Voxelotor Dosage

Applies to the following strengths: 500 mg; 300 mg

Usual Adult Dose for Sickle Cell Anemia

1500 mg orally once a day

Comment:

This drug may be given with or without hydroxyurea.

Use: For the treatment of sickle cell disease.

Usual Pediatric Dose for Sickle Cell Anemia

4 to less than 12 years:

Weight: 10 to less than 20 kg: 600 mg orally once a day
Weight: 20 to less than 40 kg: 900 mg orally once a day
Weight 40 kg or greater: 1500 mg orally once a day

12 years or older: 1500 mg orally once a day

Comment:

This drug may be given with or without hydroxyurea.

Use: For the treatment of sickle cell disease in patients 4 years or older.

Renal Dose Adjustments

Mild to severe renal impairment (CrCl 15 mL/min or greater): No adjustment recommended
ESRD: Data not available

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A and B): No adjustment recommended.

For patients 12 years or older with severe liver dysfunction (Child-Pugh C): 1000 mg orally once a day

For patients 4 years to less than 12 years with severe liver dysfunction (Child-Pugh C):

Weight: 10 to less than 20 kg: 300 mg orally once a day
Weight: 20 to less than 40 kg: 600 mg orally once a day
Weight 40 kg or greater: 900 or 1000 mg orally once a day

Dose Adjustments

Avoid Concomitant use of Strong or Moderate CYP450 3A4 Inducers; however, if use is unavoidable, voxelotor doses should be increased as follows:

12 years or older:

If concomitant use of STRONG CYP450 3A4 Inducers is unavoidable: Increase dose of voxelotor to 2500 mg orally once a day
If concomitant use of MODERATE CYP450 3A4 Inducers is unavoidable: Increase dose of voxelotor to 2000 mg orally once a day

4 to Less than 12 years:

If concomitant use of STRONG CYP450 3A4 Inducers is unavoidable: Increase voxelotor dose to:
Weight: 10 to less than 20 kg: 900 mg orally once a day
Weight: 20 to less than 40 kg: 1500 mg orally once a day
Weight 40 kg or greater: 2400 or 2500 mg orally once a day
If concomitant use of MODERATE CYP450 3A4 Inducers is unavoidable: Increase voxelotor dose to:
Weight: 10 to less than 20 kg: 900 mg orally once a day
Weight: 20 to less than 40 kg: 1200 mg orally once a day
Weight 40 kg or greater: 2000 or 2100 mg orally once a day

Precautions

CONTRAINDICATIONS:

History of serious hypersensitivity reaction to the active substance or any product excipients; clinical manifestations may include generalized rash, urticaria, mild shortness of breath, mild facial swelling, and eosinophilia

Safety and efficacy have not been established in patients younger than 4 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Oral tablets:

Take orally once a day with or without food
Tablets should be swallowed whole; do not cut, crush, or chew

Tablets for Oral Suspension:

Tablets for oral suspension should be dispersed immediately before administration
Tablet(s) should be dispersed in a cup of room temperature clear liquid (e.g., drinking water or clear soda); minimum volume of clear liquid for dispersion is 5 mL per 300 mg tablet
Place tablet(s) in appropriate amount of clear liquid; after tablet(s)starts to disintegrate, swirl contents of cup until the tablets are dispersed; wait 1 to 5 minutes and swirl again before consuming contents of the cup
The tablets will not completely dissolve and there will 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
Do not swallow whole, cut, crush, or chew the tablets for oral suspension

Tablets for oral suspension are indicated for patients 4 to less than 12 years and may be administered to patients 12 years and older who have difficulty swallowing; use the number of tablets for oral suspension needed to achieve the recommended dose

Missed dose: If a dose is missed or not administered entirely, resume dosing the following day

General:

This drug is approved under the accelerated approval based on increase in hemoglobin (Hb); continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Patient advice:

Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
Patients should be instructed to immediately report signs or symptoms of hypersensitivity reactions such as generalized rash, urticaria, shortness of breath, facial swelling, and eosinophilia.
Patient should be instructed not to breastfeed and to speak with their healthcare provided if they are pregnant or planning to become pregnant.
Patients should be instructed to tell their healthcare provider about all the medications they are taking including over the counter and herbal products.