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January 27, 2026
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Brand Name :
Oxbryta
Synonyms :
voxelotor
Class :
Hemoglobin Oxygen-Affinity Modulators
Brand Name :
Oxbryta
Synonyms :
voxelotor
Class :
Hemoglobin Oxygen-Affinity Modulators
Dosage Forms & Strengths
Tablet for oral suspension
300mg
Tablet
500mg
Administer 1500mg orally every day
Hydroxyurea can be used along if needed
Dose Adjustments
Renal impairment: No dosage adjustment is necessary
Hepatic impairment:
Mild to moderate: No dosage adjustment necessary (Child A pugh or B)
Severe: Reduce to 1000 mg every day or 900 mg oral suspension orally every day (Child-Pugh C)
CYP3A4 inducers
Avoid administering CYP3A4 inducers in combination, whether they are strong or mild.
Increase dosage to 2500 mg orally once a day for strong CYP3A4 inducers.
Increase to 2,000 mg orally every day for moderate CYP3A4 inducers.
Dosage Forms & Strengths
Tablet for oral suspension
300mg
Tablet
500mg
<4 years: Safety and efficacy not established
>12 years: Administer 1500mg orally every day
4 to 11 years:
10 to <20 kg: 600mg orally every day
20 to <40kg: 900mg orally every day
≥40kg: 1500mg orally every day
Dose Adjustments
Renal impairment: No dosage adjustment is necessary
Hepatic impairment:
Mild to moderate: No dosage adjustment necessary (Child A pugh or B)
Severe: Reduce to 1000 mg orally every day or 900 mg oral suspension orally every day (Child-Pugh C)
20 kg to <40kg: Reduce the dose to 600mg orally every day
10 kg to <20kg: Reduce the dosage to 300mg orally every day
Refer adult dosing
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
may diminish the serum concentration of Voxelotor
may diminish the serum concentration of Voxelotor
may diminish the serum concentration of Voxelotor
may diminish the serum concentration of Voxelotor
may diminish the serum concentration of Voxelotor
may diminish the serum concentration of Voxelotor
may diminish the serum concentration of Voxelotor
may diminish the serum concentration of Voxelotor
may diminish the serum concentration of Voxelotor
may diminish the serum concentration of Voxelotor
may enhance the serum concentration of CYP3A4 Inhibitors
cyclophosphamide effect of action increased by affecting enzyme CYP3A4 metabolism.
when both drugs are combined, there may be an increased level of serum concentration of alpelisib
the voxelotor on interacting with brentuximab has its effect increased by changing the intestinal or hepatic CYP3A4 enzyme metabolism.
the effect of voxelotor is decreased by lorlatinib, by altering intestinal or hepatc CYP3A4 enzyme metabolism
voxelotor increases the effect of ixazomib by altering intestinal/hepatic CYP3A4 enzyme metabolism
CYP3A strong enhancers of the small intestine may reduce the bioavailability of voxelotor
it increases the effect or level of palbociclib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
it will increase the impact or level of regorafenib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
it increases the effect or level of ruxolitinib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
it increases the effect or level of dronabinol by altering the intestinal or hepatic metabolism
may increase the level by affecting hepatic enzyme CYP3A4 metabolism
may increase the level by affecting hepatic enzyme CYP3A4 metabolism
may increase the level by affecting hepatic enzyme CYP3A4 metabolism
may increase the level by affecting hepatic enzyme CYP3A4 metabolism
it increases by affecting the hepatic enzyme CYP3A4 metabolism
relugolix/estradiol/norethindrone
it enhances by affecting the hepatic enzyme CYP3A4 metabolism
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
may enhance the serum concentration of CYP3A4 Inhibitors
Actions and Spectrum:
Its mechanism of action involves increasing the affinity of hemoglobin for oxygen, which helps prevent the formation of sickle-shaped red blood cells and reduces the occurrence of vaso-occlusive crises.
The spectrum of activity of voxelotor is primarily focused on sickle cell disease. By increasing the oxygen affinity of hemoglobin, voxelotor improves the overall oxygen-carrying capacity of red blood cells and reduces their tendency to sickle.
This can lead to fewer vaso-occlusive crises, improved oxygen delivery to tissues, and potentially better clinical outcomes for patients with SCD.
Frequency defined
>10%
Adults and adolescents( ≥12 years)
Diarrhea (23%)
Nausea (19%)
Pyrexia (15%)
Headache (32%)
Abdominal pain (23%)
Rash (15%)
Pediatrics (4 to 11 years)
Vomiting (33%)
Abdominal pain (18%)
Headache (18%)
Pyrexia (36%)
Rash (20%)
Diarrhea (18%)
Adults and adolescents (≥12 years)
Drug hypersensitivity (<10%)
<1%
hypersensitivity
Black box warning:
None
Contraindications/caution:
Contraindications:
Caution:
Pregnancy consideration: Insufficient data available
Lactation: Excretion of the drug in human breast milk is unknown
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
Pharmacodynamics:
Pharmacokinetics:
Absorption
voxelotor reaches its peak plasma and whole blood concentrations at around 2 hours. The peak plasma concentration is approximately 12.6 mcg/mL, and the peak total blood concentration is significantly higher at 179 mcg/mL. The AUC values reflect the overall exposure to voxelotor over time, with an AUC of 246 mcg⋅hr/mL in plasma and a higher AUC of 3820 mcg⋅hr/mL in whole blood.
Distribution
The high protein binding of 99.8% indicates that most of the voxelotor molecules in the bloodstream are bound to plasma proteins, such as albumin. The central compartment, represented by the plasma, has a larger Vd of 338 L, suggesting that voxelotor distributes widely in the central circulation. The peripheral compartment, also in the plasma, has a smaller Vd of 72.2 L, indicating additional distribution to peripheral tissues.
Metabolism
It is extensively metabolized in the body through Phase I and II metabolic pathways.
The primary enzyme responsible for the oxidation of voxelotor is CYP3A4, a major drug-metabolizing enzyme found in the liver and other tissues. CYP2C19, CYP2B6, and CYP2C9 also contribute to the oxidation of voxelotor, although to a lesser extent.
Elimination and Excretion
The half-life of voxelotor is reported as 35.5 hours. voxelotor and its metabolites are primarily eliminated from the body through feces and urine.
Approximately 62.6% of the administered dose of voxelotor is excreted in the feces. Approximately 35.5% of the administered dose of voxelotor is excreted in the urine.
Administration:
Patient information leaflet
Generic Name: voxelotor
Why do we use voxelotor?
The specific uses of voxelotor in sickle cell disease include:
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