Kocitaf

Kocitaf Use In Pregnancy & Lactation

Manufacturer:

Mylan

Distributor:

Atlanta Medicare
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: There are no adequate and well-controlled studies of Dolutegravir, Emtricitabine and Tenofovir alafenamide or its components in pregnant women. There are no or limited 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) indicates no malformative nor foetal/neonatal toxicity associated with emtricitabine.
In reproductive toxicity studies in animals, dolutegravir was shown to cross the placenta. Animal studies do not indicate direct or indirect harmful effects of emtricitabine or dolutegravir with respect to fertility parameters, pregnancy, foetal development, parturition or postnatal development. Studies of tenofovir alafenamide in animals have shown no evidence of harmful effects on fertility parameters, pregnancy, or foetal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Preliminary data from an observational study has identified a possible increased risk of neural tube defects when dolutegravir is administered at the time of conception compared with non-dolutegravir-containing antiretroviral regimens. As defects related to closure of the neural tube occur from conception through the first 6 weeks of gestation, embryos exposed to dolutegravir from the time of conception through the first 6 weeks of gestation are at potential risk. Due to the limited understanding of the types of reported neural tube defects associated with dolutegravir use and because the date of conception may not be determined with precision, avoid use of Dolutegravir at the time of conception through the first trimester of pregnancy.
If there are plans to become pregnant or if pregnancy is confirmed while on dolutegravir the first trimester, if possible, switch to an alternative regimen. Advise pregnant adolescents and adults of the potential risk to the embryo exposed to dolutegravir from the time of conception through the first trimester of pregnancy.
Breast-feeding: It is not known whether tenofovir alafenamide and dolutegravir is excreted in human milk. Emtricitabine is excreted in human milk. In animal studies it has been shown that tenofovir alafenamide and dolutegravir is excreted in milk. In lactating rats that received a single oral dose of 50 mg/kg at 10 days postpartum, dolutegravir was detected in milk at concentration typically higher than blood.
There is insufficient information on the effects of dolutegravir, emtricitabine and tenofovir alafenamide in newborns/infants. Therefore, Dolutegravir, Emtricitabine and Tenofovir alafenamide should not be used during breast-feeding.
In order to avoid transmission of HIV to the infant it is recommended that HIV infected women do not breast-feed their infants under any circumstances.
Fertility: There are no data on fertility from the use of Dolutegravir, Emtricitabine and Tenofovir alafenamide in humans. In animal studies there were no effects of emtricitabine and tenofovir alafenamide on mating or fertility parameters (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in