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Oxbryta is a brand name for Voxelotor. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated by physicians experienced in the management of SCD. Posology The recommended dose of Oxbryta is 1 500 mg (three 500 mg film-coated tablets) taken orally once daily. If a dose is missed, treatment should be continued on the day following the missed dose.
Paediatric population The recommended dose of Oxbryta in patients 12 to < 18 years of age is the same as for adults. The safety and efficacy of Oxbryta in paediatric patients below the age of 12 years have not been established yet. No data are available.
Special populations Renal impairment No dose adjustment is recommended in patients with mild to severe renal impairment. 4). 3 Hepatic impairment No dose adjustment of Oxbryta is recommended for patients with mild or moderate hepatic impairment.
4). Method of administration Oxbryta film-coated tablets should be swallowed whole with water. 2). Tablets should not be cut, crushed, or chewed because of the unpleasant taste.
7%). 1%). 3% of patients. 6% of patients who received voxelotor in the pivotal study. 1%). 4). Tabulated list of adverse reactions Table 1 lists adverse drug reactions that occurred in patients treated with voxelotor 1 500 mg during a 72-week, randomized, double-blind, placebo-controlled pivotal Phase 3 study (n=88), as well as adverse reactions from postmarketing experience.
Adverse reactions reported with voxelotor are listed by system organ class and preferred term. Within each system organ class, adverse reactions are listed under frequency categories. Frequencies are defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from available clinical study data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Table 1:
Adverse reactions System organ class Adverse reactionsa Frequency category Immune system disorders Drug hypersensitivity Uncommon Nervous system disorders Headache Very common Gastrointestinal disorders Diarrhoea Abdominal painb Nausea Very common Skin and subcutaneous tissue disorders Rashc Very common Pruritus Common Drug reaction with eosinophilia and systemic symptoms (DRESS) Angioedemad Not known 7 a.
Adverse reactions were NCI Grades 1 or 2 except for Grade 3 diarrhoea (n=1), nausea (n=1), rash (n=1), rash generalized (n=3) and hypersensitivity (n=1). b. Abdominal pain includes abdominal pain, abdominal pain upper, and abdominal pain lower.
c. Rash includes rash, urticaria, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash papular. d. Angioedema includes swelling of eyelid, face oedema, lip swelling, and periorbital swelling. Description of selected adverse reactions Gastrointestinal (GI) disorders In the pivotal Phase 3 study, the most commonly reported GI adverse reactions were diarrhoea, abdominal pain and nausea with diarrhoea and nausea showing a dose-dependent effect.
Hypersensitivity reactions Serious hypersensitivity reactions have been observed in < 1% of patients treated with voxelotor in clinical studies. 8). If hypersensitivity reactions occur, voxelotor must be discontinued and appropriate medical therapy must be administered.
Voxelotor must not be reinitiated in patients who experience these symptoms with previous use. 8). At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Oxbryta should be withdrawn immediately and an alternative treatment considered.
If the patient has developed a serious reaction such as DRESS with the use of Oxbryta, treatment with Oxbryta must not be restarted in this patient at any time. Laboratory test interference Oxbryta administration may interfere with measurement of haemoglobin (Hb) subtypes (HbA, HbS, and HbF) by high-performance liquid chromatography (HPLC).
If precise quantitation of Hb species is required, chromatography should be performed when the patient has not received Oxbryta therapy in the immediately preceding 10 days. 2). No dose adjustment is recommended. Safety of voxelotor has not been evaluated in SCD patients with ESRD requiring dialysis.
4 Hepatic impairment There are limited data on the safety of voxelotor in patients with SCD with different degrees of hepatic impairment. 2). 2). 5). 3%). Therefore, safety and efficacy data on other SCD genotypes are limited. Elderly Clinical studies of voxelotor did not include patients > 65 years of age.
Combination therapy with hydroxycarbamide When Oxbryta is administered in combination with hydroxycarbamide, the prescribing information of hydroxycarbamide should be consulted. Immunosuppressive effects Voxelotor decreased the humoral immune response to antigens in both rats and monkeys.
4).
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The majority of reported GI events were Grade 1 or 2 and were manageable without the need for dose interruption, reduction or treatment discontinuation and resolved with continued use. 5% of patients. 0% of patients in the voxelotor 1 500 mg, and placebo groups, respectively.
1%) report of Grade 3 diarrhoea. 1%) patient in the voxelotor 1 500 mg group. 1%) experienced drug hypersensitivity on Study Day 40. Observed symptoms included generalized morbilliform rash, urticaria, mild shortness of breath, mild facial swelling, pyrexia, headache, and diarrhoea.
Elevated eosinophils were noted. Symptoms abated after voxelotor was withheld, and recurrence was observed after reintroduction of voxelotor. Event resolved with antihistamine and oral corticosteroids. 0% of patients in the voxelotor 1 500 mg and placebo groups, respectively.
The majority of rash events were similar in appearance (consistent with typical maculopapular drug eruptions) and distribution, were not associated with extradermal symptoms, and were clinically manageable with or without treatment including oral antihistamines or topical corticosteroids.
Exposure-response analysis did not reveal a statistically significant dose- or exposure-response relationship. Paediatric population The safety profile observed in paediatric patients 12 to < 18 years of age treated with voxelotor in the clinical studies was similar to that seen in adult patients.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Clinical relevance in already immunocompromised patients or in patients treated with immunosuppressive drugs cannot be excluded. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per 1 500 mg (daily dose), that is to say essentially “sodium-free”.