastfeeding Warnings

According to some experts, breastfeeding is not recommended during use of this product and should be discontinued before starting therapy. Excreted into human milk: Unknown (dasabuvir, ombitasvir, paritaprevir); Yes (ritonavir) Excreted into animal milk: Yes (dasabuvir, 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.

See references

References for pregnancy information

  1. "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprevir/ritonavir)." AbbVie US LLC, North Chicago, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." 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.

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