Prezista

Prezista

darunavir

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Darunavir
Indications/Uses
Treatment of HIV-1 infections in adult & childn (≥6 yr), in combination w/ ritonavir & other antiretroviral agents.
Dosage/Direction for Use
Treatment-naïve adult patient 800 mg w/ ritonavir 100 mg once daily. Treatment-experienced adult patient w/ no darunavir resistance associated substitutions 800 mg once daily w/ ritonavir 100 mg once daily. Treatment-experienced adult patient w/ ≥1 darunavir resistance associated substitution 600 mg bd w/ ritonavir 100 mg bd. Childn 6 to <18 yr w/ body wt ≥20 to <30 kg 375 mg w/ ritonavir 50 mg bd, ≥30 to <40 kg 450 mg w/ ritonavir 60 mg bd, ≥40 kg 600 mg w/ ritonavir 100 mg bd.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Co-administration w/ drugs that are highly dependent on CYP3A for clearance & w/ narrow therapeutic index [eg, alfuzosin, dronaderone, colchicine, ranolazine, pimozide, dihydroergotamine, ergotamine, methylergonovine, cisapride, pimozide, orally administered midazolam/triazolam, St. John's wort, lovastatin, simvastatin, rifampin, sildenafil (for treatment of pulmonary arterial HTN)].
Special Precautions
Severe skin reactions; discontinue immediately if signs or symptoms of severe skin reactions develop. Drug-induced hepatitis. Increased risk for liver function abnormalities in patients w/ pre-existing liver dysfunction, including chronic active hepatitis B or C. 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/ PIs. Co-administration w/ CYP3A substrates, inhibitors or inducers. Not recommended in severe hepatic impairment. Pregnancy. Do not breastfeed while on treatment. Do not administer in ped patients <3 yr. Elderly ≥65 yr.
Adverse Reactions
Diarrhea, headache, abdominal pain, rash, nausea, vomiting; laboratory abnormalities (increased ALT, AST, total cholesterol, LDL-cholesterol, pancreatic lipase, pancreatic amylase). Adults: Elevated glucose levels, increased triglycerides. Ped patients: Fatigue, anorexia, pruritus, decreased appetite.
Drug Interactions
Increased plasma conc of drugs that are primarily metabolized by CYP3A & CYP2D6 or are transported by P-gp. Lowered plasma conc w/ CYP3A inducers. Increased plasma conc w/ CYP3A or P-gp inhibitors. Increased conc of both darunavir & indinavir when co-administered. Not recommended to co-administer w/ lopinavir or saquinavir w/ or w/o ritonavir. Didanosine should be administered 1 hr before or 2 hr after Prezista/ritonavir (administered w/ food). Increased conc of maraviroc; antiarrhythmics, digoxin; clarithromycin (adjust clarithromycin dose in patients w/ renal impairment); apixaban, dabigatran etexilate, rivaroxaban; carbamazepine; amitriptyline, desipramine, imipramine, nortriptyline, trazodone; itraconazole, ketoconazole; colchicine; rifabutin; antineoplastics (eg, dasatinib, nilotinib, vinblastine, vincristine); quetiapine; antipsychotics (eg, risperidone, thioridazine); β-blockers; Ca-channel blockers; systemic corticosteroid (eg, budenoside, prednisolone); inhaled corticosteroid (eg, fluticasone); bosentan; simeprevir; HMG-CoA reductase inhibitors; immunosuppressants; salmeterol; PDE-5 inhibitors; sedatives/hypnotics. Decreased conc of warfarin; phenytoin, phenobarb; paroxetine, sertraline; voriconazole; boceprevir, telaprevir; ethinyl estradiol, norethindrone. Increased conc w/ itraconazole, ketoconazole, posaconazole; simeprevir. Decreased conc w/ rifapentine; systemic dexamethasone; boceprevir, telaprevir. Increased risk of QT prolongation w/ lumefantrine. Dose adjustment may be needed for methadone during maintenance therapy in some patients.
MIMS Class
Antivirals
ATC Classification
J05AE10 - darunavir ; Belongs to the class of protease inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Prezista film-coated tab 400 mg
Packing/Price
60's
Form
Prezista film-coated tab 600 mg
Packing/Price
60's
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