Darunavir

Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. 2). - ART-experienced with no darunavir resistance associated mutations (DRV- RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l.

1).

PREZCOBIX® (darunavir/cobicistat), a fixed dose combination of darunavir and cobicistat, is indicated in combination with other antiretroviral agents for the treatment of HIV infection in treatment-naive and in treatment-experienced adult patients without DRV RAMS.

For a description of the clinical data and dosing in support of this indication, refer to 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS. 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

The safety and efficacy of PREZCOBIX have not been established in pediatric patients (see 4 DOSAGE AND ADMINISTRATION and 7 WARNINGS AND PRECAUTIONS). 2 Geriatrics Geriatrics (≥65 years of age) Clinical studies of PREZCOBIX did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

In general, caution should be exercised in the administration and monitoring of PREZCOBIX in elderly patients, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy (see 4 DOSAGE AND ADMINISTRATION and 7 WARNINGS AND PRECAUTIONS, and 10 CLINICAL PHARMACOLOGY).

2). 2): ● For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated. ● For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.

In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents.

1).

4 ) and Clinical Studies ( 14 )]. Darunavir is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. Darunavir must be co-administered with ritonavir (darunavir/ritonavir) and with other antiretroviral agents.

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