"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended 150 mg lamivudine/300 mg raltegravir (Dutrebis, Merck Sharp & Dohme Limited) for the treatment of HIV 1 infection in adults, adolesce"...
- The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies].
DOSAGE AND ADMINISTRATION
General Dosing Recommendations
- ISENTRESS Film-Coated Tablets, Chewable Tablets and For Oral Suspension can be administered with or without food [see CLINICAL PHARMACOLOGY].
- 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 [see DRUG INTERACTIONS].
- 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.
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.
- 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* 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 x 100 mgt twice daily|
|28 to less than 40||200 mg twice daily||2 x 100 mg twice daily|
|At least 40||300 mg twice daily||3 x 100 mg twice daily|
|*The weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily [see CLINICAL PHARMACOLOGY].
†The 100 mg chewable tablet can be divided into equal halves.
If at least 4 weeks of age and weighing at least 3 kg to less than 25 kg: W eight 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 [see Clinical Studies].
Table 2: Recommended Dose* 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†||4 mL (80 mg) twice daily||3 x 25 mg twice daily|
|14 to less than 20†||5 mL (100 mg) twice daily||1 x 100 mg twice daily|
|20 to less than 25||1.5 x 100 mg‡ twice daily|
|*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].
†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.
‡The 100 mg chewable tablet can be divided into equal halves.
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.
Dosage Forms And Strengths
- Film-coated Tablets
400 mg pink, oval-shaped, film-coated tablets with “227” on one side.
- Chewable Tablets
100 mg pale orange, oval-shaped, orange-banana flavored, chewable tablets scored on both sides and imprinted on one face with the Merck logo and “477” on opposite sides of the score.
25 mg pale yellow, round, orange-banana flavored, chewable tablets with the Merck logo on one side and “473” on the other side.
- For Oral Suspension
100 mg white to off-white, banana flavored, granular powder that may contain yellow or beige to tan particles in a child resistant single-use foil packet.
ISENTRESS tablets 400 mg are pink, oval-shaped, film-coated tablets with “227” on one side. They are supplied as follows:
NDC 0006-0227-61 unit-of-use bottles of 60.
ISENTRESS tablets 100 mg are pale orange, oval-shaped, orange-banana flavored, chewable tablets scored on both sides and imprinted on one face with the Merck logo and “477” on opposite sides of the score. They are supplied as follows:
NDC 0006-0477-61 unit-of-use bottles of 60.
ISENTRESS tablets 25 mg are pale yellow, round, orange-banana flavored, chewable tablets with the Merck logo on one side and “473” on the other side. They are supplied as follows:
NDC 0006-0473-61 unit-of-use bottles of 60.
ISENTRESS for oral suspension 100 mg is a white to off-white granular powder that may contain yellow or beige to tan particles, in child resistant single-use foil packets, packaged as a kit with two 5 mL dosing syringes and two mixing cups. It is supplied as follows:
NDC 0006-3603-60 unit of use carton with 60
NDC 0006-3603-01 individual packet.
Storage And Handling
400 mg Film-coated Tablets, Chewable Tablets and For Oral Suspension
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.
Store in the original package with the bottle tightly closed. Keep the desiccant in the bottle to protect from moisture.
For Oral Suspension
Store in the original container. Do not open foil packet until ready for use.
Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA. Revised April 2014
Last reviewed on RxList: 4/24/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Isentress Information
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