Prezista Dosage/Direction for Use

Testing Prior to Initiation of PREZISTA/ritonavir: In treatment-experienced patients, treatment history, genotypic and/or phenotypic testing is recommended to assess drug susceptibility of the HIV-1 virus [see Microbiology]. Refer to Recommended Dosage in Adult Patients, Recommended Dosage During Pregnancy and Recommended Dosage in Pediatric Patients (age 6 to less than 18 years, and weighing ≥40 kg) for dosing recommendations.
Appropriate laboratory testing such as serum liver biochemistries should be conducted prior to initiating therapy with PREZISTA/ritonavir [see Precautions].
Monitoring During Treatment with PREZISTA/ritonavir: Patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases should be monitored for elevation in serum liver biochemistries, especially during the first several months of PREZISTA/ritonavir treatment [see Precautions].
Recommended Dosage in 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.
Treatment-Naïve Adult Patients: The recommended oral dose of PREZISTA is 800 mg (one 800 mg tablet) taken with ritonavir 100 mg (one 100 mg tablet) once daily and with food.
Treatment-Experienced Adult Patients: The recommended oral dosage for treatment-experienced adult patients is summarized in Table 17.
Baseline genotypic testing is recommended for dose selection. However, when genotypic testing is not feasible, PREZISTA 600 mg taken with ritonavir 100 mg twice daily is recommended. (See Table 17.)

Click on icon to see table/diagram/image

Recommended Dosage During Pregnancy: No dose adjustment is required for darunavir/ritonavir during pregnancy and postpartum. PREZISTA/ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk (see Pregnancy under Use in Pregnancy & Lactation, and Pharmacology: Pharmacokinetics under Actions).
Recommended Dosage in Pediatric Patients (age 6 to less than 18 years, and weighing ≥40 kg): 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.
Before prescribing PREZISTA, children weighing greater than or equal to 40 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 less than 18 years of age and weighing at least 40 kg should not exceed the recommended adult dose. PREZISTA should be taken with ritonavir and with food.
The recommendations for the PREZISTA/ritonavir dosage regimens were based on pediatric clinical trial data and population pharmacokinetic modeling and simulation [see Use in Children under Precautions, and Pharmacology: Pharmacokinetics under Actions].
Dosing Recommendations for Treatment-Naïve Pediatric Patients or Antiretroviral Treatment-Experienced Pediatric Patients with No Darunavir Resistance Associated Substitutions: The recommended dose for pediatric patients 6 to less than 18 years of age and weighing at least 40 kg who are treatment-naïve or antiretroviral treatment-experienced with no darunavir resistance associated substitutions* is PREZISTA 800 mg with ritonavir 100 mg once daily with food.
*darunavir resistance associated substitutions: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
Dosing Recommendations for Treatment-Experienced Pediatric Patients with At Least One Darunavir Resistance Associated Substitutions: The recommended dose for pediatric patients 6 to less than 18 years of age and weighing at least 40 kg who are treatment-experienced with at least one darunavir resistance associated substitution* is PREZISTA 600 mg with ritonavir 100 mg twice daily with food.
*darunavir resistance associated substitutions: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
The use of PREZISTA/ritonavir in pediatric patients below 6 years of age is not recommended [see Precautions and Use in Children under Precautions].
Not Recommended in Patients with Severe Hepatic Impairment: No dosage adjustment is required in patients with mild or moderate hepatic impairment. No data are available regarding the use of PREZISTA/ritonavir when co‑administered to subjects with severe hepatic impairment; therefore, PREZISTA/ritonavir is not recommended for use in patients with severe hepatic impairment [see Hepatic Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions].