Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Integrase Inhibitors

Raltegravir (Isentress, RAL)

Last Updated: December 7, 2018; Last Reviewed: December 7, 2018

Excerpt from Table 10a
Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendations Use in Pregnancy
Raltegravir
(RAL)
Isentress
Isentress HD
RAL (Isentress)
Film-Coated Tablets:
  • 400 mg
Chewable Tablets:
  • 25 mg
  • 100 mg

RAL (Isentress HD)
Film-Coated Tablets:
  • 600 mg
Standard Adult Dose:
  • RAL 400-mg, film-coated tablets twice daily without regard to food
  • Two RAL 600-mg, film-coated tablets (1200 mg) once daily for ARV-naive patients or patients who are already virologically suppressed on an initial regimen of RAL 400 mg twice daily without regard to food
  • Chewable and oral suspension doses are not interchangeable with either film-coated tablets or each other
With Rifampin:
  • Two RAL 400-mg, film-coated tablets (800 mg) twice daily without regard to food

PK in Pregnancy:
  • Decreased drug concentrations in third trimester not of sufficient magnitude to warrant a change in dosing.

Dosing in Pregnancy:
  • No change in dose is indicated.
  • Once-daily dosing (i.e., two RAL 600-mg, film-coated tablets) should not be used in pregnant women until more information is available.
High placental transfer to fetus.b

No evidence of human teratogenicity (can rule out 1.5-fold increase in overall birth defects).

Case report of markedly elevated liver transaminases with RAL use in late pregnancy. Severe, potentially life-threatening, and fatal skin and HSRs have been reported in nonpregnant adults.

Chewable tablets contain phenylalanine.

To maximize RAL absorption, doses should not be administered within 2 hours of ingestion of any preparation containing minerals such as iron or calcium, including prenatal vitamins.

a Individual ARV drug doses may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Guidelines, Appendix B, Table 8).
b Placental transfer categories are determined by mean or median cord blood/maternal delivery plasma drug ratio:
          High: >0.6
          Moderate: 0.3–0.6
          Low: <0.3

Key to Acronyms: ARV = antiretroviral; BIC = bictegravir; HSR = hypersensitivity reaction; PK = pharmacokinetic; RAL = raltegravir

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