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Basic Drug Info
Drug Name:PREZISTA
Manufacturer:Ortho Biotech Products, L.P.
Other Info:

Manufactured for Tibotec, Inc.

by:JOLLC, Gurabo, Puerto RicoDistributed by:Tibotec Therapeutics, Division of Ortho Biotech Products, L.P., Raritan NJ 08869Patent Numbers: 5,843,946; 6,248,775; 6,335,460 and other US patents pendingNORVIR® is a registered trademark of its respective owner.PREZISTA® is a registered trademark of Tibotec Pharmaceuticals, Ltd.© Tibotec, Inc.

200610101706



Clinical Trials:


Indications and Usage
PREZISTA®, co-administered with 100 mg ritonavir (PREZISTA/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.This indication is based on analyses of plasma HIV RNA levels and CD4+ cell counts from 2 controlled Phase 3 trials of 48 weeks duration in antiretroviral treatment-naïve and treatment-experienced patients and 2 controlled Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced patients.In treatment-experienced patients, the following points should be considered when initiating therapy with PREZISTA/rtv:Treatment history and, when available, genotypic or phenotypic testing, should guide the use of PREZISTA/rtv [see Clinical Pharmacology (12.4)].The use of other active agents with PREZISTA/rtv is associated with a greater likelihood of treatment response [see Clinical Pharmacology (12.4) and Clinical Studies (14.3)].The risks and benefits of PREZISTA/rtv have not been established in pediatric patients.No clinical studies have demonstrated the effect of PREZISTA/rtv on clinical progression of HIV-1.
HIV Infections -- any state of infection accompanied by evidence of HIV in the body (positive test for HIV genome, cDNA, proteins, antigens, or antibodies); may be medically asymptomatic or symptomatic; use AIDS when appropriate.

Disease Progression -- The worsening of a disease over time. This concept is most often used for chronic and incurable diseases where the stage of the disease is an important determinant of therapy and prognosis.

Contraindications

Co-administration of PREZISTA/rtv 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).

These drugs and other contraindicated drugs (which may lead to reduced efficacy of darunavir) are listed in Table 1 [also see Drug Interactions (7.3), Table 6].Table 1: Drugs That Are Contraindicated With PREZISTA/rtv Drug ClassDrugs Within Class That Are Contraindicated With PREZISTA/rtvClinical Comment Ergot DerivativesDihydroergotamine, Ergonovine, Ergotamine, MethylergonovinePotential for serious and/or life-threatening events such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues. GI Motility AgentCisapridePotential for serious and/or life-threatening reactions such as cardiac arrhythmias. NeurolepticPimozidePotential for serious and/or life-threatening reactions such as cardiac arrhythmias. Sedative/hypnoticsOrally administered Midazolam, TriazolamTriazolam and orally administered midazolam are extensively metabolized by CYP3A.

Co-administration of triazolam or orally administered midazolam with PREZISTA/rtv may cause large increases in the concentrations of these benzodiazepines.

Potential for serious and/or life-threatening events such as prolonged or increased sedation or respiratory depression. Herbal ProductsSt.

John's Wort (Hypericum perforatum)Patients taking PREZISTA/rtv should not use products containing St.

John's wort because co-administration may result in reduced plasma concentrations of darunavir.

This may result in loss of therapeutic effect and development of resistance. HMG CoA Reductase InhibitorsLovastatin, SimvastatinPotential for serious reactions such as myopathy including rhabdomyolysis.For dosing recommendation regarding atorvastatin and pravastatin, see Table 6: Established and Other Potentially Significant Drug Interactions: Alterations in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction. AntimycobacterialRifampinRifampin is a potent inducer of CYP450 metabolism.

PREZISTA/rtv should not be used in combination with rifampin, as this may cause significant decreases in darunavir plasma concentrations.

This may result in loss of therapeutic effect to PREZISTA. Due to the need for co-administration of PREZISTA with 100 mg of ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications.
Ischemia -- A hypoperfusion of the BLOOD through an organ or tissue caused by a PATHOLOGIC CONSTRICTION or obstruction of its BLOOD VESSELS, or an absence of BLOOD CIRCULATION.

cardiac arrhythmia -- any variation from the normal rhythm or rate of the heart beat.

Sedation --

LUNG FUNCTION DECREASED --

Myopathy -- Acquired, familial, and congenital disorders of SKELETAL MUSCLE and SMOOTH MUSCLE.

Rhabdomyolysis -- Necrosis or disintegration of skeletal muscle often followed by myoglobinuria.


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