Drug Detail:Oxbryta (Voxelotor [ vox-el-oh-tor ])
Generic Name: Voxelotor 500mg
Dosage Form: tablet, film coated
Drug Class: Miscellaneous uncategorized agents
Recommended Dosage for Adults and Pediatric Patients 12 Years and Older
The recommended dosage of OXBRYTA is 1,500 mg orally once daily.
Recommended Dosage for Pediatric Patients 4 Years to Less Than 12 Years
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 |
Recommended Dosage for Adults and Pediatric Patients 12 Years and Older with Hepatic Impairment
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)].
Recommended Dosage for Pediatric Patients 4 Years to Less Than 12 Years with Hepatic Impairment
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) or 900 mg (three 300 mg tablets for oral suspension or three 300 mg tablets) |
| 20 kg to less than 40 kg | 600 mg |
| 10 kg to less than 20 kg | 300 mg |
Recommended Dosage of OXBRYTA for Adults and Pediatric Patients 12 Years and Older When Used with Concomitant Strong or Moderate CYP3A4 Inducers
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.
Recommended Dosage of OXBRYTA for Pediatric Patients 4 Years to Less Than 12 Years When Used with Concomitant Strong or Moderate CYP3A4 Inducers
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) or 2,400 mg (eight 300 mg tablets for oral suspension or eight 300 mg tablets) |
2,000 mg (four 500 mg tablets) or 2,100 mg (seven 300 mg tablets for oral suspension or seven 300 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 |
Important Administration Instructions
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) |
- After the tablets start to disintegrate, swirl the contents of the cup until the tablets are dispersed, wait 1 to 5 minutes, swirl the contents of the cup again, and then orally administer the contents of the cup. The tablet(s) will not completely dissolve; there will still be small tablet clumps in the mixture.
- Resuspend any residue left in the cup in more clear drink and administer. Repeat until no tablet residue is left in the cup.
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.
