くすりのしおり

Internal
Revised: 4/2021

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 :
Zejula capsules 100mg
 Active ingredient:
Niraparib tosilate hydrate
 Dosage form:
purple and white capsule, major axis: approx. 22 mm, minor axis: approx. 8 mm
 Print on wrapping:
(Face) nothing mentioned, (Back) 100mg, ゼジューラ, Niraparib 100mg, 冷蔵・遮光保管

Effects of this medicine

This medicine inhibits poly(adenosine 5'-diphosphate) ribose polymerase (PARP), a DNA repair enzyme, to suppress the growth of cancer cells.
It is usually used for maintenance therapy after the initial chemotherapy for ovarian cancer, for maintenance therapy in recurrent ovarian cancer sensitive to platinum-based anticancer medicines and to treat recurrent ovarian cancer with homologous recombination repair deficiency which is sensitive to platinum-based anticancer medicines.

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 hypertension or liver dysfunction.
  • If you are 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, take 2 capsules (200 mg of niraparib) at a time, once a day. However, if your weight is 77 kg or over and your platelet count is 150,000/mcL or over before the initial administration, take 3 capsules (300 mg) at a time, once a day. The dosage may be decreased according to the conditions. In any case, strictly follow the instructions.
  • If you miss a dose, skip the missed dose and follow your regular dosing schedule. 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

  • Blood tests are regularly conducted before and during the treatment with this medicine.
  • It should be observed whether your blood pressure is properly managed before the treatment with this medicine and your blood pressure should be regularly measured during the treatment.
  • If you have a possibility of pregnancy, avoid pregnancy while you are taking this medicine and for a certain period of time after you discontinue this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include anemia, headache, insomnia, nausea, constipation, vomiting, loss of appetite, diarrhea, fatigue and asthenia. 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, see your doctor immediately.
  • fever, chills, sore throat, nose bleeding, gum bleeding, bruise, bleeding tendency, dull headache, palpitation, shortness of breath [myelosuppression]
  • headache, stiff shoulder, dizziness, palpitation, shortness of breath, facial flushing, general malaise [hypertension]
  • headache, decreased consciousness, loss of consciousness, convulsion, vision disturbance [reversible posterior leukoencephalopathy syndrome]
  • cough, shortness of breath, breathing difficulty, fever [interstitial pneumonia]
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 reach of children. Store at 2 to 8 degrees Celsius (in a refrigerator, etc.), away from light.
  • Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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