Basic Information
PREZISTA™ TABLET 800MG
TABLET, FILM COATED
Regulatory Information
SIN14595P
August 28, 2014
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 4, 2025
XJ05AE10
Company Information
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Active Ingredients
Strength: 800 mg
Detailed Information
Contraindications
**Contraindications** Hypersensitivity to darunavir or to any of the excipients. Darunavir and ritonavir are both inhibitors of the cytochrome P450 3A (CYP3A) isoform. PREZISTA®/rtv should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which increased plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). Examples include alfuzosin, astemizole, cisapride, colchicine (in patients with renal and/or hepatic impairment), dapoxetine, dronedarone, elbasvir/grazoprevir, the ergot alkaloids (e.g., ergotamine, dihydroergotamine, ergonovine and methylergonovine), ivabradine, lomitapide, lovastatin, lurasidone, midazolam (oral), naloxegol, pimozide, ranolazine, sildenafil (when used for treatment of pulmonary arterial hypertension), simvastatin, terfenadine, ticagrelor, and triazolam (see _Interactions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients taking PREZISTA® should not use products containing potent CYP3A inducers such as rifampin or St. John’s wort because co-administration may result in reduced plasma concentrations of darunavir. This may result in loss of therapeutic effect and development of resistance.
Indication Information
**Indications** **Adult patients** PREZISTA®, in combination with 100 mg low dose ritonavir (PREZISTA®/rtv) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection. **Pediatric patients** PREZISTA®, in combination with low dose ritonavir (PREZISTA®/rtv) and with other antiretroviral agents, is indicated for the treatment of HIV infection in treatment-experienced pediatric patients of 6 years and above and at least 20kg body weight. In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with PREZISTA®/rtv: - Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA®/rtv.