Prezcobix

Darunavir 800 mg, cobicistat 150 mg

In combination w/ other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve & treatment-experienced adults w/ no darunavir resistance-associated substitutions.

1 tab once daily.

Should be taken with food.

Concomitant use w/ alfuzosin; carbamazepine, phenobarb, phenytoin; colchicine (in patients w/ renal &/or hepatic impairment); rifampin; lurasidone, pimozide; dronedarone, ivabradine, ranolazine; dihydroergotamine, ergotamine, methylergonovine; St. John's wort; elbasvir/grazoprevir; lomitapide, lovastatin, simvastatin; naloxegol; sildenafil (when used for pulmonary arterial HTN treatment); orally administered midazolam, triazolam.

Discontinue immediately if signs or symptoms of severe skin reactions develop. Increased risk for liver function abnormalities in patients w/ pre-existing liver dysfunction, including chronic active hepatitis B or C. Interrupt or discontinue treatment in case of evidence of new or worsening liver dysfunction. Cobicistat decreases estimated CrCl w/o affecting actual renal glomerular function. Assess estimated CrCl prior to starting therapy. New onset or worsening renal impairment when used w/ tenofovir disoproxil fumarate. When co-administering w/ tenofovir disoproxil fumarate assess estimated CrCl, urine glucose, & urine protein at baseline, & routinely monitor during treatment; monitor serum P in patient w/ or at risk for renal impairment. Darunavir contains a sulfonamide moiety; monitor patients w/ known sulfonamide allergy after treatment initiation. Reports of new onset DM, exacerbation of pre-existing DM, hyperglycemia; redistribution/accumulation of body fat; immune reconstitution syndrome. Reports of increased bleeding, including spontaneous skin hematomas & hemarthrosis in patients w/ hemophilia type A & B treated w/ HIV PIs. HIV genotypic testing is recommended for antiretroviral treatment‑experienced patients. When HIV genotypic testing is not feasible, Prezcobix can be used in PI-naïve patients, but is not recommended in PI‑experienced patients. Co-administration w/ CYP3A substrates, inhibitors or inducers. Not recommended in combination w/ other antiretroviral drugs that require pharmacokinetic boosting (ie, another PI or elvitegravir); products containing darunavir or cobicistat; ritonavir. Not recommended in patients w/ estimated CrCl <70 mL/min when co-administered w/ tenofovir disoproxil fumarate. Not recommended for use in patients w/ severe hepatic impairment. Additional or alternative (non-hormonal) forms of contraception should be considered when co-administered w/ estrogen-containing contraceptives. Clinical monitoring is recommended when co-administered w/ drospirenone. Not recommended during pregnancy. Should not be initiated in pregnant individuals. Do not breastfeed while on treatment. Safety, effectiveness, & pharmacokinetics in ped patients <18 yr have not been established. Darunavir is not recommended in childn <3 yr. Caution in elderly patients.

Diarrhea, nausea, rash, headache, abdominal pain, vomiting.

Increased plasma conc of drugs that are primarily metabolized by CYP3A &/or CYP2D6 or are substrates of P-gp, BCRP, MATE1, OATP1B1 or OATP1B3. Co-administration w/ drugs that have active metabolite(s) formed by CYP3A may result in reduced plasma conc of these active metabolite(s). Lowered plasma conc w/ CYP3A inducers. Increased plasma conc w/ CYP3A inhibitors. Loss of therapeutic effect & development of resistance to darunavir w/ efavirenz, etravirine, nevirapine; carbamazepine, phenobarb, phenytoin; rifampin; systemic dexamethasone or other systemic corticosteroids; bosentan; St. John's wort. Increased conc of darunavir, cobicistat & the co-administered antibacterials (clarithromycin, erythromycin, telithromycin) or antifungals (itraconazole, isavuconazole, ketoconazole). Potential decreased darunavir conc w/ rifapentine. Potential changes in exposures w/ eslicarbazepine, oxcarbazepine. Increased conc of maraviroc; alfuzosin; anticancer agents (eg, dasatinib, nilotinib, vinblastine, vincristine); apixaban, rivaroxaban; clonazepam; TCAs, trazodone; colchicine; rifabutin; lurasidone, pimozide, antipsychotics (eg, perphenazine, risperidone, thioridazine), quetiapine; β-blockers; Ca-channel blockers; ranolazine, ivabradine, dronedarone, antiarrhythmics, digoxin; corticosteroids; bosentan; ergot derivatives; elbasvir/grazoprevir, glecaprevir/pibrentasvir; immunosuppressants; salmeterol; HMG-CoA reductase inhibitors, lomitapide; fentanyl, oxycodone, tramadol; naloxegol; PDE-5 inhibitors; ticagrelor; orally administered midazolam/triazolam, sedatives/hypnotics; fesoterodine, solifenacin. Monitor INR when co-administering w/ warfarin. Potential decrease of antimalarial efficacy of artemether or lumefantrine, or potential QT prolongation. Potential for hyperkalemia w/ drospirenone. Additional or alternative (non-hormonal) forms of contraception should be considered when estrogen-containing contraceptives are co-administered w/ Prezcobix. Dose adjustment may be needed for buprenorphine, buprenorphine/naloxone or methadone. Potential reduction of antiplatelet activity of clopidogrel. Didanosine should be administered 1 hr before or 2 hr after Prezcobix (administered w/ food).

Antivirals

J05AR14 - darunavir and cobicistat ; Belongs to the class of antivirals for treatment of HIV infections, combinations.

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