Voxelotor

Voxelotor Brand Name

Oxbryta

What is Voxelotor

Voxelotor is a first-in-class oral hemoglobin S polymerization inhibitor indicated for the treatment of sickle cell disease.

Accelerated FDA-approval was based on significant and sustained improvements in hemoglobin with voxelotor compared to placebo in the HOPE trial, in which 274 patients were randomized to daily administration of voxelotor 1,500 mg (n = 90), voxelotor 900 mg (n = 92), or placebo (n = 92).

The majority of patients had HbS or HbS/beta⁰-thalassemia genotype and were receiving background hydroxyurea therapy. In the trial, 51% (95% CI, 41 to 61) of patients receiving voxelotor 1,500 mg/day achieved a more than 1 g/dL increase in hemoglobin after 24 weeks of treatment, compared to 6.5% (95% CI, 1 to 12) of those receiving placebo (p less than 0.001).

Reductions in anemia were observed in both voxelotor groups. All measures of hemolysis (indirect bilirubin concentration, percentage of reticulocytes, absolute reticulocyte count, lactate dehydrogenase concentration) showed a response that improved with increasing whole-blood concentrations of voxelotor.

The high-dose voxelotor group had significantly greater reductions from baseline in indirect bilirubin concentrations (mean change -29.1% vs. -3.2%) and percentage of reticulocytes (mean change -19.9% vs. +4.5%) compared to the placebo group.

Indications

• sickle cell disease

Side Effects

1. abdominal pain
2. diarrhea
3. eosinophilia
4. fatigue
5. fever
6. headache
7. maculopapular rash
8. nausea
9. pulmonary embolism
10. rash
11. urticaria

Monitoring Parameters

• laboratory monitoring not necessary

Contraindications

• breast-feeding
• hepatic disease
• laboratory test interference
• pregnancy

Interactions

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