Prezista

/ Janssen

Adult Patients: PREZISTA must be co-administered with ritonavir to exert its therapeutic effect. Failure to correctly co-administer PREZISTA with ritonavir will result in plasma levels of darunavir that will be insufficient to achieve the desired antiviral effect and will alter some drug interactions.
Pediatric Patients (age 6 to < 18 years): Do not use once daily dosing in pediatric patients. Healthcare professionals should pay special attention to accurate dose selection of PREZISTA, transcription of the medication order, dispensing information and dosing instruction to minimize risk for medication errors, overdose, and underdose. Prescribers should select the appropriate dose of PREZISTA/ritonavir for each individual child based on body weight (kg) and should not exceed the recommended dose for treatment-experienced adults. Before prescribing PREZISTA, children weighing greater than or equal to 20 kg should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a tablet, the use of PREZISTA tablets may not be appropriate.
The recommended dose of PREZISTA/ritonavir for pediatric patients (6 to < 18 years of age and weighing at least (20 kg)) is based on body weight and should not exceed the recommended treatmentexperienced adult dose (PREZISTA/ritonavir 600/100 mg b.i.d.). PREZISTA tablets should be taken with ritonavir twice daily and with food.
Do not use PREZISTA /ritonavir in pediatric patients below 3 years of age.
Prezista Tabs are intended only for pediatric patients ≥6years old weighing ≥20 Kg.
See prescribing information for full details.

Co-administered with 100 mg ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of HIV infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.

Known hypersensitivity to any of the ingredients of the product. Co-administration with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. : Astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, midazolam, triazolam.
See prescribing information for full details.

Patients with severe hepatic impairment. Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C. Caution should be exercised in elderly patients.
Pregnancy and lactation: Should be used during pregnancy only if the potential benefit justifies the potential risk. Mothers should be instructed not to breastfeed if they are receiving treatment.
Pediatric use: Safety and effectiveness in pediatric patients have not been established.
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The most common adverse events (>10%), (regardless of causality or frequency) were diarrhea, nausea, headache and nasophyringitis.
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Carbamazepine, phenobarbital, phenytoin, rifampin, St. John’s wort (Hypericum perforatum), lovastatin, simvastatin.
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