VOXELOTOR

Other

Brand names: OXBRYTA

Oral

Mechanism of Action

12.1 Mechanism of Action Voxelotor is a hemoglobin S (HbS) polymerization inhibitor that binds to HbS with a 1:1 stoichiometry and exhibits preferential partitioning to red blood cells (RBCs). By increasing the affinity of Hb for oxygen, voxelotor demonstrates dose-dependent inhibition of HbS polymerization. Nonclinical studies suggest that voxelotor may inhibit RBC sickling, improve RBC deformability, and reduce whole blood viscosity.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS OXBRYTA is contraindicated in patients with a history of serious drug hypersensitivity reaction to voxelotor or excipients. Clinical manifestations may include generalized rash
• urticaria
• mild shortness of breath
• mild facial swelling
• and eosinophilia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. Prior drug hypersensitivity to voxelotor or excipients. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Observe for signs and symptoms and manage promptly
1 Hypersensitivity Reactions Serious hypersensitivity reactions after administration of OXBRYTA have occurred in <1% of patients treated

Known Side Effects

6 documented side effects by frequency

Diarrhea

1-10%

Nausea

1-10%

Headache

0.1-1%

Fatigue

0.1-1%

Vomiting

0.1-1%

Abdominal Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral