The clinical safety of Oxbryta in clinical trials

Adverse reactions in adults and adolescents in the HOPE trial through week 72

Adverse reactions (≥10%) in patients receiving Oxbryta (voxelotor) tablets with a difference between arms of >3% compared to placebo through week 72^1,2

*Adverse reactions were Grades 1 or 2 except for Grade 3 headache (2), diarrhea (1), nausea (1), rash (1), and rash generalized (3).
†Included abdominal pain, lower abdominal pain, and upper abdominal pain.
‡Included rash, urticaria, generalized rash, macular rash, maculo-papular rash, pruritic rash and papular rash.

Safety considerations

• In the HOPE trial, dose modifications (dose reduction or dosing interruption) due to a non–treatment related adverse event occurred in 48% (42/88) of patients who received Oxbryta 1,500 mg²
  • Dose modifications (dose reduction or dosing interruption) due to an adverse reaction occurred in 13.6% (12/88) of patients who received Oxbryta 1,500 mg¹
  • The adverse reactions requiring dose modification included rash (4.5%), diarrhea (3.4%), headache (2.3%), nausea (2.3%), abdominal pain (1.1%), and drug hypersensitivity (1.1%)¹
• The safety profile observed through week 24 was similar to that observed through week 72^1,2
• Serious adverse reactions occurred in 3% (3/88) of patients who received Oxbryta 1,500 mg, which included headache, drug hypersensitivity, and pulmonary embolism occurring in 1 patient each¹
• The safety profile observed in pediatric patients 12 to <17 years of age treated with Oxbryta was similar to that seen in adult patients¹
• Clinically relevant adverse reactions occurring in <10% of patients who received Oxbryta 1,500 mg included drug hypersensitivity¹
• Permanent discontinuation due to an adverse reaction (Grades 1-4) occurred in 5% (4/88) of patients who received Oxbryta 1,500 mg¹