The recommended dosage of OXBRYTA is 1,500 mg orally once daily.
For pediatric patients 4 years to less than 12 years, select the appropriate product (OXBRYTA tablets or OXBRYTA tablets for oral suspension) based on patient's ability to swallow tablets and patient's weight.
The recommended dosage of OXBRYTA for pediatric patients 4 years to less than 12 years is shown in Table 1.
| Body Weight | Recommended Dose (once daily) |
|---|---|
40 kg or greater | 1,500 mg |
20 kg to less than 40 kg | 900 mg |
10 kg to less than 20 kg | 600 mg |
The recommended dosage of OXBRYTA in adults and pediatric patients 12 years and older with severe hepatic impairment (Child Pugh C) is 1,000 mg orally once daily.
No dosage adjustment of OXBRYTA is required for patients with mild or moderate hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
The recommended dosage of OXBRYTA in pediatric patients 4 years to less than 12 years with severe hepatic impairment (Child Pugh C) is described in Table 2.
No dosage adjustment of OXBRYTA is required for patients with mild or moderate hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
| Body Weight | Recommended Dose (once daily) |
|---|---|
40 kg or greater | 1,000 mg (two 500 mg tablets) |
20 kg to less than 40 kg | 600 mg |
10 kg to less than 20 kg | 300 mg |
CYP3A4 Inducers
Avoid concomitant use of strong or moderate CYP3A4 inducers with OXBRYTA [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
If concomitant use of strong CYP3A4 inducers is unavoidable, the recommended dosage of OXBRYTA is 2,500 mg orally once daily. If concomitant use of moderate CYP3A4 inducers is unavoidable, the recommended dosage of OXBRYTA is 2,000 mg orally once daily.
CYP3A4 Inducers
Avoid concomitant use of strong or moderate CYP3A4 inducers with OXBRYTA [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. If concomitant use of strong or moderate CYP3A4 inducers is unavoidable, see Table 3 for dosage.
| Body Weight | Recommended Dose (once daily) | |
|---|---|---|
| Concomitant Use of Strong CYP3A4 Inducers | Concomitant Use of Moderate CYP3A4 Inducers | |
40 kg or greater | 2,500 mg (five 500 mg tablets) | 2,000 mg (four 500 mg tablets) |
20 kg to less than 40 kg | 1,500 mg | 1,200 mg |
10 kg to less than 20 kg | 900 mg | 900 mg |
Administer OXBRYTA orally, once daily with or without food. If a dose is missed, or not administered entirely, resume dosing the following day.
OXBRYTA may be given with or without hydroxyurea.
OXBRYTA 300 mg and 500 mg Tablets
Patients should swallow OXBRYTA tablets whole. Do not cut, crush, or chew the tablets.
OXBRYTA 300 mg Tablets for Oral Suspension
Patients should disperse tablets for oral suspension immediately before administration in a cup and in room temperature clear liquid (such as drinking water, clear soda, apple juice, clear electrolyte drinks, clear flavored drinks, or clear sports drinks) before swallowing.
Do not swallow whole, cut, crush, or chew the tablets for oral suspension.
| Recommended Daily Dose | Number of Tablets for Oral Suspension | Minimum Recommended Volume of Clear Drink |
|---|---|---|
300 mg | 1 | 5 mL (1 teaspoon) |
600 mg | 2 | 10 mL (2 teaspoons) |
900 mg | 3 | 15 mL (3 teaspoons) |
1,200 mg | 4 | 20 mL (4 teaspoons) |
1,500 mg | 5 | 25 mL (5 teaspoons) |
2,100 mg | 7 | 35 mL (7 teaspoons) |
2,400 mg | 8 | 40 mL (8 teaspoons) |
Tablets for oral suspension may be substituted for tablets in adults and pediatric patients 12 years and older with difficulty swallowing the tablets. Use the number of tablets for oral suspension needed to achieve the recommended dose.
The recommended dosage of OXBRYTA is 1,500 mg orally once daily.
For pediatric patients 4 years to less than 12 years, select the appropriate product (OXBRYTA tablets or OXBRYTA tablets for oral suspension) based on patient's ability to swallow tablets and patient's weight.
The recommended dosage of OXBRYTA for pediatric patients 4 years to less than 12 years is shown in Table 1.
| Body Weight | Recommended Dose (once daily) |
|---|---|
40 kg or greater | 1,500 mg |
20 kg to less than 40 kg | 900 mg |
10 kg to less than 20 kg | 600 mg |
The recommended dosage of OXBRYTA in adults and pediatric patients 12 years and older with severe hepatic impairment (Child Pugh C) is 1,000 mg orally once daily.
No dosage adjustment of OXBRYTA is required for patients with mild or moderate hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
The recommended dosage of OXBRYTA in pediatric patients 4 years to less than 12 years with severe hepatic impairment (Child Pugh C) is described in Table 2.
No dosage adjustment of OXBRYTA is required for patients with mild or moderate hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
| Body Weight | Recommended Dose (once daily) |
|---|---|
40 kg or greater | 1,000 mg (two 500 mg tablets) |
20 kg to less than 40 kg | 600 mg |
10 kg to less than 20 kg | 300 mg |
CYP3A4 Inducers
Avoid concomitant use of strong or moderate CYP3A4 inducers with OXBRYTA [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
If concomitant use of strong CYP3A4 inducers is unavoidable, the recommended dosage of OXBRYTA is 2,500 mg orally once daily. If concomitant use of moderate CYP3A4 inducers is unavoidable, the recommended dosage of OXBRYTA is 2,000 mg orally once daily.
CYP3A4 Inducers
Avoid concomitant use of strong or moderate CYP3A4 inducers with OXBRYTA [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. If concomitant use of strong or moderate CYP3A4 inducers is unavoidable, see Table 3 for dosage.
| Body Weight | Recommended Dose (once daily) | |
|---|---|---|
| Concomitant Use of Strong CYP3A4 Inducers | Concomitant Use of Moderate CYP3A4 Inducers | |
40 kg or greater | 2,500 mg (five 500 mg tablets) | 2,000 mg (four 500 mg tablets) |
20 kg to less than 40 kg | 1,500 mg | 1,200 mg |
10 kg to less than 20 kg | 900 mg | 900 mg |
Administer OXBRYTA orally, once daily with or without food. If a dose is missed, or not administered entirely, resume dosing the following day.
OXBRYTA may be given with or without hydroxyurea.
OXBRYTA 300 mg and 500 mg Tablets
Patients should swallow OXBRYTA tablets whole. Do not cut, crush, or chew the tablets.
OXBRYTA 300 mg Tablets for Oral Suspension
Patients should disperse tablets for oral suspension immediately before administration in a cup and in room temperature clear liquid (such as drinking water, clear soda, apple juice, clear electrolyte drinks, clear flavored drinks, or clear sports drinks) before swallowing.
Do not swallow whole, cut, crush, or chew the tablets for oral suspension.
| Recommended Daily Dose | Number of Tablets for Oral Suspension | Minimum Recommended Volume of Clear Drink |
|---|---|---|
300 mg | 1 | 5 mL (1 teaspoon) |
600 mg | 2 | 10 mL (2 teaspoons) |
900 mg | 3 | 15 mL (3 teaspoons) |
1,200 mg | 4 | 20 mL (4 teaspoons) |
1,500 mg | 5 | 25 mL (5 teaspoons) |
2,100 mg | 7 | 35 mL (7 teaspoons) |
2,400 mg | 8 | 40 mL (8 teaspoons) |
Tablets for oral suspension may be substituted for tablets in adults and pediatric patients 12 years and older with difficulty swallowing the tablets. Use the number of tablets for oral suspension needed to achieve the recommended dose.
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