Vocabria Use In Pregnancy & Lactation

Pregnancy: There are a limited amount of data from the use of cabotegravir in pregnant women. The effect of Vocabria on human pregnancy is unknown.
Cabotegravir was not teratogenic when studied in pregnant rats and rabbits but, exposures higher than the therapeutic dose showed reproductive toxicity in animals (see Pharmacology: Toxicology: Preclinical safety data under Actions). The relevance to human pregnancy is unknown.
Vocabria is not recommended during pregnancy unless the expected benefit justifies the potential risk to the foetus.
Suspension for injection: Cabotegravir has been detected in systemic circulation for up to 12 months or longer after an injection (see Precautions).
Breast-feeding: It is expected that cabotegravir will be secreted into human milk based on animal data, although this has not been confirmed in humans.
It is recommended that HIV infected women/living with HIV do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Suspension for injection: Cabotegravir may be present in human milk for up to 12 months or longer after the last cabotegravir injection.
Fertility: There are no data on the effects of cabotegravir on human male or female fertility. Animal studies indicate no effects of cabotegravir on male or female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).