Symtuza Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of Symtuza in pregnant women. A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of darunavir, cobicistat or tenofovir alafenamide. A large amount of data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor foetal/neonatal toxicity associated with emtricitabine.
Animal studies do not indicate direct or indirect harmful effects of darunavir or emtricitabine with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Animal studies do not indicate direct harmful effects of cobicistat or tenofovir alafenamide with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Treatment with darunavir/cobicistat (two of the components of Symtuza) during pregnancy results in low darunavir exposure (see Pharmacology: Pharmacokinetics under Actions), which may be associated with an increased risk of treatment failure and an increased risk of HIV transmission to the child. Therefore, therapy with Symtuza should not be initiated during pregnancy, and women who become pregnant during therapy with Symtuza should be switched to an alternative regimen (see Dosage & Administration and Precautions).
Breast-feeding: Emtricitabine is excreted in human milk. It is unknown whether darunavir, cobicistat, or tenofovir alafenamide are excreted in human milk. Studies in animals have demonstrated that darunavir, cobicistat and tenofovir are excreted in milk. Studies in rats have demonstrated that darunavir is excreted in milk and at high levels (1,000 mg/kg/day) resulted in toxicity of the offspring.
Because of the potential for adverse reactions in breast-fed infants, women should be instructed not to breast-feed if they are receiving Symtuza.
In order to avoid transmission of HIV to the infant it is recommended that women living with HIV do not breast-feed.
Fertility: No human data on the effect of darunavir, cobicistat, emtricitabine, or tenofovir alafenamide on fertility are available. There was no effect on mating or fertility in animals (see Pharmacology: Toxicology: Preclinical safety data under Actions). Based on animal studies, no effect on reproduction or fertility is expected with Symtuza.