Active Ingredient: Ruxolitinib
Ruxolitinib is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
For this indication, competent medicine agencies globally authorize below treatments:
Oral, between 10 milligrams ruxolitinib and 25 milligrams ruxolitinib, 2 times daily. The maximum allowed total dose is 50 milligrams ruxolitinib daily.
The recommended starting dose of ruxolitinib in polycythaemia vera (PV) is 10 mg given orally twice daily.
Doses may be titrated based on safety and efficacy.
If efficacy is considered insufficient and blood counts are adequate, doses may be increased by a maximum of 5 mg twice daily, up to the maximum dose of 25 mg twice daily.
The starting dose should not be increased within the first four weeks of treatment and thereafter no more frequently than at 2-week intervals.
Treatment should also be interrupted when haemoglobin is below 8 g/dl. After recovery of blood counts above these levels, dosing may be re-started at 5 mg twice daily and gradually increased based on careful monitoring of complete blood cell count, including a white blood cell count differential.
In PV, dose reductions should also be considered if haemoglobin decreases below 12 g/dl and is recommended if it decreases below 10 g/dl.
Ruxolitinib is to be taken orally, with or without food. If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose.
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