OXBRYTA Film-coated tablet (2020)

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Global Blood Therapeutics Inc.

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1. Indications and Usage

OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older. This indication is approved under accelerated approval based on increase ...

2. Dosage and Administration

2.1 Recommended Dosage for Sickle Cell Disease The recommended dosage of OXBRYTA is 1,500 mg taken orally once daily with or without food. If a dose is missed, continue dosing on the day following the ...

3. Dosage Forms and Strengths

Tablets: 500 mg light yellow to yellow, oval shaped, biconvex, debossed with GBT 500 on one side.

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 ...

5. Warnings and Precautions

5.1 Hypersensitivity Reactions Serious hypersensitivity reactions after administration of OXBRYTA have occurred in <1% of patients treated. Clinical manifestations may include generalized rash, urticaria, ...

6. Adverse Reactions

The following clinically significant adverse reaction is discussed in other sections of the labeling: Hypersensitivity Reactions [see Contraindications (4)].

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

7. Drug Interactions

7.1 Effect of Other Drugs on Voxelotor Strong CYP3A4 Inhibitors or Fluconazole Co-administration of strong CYP3A4 inhibitors or fluconazole may increase voxelotor plasma concentrations and may lead to ...

8.1. Pregnancy

Risk Summary There are no available data on OXBRYTA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction ...

8.2. Lactation

Risk Summary There are no data on the presence of voxelotor in human milk, the effects on the breastfed child, or the effects on milk production. Voxelotor was detected in milk in lactating rats. Plasma ...

8.4. Pediatric Use

The safety and effectiveness of OXBRYTA for sickle cell disease have been established in pediatric patients aged 12 years and older. Use of OXBRYTA for sickle cell disease is supported by evidence from ...

8.5. Geriatric Use

Clinical studies of OXBRYTA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

8.6. Hepatic Impairment

Severe hepatic impairment increases voxelotor exposures [see Clinical Pharmacology (12.3)]. Reduce OXBRYTA dose [see Dosage and Administration (2.2)].

11. Description

Voxelotor is a hemoglobin S polymerization inhibitor. The chemical name of voxelotor is: 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde. Voxelotor has a molecular ...

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 ...

12.2. Pharmacodynamics

The pharmacodynamic effect of voxelotor treatment demonstrated a dose-dependent increase in Hb oxygen affinity as determined by the change in p50 (partial pressure of oxygen at which Hb oxygen saturation ...

12.3. Pharmacokinetics

Voxelotor is absorbed into plasma and is then distributed predominantly into RBCs due to its preferential binding to Hb. The major route of elimination of voxelotor is by metabolism with subsequent excretion ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Voxelotor was not carcinogenic in a 26-week study in RasH2 transgenic mice at oral doses of 30, 150, or 500 mg/kg/day. Voxelotor was not genotoxic in the reverse mutation bacterial (Ames) test, rat Comet ...

14. Clinical Studies

The efficacy and safety of OXBRYTA in sickle cell disease (SCD) was evaluated in HOPE, a randomized, double-blind, placebo-controlled, multicenter trial [NCT 03036813]. In this study, 274 patients were ...

16.1. How Supplied

The 500 mg tablet is film-coated, light yellow to yellow, oval shaped, biconvex, debossed with GBT 500 on one side, and available in: Bottles of 90 tablets with child-resistant closure: NDC 72786-101-01 ...

16.2. Storage and Handling

Store at or below 30°C (86°F).

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise patients that serious hypersensitivity reactions may occur, and to notify their healthcare providers if they develop ...