Isentress

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Uses

ISENTRESS1 is indicated in combination with other anti-retroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.

This indication is based on analyses of plasma HIV-1 RNA levels up through 48 weeks in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults and one was conducted in treatment-naïve adults.

The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies (14)].

The safety and efficacy of ISENTRESS have not been established in pediatric patients.

1: Registered trademark of MERCK & CO., Inc.
COPYRIGHT © 2007, 2009 MERCK & CO., Inc.
All rights reserved

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Other Information

ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide monopotassium salt.

The empirical formula is C20H20FKN6O5 and the molecular weight is 482.51. The structural formula is:

Raltegravir potassium is a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in isopropanol.

Each film-coated tablet of ISENTRESS for oral administration contains 434.4 mg of raltegravir potassium (as salt), equivalent to 400 mg of raltegravir (free phenol) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide.

Sources

Isentress Manufacturers

State Of Florida Doh Central Pharmacy

Isentress | State Of Florida Doh Central Pharmacy

For the treatment of patients with HIV-1 infection, the dosage of ISENTRESS is 400 mg administered orally, twice daily with or without food. During coadministration with rifampin, the recommended dosage of ISENTRESS is 800 mg twice daily with or without food.

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Physicians Total Care, Inc.

Isentress | Physicians Total Care, Inc.

2.1 General Dosing Recommendations ISENTRESS Film-Coated Tablets and Chewable Tablets can be administered with or without food [see Clinical Pharmacology (12.3)]. Maximum dose of chewable tablets is 300 mg twice daily. ISENTRESS Chewable Tablets may be chewed or swallowed whole. ISENTRESS Film-Coated Tablets must be swallowed whole. Because the formulations are not bioequivalent, do not substitute chewable tablets for the 400 mg film-coated tablet. 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 (7)]. 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
For the treatment of children and adolescents with HIV-1 infection, the dosage of ISENTRESS is as follows:
12 years of age and older: One 400 mg film-coated tablet orally, twice daily 6 to less than 12 years of age:
If at least 25 kg in weight: One 400 mg film-coated tablet orally, twice daily OR Chewable tablets: weight based to maximum dose 300 mg, twice daily as specified in Table 1 If less than 25 kg in weight: Chewable tablets: weight based to maximum dose 300 mg, twice daily as specified in Table 1 2 to less than 6 years of age:
If at least 10 kg in weight: Chewable tablets: weight based to maximum dose 300 mg, twice daily as specified in Table 1 Table 1: Recommended Dose for ISENTRESS Chewable Tablets in Pediatric Patients 2 to Less Than 12 Years of Age Body Weight
(kg) Dose Number of Chewable Tablets 10 to less than 14 75 mg twice daily 3 × 25 mg twice daily 14 to less than 20 100 mg twice daily 1 × 100 mg twice daily 20 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

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Remedyrepack Inc.

Isentress | Remedyrepack Inc.

ISENTRESS can be administered with or without food (2.1).

ISENTRESS 400 mg film-coated tablets cannot be substituted with ISENTRESS 25 mg and 100 mg chewable tablets (2.1).

Adults
400 mg film-coated tablet orally, twice daily (2.2). During coadministration with rifampin in adults, 800 mg twice daily (2.1).
Children and Adolescents
12 years of age and older: One 400 mg film-coated tablet orally, twice daily (2.3). 6 to less than 12 years of age: If at least 25 kg in weight:
One 400 mg film-coated tablet orally, twice daily OR
Chewable tablets: weight based to maximum dose 300 mg twice daily (2.3). If less than 25 kg in weight:
Chewable tablets: weight based to maximum dose 300 mg twice daily (2.3). 2 to less than 6 years of age: If at least 10 kg in weight:
Chewable tablets: weight based to maximum dose 300 mg twice daily (2.3).

ISENTRESS Film-Coated Tablets and Chewable Tablets can be administered with or without food [see Clinical Pharmacology (12.3)]. Maximum dose of chewable tablets is 300 mg twice daily. ISENTRESS Chewable Tablets may be chewed or swallowed whole. ISENTRESS Film-Coated Tablets must be swallowed whole. Because the formulations are not bioequivalent, do not substitute chewable tablets for the 400 mg film-coated tablet. 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 (7)].

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.

For the treatment of children and adolescents with HIV-1 infection, the dosage of ISENTRESS is as follows:
12 years of age and older: One 400 mg film-coated tablet orally, twice daily 6 to less than 12 years of age:
If at least 25 kg in weight: One 400 mg film-coated tablet orally, twice daily OR Chewable tablets: weight based to maximum dose 300 mg, twice daily as specified in Table 1 If less than 25 kg in weight: Chewable tablets: weight based to maximum dose 300 mg, twice daily as specified in Table 1 2 to less than 6 years of age:
If at least 10 kg in weight: Chewable tablets: weight based to maximum dose 300 mg, twice daily as specified in Table 1 Table 1: Recommended Dose* for ISENTRESS Chewable Tablets in Pediatric Patients 2 to Less Than 12 Years of Age Body Weight
(kg) Dose Number of Chewable Tablets 10 to less than 14 75 mg twice daily 3 × 25 mg twice daily 14 to less than 20 100 mg twice daily 1 × 100 mg twice daily 20 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
1

2

1 The weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily. 2 The 100 mg chewable tablet can be divided into equal halves.

No Recall
Remedyrepack Inc.

Isentress | Remedyrepack Inc.

ISENTRESS can be administered with or without food (2.1).

ISENTRESS 400 mg film-coated tablets cannot be substituted with ISENTRESS 25 mg and 100 mg chewable tablets (2.1).

Adults
400 mg film-coated tablet orally, twice daily (2.2). During coadministration with rifampin in adults, 800 mg twice daily (2.1).
Children and Adolescents
12 years of age and older: One 400 mg film-coated tablet orally, twice daily (2.3). 6 to less than 12 years of age: If at least 25 kg in weight:
One 400 mg film-coated tablet orally, twice daily OR
Chewable tablets: weight based to maximum dose 300 mg twice daily (2.3). If less than 25 kg in weight:
Chewable tablets: weight based to maximum dose 300 mg twice daily (2.3). 2 to less than 6 years of age: If at least 10 kg in weight:
Chewable tablets: weight based to maximum dose 300 mg twice daily (2.3).

ISENTRESS Film-Coated Tablets and Chewable Tablets can be administered with or without food [see Clinical Pharmacology (12.3)]. Maximum dose of chewable tablets is 300 mg twice daily. ISENTRESS Chewable Tablets may be chewed or swallowed whole. ISENTRESS Film-Coated Tablets must be swallowed whole. Because the formulations are not bioequivalent, do not substitute chewable tablets for the 400 mg film-coated tablet. 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 (7)].

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.

For the treatment of children and adolescents with HIV-1 infection, the dosage of ISENTRESS is as follows:
12 years of age and older: One 400 mg film-coated tablet orally, twice daily 6 to less than 12 years of age:
If at least 25 kg in weight: One 400 mg film-coated tablet orally, twice daily OR Chewable tablets: weight based to maximum dose 300 mg, twice daily as specified in Table 1 If less than 25 kg in weight: Chewable tablets: weight based to maximum dose 300 mg, twice daily as specified in Table 1 2 to less than 6 years of age:
If at least 10 kg in weight: Chewable tablets: weight based to maximum dose 300 mg, twice daily as specified in Table 1 Table 1: Recommended Dose* for ISENTRESS Chewable Tablets in Pediatric Patients 2 to Less Than 12 Years of Age Body Weight
(kg) Dose Number of Chewable Tablets 10 to less than 14 75 mg twice daily 3 × 25 mg twice daily 14 to less than 20 100 mg twice daily 1 × 100 mg twice daily 20 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
1

2

1 The weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily. 2 The 100 mg chewable tablet can be divided into equal halves.

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Dispensing Solutions, Inc.

Isentress | Dispensing Solutions, Inc.

2.1 General Dosing Recommendations ISENTRESS Film-Coated Tablets and Chewable Tablets can be administered with or without food [see Clinical Pharmacology (12.3)]. Maximum dose of chewable tablets is 300 mg twice daily. ISENTRESS Chewable Tablets may be chewed or swallowed whole. ISENTRESS Film-Coated Tablets must be swallowed whole. Because the formulations are not bioequivalent, do not substitute chewable tablets for the 400 mg film-coated tablet. 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 (7)]. 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
For the treatment of children and adolescents with HIV-1 infection, the dosage of ISENTRESS is as follows:
12 years of age and older: One 400 mg film-coated tablet orally, twice daily 6 to less than 12 years of age:
If at least 25 kg in weight: One 400 mg film-coated tablet orally, twice daily OR Chewable tablets: weight based to maximum dose 300 mg, twice daily as specified in Table 1 If less than 25 kg in weight: Chewable tablets: weight based to maximum dose 300 mg, twice daily as specified in Table 1 2 to less than 6 years of age:
If at least 10 kg in weight: Chewable tablets: weight based to maximum dose 300 mg, twice daily as specified in Table 1 Table 1: Recommended Dose* for ISENTRESS Chewable Tablets in Pediatric Patients 2 to Less Than 12 Years of Age 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. † The 100 mg chewable tablet can be divided into equal halves. 10 to less than 14 75 mg twice daily 3 × 25 mg twice daily 14 to less than 20 100 mg twice daily 1 × 100 mg twice daily 20 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

No Recall
Merck Sharp & Dohme Corp.

Isentress | Merck Sharp & Dohme Corp.

2.1 General Dosing Recommendations ISENTRESS Film-Coated Tablets, Chewable Tablets and For Oral Suspension can be administered with or without food [see Clinical Pharmacology (12.3)]. 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 (7.2)]. 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* 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 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 [see Clinical Studies (14.3)]. 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 * 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)]. † 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. 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 × 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‡ 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.

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