Abalam Use In Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled trials in pregnant women and the safe use of abacavir, lamivudine or Abacavir sulfate and Lamivudine tablets in human pregnancy has not been established. Therefore administration of Abacavir sulfate and Lamivudine tablets in pregnancy should be considered only if the benefit to the mother outweighs the possible risk to the foetus.
Abacavir has been evaluated in the Antiretroviral Pregnancy Registry in over 2,000 women during pregnancy and postpartum. Available human data from the Antiretroviral Pregnancy Registry do not show an increased risk of major birth defects for abacavir compared to the background rate (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions). Lamivudine has been evaluated in the Antiretroviral Pregnancy Registry in over 11,000 women during pregnancy and postpartum. Available human data from the Antiretroviral Pregnancy Registry do not show an increased risk of major birth defects for lamivudine compared to the background rate (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Abacavir and lamivudine have been associated with findings in animal reproductive studies (see Pharmacology: Toxicology: Pre-Clinical Safety Data under Actions).
There have been reports of mild, transient elevations in serum lactate levels, which may be due to mitochondrial dysfunction, in neonates and infants exposed in utero or peri-partum to nucleoside reverse transcriptase inhibitors (NRTIs). The clinical relevance of transient elevations in serum lactate is unknown. There have also been very rare reports of developmental delay, seizures and other neurological disease. However, a causal relationship between these events and NRTI exposure in utero or peri-partum has not been established. These findings do not affect current recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Lactation: Health experts recommend that where possible HIV infected women do not breast-feed their infants in order to avoid transmission of HIV. Lamivudine is excreted in human milk at similar concentrations to those found in serum. It is expected that abacavir will also be secreted into human milk, although this has not been confirmed. It is therefore recommended that mothers do not breast-feed while receiving treatment with Abacavir sulfate and Lamivudine tablets.