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Raltegravir use while Breastfeeding

Drugs containing Raltegravir: Isentress, Isentress HD, Dutrebis

Medically reviewed by Drugs.com. Last updated on Jun 13, 2021.

Raltegravir Levels and Effects while Breastfeeding

Summary of Use during Lactation

Minimal published information is available on the use of raltegravir during breastfeeding. The levels in milk are low and blood levels in a breastfed infant were barely detectable. There does not appear to be any concern for infant toxicity with raltegravir in milk.

Drug Levels

Maternal Levels. A woman infected with HIV was receiving raltegravir 800 mg, emtricitabine 200 mg and tenofovir disoproxil 245 mg once daily. She exclusively breastfed her infant for 4 months, then partially until 9 months postpartum. Breastmilk samples were taken over 12- to 24-hour periods at 4 and 8 months postpartum. At 4 months postpartum, the average milk concentration over 12 hours was 0.66 mg/L with an estimated daily infant dose of 0.099 mg/kg or 0.8% of the approved daily raltegravir dosage. At 8 months postpartum, a peak milk level of about 6 mg/L occurred at about 6 hours after the dose. The level fell to about 0.3 mg/L at 24 hours after the dose.[1]

Infant Levels. A woman infected with HIV was receiving raltegravir 800 mg, emtricitabine 200 mg and tenofovir disoproxil 245 mg once daily. She exclusively breastfed her infant for 4 months, then partially until 9 months postpartum. Single blood samples taken from the infant at 4 hours after a maternal dose at 4 and 8 months postpartum were below the lower limit of quantification (0.01 mg/L) of the assay.[1]

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Lamivudine, Nelfinavir, Nevirapine, Zidovudine

References

1.
Feiterna-Sperling C, Bukkems VE, Teulen MJA, et al. Low raltegravir transfer into the breastmilk of a woman living with HIV. Aids. 2020;34:1863–5. [PubMed: 32675580]

Substance Identification

Substance Name

Raltegravir

CAS Registry Number

518048-05-0

Drug Class

Breast Feeding

Lactation

Anti-Infective Agents

Anti-HIV Agents

Antiviral Agents

Anti-Retroviral Agents

HIV Integrase Inhibitors

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Further information

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