RAVICTI® – dosing guide1

The daily dose of RAVICTI® (glycerol phenylbutyrate) should be individually adjusted according to the patient’s protein tolerance and daily dietary protein intake.

Nearly tasteless liquid

No pill or powder preparation

Take with meals via oral dosing syringe

  • The recommended total daily dose of RAVICTI is based on body surface area (BSA) and ranges from 4.5 ml/m2/day to 11.2 ml/m2/day
  • The total daily dose should be divided into equal amounts and given with each meal or feeding (e.g. three times to six times per day*)
  • Each dose should be rounded up to the nearest 0.1 ml for patients less than 2 years of age and 0.5 ml for patients 2 years of age and older
Recommended starting dosage in phenylbutyrate-naïve patients:
  • 8.5 ml/m2/day (9.4 g/m2/day) in patients with a body surface area (BSA) < 1.3 m2
  • 7 ml/m2/day (8 g/m2/day) in patients with BSA ≥ 1.3 m2

Initial dosage in patients switching from sodium phenylbutyrate to RAVICTI should receive the dosage of RAVICTI that contains the same amount of phenylbutyric acid.

 

The conversion is as follows:

Total daily dosage of RAVICTI (ml) = total daily dosage of sodium phenylbutyrate tablets (g) x 0.86

Total daily
dosage of sodium phenylbutyrate (g)

Multiply

by 0.86

Equals total
daily dosage
of RAVICTI (ml)

Divide total daily
dosage of RAVICTI
by 3 doses/day*

Round each dose of RAVICTI
up to the nearest 0.1 ml for patients less than 2 years

Round each dose of RAVICTI
up to the nearest 0.5 ml for patients 2 years of age and older

2

0.86

1.72

0.57

0.6

1

3

0.86

2.58

0.86

0.9

1

4

0.86

3.44

1.15

1.2

1.5

5

0.86

4.3

1.43

1.5

1.5

6

0.86

5.16

1.72

1.8

2

7

0.86

6.02

2.00

2

2

8

0.86

6.88

2.29

2.3

2.5

9

0.86

7.74

2.58

2.6

3

10

0.86

8.6

2.87

2.9

3

11

0.86

9.46

3.15

3.2

3.5

12

0.86

10.32

3.44

3.5

3.5

13

0.86

11.18

3.73

3.8

4

14

0.86

12.04

4.01

4.1

4.5

15

0.86

12.9

4.3

4.3

4.5

16

0.86

13.76

4.59

4.6

5

17

0.86

14.62

4.87

4.9

5

18

0.86

15.48

5.16

5.2

5.5

19

0.86

16.34

5.45

5.5

5.5

20

0.86

17.2

5.73

5.8

6

Total daily dosage of RAVICTI (ml) = total daily dosage of sodium phenylbutyrate granules (containing 940 mg sodium phenylbutyrate/g) x 0.81

Total daily dosage of sodium phenylbutyrate granules (containing 940 mg sodium phenylbutyrate/g)

Multiply

by 0.81

Equals total
daily dosage
of RAVICTI (ml)

Divide total daily
dosage of RAVICTI
by 3 doses/day*

Round each dose of RAVICTI up to the nearest 0.1 ml for patients less than 2 years

Round each dose of RAVICTI
up to the nearest 0.5 ml for patients 2 years of age and older

2

0.81

1.62

0.54

0.6

1

3

0.81

2.43

0.81

0.9

1

4

0.81

3.24

1.08

1.1

1.5

5

0.81

4.05

1.35

1.4

1.5

6

0.81

4.86

1.62

1.7

2

7

0.81

5.67

1.89

1.9

2.0

8

0.81

6.48

2.16

2.2

2.5

9

0.81

7.29

2.43

2.5

2.5

10

0.81

8.1

2.7

2.7

3

11

0.81

8.91

2.97

3

3

12

0.81

9.72

3.24

3.3

3.5

13

0.81

10.53

3.51

3.6

4

14

0.81

11.34

3.78

3.8

4

15

0.81

12.15

4.05

4.1

4.5

16

0.81

12.96

4.32

4.4

4.5

17

0.81

13.77

4.59

4.6

5

18

0.81

14.58

4.86

4.9

5

19

0.81

15.39

5.13

5.2

5.5

20

0.81

16.2

5.4

5.4

5.5

For further guidance regarding dose adjustments, please see section 4.2 in the SPC.

Switching from all Sodium benzoate (NaBZ) formulations except injection to RAVICTI
Patients switched from sodium benzoate should be considered as phenylbutyrate naïve and consequently should be dosed accordingly.

Initial dosage in patients switching from sodium phenylacetate/sodium benzoate injection to RAVICTI
Once stable with controlled ammonia, patients switching to RAVICTI should receive a dose of RAVICTI at the higher end of the treatment (11 ml/m2/day) with measurements of plasma ammonia to guide further dosing.

* Depending on patients feeding schedule (dose should be divided into equal amounts and given with each meal or feeding, e.g. 3-6 times per day).

References:
1
. Summary of Product Characteristics RAVICTI.