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HepBest

HepBest Use In Pregnancy & Lactation

tenofovir alafenamide

Manufacturer:

Mylan Labs

Distributor:

Viatris Pharma
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tenofovir alafenamide in pregnant women. However, a large amount of data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity associated with the use of tenofovir disoproxil.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
The use of tenofovir alafenamide may be considered during pregnancy, if necessary.
Breast-feeding: It is not known whether tenofovir alafenamide is secreted in human milk. However, in animal studies it has been shown that tenofovir is secreted into milk. There is insufficient information on the effects of tenofovir in newborns/infants.
A risk to the breast-fed newborns/infants cannot be excluded; therefore, tenofovir alafenamide should not be used during breast-feeding.
Fertility: No human data on the effect of tenofovir alafenamide on fertility are available. Animal studies do not indicate harmful effects of tenofovir alafenamide on fertility.
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