Dosing
Once-Daily PREZCOBIX® Helps Reduce Pill Burden
Coformulated in a fixed-dose combination1
DARUNAVIR 800 mg/COBICISTAT 150 mg
The recommended dose of PREZCOBIX® is one tablet taken once daily with food as part of combination ARV therapy for HIV-1–infected adults with no DRV RAMs*1
PREZCOBIX® combined with DESCOVY® (emtricitabine 200 mg/tenofovir alafenamide 25 mg) can be used in HIV-1–infected adults who have a CrCl ≥30 mL/min†2
- This recommendation is based on drug-drug interaction studies‡2,3
- No clinically significant drug interactions have been observed or expected2,3
* DRV RAMs=darunavir resistance-associated mutations: V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V.
† When PREZCOBIX® is used with TDF/FTC, HIV-1–infected adults must have a CrCl ≥70 mL/min.1
‡ This DHHS recommendation is based on data from comparative trials demonstrating that TAF-containing regimens are as effective in achieving or maintaining virologic suppression as TDF-containing regimens, but with more favorable effects on markers of renal and bone health.2
PREZCOBIX® COADMINISTRATION GUIDANCE1
| Drugs that are contraindicated | ||||
|---|---|---|---|---|
| Alpha 1-adrenoreceptor antagonist: | alfuzosin | |||
| Anticonvulsants: | carbamazepine, phenobarbital, phenytoin | |||
| Anti-gout: | colchicine in patients with renal or hepatic impairment | |||
| Antimycobacterial: | rifampin | |||
| Antipsychotics: | lurasidone, pimozide | |||
| Cardiac Disorders: | dronedarone, ivabradine, ranolazine | |||
| Ergot derivatives: | dihydroergotamine, ergotamine, methylergonovine | |||
| Gastrointestinal motility agent: | cisapride | |||
| Hepatitis C direct-acting antivirals: | elbasvir/grazoprevir | |||
| Herbal product: | St. John's Wort (Hypericum perforatum) | |||
| Lipid modifying agents: | lomitapide, lovastatin, simvastatin | |||
| Opioid Antagonist: | naloxegol | |||
| PDE-5 inhibitor: | sildenafil for treatment of pulmonary arterial hypertension | |||
| Sedatives/hypnotics: | midazolam (oral), triazolam | |||
| Coadministration not recommended | ||||
| Anticoagulant: | rivaroxaban | |||
| Anticonvulsants: | oxcarbazepine, eslicarbazepine | |||
| Antifungal: | voriconazole | |||
| Antimycobacterial: | rifapentine | |||
| Systemic/Inhaled/Nasal/Ophthalmic Corticosteroids: | betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone | |||
| Hepatitis C direct-acting antivirals: | glecaprevir/pibrentasvir, simeprevir | |||
| Immunosuppressant/neoplastic: | everolimus | |||
| Inhaled β-agonist: | salmeterol | |||
| NNRTIs: | efavirenz, etravirine, nevirapine | |||
| PDE-5 inhibitor: | avanafil | |||
| PK-boosted ARVs: | other HIV PIs or elvitegravir | |||
| Platelet aggregation inhibitor: | ticagrelor | |||
No dose adjustment required*1
| Acid modifying medications: | antacids, H2-receptor antagonists, proton pump inhibitors |
| INSTIs: | dolutegravir, raltegravir |
| NNRTI: | rilpivirine |
| NRTIs: | all NRTIs except for didanosine |
* No clinically relevant drug-drug interaction is expected when PREZCOBIX® is coadministered.
ARV=antiretroviral; CrCl=creatinine clearance; DHHS=Department of Health and Human Services; INSTI=integrase strand transfer inhibitor; NNRTI=non-nucleoside reverse transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; PDE-5=phosphodiesterase type 5; PI=protease inhibitor; PK=pharmacokinetic; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate.
References: 1. PREZCOBIX® [Prescribing Information]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP. 2. Department of Health & Human Services. Guidelines for the use of antiretroviral agents in HIV-1–infected adults and adolescents. https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Published October 17, 2016. Accessed October 17, 2017. 3. Data on file. Janssen Therapeutics, Division of Janssen Products, LP.