Darunavir 800 mg Tablets

Warning and Precautions

• Darunavir 800 mg must be co-administered with ritonavir and food to achieve the desired antiviral effect. In absence of doing so darunavir with ritonavir and food may result in a loss of efficacy of darunavir.
• Should monitor liver function prior and while on therapy, mainly in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases.
• Post injury of the liver including fatalities in the patient suffering from cirrhosis or chronic hepatitis has been reported.
• Skin reactions such as Stevens Johnson Syndrome, toxic epidermal necrolysis occurs.
• Patients with Darunavir 600 mg may develop diabetes mellitus or hyperglycemia.
• Not recommended to the patient suffering from sulfonamide allergy.
• Not be used in pediatric patients of less than 3 years.
• Daruvir/Ritonavir should not be used in patients with severe hepatic impairment.
• The co-administration of Darunavir Ritonavir and PIs other than lopinavir ritonavir, atazanavir, saquinavir and indinavir has not been specified. Therefore this combination should be avoided.
• It is not known whether darunavir is secreted in human milk, darunavir is secreted into the milk of lactating rats. Because of both the potential for Human Immunodeficiency Virus (HIV) transmission and the potential for severe side effects in nursing infants, mothers are advised they should avoid breastfeed while taking PREZISTA.
• Population pharmacokinetic analysis showed higher mean darunavir exposure in HIV-1-infected females compared to males. This difference is not clinically relevant.
• Population pharmacokinetic analysis of darunavir in HIV-1-infected subjects indicated that race had no apparent effect on the exposure to darunavir.