Isentress

(Raltegravir)

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Dosage & Administration

ISENTRESS and ISENTRESS HD can be administered with or without food (

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.
* 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.

* 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.

Do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg or 600 mg film-coated tablet.

See specific dosing guidance for chewable tablets and the formulation for oral suspension (

2.1 General Dosing Recommendations

[see Clinical Pharmacology (12.3)]

Instructions for Use

Do not shake.

Adults

* Treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily:
* 1200 mg (2 × 600 mg) film-coated tablet orally, once daily or
* 400 mg film-coated tablet orally, twice daily (

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

).

* Treatment-experienced patients:
* 400 mg film-coated tablet orally, twice daily (

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

).

* During coadministration with rifampin in adults, 800 mg (2 × 400 mg) twice daily (

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

Pediatrics

* If weighing at least 40 kg, and either
* treatment-naïve patients or
* patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily:
* 1200 mg (2 × 600 mg) film-coated tablet orally, once daily or
* 400 mg film-coated tablet orally, twice daily or
* 300 mg (3 × 100 mg) chewable tablets, 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 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 dailyIf able to swallow a tablet	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 DosageThe weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily
[see Clinical Pharmacology (12.3)]
.with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg
Body Weight (kg)	Dose	Number of 100 mg Chewable Tablets
25 to less than 28	150 mg twice daily	1.5 × 100 mgThe 100 mg chewable tablet can be divided into equal halves.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 DosageThe 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 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 TabletsThe chewable tablets are available as 25 mg and 100 mg tablets.
3 to less than 4	2.5 mL (25 mg) twice daily	1 × 25 mg twice dailyMay be administered as a crushed tablet(s); see General Dosing Recommendations (2.1) for guidance.
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 mgThe 100 mg chewable tablet can be divided into equal halves.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.
Birth to 1 Week - Once daily dosingThe dosing recommendations are based on approximately 1.5 mg/kg/dose.
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 dosingThe dosing recommendations are based on approximately 3 mg/kg/dose.
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

).

* If weighing 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 2 (

2.3 Pediatrics

[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 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 dailyIf able to swallow a tablet	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 DosageThe weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily
[see Clinical Pharmacology (12.3)]
.with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg
Body Weight (kg)	Dose	Number of 100 mg Chewable Tablets
25 to less than 28	150 mg twice daily	1.5 × 100 mgThe 100 mg chewable tablet can be divided into equal halves.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 DosageThe 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 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 TabletsThe chewable tablets are available as 25 mg and 100 mg tablets.
3 to less than 4	2.5 mL (25 mg) twice daily	1 × 25 mg twice dailyMay be administered as a crushed tablet(s); see General Dosing Recommendations (2.1) for guidance.
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 mgThe 100 mg chewable tablet can be divided into equal halves.twice daily

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.
Birth to 1 Week - Once daily dosingThe dosing recommendations are based on approximately 1.5 mg/kg/dose.
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 dosingThe dosing recommendations are based on approximately 3 mg/kg/dose.
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

).
* If weighing at least 3 kg to less than 25 kg: Weight-based dosing using the chewable tablet or oral suspension, as specified in Table 4 (

2.3 Pediatrics

[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 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 dailyIf able to swallow a tablet	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 DosageThe weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily
[see Clinical Pharmacology (12.3)]
.with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg
Body Weight (kg)	Dose	Number of 100 mg Chewable Tablets
25 to less than 28	150 mg twice daily	1.5 × 100 mgThe 100 mg chewable tablet can be divided into equal halves.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 DosageThe 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 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 TabletsThe chewable tablets are available as 25 mg and 100 mg tablets.
3 to less than 4	2.5 mL (25 mg) twice daily	1 × 25 mg twice dailyMay be administered as a crushed tablet(s); see General Dosing Recommendations (2.1) for guidance.
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 mgThe 100 mg chewable tablet can be divided into equal halves.twice daily

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.
Birth to 1 Week - Once daily dosingThe dosing recommendations are based on approximately 1.5 mg/kg/dose.
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 dosingThe dosing recommendations are based on approximately 3 mg/kg/dose.
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

).
* For neonates (birth to 4 weeks [28 days] of age): Weight-based dosing of the oral suspension as specified in Table 5 (

2.3 Pediatrics

[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 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 dailyIf able to swallow a tablet	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 DosageThe weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily
[see Clinical Pharmacology (12.3)]
.with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg
Body Weight (kg)	Dose	Number of 100 mg Chewable Tablets
25 to less than 28	150 mg twice daily	1.5 × 100 mgThe 100 mg chewable tablet can be divided into equal halves.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 DosageThe 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 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 TabletsThe chewable tablets are available as 25 mg and 100 mg tablets.
3 to less than 4	2.5 mL (25 mg) twice daily	1 × 25 mg twice dailyMay be administered as a crushed tablet(s); see General Dosing Recommendations (2.1) for guidance.
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 mgThe 100 mg chewable tablet can be divided into equal halves.twice daily

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.
Birth to 1 Week - Once daily dosingThe dosing recommendations are based on approximately 1.5 mg/kg/dose.
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 dosingThe dosing recommendations are based on approximately 3 mg/kg/dose.
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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Isentress Prescribing Information

Adult Patients:

ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients (

1 INDICATIONS AND USAGE

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 .

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.

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 (

1 INDICATIONS AND USAGE

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 .

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.

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 (

1 INDICATIONS AND USAGE

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 .

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.

ISENTRESS and ISENTRESS HD can be administered with or without food (

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.
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.
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.

Do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg or 600 mg film-coated tablet.

See specific dosing guidance for chewable tablets and the formulation for oral suspension (

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.
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.
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

Treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily:

1200 mg (2 × 600 mg) film-coated tablet orally, once daily or

400 mg film-coated tablet orally, twice daily (

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

Treatment-experienced patients:

400 mg film-coated tablet orally, twice daily (

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

During coadministration with rifampin in adults, 800 mg (2 × 400 mg) twice daily (

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

Pediatrics

If weighing at least 40 kg, and either

treatment-naïve patients or

patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily:

1200 mg (2 × 600 mg) film-coated tablet orally, once daily or
400 mg film-coated tablet orally, twice daily or

300 mg (3 × 100 mg) chewable tablets, twice daily (

2.3 Pediatrics

[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 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 dailyIf able to swallow a tablet	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 DosageThe weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily
[see Clinical Pharmacology (12.3)]
.with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg
Body Weight (kg)	Dose	Number of 100 mg Chewable Tablets
25 to less than 28	150 mg twice daily	1.5 × 100 mgThe 100 mg chewable tablet can be divided into equal halves.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 DosageThe 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 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 TabletsThe chewable tablets are available as 25 mg and 100 mg tablets.
3 to less than 4	2.5 mL (25 mg) twice daily	1 × 25 mg twice dailyMay be administered as a crushed tablet(s); see General Dosing Recommendations (2.1) for guidance.
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 mgThe 100 mg chewable tablet can be divided into equal halves.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.
Birth to 1 Week - Once daily dosingThe dosing recommendations are based on approximately 1.5 mg/kg/dose.
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 dosingThe dosing recommendations are based on approximately 3 mg/kg/dose.
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

If weighing 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 2 (

2.3 Pediatrics

[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 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 dailyIf able to swallow a tablet	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 DosageThe weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily
[see Clinical Pharmacology (12.3)]
.with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg
Body Weight (kg)	Dose	Number of 100 mg Chewable Tablets
25 to less than 28	150 mg twice daily	1.5 × 100 mgThe 100 mg chewable tablet can be divided into equal halves.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 DosageThe 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 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 TabletsThe chewable tablets are available as 25 mg and 100 mg tablets.
3 to less than 4	2.5 mL (25 mg) twice daily	1 × 25 mg twice dailyMay be administered as a crushed tablet(s); see General Dosing Recommendations (2.1) for guidance.
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 mgThe 100 mg chewable tablet can be divided into equal halves.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.
Birth to 1 Week - Once daily dosingThe dosing recommendations are based on approximately 1.5 mg/kg/dose.
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 dosingThe dosing recommendations are based on approximately 3 mg/kg/dose.
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

If weighing at least 3 kg to less than 25 kg: Weight-based dosing using the chewable tablet or oral suspension, as specified in Table 4 (

2.3 Pediatrics

[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 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 dailyIf able to swallow a tablet	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 DosageThe weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily
[see Clinical Pharmacology (12.3)]
.with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg
Body Weight (kg)	Dose	Number of 100 mg Chewable Tablets
25 to less than 28	150 mg twice daily	1.5 × 100 mgThe 100 mg chewable tablet can be divided into equal halves.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 DosageThe 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 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 TabletsThe chewable tablets are available as 25 mg and 100 mg tablets.
3 to less than 4	2.5 mL (25 mg) twice daily	1 × 25 mg twice dailyMay be administered as a crushed tablet(s); see General Dosing Recommendations (2.1) for guidance.
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 mgThe 100 mg chewable tablet can be divided into equal halves.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.
Birth to 1 Week - Once daily dosingThe dosing recommendations are based on approximately 1.5 mg/kg/dose.
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 dosingThe dosing recommendations are based on approximately 3 mg/kg/dose.
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

For neonates (birth to 4 weeks [28 days] of age): Weight-based dosing of the oral suspension as specified in Table 5 (

2.3 Pediatrics

[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 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 dailyIf able to swallow a tablet	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 DosageThe weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily
[see Clinical Pharmacology (12.3)]
.with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg
Body Weight (kg)	Dose	Number of 100 mg Chewable Tablets
25 to less than 28	150 mg twice daily	1.5 × 100 mgThe 100 mg chewable tablet can be divided into equal halves.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 DosageThe 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 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 TabletsThe chewable tablets are available as 25 mg and 100 mg tablets.
3 to less than 4	2.5 mL (25 mg) twice daily	1 × 25 mg twice dailyMay be administered as a crushed tablet(s); see General Dosing Recommendations (2.1) for guidance.
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 mgThe 100 mg chewable tablet can be divided into equal halves.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.
Birth to 1 Week - Once daily dosingThe dosing recommendations are based on approximately 1.5 mg/kg/dose.
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 dosingThe dosing recommendations are based on approximately 3 mg/kg/dose.
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

Film-coated Tablets
- 400 mg pink, oval-shaped, film-coated tablets with "227" on one side (ISENTRESS).
- 600 mg yellow, oval-shaped, film-coated tablets with corporate logo and "242" on one side and plain on the other side (ISENTRESS HD).
Chewable Tablets
- 100 mg pale orange, oval-shaped, orange-banana flavored, chewable tablets scored on both sides and imprinted on one face with the corporate logo and "477" on opposite sides of the score.
- 25 mg pale yellow, round, orange-banana flavored, chewable tablets with the corporate 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.

Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission (

8.2 Lactation

Risk Summary

The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. There are no data on the presence of raltegravir in human milk, the effects on the breastfed infant, or the effects on milk production. When administered to lactating rats, raltegravir was present in milk

(see Data).

Because of the potential for: 1) HIV transmission (in HIV-negative infants), 2) developing viral resistance (in HIV-positive infants), and 3) adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving ISENTRESS/ISENTRESS HD.

Data

Raltegravir was excreted into the milk of lactating rats following oral administration (600 mg/kg/day) from gestation day 6 to lactation day 14, with milk concentrations approximately 3 times that of maternal plasma concentrations observed 2 hours postdose on lactation day 14.

Severe, potentially life-threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolysis. Immediately discontinue treatment with ISENTRESS or ISENTRESS HD and other suspect agents if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develops and monitor clinical status, including liver aminotransferases closely (
5.1 Severe Skin and Hypersensitivity Reactions
Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens-Johnson syndrome and toxic epidermal necrolysis. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure. Discontinue ISENTRESS or ISENTRESS HD and other suspect agents immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema). Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated. Delay in stopping ISENTRESS or ISENTRESS HD treatment or other suspect agents after the onset of severe rash may result in a life-threatening reaction.
).
Monitor for Immune Reconstitution Syndrome (
5.2 Immune Reconstitution Syndrome
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including ISENTRESS. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as
Mycobacterium avium
infection, cytomegalovirus,
Pneumocystis jiroveci
pneumonia, tuberculosis), which may necessitate further evaluation and treatment.
Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.
).
Inform patients with phenylketonuria that the 100 mg and 25 mg chewable tablets contain phenylalanine (
5.3 Phenylketonurics
ISENTRESS Chewable Tablets contain phenylalanine, a component of aspartame. Each 25 mg ISENTRESS Chewable Tablet contains approximately 0.05 mg phenylalanine. Each 100 mg ISENTRESS Chewable Tablet contains approximately 0.10 mg phenylalanine. Phenylalanine can be harmful to patients with phenylketonuria.
).

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