RECENT MAJOR CHANGES

INDICATIONS AND USAGE

PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV infection in adult patients. PREZISTA is also indicated for the treatment of HIV infection in pediatric patients 6 years of age and older. PREZISTA must be co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents. (1)

DOSAGE AND ADMINISTRATION

• Treatment-naïve adult patients: 800 mg (two 400 mg tablets) taken with ritonavir 100 mg once daily and with food. (2.1)
• Treatment-experienced adult patients: 600 mg (one 600 mg tablet or two 300 mg tablets) taken with ritonavir 100 mg twice daily and with food. (2.1)
• Pediatric patients (6 to < 18 years of age and weighing at least 44 lbs (20 kg)): dosage of PREZISTA and ritonavir is based on body weight and should not exceed the treatment-experienced adult dose. Do not use once daily dosing in pediatric patients. PREZISTA tablets should be taken with ritonavir twice daily and with food. (2.2)
• PREZISTA/ritonavir is not recommended for use in patients with severe hepatic impairment. (2.3)

DOSAGE FORMS AND STRENGTHS

75 mg tablets, 150 mg tablets, 300 mg tablets, 400 mg tablets, and 600 mg tablets (3)

CONTRAINDICATIONS

Co-administration with alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, St. Johns Wort, lovastatin, simvastatin, rifampin and sildenafil (for treatment of pulmonary arterial hypertension). (4)

• Due to the need for co-administration of PREZISTA with 100 mg of ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications.

WARNINGS AND PRECAUTIONS

• Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA/ritonavir. Monitor liver function before and during therapy, especially in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases. (5.2, 6)
• Skin reactions ranging from mild to severe, including Stevens-Johnson Syndrome and toxic epidermal necrolysis, have been reported. Discontinue treatment if severe reaction develops. (5.3, 6)
• Use with caution in patients with a known sulfonamide allergy. (5.4)
• Patients may develop new onset diabetes mellitus or hyperglycemia. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. (5.6)
• Patients may develop redistribution/accumulation of body fat (5.7) or immune reconstitution syndrome. (5.8)
• Patients with hemophilia may develop increased bleeding events. (5.9)
• PREZISTA/ritonavir should not be used in pediatric patients below 3 years of age. (5.11)

ADVERSE REACTIONS

• The most common clinical adverse drug reactions to PREZISTA/ritonavir (incidence ≥ 5%) of at least moderate intensity (≥ Grade 2) were diarrhea, nausea, rash, headache, abdominal pain and vomiting. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Tibotec Therapeutics at 1-877-REACH-TT or 1-877-732-2488 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

• Co-administration of PREZISTA/ritonavir with other drugs can alter the concentration of other drugs and other drugs may alter the concentrations of darunavir. The potential drug-drug concentrations must be considered prior to and during therapy. (4, 5.5, 7, 12.3).

USE IN SPECIFIC POPULATIONS

• Use during pregnancy only if the potential benefit justifies the potential risk. (8.1)
  • An Antiviral Pregnancy Registry has been established. Register patients by calling 1-800-258-4263.
• Mothers should be instructed not to breastfeed due to the potential for HIV transmission and the potential for serious adverse reactions in nursing infants. (8.3)