ISENTRESS

ISENTRESS- raltegravir potassium tablet, film coated
REMEDYREPACK INC.

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 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 [see Clinical Pharmacology (12.3)] .
  • 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.
  • 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.
    • Discard any remaining suspension into the trash.
    • For more details on preparation and administration of the suspension, see Instructions for Use.

2.2 Adults

The recommended adult dosage of ISENTRESS film-coated tablets is displayed in Table 1. ISENTRESS and ISENTRESS HD should be taken by mouth and may be taken with or without food [see Clinical Pharmacology (12.3)] .

Table 1: Dosing Recommendations for ISENTRESS and ISENTRESS HD in Adult Patients
Population Recommended Dose
Treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily 1200 mg (2 × 600 mg) once daily or 400 mg twice daily
Treatment-experienced 400 mg twice daily
Treatment-naïve or treatment-experienced when coadministered with rifampin [ see Drug Interactions (7.1)] 800 mg (2 × 400 mg) twice daily

2.3 Pediatrics

The recommended pediatric dosage of ISENTRESS is displayed in Table 2. ISENTRESS film-coated tablets, chewable tablets and for oral suspension should be taken by mouth and may be taken with or without food [see Clinical Pharmacology (12.3)] .

Table 2: Dosing Recommendations for ISENTRESS and ISENTRESS HD in Pediatric Patients
Recommended Pediatric Dosage and Formulation
Population/Weight Film-Coated Tablets 400 mg Film-Coated Tablets 600 mg Chewable Tablets 100 mg and 25 mg For Oral Suspension 100 mg
*
If able to swallow a tablet
If at least 40 kg and either
  • treatment-naïve or
  • virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily
400 mg twice daily 1200 mg (2 × 600 mg) once daily 300 mg twice daily (see Table 3) NA
If at least 25 kg 400 mg twice daily * NA Weight-based dosing twice daily (see Table 3) NA
If at least 4 weeks of age and weighing 3 kg to less than 25 kg NA NA Weight-based dosing twice daily (see Table 4) Weight-based dosing twice daily up to 20 kg (see Table 4)
From birth to 4 weeks (28 days) weighing at least 2 kg NA NA NA Weight-based dosing once daily or twice daily (see Table 5)
Table 3: Alternative Dosage * with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg
Body Weight (kg) Dose Number of Chewable Tablets
*
The weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily [see Clinical Pharmacology (12.3)] .
The 100 mg chewable tablet can be divided into equal halves.
25 to less than 28 150 mg twice daily 1.5 × 100 mg 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
Table 4: Recommended Dosage * for ISENTRESS For Oral Suspension and Chewable Tablets in Pediatric Patients at Least 4 Weeks of Age and Weighing at Least 3 kg and Less than 25 kg
Body Weight (kg) Volume (Dose) of Suspension to be Administered Number of Chewable Tablets
*
The weight-based dosing recommendation for the chewable tablet and oral suspension is based on approximately 6 mg/kg/dose twice daily [see Clinical Pharmacology (12.3)] .
The chewable tablets are available as 25 mg and 100 mg tablets.
For weight between 11 and 20 kg, either formulation can be used.
§
The 100 mg chewable tablet can be divided into equal halves.
3 to less than 4 2.5 mL (25 mg) twice daily
4 to less than 6 3 mL (30 mg) twice daily
6 to less than 8 4 mL (40 mg) twice daily
8 to less than 11 6 mL (60 mg) twice daily
11 to less than 14 8 mL (80 mg) twice daily 3 × 25 mg twice daily
14 to less than 20 10 mL (100 mg) twice daily 1 × 100 mg twice daily
20 to less than 25 1.5 × 100 mg § twice daily
  • For full-term neonates (birth to 4 weeks [28 days] of age): Weight-based dosing of the oral suspension as specified in Table 5.
  • No data are available in pre-term neonates. The use of ISENTRESS is not recommended in pre-term neonates.
Table 5: Recommended Dose for ISENTRESS For Oral Suspension in Full-Term Neonates (Birth to 4 Weeks [28 days] of Age)
Body Weight (kg) Volume (Dose) of Suspension to be Administered
Note: If the mother has taken ISENTRESS or ISENTRESS HD 2-24 hours before delivery, the neonate’s first dose should be given between 24-48 hours after birth.
*
The dosing recommendations are based on approximately 1.5 mg/kg/dose.
The dosing recommendations are based on approximately 3 mg/kg/dose.
Birth to 1 Week — Once daily dosing *
2 to less than 3 0.4 mL (4 mg) once daily
3 to less than 4 0.5 mL (5 mg) once daily
4 to less than 5 0.7 mL (7 mg) once daily
1 to 4 Weeks — Twice daily dosing
2 to less than 3 0.8 mL (8 mg) twice daily
3 to less than 4 1 mL (10 mg) twice daily
4 to less than 5 1.5 mL (15 mg) twice daily

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