Oxbryta (Voxelotor)

By European Oxbryta from Insulinhub.com

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2 Manufacturing plans are authorized Oxbryta in Europe: Pfizer Service Company BV Hoge Wei 10 1930 Zaventem Belgium Global Blood Therapeutics Netherlands B.V. Strawinskylaan 3051 1077ZX Amsterdam Netherlands

Information about Oxbryta (Voxelotor)

Oxbryta is a medication containing voxelotor, a first-in-class therapy used to treat sickle cell disease (SCD). Voxelotor works by increasing hemoglobin’s affinity for oxygen, helping to prevent the sickling of red blood cells and reduce the associated complications of sickle cell disease, such as pain crises and organ damage.

Product Highlights

• Oxbryta is indicated for the treatment of sickle cell disease (SCD), a genetic blood disorder characterized by the production of abnormal hemoglobin (hemoglobin S), which leads to red blood cells becoming rigid and sickle-shaped.
• This results in blockages in blood vessels, pain crises, and various long-term complications. 
• Oxbryta helps to reduce the frequency of these sickle cell-related complications and improve overall blood flow.
• Oxbryta is used to treat SCD in adults and pediatric patients (12 years and older). It helps improve hemoglobin levels and reduce the frequency of vaso-occlusive crises, which are painful episodes caused by the sickling of red blood cells.

Key Ingredient

• Voxelotor

Key Benefits

• By preventing red blood cells from sickling, Oxbryta can help reduce the frequency and severity of painful vaso-occlusive crises, one of the most common and debilitating symptoms of sickle cell disease.
• Oxbryta works to raise hemoglobin levels and stabilize the oxygenation of red blood cells, improving the overall oxygen-carrying capacity of the blood.
• Oxbryta is taken as an oral tablet, offering a convenient treatment option for patients compared to other sickle cell treatments that may require injections or infusions.
• Reducing the sickling of red blood cells can help prevent long-term complications of sickle cell disease, such as organ damage and strokes.
• Clinical studies have shown that voxelotor can provide significant benefits over time, helping to manage the chronic symptoms of sickle cell disease and improve quality of life for patients.

Direction of Use

• The usual recommended dose of Oxbryta is 1,500 mg taken once daily, with or without food.
• Take the tablet whole with a glass of water. Do not crush, chew, or divide the tablet.
• For optimal effectiveness, Oxbryta should be taken at the same time each day to maintain steady blood levels of the drug.

Safety Concerns

• The most common side effects of Oxbryta include headaches, diarrhea, and nausea. These side effects are usually mild and typically resolve within the first few weeks of treatment.
• Oxbryta may cause liver enzyme elevations, so liver function should be monitored regularly during treatment. Patients with existing liver conditions should use Oxbryta with caution.
• Oxbryta is metabolized by the cytochrome P450 enzyme system, particularly CYP3A. Caution is advised when using Oxbryta in combination with drugs that affect CYP3A, such as certain antifungals, antivirals, and antibiotics.
• Although voxelotor increases hemoglobin levels, it is important to monitor for any significant changes, as the drug can affect oxygen-carrying capacity. Regular blood tests may be required.
• The safety of Oxbryta during pregnancy and breastfeeding has not been established. It should be used during pregnancy only if the potential benefits are greater than the potential risks to the fetus.

Avoid Oxbryta (Voxelotor) If

• Patients who have a known allergy to voxelotor or any of its ingredients should avoid using Oxbryta.
• Due to potential liver enzyme elevations, Oxbryta should be avoided in patients with severe liver impairment. In cases of mild to moderate liver impairment, Oxbryta may be used with caution, and liver function should be closely monitored.
• Oxbryta is a pregnancy Category C drug, which means it should only be used during pregnancy if the potential benefits outweigh the potential risks to the fetus. Speak with a healthcare provider before using it during pregnancy.
• It is unknown whether voxelotor passes into breast milk, so caution is advised when using Oxbryta while breastfeeding. Consult a healthcare provider for guidance.
• Patients with a history of hemolysis or severe anemia should be closely monitored if using Oxbryta, as it could potentially affect red blood cell turnover.