Daru-Rito Use In Pregnancy & Lactation

Darunavir: Pregnancy: As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account.
There are no adequate and well controlled studies on pregnancy outcome with darunavir in pregnant women. Studies in animals do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Darunavir co-administered with low dose ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk.
Breast-feeding: It is not known whether darunavir is excreted in human milk. Studies in rats have demonstrated that darunavir is excreted in milk and at high levels (1,000 mg/kg/day) resulted in toxicity. Because of both the potential for HIV transmission and the potential for adverse reactions in breast-fed infants, mothers should be instructed not to breast-feed under any circumstances if they are receiving Darunavir.
Fertility: No human data on the effect of darunavir on fertility are available. There was no effect on mating or fertility with darunavir treatment in rats (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Ritonavir: A limited number (>800) of pregnant women were exposed to Ritonavir during pregnancy; a very limited number (<300) were exposed during the first trimester. These data largely refer to exposures where Ritonavir was used in combination therapy and not at therapeutic Ritonavir doses but at lower doses as a pharmacokinetic enhancer for other PIs. These limited data indicate no increase in the rate of birth defects compared to rates observed in population-based birth defect surveillance systems. Animal data have shown reproductive toxicity. The use of Ritonavir tablets may be considered in pregnancy only when the benefits outweigh the risk to the foetus.
Ritonavir adversely interacts with oral contraceptives (OCs). Therefore, an alternative, effective and safe method of contraception should be used during treatment.
Breast-Feeding: Current recommendations on HIV and breastfeeding (e.g. those from the WHO) should be consulted before advising patients on this matter. Preferred options may vary depending on the local circumstances.
It is not known whether this medicine is excreted in human milk. Milk excretion has not been measured in the animal studies, however a study in rats showed some effects on offspring development during lactation which are compatible with excretion of ritonavir in milk in that species.