Raltegravirdosage

ISENTRESS can be administered with or without food. Do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg film-coated tablet. See specific dosing guidance for chewable tablets and the formulation for oral suspension. Adults 400 mg film-coated tablet orally, twice daily. During coadministration with rifampin in adults, 800 mg twice daily. Children and Adolescents If at least 25 kg: One 400 mg film-coated tablet orally, twice daily. If unable to swallow a tablet, consider the chewable tablet, as specified in Table 1. If at least 3 kg to less than 25 kg: Weight based dosing, as specified in Table 2. For patients weighing between 11 and 20 kg, either the chewable tablet or the formulation for oral suspension can be used, as specified in Table 2.

2.1 General

Dosing Recommendations ISENTRESS Film-Coated Tablets, Chewable Tablets and For Oral Suspension can be administered with or without food. Because the formulations are not bioequivalent, do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg film-coated tablet. See specific dosing guidance for chewable tablets and the formulation for oral suspension. During coadministration of ISENTRESS 400 mg film-coated tablets with rifampin, the recommended dosage of ISENTRESS is 800 mg twice daily in adults. There are no data to guide co-administration of ISENTRESS with rifampin in patients below 18 years of age. Maximum dose of chewable tablets is 300 mg twice daily. Maximum dose of oral suspension is 100 mg twice daily. Each single-use packet for oral suspension contains 100 mg of raltegravir which is suspended in 5 mL of water giving a final concentration of 20 mg/mL. 2.2 Adults For the treatment of adult patients with HIV-1 infection, the dosage of ISENTRESS is one 400 mg film-coated tablet administered orally, twice daily.

2.3 Pediatrics

If at least 25 kg: One 400 mg film-coated tablet orally, twice daily. If unable to swallow a tablet, consider the chewable tablet, as specified in Table 1.

Table 1: Alternative Dose The weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily. with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg Body Weight (kg) Dose Number of Chewable Tablets 25 to less than 28 150 mg twice daily 1.5 × 100 mg The 100 mg chewable tablet can be divided into equal halves. twice daily 28 to less than 40 200 mg twice daily 2 × 100 mg twice daily At least 40 300 mg twice daily 3 × 100 mg twice daily If at least 4 weeks of age and weighing at least 3 kg to less than 25 kg: Weight based dosing, as specified in Table 2. For patients weighing between 11 and 20 kg, either the chewable tablet or oral suspension can be used, as specified in Table 2. Patients can remain on the oral suspension as long as their weight is below 20 kg. Refer to Table 2 for appropriate dosing.

Table 2: Recommended Dose The weight-based dosing recommendation for the chewable tablet and oral suspension is based on approximately 6 mg/kg/dose twice daily. for ISENTRESS For Oral Suspension and Chewable Tablets in Pediatric Patients Weighing Less than 25 kg Body Weight (kg) Volume (Dose) of Suspension to be Administered Number of Chewable Tablets 3 to less than 4 1 mL (20 mg) twice daily 4 to less than 6 1.5 mL (30 mg) twice daily 6 to less than 8 2 mL (40 mg) twice daily 8 to less than 11 3 mL (60 mg) twice daily 11 to less than 14 For weight between 11 and 20 kg either formulation can be used.

Note: The chewable tablets are available as 25 mg and 100 mg tablets. 4 mL (80 mg) twice daily 3 × 25 mg twice daily 14 to less than 20 5 mL (100 mg) twice daily 1 × 100 mg twice daily 20 to less than 25 1.5 × 100 mg The 100 mg chewable tablet can be divided into equal halves. twice daily

2.4 Method of

Administration ISENTRESS Film-Coated Tablets Film-Coated Tablets must be swallowed whole ISENTRESS Chewable Tablets Chewable Tablets may be chewed or swallowed whole ISENTRESS For Oral Suspension Each single-use ISENTRESS packet for oral suspension contains 100 mg of raltegravir which is to be suspended in 5 mL of water giving a final concentration of 20 mg/mL. Pour packet contents of ISENTRESS for oral suspension into 5 mL of water and mix Once mixed, measure the recommended volume (dose) of suspension with a syringe and administer the dose orally The volume (dose) of suspension should be administered orally within 30 minutes of mixing Discard any remaining suspension For more details on preparation and administration of the suspension, see Instructions for Use.