Drug Detail:Isentress (Raltegravir [ ral-teg-ra-veer ])
Generic Name: RALTEGRAVIR POTASSIUM 400mg
Dosage Form: tablet, film coated
Drug Class: Integrase strand transfer inhibitor
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.
- 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.
- Preparation of the crushed 25 mg chewable tablet:
- 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.
- Discard any remaining suspension into the trash.
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)] .
| 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 |
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)] .
| 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 100 mg 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 | 1 × 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 | 2 × 25 mg twice daily ‡ |
| 8 to less than 10 | 6 mL (60 mg) twice daily | |
| 10 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 | Not applicable | 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 |
