PREZISTA must always be given with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products. The prescribing information of ritonavir must therefore be consulted prior to initiation of therapy with PREZISTA/rtv.
After therapy with PREZISTA has been initiated, patients should be advised not to alter the dosage, dosage form or discontinue therapy without instruction of their physician.
Dosage - Adults: The recommended dosage of PREZISTA is 600 mg twice daily (b.i.d.) taken with ritonavir 100 mg b.i.d. and with food.
The type of food does not affect the exposure to darunavir. Ritonavir is used as a pharmacokinetic enhancer of darunavir (see Interactions and Pharmacology: Pharmacokinetics under Actions).
Children (less than 12 years of age) and adolescents (12 to 17 years of age): PREZISTA/rtv is not approved for use in these populations.
Pregnancy and Postpartum: No dose adjustment is required for darunavir/ritonavir during pregnancy and postpartum. Caution should be used in patients with concomitant medications which may further decrease darunavir exposure (see Use in Pregnancy & Lactation and Pharmacology: Pharmacokinetics: Special Populations - Pregnancy and Postpartum under Actions).
Missed dose(s): 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.
The guidance is based on the 15 hour half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 12 hours.
Special populations: Elderly (65 years of age and older): Limited information is available on the use of PREZISTA in patients 65 and older. Therefore PREZISTA should be used with caution in this age group. (see Precautions and Pharmacology: Pharmacokinetics - Elderly under Actions).
Renal impairment: No dose adjustment is required in patients with renal impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. There are no data regarding the use of PREZISTA when co-administered to patients with severe hepatic impairment; therefore, specific dosage recommendations cannot be made. PREZISTA should be used with caution in patients with severe hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Administration: Method of administration: oral administration.
PREZISTA must be taken with food. The type of food does not affect the exposure to PREZISTA (see Pharmacology: Pharmacokinetics: Absorption under Actions).