Ruxolitinib is a janus kinase inhibitor sold in the U.S. under 3 brand and generic names, for polycythemia vera and primary myelofibrosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Jakafi (application NDA202192). Other ruxolitinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Doses should be individualized based on safety and efficacy. Starting doses per indication are noted below. Myelofibrosis ( 2.2 ) The starting dose of JAKAFI/JAKAFI XR is based on patient’s baseline platelet count: • Greater than 200 × 10 9 /L: JAKAFI 20 mg given orally twice daily or JAKAFI XR 44 mg given orally once daily. • 100 x 10 9 /L to 200 x 10 9 /L: JAKAFI 15 mg given orally twice daily or JAKAFI XR 33 mg given orally once daily. • 50 x 10 9 /L to less than 100 x 10 9 /L: JAKAFI 5 mg given orally twice daily or JAKAFI XR 11 mg given orally once daily. Polycythemia Vera ( 2.3 ) The starting dose of JAKAFI is 10 mg given orally twice daily or JAKAFI XR 22 mg given orally once daily. Acute Graft-Versus-Host Disease ( 2.4 ) The starting dose of JAKAFI is 5 mg given orally twice daily or JAKAFI XR 11 mg given orally once daily. Chronic Graft-Versus-Host Disease ( 2.5 ) The starting dose of JAKAFI is 10 mg given orally twice daily or JAKAFI XR 22 mg given orally once daily. 2.1 Monitoring to Assess Safety Prior to JAKAFI/JAKAFI XR treatment: Perform a complete blood count (CBC) [see Warnings and Precautions ( 5.1 )] . Inquire about past infections, including tuberculosis, herpes simplex, herpes zoster, and hepatitis B [see Warnings and Precautions ( 5.2 )] . During treatment with JAKAFI/JAKAFI XR : Perform a CBC every 2 to 4 weeks until doses are stabilized, and then as…
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Thrombocytopenia, Anemia and Neutropenia [see Warnings and Precautions ( 5.1 )] Risk of Infection [see Warnings and Precautions ( 5.2 )] Symptom Exacerbation Following Interruption or Discontinuation of Treatment [see Warnings and Precautions ( 5.3 )] Non-Melanoma Skin Cancer [see Warnings and Precautions ( 5.4 )] Lipid Elevations [ see Warnings and Precautions ( 5.5 )] Major Adverse Cardiovascular Events (MACE) [ see Warnings and Precautions ( 5.6 )] Thrombosis [ see Warnings and Precautions ( 5.7 )] Secondary Malignancies [ see Warnings and Precautions ( 5.8 )] In myelofibrosis and polycythemia vera, the most common hematologic adverse reactions (incidence > 20%) are thrombocytopenia and anemia. The most common nonhematologic adverse reactions (incidence ≥ 15%) are bruising, dizziness, headache, and diarrhea. ( 6.1 ) In acute graft-versus-host disease, the most common hematologic adverse reactions (incidence > 50%) are anemia, thrombocytopenia, and neutropenia. The most common nonhematologic adverse reactions (incidence > 50%) are infections (pathogen not specified) and edema. ( 6.1 ) In chronic graft-versus-host disease, the most common hematologic adverse reactions (incidence > 35%) are anemia and thrombocytopenia. The most common nonhematologic adverse…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| C;8 | 8 mg | purple | round | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
None. None. ( 4 )
Fluconazole: Avoid concomitant use with fluconazole doses greater than 200 mg. Reduce JAKAFI/JAKAFI XR dosage with fluconazole doses less than or equal to 200 mg. ( 2.6 , 7 ) Strong CYP3A4 Inhibitors: Reduce, interrupt, or discontinue JAKAFI/JAKAFI XR doses as recommended except in patients with acute or chronic graft-versus-host-disease. ( 2.6 , 7 ) 7.1 Effect of Other Drugs on JAKAFI/JAKAFI XR Fluconazole Concomitant use of JAKAFI/JAKAFI XR with fluconazole increases ruxolitinib exposure [ see Clinical Pharmacology ( 12.3 )] , which may increase the risk of exposure-related adverse reactions. Avoid concomitant use of JAKAFI/JAKAFI XR with fluconazole doses of greater than 200 mg daily. Reduce the JAKAFI/JAKAFI XR dosage when used concomitantly with fluconazole doses of less than or equal to 200 mg [ see Dosage and Administration ( 2.6 )] . Strong CYP3A4 Inhibitors Concomitant use of JAKAFI/JAKAFI XR with strong CYP3A4 inhibitors increases ruxolitinib exposure [ see Clinical Pharmacology ( 12.3 )] , which may increase the risk of exposure-related adverse reactions. Reduce the JAKAFI/JAKAFI XR dosage when used concomitantly with strong CYP3A4 inhibitors except in patients with aGVHD or cGVHD [ see Dosage and Administration ( 2.6 )] . Strong CYP3A4 Inducers Concomitant use of JAKAFI/JAKAFI XR with strong CYP3A4 inducers may decrease ruxolitinib exposure [ see Clinical…
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