Apretude Use In Pregnancy & Lactation

Fertility: Animal studies indicate no effects of cabotegravir on male or female fertility (see Pharmacology: Toxicology: Non-clinical Information under Actions).
Pregnancy: There are limited data for APRETUDE in pregnant women. The effect on human pregnancy is unknown.
Cabotegravir was not teratogenic when studied in pregnant rats and rabbits but caused a delay in delivery that was associated with reduced survival and viability of rat offspring at exposures higher than for therapeutic doses (see Pharmacology: Toxicology: Non-clinical Information under Actions). The relevance to human pregnancy is unknown.
APRETUDE should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.
Cabotegravir has been detected in systemic circulation for up to 12 months or longer after an injection, therefore, consideration should be given to the potential for foetal exposure during pregnancy (see Precautions).
Lactation: It is expected that cabotegravir will be secreted into human milk based on animal data, although this has not been confirmed in humans. Cabotegravir may be present in human milk for up to 12 months or longer after the last APRETUDE injection.
It is recommended that women breast-feed only if the expected benefit justifies the potential risk to the infant.