Rekambys Use In Pregnancy & Lactation

Pregnancy: The effect of REKAMBYS on human pregnancy is unknown.
A moderate amount of data with oral rilpivirine in pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or foetal/neonatal toxicity of rilpivirine.
A study of 19 pregnant women treated with oral rilpivirine in combination with a background regimen during the second and third trimesters, and postpartum, showed lower exposures of oral rilpivirine during pregnancy, therefore viral load should be monitored closely if REKAMBYS is used during pregnancy.
Animal studies do not indicate reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
REKAMBYS is not recommended during pregnancy unless the expected benefit justifies the potential risk.
An alternative oral regimen should be considered in line with current treatment guidelines. After discontinuation of REKAMBYS, rilpivirine may remain in systemic circulation for up to 4 years in some patients (see Precautions).
Breast-feeding: It is expected that rilpivirine will be secreted into human milk based on animal data, although this has not been confirmed in humans. Rilpivirine may be present in human milk for up to 4 years in some patients after discontinuation of REKAMBYS.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Fertility: No human data on the effect of rilpivirine on fertility are available. No clinically relevant effects on fertility were seen in animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions).