Generic name: darunavir ethanolate
Dosage form: tablet, film coated; oral suspension
This dosage information does not include all the information needed to use Prezista safely and effectively. See full prescribing information for Prezista.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
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.
â€‹Patients who have difficulty swallowing PREZISTA tablets can use the 100 mg/mL PREZISTA oral suspension.
â€‹Treatment-Naïve Adult Patients
â€‹The recommended oral dose of PREZISTA is 800 mg (two 400 mg tablets or 8 mL of the oral suspension) taken with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL of a 80 mg/mL ritonavir oral solution) once daily and with food.
â€‹Treatment-Experienced Adult Patients
|â€‹Treatment-Experienced Adult Patients|
|With no darunavir resistance associated substitutions*||With at least one darunavir resistance associated substitution*|
|PREZISTA 800 mg (two 400 mg tablets or 8 mL†) once daily with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL) once daily and with food||PREZISTA 600 mg (e.g. one 600 mg tablet or 6 mL) twice daily with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL) twice daily and with food|
For antiretroviral treatment-experienced patients genotypic testing is recommended. However, when genotypic testing is not feasible, PREZISTA/ritonavir 600/100 mg twice daily dosing is recommended.
Pediatric Patients (age 3 to less than 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.
â€‹Before prescribing PREZISTA, children weighing greater than or equal to 15 kg should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a tablet, the use of PREZISTA oral suspension should be considered.
â€‹The recommended dose of PREZISTA/ritonavir for pediatric patients (3 to less than 18 years of age and weighing at least 10 kg is based on body weight (see Tables 1, 2 and 3) and should not exceed the recommended treatment-experienced adult dose (PREZISTA/ritonavir 600/100 mg twice daily). PREZISTA should be taken with ritonavir twice daily and with food.
â€‹Dosing recommendations for pediatric patients weighing at least 10 kg but less than 15 kg
â€‹The weight-based dose in pediatric patients weighing less than 15 kg is PREZISTA 20 mg/kg with ritonavir 3 mg/kg which can be dosed using the following table:
(twice daily with food)
|Greater than or equal to 10 kg to less than 11 kg
||PREZISTA 200 mg (2 mL) with ritonavir 32 mg (0.4 mL)|
|Greater than or equal to 11 kg to less than 12 kg
||PREZISTA 220 mg (2.2 mL) with ritonavir 32 mg (0.4 mL)|
|Greater than or equal to 12 kg to less than 13 kg
||PREZISTA 240 mg (2.4 mL) with ritonavir 40 mg (0.5 mL)|
|Greater than or equal to 13 kg to less than 14 kg
||PREZISTA 260 mg (2.6 mL) with ritonavir 40 mg (0.5 mL)|
|Greater than or equal to 14 kg to less than 15 kg
||PREZISTA 280 mg (2.8 mL) with ritonavir 48 mg (0.6 mL)|
â€‹Dosing recommendations for pediatric patients weighing at least 15 kg
â€‹Pediatric patients who weigh at least 15 kg and are able to swallow tablets can be dosed using the following table:
(twice daily with food)
|Greater than or equal to 15 kg to less than 30 kg||PREZISTA 375 mg with ritonavir* 50 mg (0.6 mL)
|Greater than or equal to 30 kg to less than 40 kg||PREZISTA 450 mg with ritonavir* 60 mg (0.75 mL)
|Greater than or equal to 40 kg||PREZISTA 600 mg with ritonavir†100 mg
â€‹Pediatric patients who weigh at least 15 kg but are unable to swallow tablets can be dosed using the following table:
(twice daily with food)
|Greater than or equal to 15 kg to less than 30 kg||PREZISTA 375 mg† (3.8 mL) with ritonavir 50 mg (0.6 mL)
|Greater than or equal to 30 kg to less than 40 kg||PREZISTA 450 mg‡ (4.6 mL) with ritonavir 60 mg (0.75 mL)
|Greater than or equal to 40 kg
||PREZISTA 600 mg (6 mL) with ritonavir 100 mg (1.25 mL)|
Patients with Hepatic Impairment
No dose 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 Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].