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 721,2
Adverse Reaction*
Oxbryta
1,500 mg (n=88)
Placebo
(n=91)
Headache
32% (28)
25% (23)
Diarrhea
23% (20)
11% (10)
Abdominal Pain†
23% (20)
16% (15)
Nausea
19% (17)
10% (9)
Rash‡
15% (13)
11% (10)
Pyrexia
15% (13)
8% (7)
*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 721,2
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
Clinical safety was studied in the HOPE-KIDS 1 trial1,2
The safety of Oxbryta in pediatric patients 4 to <12 years with SCD was evaluated in an open-label, Phase 2 study1
45 patients 4 to <12 years of age received doses of Oxbryta tablets for oral suspension based on weight at baseline1
35 patients received Oxbryta for 24 weeks1
26 patients received Oxbryta for 48 weeks1
The most common adverse reactions (>10%) reported in pediatric patients 4 to <12 years were pyrexia (36%), vomiting (33%), rash (20%), abdominal pain (18%), diarrhea (18%), and headache (18%)1
The overall safety profile of Oxbryta in pediatric patients 4 to <12 years was similar to that seen in adults and pediatric patients ≥12 years1
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A message from Dr. Ted W. Love
President and CEO, Global Blood Therapeutics, Inc.
Thank you for visiting the virtual 62nd ASH® Annual Meeting and Exposition!
Thank you for visiting the virtual 62nd ASH® Annual Meeting and Exposition!
We are proud to participate in this important meeting and appreciate your interest in learning more about GBT and Oxbryta® (voxelotor) tablets. We at GBT share your passion and commitment to improving the lives of patients. Together, we can make a difference.
I encourage you to explore our website to learn more about Oxbryta.
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