The clinical safety profile for Oxbryta

Adverse reactions in adults and adolescents in the pivotal study at 24 weeks1

  • 41% (36/88) of patients who received Oxbryta required a dose modification
  • 5% (4/88) permanently discontinued therapy due to an adverse reaction (Grade 1-4)
    • Most frequent adverse reactions requiring dosage interruption occurring in more than 1 patient who received Oxbryta 1,500 mg included diarrhea, headache, rash, and vomiting. Patients needing a temporary modification based on physician discretion/adverse reaction severity could be lowered to 1,200 mg/day until the event subsided and patients could return to 1,500 mg/day2

Adverse reactions (≥10%) in patients receiving Oxbryta with a difference between arms of >3% compared to placebo

Adverse Reaction*

Oxbryta

1,500 mg (n=88)

Placebo

(n=91)

Headache

23 (26%)

20 (22%)

Diarrhea

18 (20%)

9 (10%)

Abdominal pain

17 (19%)

12 (13%)

Nausea

15 (17%)

9 (10%)

Fatigue

12 (14%)

9 (10%)

Rash

12 (14%)

9 (10%)

Pyrexia

11 (12%)

6 (7%)

Additional safety1

  • Serious adverse reactions that occurred in 3% (3/88) of patients receiving Oxbryta included headache, drug hypersensitivity, and pulmonary embolism occurring in one patient each
  • Clinically relevant adverse reactions occurring in <10% of patients included drug hypersensitivity

*Adverse reactions were Grade 1 or 2 except for Grade 3 diarrhea (n=1), nausea (n=1), rash (n=1), and rash generalized (n=3).

Abdominal pain (grouped PTs) included the following PTs: abdominal pain and upper abdominal pain.

Rash (grouped PTs) includes the following PTs: rash, urticaria, generalized rash, maculo-papular rash, pruritic rash, papular rash, erythematous rash, and vesicular rash.

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