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Indinavir Pregnancy and Breastfeeding Warnings

Indinavir is also known as: Crixivan

Indinavir Pregnancy Warnings

Indinavir has been assigned to pregnancy category C by the FDA. Animal reproduction studies with dosages proportional to normal human dosages have failed to reveal evidence of teratogenicity, but an increased incidence of supernumerary and cervical ribs was observed in the rat. Fetal plasma drug levels were 1% to 50% of maternal plasma levels, depending on the species and dosage. Hyperbilirubinemia has occurred during treatment with indinavir, and it is not known whether maternally administered indinavir will exacerbate the condition in neonates. Exacerbation of neonatal hyperbilirubinemia has been observed in rhesus monkeys after neonatal administration but has not occurred after in utero exposure. Indinavir is only recommended for use during pregnancy if the potential benefit outweighs the risk to the fetus. An optimal dose has not been determined during pregnancy. In a clinical trial (PACTG 358), 16 HIV-infected pregnant patients at 14 to 28 weeks gestation at enrollment received indinavir 800 mg every 8 hours with zidovudine and lamivudine. Average indinavir plasma levels were 78% lower than at 6 weeks postpartum. In addition, minimum plasma concentrations (Cmin) were below the level of quantification in 6 patients. Because of the lower indinavir exposure and limited safety data, the use of indinavir in HIV-infected pregnant patients is not recommended by the manufacturer. The U.S. Public Health Service Task Force considers indinavir an alternative protease inhibitor if saquinavir or nelfinavir cannot be used. Concomitant ritonavir may be required to increase indinavir plasma levels. Optimal dosages have not been established but a study to evaluate the pharmacokinetics during pregnancy of indinavir 800 mg plus ritonavir 100 mg twice daily is underway.

To monitor maternal-fetal outcomes of pregnant women exposed to indinavir, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263 (USA).

See references

Indinavir Breastfeeding Warnings

There are no data on the excretion of indinavir into human milk. It is excreted into rat milk. In addition, HIV-infected mothers should not breast-feed their infants due to the risk of transmission of HIV via breast milk.

See references

References for pregnancy information

  1. "Product Information. Crixivan (indinavir)." Merck & Co, Inc, West Point, PA.
  2. Unadkat JD, Wara DW, Hughes MD, et al. "Pharmacokinetics and safety of indinavir in human immunodeficiency virus-infected pregnant women." Antimicrob Agents Chemother 51 (2007): 783-6
  3. Kosel BW, Beckerman KP, Hayashi S, Homma M, Aweeka FT "Pharmacokinetics of nelfinavir and indinavir in HIV-1-infected pregnant women." AIDS 17 (2003): 1195-1199
  4. Ter Hofstede HJ, Koopmans PP, Burger DM "Stavudine plasma concentrations and lipoatrophy." J Antimicrob Chemother 61 (2008): 933-8
  5. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. National Institute of Health "Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Available from: URL: http://aidsinfo.nih.gov/contentfiles/PerinatalGL.pdf." ([2011 Sep 14]):

References for breastfeeding information

  1. Fairbrothers D, Kirby E, Lester RM, Wegmann PC, Marshall F, Parkin WE "Recommendations for assisting in the prevention of perinatal transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus and AIDS." MMWR Morb Mortal Wkly Rep 34 (1985): 721-34
  2. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  3. "Product Information. Crixivan (indinavir)." Merck & Co, Inc, West Point, PA.
  4. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. National Institute of Health "Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Available from: URL: http://aidsinfo.nih.gov/contentfiles/PerinatalGL.pdf." ([2011 Sep 14]):
  5. Newell ML, Dunn D, Peckham CS, Ades AE, Pardi G, Semprini AE "Risk factors for mother-to-child transmission of HIV-1." Lancet 339 (1992): 1007-12

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