Odefsey Use In Pregnancy & Lactation

Women of childbearing potential/contraception in males and females: The use of Odefsey should be accompanied by the use of effective contraception.
Pregnancy: There are no adequate and well-controlled studies of Odefsey or its components in pregnant women.
There is a limited amount of data (less than 300 pregnancy outcomes) from the use of tenofovir alafenamide in pregnant women. A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no malformative or foetal/neonatal toxicity of rilpivirine (see Precautions and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions). Lower exposures of rilpivirine were observed during pregnancy; therefore viral load should be monitored closely. 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 with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions) with the components of Odefsey.
Odefsey should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Breast-feeding: Emtricitabine is excreted in human milk. It is not known whether rilpivirine or tenofovir alafenamide are excreted in human milk. In animal studies it has been shown that tenofovir is excreted in milk. Rilpivirine is excreted in the milk of rats.
There is insufficient information on the effects of all the components of Odefsey in newborns/infants.
Because of the potential for adverse reactions in breastfed infants, women should be instructed not to breast-feed if they are receiving Odefsey.
In order to avoid transmission of HIV to the infant it is recommended that women living with HIV do not breast-feed their infants.
Fertility: No human data on the effect of Odefsey on fertility are available. Animal studies do not indicate harmful effects of emtricitabine, rilpivirine hydrochloride or tenofovir alafenamide on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).