Rescriptor (Delavirdine Mesylate) - Indications and Dosage

INDICATIONS AND USAGE

RESCRIPTOR Tablets are indicated for the treatment of HIV-1 infection in combination with at least 2 other active antiretroviral agents when therapy is warranted.

The following should be considered before initiating therapy with RESCRIPTOR in treatment-naive patients. There are insufficient data directly comparing RESCRIPTOR - containing antiretroviral regimens with currently preferred 3-drug regimens for initial treatment of HIV. In studies comparing regimens consisting of 2 NRTIs (currently considered suboptimal) to RESCRIPTOR plus 2 NRTIs, the proportion of patients receiving the RESCRIPTOR regimen who achieved and sustained an HIV-1 RNA level <400 copies/mL over one year of therapy was relatively low (see DESCRIPTION OF CLINICAL STUDIES).

Resistant virus emerges rapidly when RESCRIPTOR is administered as monotherapy. Therefore, RESCRIPTOR should always be administered in combination with other antiretroviral agents.

DOSAGE AND ADMINISTRATION

The recommended dosage for RESCRIPTOR Tablets is 400 mg (four 100-mg or two 200-mg tablets) three times daily. RESCRIPTOR should be used in combination with other antiretroviral therapy. The complete prescribing information for other antiretroviral agents should be consulted for information on dosage and administration.

The 100-mg RESCRIPTOR Tablets may be dispersed in water prior to consumption. To prepare a dispersion, add four 100-mg RESCRIPTOR Tablets to at least 3 ounces of water, allow to stand for a few minutes, and then stir until a uniform dispersion occurs (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). The dispersion should be consumed promptly. The glass should be rinsed with water and the rinse swallowed to insure the entire dose is consumed. The 200-mg tablets should be taken as intact tablets, because they are not readily dispersed in water. Note: The 200-mg tablets are approximately one third smaller in size than the 100-mg tablets.

RESCRIPTOR Tablets may be administered with or without food (see CLINICAL PHARMACOLOGY: Pharmacokinetics-Absorption and Bioavailability). Patients with achlorhydria should take RESCRIPTOR with an acidic beverage (e.g., orange or cranberry juice). However, the effect of an acidic beverage on the absorption of delavirdine in patients with achlorhydria has not been investigated.

Patients taking both RESCRIPTOR and antacids should be advised to take them at least one hour apart.

HOW SUPPLIED

RESCRIPTOR Tablets are available as follows:

100 mg: white, capsule-shaped tablets marked with "U 3761".
Bottles of 360 tablets NDC 63010-020-36
200 mg: white, capsule-shaped tablets marked with "RESCRIPTOR 200 mg".
Bottles of 180 tablets NDC 63010-021-18
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Keep container tightly closed. Protect from high humidity.

Rx only