VIRACEPT Dosage and Administration

(nelfinavir mesylate)

2 DOSAGE AND ADMINISTRATION

2.1 Adults and Adolescents (13 years and older)

The recommended dose is 1250 mg (five 250 mg tablets or two 625 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. VIRACEPT should be taken with a meal. Patients unable to swallow the 250 or 625 mg tablets may dissolve the tablets in a small amount of water [see Dosage and Administration (2.3)].

2.2 Pediatric Patients (2 to less than 13 years)

In children 2 years of age and older, the recommended oral dose of VIRACEPT Oral Powder or 250 mg tablets is 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily. All doses should be taken with a meal. Doses higher than the adult maximum dose of 2500 mg per day have not been studied in children.

For children unable to swallow tablets, VIRACEPT 250 mg tablet(s) may be dissolved in a small amount of water or, VIRACEPT Oral Powder may be administered [see Dosage and Administration (2.3)].

The healthcare provider should assess appropriate formulation and dosage for each patient. Tables 1 and 2 provide dosing guidelines for VIRACEPT tablets and powder based on age and body weight.

Table 1: Dosing Table for Children 2 to less than 13 years of age (tablets)
Body weightTwice daily (BID)
45 – 55 mg/kg
≥2 years		Three times daily (TID)
25 – 35 mg/kg
≥2 years
Number of tablets
(250 mg)		Number of tablets
(250 mg)
Kg
*
For BID dosing, the maximum dose per day is 5 tablets BID
†
For TID dosing, the maximum dose per day is 3 tablets TID

10 – 12

2

1

13 – 18

3

2

19 – 20

4

2

≥21

4 – 5*

3†

Table 2: Dosing Table for Children 2 to less than 13 years of age (powder)
Body weightTwice daily (BID)
45 – 55 mg/kg		Three times daily (TID)
25 – 35 mg/kg
*
If a teaspoon is used to measure VIRACEPT oral powder, 1 level teaspoon contains 200 mg of VIRACEPT (4 level scoops equals 1 level teaspoon)
†
Use VIRACEPT 250 mg tablet

Kg

Scoops of powder
(50 mg/1 g)

Teaspoons* of powder

Scoops of powder
(50 mg/1 g)

Teaspoons* of powder

9.0 to <10.5

10

2½

6

1½

10.5 to <12

11

2¾

7

1¾

12 to <14

13

3¼

8

2

14 to <16

15

3¾

9

2¼

16 to <18

Not recommended†

Not recommended†

10

2½

18 to <23

Not recommended†

Not recommended†

12

3

≥23

Not recommended†

Not recommended†

15

3¾

2.3 Method of Administration

For Patients Unable to Swallow Viracept Tablets

•
Place VIRACEPT tablet(s) in small amount of water.
•
Once dissolved, mix the cloudy liquid well, and consume it immediately.
•
The glass should be rinsed with water and the rinse swallowed to ensure the entire dose is consumed.

Viracept Oral Powder

•
Mix VIRACEPT Oral Powder with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplements
•
Once mixed, the entire contents must be consumed in order to obtain the full dose.
•
If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours.
•
Acidic food or juice (e.g., orange juice, apple juice, or apple sauce) are not recommended for mixing VIRACEPT Oral Powder because the combination may result in a bitter taste.
•
VIRACEPT Oral Powder should not be reconstituted with water in its original container.

2.4 Hepatic Impairment

VIRACEPT can be used in patients with mild hepatic impairment without any dose adjustment. VIRACEPT should not be used in patients with either moderate or severe hepatic impairment [see Warnings and Precautions (5.2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Adults and Adolescents (13 years and older)

The recommended dose is 1250 mg (five 250 mg tablets or two 625 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. VIRACEPT should be taken with a meal. Patients unable to swallow the 250 or 625 mg tablets may dissolve the tablets in a small amount of water [see Dosage and Administration (2.3)].

2.2 Pediatric Patients (2 to less than 13 years)

In children 2 years of age and older, the recommended oral dose of VIRACEPT Oral Powder or 250 mg tablets is 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily. All doses should be taken with a meal. Doses higher than the adult maximum dose of 2500 mg per day have not been studied in children.

For children unable to swallow tablets, VIRACEPT 250 mg tablet(s) may be dissolved in a small amount of water or, VIRACEPT Oral Powder may be administered [see Dosage and Administration (2.3)].

The healthcare provider should assess appropriate formulation and dosage for each patient. Tables 1 and 2 provide dosing guidelines for VIRACEPT tablets and powder based on age and body weight.

Table 1: Dosing Table for Children 2 to less than 13 years of age (tablets)
Body weightTwice daily (BID)
45 – 55 mg/kg
≥2 years		Three times daily (TID)
25 – 35 mg/kg
≥2 years
Number of tablets
(250 mg)		Number of tablets
(250 mg)
Kg
*
For BID dosing, the maximum dose per day is 5 tablets BID
†
For TID dosing, the maximum dose per day is 3 tablets TID

10 – 12

2

1

13 – 18

3

2

19 – 20

4

2

≥21

4 – 5*

3†

Table 2: Dosing Table for Children 2 to less than 13 years of age (powder)
Body weightTwice daily (BID)
45 – 55 mg/kg		Three times daily (TID)
25 – 35 mg/kg
*
If a teaspoon is used to measure VIRACEPT oral powder, 1 level teaspoon contains 200 mg of VIRACEPT (4 level scoops equals 1 level teaspoon)
†
Use VIRACEPT 250 mg tablet

Kg

Scoops of powder
(50 mg/1 g)

Teaspoons* of powder

Scoops of powder
(50 mg/1 g)

Teaspoons* of powder

9.0 to <10.5

10

2½

6

1½

10.5 to <12

11

2¾

7

1¾

12 to <14

13

3¼

8

2

14 to <16

15

3¾

9

2¼

16 to <18

Not recommended†

Not recommended†

10

2½

18 to <23

Not recommended†

Not recommended†

12

3

≥23

Not recommended†

Not recommended†

15

3¾

2.3 Method of Administration

For Patients Unable to Swallow Viracept Tablets

•
Place VIRACEPT tablet(s) in small amount of water.
•
Once dissolved, mix the cloudy liquid well, and consume it immediately.
•
The glass should be rinsed with water and the rinse swallowed to ensure the entire dose is consumed.

Viracept Oral Powder

•
Mix VIRACEPT Oral Powder with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplements
•
Once mixed, the entire contents must be consumed in order to obtain the full dose.
•
If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours.
•
Acidic food or juice (e.g., orange juice, apple juice, or apple sauce) are not recommended for mixing VIRACEPT Oral Powder because the combination may result in a bitter taste.
•
VIRACEPT Oral Powder should not be reconstituted with water in its original container.

2.4 Hepatic Impairment

VIRACEPT can be used in patients with mild hepatic impairment without any dose adjustment. VIRACEPT should not be used in patients with either moderate or severe hepatic impairment [see Warnings and Precautions (5.2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
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