Delstrigo Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data from the use of doravirine in pregnant women. A large amount of data on pregnant women (more than 3,000 outcomes from first trimester) taking the individual active component lamivudine in combination with other antiretrovirals indicates no malformative toxicity. A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with tenofovir disoproxil.
Antiretroviral pregnancy registry: To monitor maternal-foetal outcomes in patients exposed to antiretroviral medicinal products while pregnant, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients in this registry.
Animal studies with doravirine do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Animal studies with tenofovir disoproxil do not indicate direct or indirect harmful effects of tenofovir disoproxil with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Animal studies with lamivudine showed an increase in early embryonic deaths in rabbits but not in rats (see Pharmacology: Toxicology: Preclinical safety data under Actions). Placental transfer of lamivudine has been shown to occur in humans. Lamivudine may inhibit cellular DNA replication (see Pharmacology: Toxicology: Preclinical safety data under Actions). The clinical relevance of this finding is unknown.
As a precautionary measure, it is preferable to avoid the use of Delstrigo during pregnancy.
Breast-feeding: It is unknown whether doravirine is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of doravirine in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Lamivudine has been identified in breast-fed newborns/infants of treated women. Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breast-fed infants of mothers treated for HIV are very low (< 4 % of maternal serum concentrations) and progressively decrease to undetectable levels when breast-fed infants reach 24 weeks of age. There are no data available on the safety of lamivudine when administered to babies less than three months old.
Tenofovir is excreted in human milk. There is insufficient information on the effects of tenofovir in newborns/infants.
It is recommended that women living with HIV do not breast-feed their infants in order to avoid transmission of HIV.
Fertility: No human data on the effect of Delstrigo on fertility are available. Animal studies do not indicate harmful effects of doravirine, lamivudine, or tenofovir disoproxil on fertility at exposure levels higher than the exposure in humans at the recommended clinical dose (see Pharmacology: Toxicology: Preclinical safety data under Actions).