Ruxolitinib INN

Composition: Each tablet contains Ruxolitinib 5mg as Ruxolitinib Phosphate INN.

Indications: Myelofibrosis: It is indicated for treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF.

Polycythemia Vera: Ruxolitinib is indicated for treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.

Dosage and Administration: Myelofibrosis: The recommended starting dose of Ruxolitinib is based on platelet count.

Ruxolitinib Starting Doses for Myelofibrosis

Platelet Count

Starting Dose

Greater than 200 X 109/L

20 mg orally twice daily

100 X 109/L to 200 X 109/L

15 mg orally twice daily

50 X 109/L to less than 100 X 109/L

5 mg orally twice daily

Polycythemia Vera: The recommended starting dose of Ruxolitinib is 10 mg twice daily. Doses may be titrated based on safety and efficacy. Or as directed by the registered physician.

Use in Pregnancy and Lactation: There are no adequate and well-controlled studies in pregnant women. Nursing mother: It is not known whether Ruxolitinib is excreted in human milk. Because many drugs are excreted in human milk, breastfeeding should be discontinued during treatment with Ruxolitinib and for two weeks after the final dose.

Packing: Each box contains 50’s tablets in blister pack.

Prescribing Description

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