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Antiretrovirals

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Daruvir

Darunavir Tablets

COMPOSITION

DARUVIR Tablets
Each tablet contains:
Darunavir ….. 300 mg

INDICATIONS

DARUVIR , co-administered with ritonavir (darunavir/rtv) and with other antiretroviral agents, are indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.

In treatment-experienced adult patients, the following points should be considered when initiating therapy with DARUVIR :

Treatment history and, when available, genotypic or phenotypic testing should guide the use of DARUVIR .
The use of other active agents with DARUVIR is associated with a greater likelihood of treatment.

DOSAGE AND ADMINISTRATION

Treatment-Experienced Adult Patients
The recommended oral dose of DARUVIR is 600 mg ( two 300 mg tablets) taken with ritonavir 100 mg twice daily and with food.

DARUVIR must be co-administered with RITOMUNE (ritonavir 100 mg tablets) to exert its therapeutic effect. Failure to correctly co-administer DARUVIR with ritonavir will result in plasma levels of darunavir that will be insufficient to achieve the desired antiviral effect and will alter some drug interactions.

Patients with Hepatic Impairment
No dose adjustment is required in patients with mild or moderate hepatic impairment. No data are available regarding the use of darunavir/rtv when co-administered to subjects with severe hepatic impairment; therefore, DARUVIR / rtv are not recommended for use in patients with severe hepatic impairment ( see USE IN SPECIFIC POPULATIONS AND PHARMACOLOGY, Pharmacokinetics, Special Populations, Hepatic Impairment ).

CONTRAINDICATIONS

Co-administration of DARUVIR /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 2 (also see WARNINGS AND PRECAUTIONS, Drug Interactions, Table 3 ).

Table 2: Drugs within class that are contraindicated with d arunavir drug class drugs within class that are contraindicated with DARUVIR Tablets

Drug Class	Drugs Within Class That Are Contraindicated with DARUVIR Tablets/ r tv	Clinical Comment
Alpha 1adrenoreceptor antagonist	Alfuzosin	Potential for serious and/or life-threatening reactions such as hypotension.
Ergot Derivatives	Dihydroergotamine, ergonovine, ergotamine, methylergonovine	Potential for serious and/or life-threatening events such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
Gastrointestinal Motility Agent	Cisapride	Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Neuroleptic	Pimozide	Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Sedative/ h ypnotics	Orally administered midazolam, triazolam	Triazolam and orally administered midazolam are extensively metabolized by CYP3A. Co-administration of triazolam or orally administered midazolam with DARUVIR / ritonavir 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 Products	St. John`s wort ( Hypericum perforatum )	Patients taking DARUVIR / ritonavir 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 Inhibitors	Lovastatin, simvastatin	Potential for serious reactions such as myopathy, including rhabdomyolysis. For dosing recommendation regarding atorvastatin and pravastatin, see WARNINGS AND PRECAUTIONS, Drug Interactions, Table 3 : Established and Other Potentially Significant Drug Interactions: Alterations in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction.
Antimycobacterial	Rifampin	Rifampin is a potent inducer of CYP450 metabolism. DARUVIR / ritonavir 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 darunavir.

Due to the need for co-administration of DARUVIR with ritonavir, please refer to the ritonavir prescribing information for a description of ritonavir contraindications.

PACKAGING INFORMATION

DARUVIR Tablets------- Bottle of 60 tablets

For full prescribing information, click here

Last Updated: February 2010

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