Posology : מינונים

4.2 Posology and method of administration
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*
800 mg PREZISTA once daily with ritonavir
100 mg once 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.

Advice on missed doses
If once daily dose of PREZISTA and/or ritonavir is 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 is 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 a patient vomits within 4 hours of taking the medicine, another dose of PREZISTA with ritonavir should be taken with food as soon as possible. If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose of PREZISTA with cobicistat or ritonavir until the next regularly scheduled time.

Elderly

Limited information is available in this population, and therefore, PREZISTA should be used with caution in this age group (see sections 4.4 and 5.2).


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). (see sections 4.3, 4.4 and 5.2).

Renal impairment

No dose adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
Pregnancy and postpartum
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 sections 4.4, 4.6 and 5.2).

Treatment with darunavir/cobicistat 800/150 mg during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2). Therefore, therapy with PREZISTA/cobicistat should not be initiated during pregnancy, and women who become pregnant during therapy with PREZISTA/cobicistat should be switched to an alternative regimen, (see sections 4.4 and 4.6). PREZISTA/ritonavir may be considered as an alternative.

Method of administration
Patients should be advised to take PREZISTA and ritonavir with food every day as prescribed.