Active Ingredient: Ruxolitinib
Ruxolitinib is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, between 5 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 myelofibrosis (MF) is based on platelet counts (see table).
Starting doses in myelofibrosis:
| Platelet count | Starting dose |
|---|---|
| Greater than 200,000/mm³ | 20 mg orally twice daily |
| 100,000 to 200,000/mm³ | 15 mg orally twice daily |
| 75,000 to less than 100,000/mm³ | 10 mg orally twice daily |
| 50,000 to less than 75,000/mm³ | 5 mg 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 be discontinued for platelet counts less than 50,000/mm³ or absolute neutrophil counts less than 500/mm³. 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.
Dose reductions should be considered if the platelet count decreases during treatment as outlined in the following table, with the goal of avoiding dose interruptions for thrombocytopenia.
Dosing recommendation for MF patients with thrombocytopenia:
| Dose at time of platelet decline | |||||
| 25 mg twice daily | 20 mg twice daily | 15 mg twice daily | 10 mg twice daily | 5 mg twice daily | |
| Platelet count | New dose | ||||
| 100,000 to <125,000/mm³ | 20 mg twice daily | 15 mg twice daily | No change | No change | No change |
| 75,000 to <100,000/mm³ | 10 mg twice daily | 10 mg twice daily | 10 mg twice daily | No change | No change |
| 50,000 to <75,000/mm³ | 5 mg twice daily | 5 mg twice daily | 5 mg twice daily | 5 mg twice daily | No change |
| Less than 50,000/mm³ | Hold | Hold | Hold | Hold | Hold |
Treatment of MF may be continued as long as the benefit-risk remains positive. However the treatment should be discontinued after 6 months if there has been no reduction in spleen size or improvement in symptoms since initiation of therapy.
It is recommended that, for patients who have demonstrated some degree of clinical improvement, ruxolitinib therapy be discontinued if they sustain an increase in their spleen length of 40% compared with baseline size (roughly equivalent to a 25% increase in spleen volume) and no longer have tangible improvement in disease-related symptoms.
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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