ISENTRESS- raltegravir potassium tablet, film coated
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.
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.
- 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.
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)] .
|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|
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)] .
|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 at least 40 kg and either
||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)|
|Body Weight (kg)||Dose||Number of Chewable Tablets|
|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|
|Body Weight (kg)||Volume (Dose) of Suspension to be Administered||Number of Chewable Tablets †|
|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.
|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.|
|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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