Prezcobix

Prezcobix

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Darunavir 800 mg, cobicistat 150 mg
Indications/Uses
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.
Dosage/Direction for Use
Administration
Should be taken with food.
Contraindications
Concomitant use w/ alfuzosin; ranolazine; dronedarone; carbamazepine, phenobarb, phenytoin; colchicine (in patients w/ renal &/or hepatic impairment); rifampin; lurasidone, pimozide; dihydroergotamine, ergotamine, methylergonovine; cisapride; St. John's wort; elbasvir/grazoprevir; lomitapide, lovastatin, simvastatin; sildenafil (when used for pulmonary arterial HTN treatment); orally administered midazolam, triazolam.
Special Precautions
Severe skin reactions; 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. Cobicistat decreases estimated CrCl w/o affecting actual renal glomerular function. Assess estimated CrCl prior to initiating therapy. New onset or worsening renal impairment when used w/ tenofovir disoproxil fumarate. Patients w/ known sulfonamide allergy. New onset DM, exacerbation of pre-existing DM, hyperglycemia. Redistribution/accumulation of body fat. Immune reconstitution syndrome. Increased bleeding in patients w/ hemophilia type A & B treated w/ HIV PIs. 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); other products containing darunavir or cobicistat; ritonavir. Not recommended in patients w/ severe hepatic impairment. Not recommended in patients w/ estimated CrCl <70 mL/min if co-administered w/ tenofovir disoproxil fumarate. Not recommended during pregnancy. Do not breastfeed while on treatment. Not recommended in childn <3 yr. Elderly ≥65 yr.
Adverse Reactions
Diarrhea, nausea, rash, headache, abdominal pain, vomiting.
Drug Interactions
Increased plasma conc of drugs that are primarily metabolized by CYP3A &/or CYP2D6 or are substrates of P-gp, BCRP, MATE1, OATP1B1 or OATP1B3. Lowered plasma conc w/ CYP3A inducers. Increased plasma conc w/ CYP3A inhibitors. Loss of therapeutic effect & development of resistance w/ efavirenz, etravirine, nevirapine; carbamazepine, phenobarb, phenytoin; rifampin; systemic dexamethasone or other systemic corticosteroids; St. John's wort. Potential decreased darunavir conc w/ rifapentine. Potential changes in exposures w/ eslicarbazepine, oxcarbazepine. Increased conc w/ itraconazole, ketoconazole, posaconazole; antibacterials (clarithromycin, erythromycin, telithromycin). Increased conc of maraviroc; alfuzosin; ranolazine; dronedarone, antiarrhythmics, digoxin; antibacterial (clarithromycin, erythromycin, telithromycin); anticancer agents (eg, dasatinib, nilotinib, vinblastine, vincristine); apixaban, rivaroxaban; clonazepam; TCAs, trazodone; itraconazole, ketoconazole; colchicine; rifabutin; lurasidone, pimozide, antipsychotics (eg, perphenazine, risperidone, thioridazine), quetiapine; β-blockers; Ca-channel blockers; corticosteroids; bosentan; ergot derivatives; cisapride; elbasvir/grazoprevir; simeprevir; immunosuppressants; salmeterol; HMG-CoA reductase inhibitors, lomitapide; fentanyl, oxycodone, tramadol; PDE-5 inhibitors; ticagrelor; midazolam, triazolam, sedatives/hypnotics. Monitor INR when co-administering w/ warfarin. Didanosine should be administered 1 hr before or 2 hr after Prezcobix (administered w/ food). Potential decrease of antimalarial efficacy of artemether or lumefantrine, or potential QT prolongation. Additional or alternative (non-hormonal) forms of contraception should be considered when estrogen-containing contraceptives are co-administered w/ Prezcobix. Potential for hyperkalemia w/ drospirenone. Dose adjustment may be needed for buprenorphine, buprenorphine/naloxone or methadone.
MIMS Class
ATC Classification
J05AR14 - darunavir and cobicistat ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Prezcobix FC tab 800 mg/150 mg
Packing/Price
30's
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