くすりのしおり

Internal
Revised: 11/2018

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
JAKAVI Tablets 10mg[polycythemia vera]
 Active ingredient:
Ruxolitinib Phosphate
 Dosage form:
white tablet, diameter: 9.3 mm, thickness: 4.5 mm
 Print on wrapping:
ジャカビ10mg, JAKAVI10mg, NVR L10

Effects of this medicine

This medicine controls the increased blood cell counts (mainly red blood cells) and reduces the size of enlarged spleen (splenomegaly) due to polycythemia vera by selectively blocking the action of certain enzymes (Janus Kinases) involved in polycythemia vera.
It is usually used to treat polycythemia vera (only if conventional therapy is inadequate or ineligible).

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch rash, etc.) to any medicines.
    If you have any infections or have ever had tuberculosis or hepatitis.
  • If you are pregnant, possibly pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In general, for adults, start with taking 10 mg of ruxolitinib at a time, twice a day, about every 12 hours as a guide. The dosage may be adjusted according to your symptoms, but never more than 25 mg at a time, twice a day. This medicine contains 10 mg of Ruxolitinib in a tablet. Strictly follow the instructions.
  • If you miss a dose, skip the missed dose and take your next dose at the schedule time. You should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • This medicine may increase susceptibility to infection. Wash your hands and gargle frequently, and maintain hygiene.
  • Avoid taking hypericum perforatum (Saint John's wort)-contained supplements, etc., since it may weaken the therapeutic effects of this medicine.
  • Women of childbearing potential should use highly effective contraception while taking this medicine, since fetal toxicity was reported in an animal study.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include anemia, weight gain, dizziness and headache. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • symptoms of anemia, fever, bleeding tendency [myelosuppression]
  • cold-like symptoms, malaise, vomiting [infection]
  • disturbance of consciousness/memory/speech, lightheadedness, convulsion [progressive multifocal leukoencephalopathy: PML]
  • general malaise, loss of appetite, nausea [abnormal liver function]
  • fever, dry cough, respiratory distress  [interstitial lung disease]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist or the medical institution how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.