INDICATIONS AND USAGE（适应症）

Adult Patients:

ISENTRESS® and ISENTRESS® HD are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.

Pediatric Patients:

ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg.

ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg.

DOSAGE（服用剂量）

General Dosing Recommendations

Because the formulations have different pharmacokinetic profiles, do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg film-coated tablet or the ISENTRESS HD 600 mg film-coated tablet. See specific dosing guidance for chewable tablets and the formulation for oral suspension.

Because the extent to which ISENTRESS may be dialyzable is unknown, dosing before a dialysis session should be avoided.

ISENTRESS film-coated tablets must be swallowed whole.

ISENTRESS chewable tablets may be chewed or swallowed whole. Maximum daily dose is 300 mg taken by mouth twice daily.

For children who have difficulty chewing the 25 mg chewable tablet, the tablet may be crushed.

Preparation of the crushed 25 mg chewable tablet:

Place the tablet(s) in a small, clean cup. For each tablet, add a teaspoonful (~5 mL) of liquid (for example, water, juice, or breast milk).

Within 2 minutes, the tablet(s) will absorb the liquid and fall apart.

Using a spoon, crush any remaining pieces of the tablet(s). Immediately administer the entire dose orally.

If any portion of the dose is left in the cup, add another teaspoonful (~5 mL) of liquid, swirl and administer immediately.

ISENTRESS for oral suspension:

See Instructions for Use for details on preparation and administration of ISENTRESS for oral suspension.

Using the provided mixing cup, combine 10 mL of water and the entire contents of one packet of ISENTRESS for oral suspension and mix. Each single-use packet for oral suspension contains 100 mg of raltegravir which is suspended in 10 mL of water giving a final concentration of 10 mg per mL. Maximum daily dose is 100 mg taken by mouth twice daily.

Gently swirl the mixing cup for 45 seconds in a circular motion to mix the powder into a uniform suspension. Do not shake.

Once mixed, measure the prescribed dose volume of suspension with a syringe and administer the dose orally. The dose should be administered orally within 30 minutes of mixing.

ADVERSE REACTIONS（不良反应）

Blood and Lymphatic System Disorders: thrombocytopenia

Gastrointestinal Disorders: diarrhea

Hepatobiliary Disorders: hepatic failure (with and without associated hypersensitivity) in patients with underlying liver disease and/or concomitant medications

Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis

Nervous System Disorders: cerebellar ataxia

Psychiatric Disorders: anxiety, paranoia

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/89a5ec53-d956-4329-8004-0f40f51c88a3/spl-doc?hl=Isentress

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