Prezcobix Patient Counseling Information

Advise the patient to read the patient labeling (Patient Information).
Instructions for Use: Advise patients to take PREZCOBIX with food every day on a regular dosing schedule, as missed doses can result in development of resistance. Inform patients not to alter the dose of PREZCOBIX or discontinue therapy with PREZCOBIX without consulting their physician [see Testing Prior to Initiation of PREZCOBIX under Dosage & Administration].
Hepatotoxicity: Inform patients that drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) and liver injury, including some fatalities, could potentially occur with PREZCOBIX. Advise patients to contact their healthcare provider immediately if signs and symptoms of liver problems develop [see Hepatotoxicity under Precautions].
Severe Skin Reactions: Inform patients that skin reactions ranging from mild to severe, including Stevens-Johnson Syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, could potentially occur with PREZCOBIX. Advise patients to contact their healthcare provider immediately if signs or symptoms of severe skin reactions develop, including but not limited to severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, and/or conjunctivitis [see Severe Skin Reactions under Precautions].
Renal Impairment: Inform patients that renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported when cobicistat is used in combination with a tenofovir DF-containing regimen [see New Onset or Worsening Renal Impairment When Used With Tenofovir Disoproxil Fumarate under Precautions].
Pregnancy: Advise patients that PREZCOBIX is not recommended during pregnancy and to alert their healthcare provider if they get pregnant while taking PREZCOBIX [see Pregnancy under Use in Pregnancy & Lactation]. Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant individuals exposed to PREZCOBIX [see Pregnancy under Use in Pregnancy & Lactation].
Lactation: Instruct individuals with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Lactation under Use in Pregnancy & Lactation].
Drug Interactions: PREZCOBIX may interact with many drugs; therefore, inform patients of the potential serious drug interactions with PREZCOBIX, and that some drugs are contraindicated with PREZCOBIX and other drugs may require dosage adjustment. Advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including St. John's wort.
Immune Reconstitution Syndrome: Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Immune Reconstitution Syndrome under Precautions].
Fat Redistribution: Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including PREZCOBIX and that the cause and long-term health effects of these conditions are not known at this time [see Fat Redistribution under Precautions].