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PREZCOBIX is a brand name for Darunavir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's HC label. Tap a section to expand.
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 CONTRAINDICATIONS PREZCOBIX is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the
). Rash was mostly mild-to-moderate, often occurring within the first four weeks of treatment and resolving with continued dosing. 5%. Rash occurred more commonly in treatment-experienced patients receiving regimens containing darunavir/ritonavir + raltegravir compared to subjects receiving darunavir/ritonavir without raltegravir or raltegravir without darunavir/ritonavir.
However, rash that was considered drug related occurred at similar rates for all three groups. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations due to rash. 2% discontinued treatment due to rash.
Rash was mostly mild-to-moderate, often occurring within the first four weeks of treatment and resolving with continued dosing (see 8 ADVERSE REACTIONS). 1 Pregnant Women PREZCOBIX is not recommended for use during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy.
PREZCOBIX should not be initiated in pregnant women. An alternative regimen is recommended for women who become pregnant during therapy with PREZCOBIX. PREZCOBIX in combination with a background regimen was evaluated in a clinical trial of 7 pregnant women during the second and third trimesters, and postpartum (6-12 weeks).
3 Pharmacokinetics, Special Populations and Conditions, Pregnancy and Breast-feeding). There are no clinical data on the virologic response when PREZCOBIX is initiated during pregnancy. At clinically relevant exposures of darunavir and cobicistat, animal studies do not indicate direct or indirect harmful effects with respect to developmental or reproductive toxicity and fertility.
0 Page 13 of 65 Unclassified / Non classifié humans at the recommended clinical dose boosted with ritonavir (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicity).
10/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................. 2 TABLE OF CONTENTS ....................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 4 1 INDICATIONS ......................................................................................................... 1 Pediatrics ..............................................................................................................
2 Geriatrics .............................................................................................................. 4 2 CONTRAINDICATIONS .........................................................................................
4 4 DOSAGE AND ADMINISTRATION ....................................................................... 1 Dosing Considerations ....................................................................................... 2 Recommended Dose and Dosage Adjustment ..............................................
4 Administration ...................................................................................................... 5 Missed Dose ........................................................................................................
7 5 OVERDOSAGE....................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 7 7 WARNINGS AND PRECAUTIONS........................................................................
1 Special Populations .......................................................................................... 1 Pregnant Women .......................................................................................... 2 Breast-feeding................................................................................................
PREZCOBIX is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
PREZCOBIX is contraindicated in patients with severe (Child-Pugh Class C) hepatic insufficiency. Administration of PREZCOBIX is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index).
Darunavir and cobicistat are both substrates of the CYP3A isoform. Co-administration of PREZCOBIX is contraindicated with potent CYP3A inducers as it may lead to lower exposures of darunavir and cobicistat and potential loss of efficacy of darunavir and possible resistance.
4 Drug-Drug Interactions, Table 4). 0 Page 5 of 65 Unclassified / Non classifié Table 1: Drugs that are Contraindicated with PREZCOBIX Drug Class Drugs within Class that are Contraindicated with PREZCOBIX Alpha 1-Adrenoreceptor Antagonist alfuzosin Antiarrhythmics/Antianginals amiodarone, dronedarone, ivabradine, lidocaine (systemic) Direct Oral Anti-coagulants (DOACs) apixaban, dabigatran, rivaroxaban Anti-convulsants carbamezepine, phenobarbital, phenytoin Anti-gout colchicine (in patients with renal and/or hepatic impairment) Antimycobacterial rifampin Antivirals (Hepatitis C virus [HCV] direct-acting antivirals) elbasvir/grazoprevir Ergot Derivatives dihydroergotamine, ergonovine, ergotamine Herbal Products St.
John’s wort (Hypericum perforatum) HMG-CoA Reductase Inhibitors / Other lipid modifying agents lovastatin, simvastatin lomitapide Inhaled Beta Agonist salmeterol Neuroleptics lurasidone, pimozide Opioid Antagonist naloxegol PDE-5 Inhibitor sildenafil (for treatment of pulmonary arterial hypertension) Platelet Aggregation Inhibitor ticagrelor Sedatives/Hypnotics triazolam
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Antiretroviral Pregnancy Registry:
To monitor maternal-fetal outcomes of pregnant women exposed to PREZCOBIX, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263. 2 Breast-feeding HIV-infected mothers should not breast-feed their infants to avoid risking postnatal transmission of HIV.
It is not known whether darunavir, cobicistat or their metabolites are excreted in human milk. Animal studies have demonstrated that darunavir and cobicistat are excreted in milk. Because of both the potential for HIV transmission and the potential for serious adverse events in nursing infants, mothers should be instructed not to breast-feed if they are receiving PREZCOBIX (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicity).
3 Pediatrics Pediatrics (<18 years of age) PREZCOBIX is not indicated in pediatric patients <18 years of age. The safety and efficacy of PREZCOBIX have not been established in pediatric patients. 3 Pharmacokinetics, Special Populations and Conditions, Pediatrics and 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicity).
4 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.
1 Adverse Reaction Overview The overall safety profile of PREZCOBIX is based on all available clinical data from the Phase 3 single-arm trial (GS-US-216-0130) and on all available clinical trial and post-marketing data on darunavir/ritonavir and cobicistat in combination with other antiretroviral agents and is consistent with the data presented below.
ADRs to darunavir/ ritonavir or to cobicistat are considered ADRs to PREZCOBIX unless otherwise specified. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. 0 Page 14 of 65 Unclassified / Non classifié should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. d. The safety of darunavir in combination with cobicistat has been evaluated in a Phase 3 single arm trial (GSUS-216-0130), in which 295 treatment-naive patients and 18 treatment- experienced patients received darunavir 800 mg once daily in combination with cobicistat 150 mg once daily as single agents and other antiretrovirals for at least 48 weeks.
4 weeks. The majority of the ADRs reported during treatment with darunavir/cobicistat in GS-US-216- 0130 were mild in severity. The most frequent (≥5%) ADRs to […]
3 Pediatrics ........................................................................................................ 4 Geriatrics ........................................................................................................
13 8 ADVERSE REACTIONS ...................................................................................... 1 Adverse Reaction Overview ............................................................................ 2 Clinical Trial Adverse Reactions .....................................................................
3 Less Common Clinical Trial Adverse Reactions .......................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...............................................................................................
5 Post-Market Adverse Reactions ..................................................................... 18 9 DRUG INTERACTIONS ....................................................................................... 1 Serious Drug Interactions ................................................................................
2 Drug Interactions Overview ............................................................................. 4 Drug-Drug Interactions ..................................................................................... 5 Drug-Food Interactions ..........................................................................................
6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions .................................................................. 37 10 CLINICAL PHARMACOLOGY.............................................................................
1 Mechanism of Action ........................................................................................ 2 Pharmacodynamics .......................................................................................... 3 Pharmacokinetics ..............................................................................................
38 11 STORAGE, STABILITY AND DISPOSAL ........................................................... 43 PART II: SCIENTIFIC INFORMATION ........................................................................... 44 13 PHARMACEUTICAL INFORMATION .................................................................
44 14 CLINICAL TRIALS ............................................................................................... 1 Clinical Trials By Indication .............................................................................. 2 Comparative Bioavailability Studies ...............................................................
48 15 MICROBIOLOGY .................................................................................................. 50 16 NON-CLINICAL TOXICOLOGY ........................................................................... 52 PATIENT MEDICATION INFORMATION .......................................................................
0 Page 4 of 65 Unclassified / Non classifié PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS 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. […]