Posology : מינונים

2 DOSAGE AND ADMINISTRATION
2.1 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 tablets is 800 mg taken with ritonavir 100 mg once daily and with food.

Treatment-Experienced Adult Patients
Treatment-Experienced Adult Patients

With no darunavir resistance associated substitutions*       With at least one darunavir resistance associated substitution*

800 mg PREZISTA once daily with ritonavir 100 mg once        600 mg PREZISTA twice daily taken with ritonavir 100 mg daily and with food                                          twice daily and with food 
* V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V 
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.

2.2 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 (see Table 1) and should not exceed the recommended treatment- experienced adult dose (PREZISTA/ritonavir 600/100 mg b.i.d.). PREZISTA tablets should be taken with ritonavir twice daily and with food.


Table 1: Recommended Dose for Pediatric Patients (6 to < 18 years of age) for PREZISTA Tablets with ritonavir Body Weight                                                 Dose
(kg)
≥ 20 kg – < 30 kg                               375 mg PREZISTA/50 mg ritonavir twice daily ≥ 30 kg – < 40 kg                               450 mg PREZISTA/60 mg ritonavir twice daily ≥ 40 kg                                         600 mg PREZISTA/100 mg ritonavir twice daily 
Do not use PREZISTA /ritonavir in pediatric patients below 3 years of age [see Warnings and Precautions (5.11) and Nonclinical Toxicology (12.2)].
Prezista Tabs are intended only for pediatric patients ≥6years old weighing ≥20 Kg.

2.3 Missed dose(s)
If using the once daily regimen: in case a dose of PREZISTA and/or ritonavir was missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of PREZISTA and ritonavir with food as soon as possible. If this was noticed later than 12 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
If using the twice daily regimen: in case a dose of PREZISTA and/or ritonavir was missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of PREZISTA and ritonavir with food as soon as possible. If this was noticed later than 6 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.

2.4 Patients with Hepatic Impairment
Darunavir is metabolised by the hepatic system. No dose adjustment is recommended in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, PREZISTA should be used with caution in these patients. No pharmacokinetic data are available in patients with severe hepatic impairment. Severe hepatic impairment could result in an increase of darunavir exposure and a worsening of its safety profile. Therefore, PREZISTA must not be used in patients with severe hepatic impairment (Child-Pugh Class C).