くすりのしおり

Internal
Revised: 5/2019

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 :
Pomalyst Capsules 4mg
 Active ingredient:
Pomalidomide
 Dosage form:
capsule with dark blue opaque cap imprinted with “POML” and blue opaque body imprinted with “4mg”, major axis: 18.0 mm, minor axis: 6.35 mm
 Print on wrapping:
(face) ポマリスト 4mg, 妊婦・妊娠の可能性のある方は服薬禁止, この薬は特別な管理が必要です
(back) Pomalyst 4mg, ポマリスト 4mg, 妊婦・妊娠の可能性のある方は服薬禁止

Effects of this medicine

This medicine reduces myeloma cells by various effects including modulating effect of cytokine production, inhibiting proliferation of hematopoietic tumor cells and inhibiting angiogenesis.
It is usually used to relapsed or refractory multiple myeloma.

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 risk for deep vein thrombosis.
    If you have bone-marrow suppression or renal/liver disorder.
  • 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 combination with dexamethasone: In general, for adults, repeat the cycle of taking 1 capsule (4 mg of the active ingredient) at a time, once a day for 21 days, followed by a 7-day rest. The dosage may be decreased according to your symptoms.
    In combination with bortezomib and dexamethasone: In general, for adults, repeat the cycle of taking 1 capsule (4 mg of the active ingredient) at a time, once a day for 14 days, followed by a 7-day rest. The dosage may be decreased according to your symptoms.
    This preparation contains 4 mg of the active ingredient in a capsule. Strictly follow the instructions.
  • Do not chew/crush/open the capsule to prevent the scattering accident of the medicine.
  • If you miss a dose and remember it within 12 hours, take the missed dose as soon as possible. If it already has passed more than 12 hours from the scheduled time, skip the missed dose and continue your regular dosing schedule from the next day. 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

  • Strictly follow procedures for proper management of Revlimid and Pomalyst (RevMate) to prevent medicine exposure to a fetus.
  • This medicine may cause teratogenesis (deformed fetus). Female patients with a possibility of pregnancy should take a pregnancy test before starting this medicine, and both man and woman should avoid pregnancy with reliable methods from 4 weeks before starting this medicine to 4 weeks after withdrawal of this medicine. Female patients should take a pregnancy test periodically at intervals not exceeding 4 weeks during taking this medicine. (No birth control method is 100% effective. Avoiding sexual relations is a reliable method to avoid pregnancy.)
  • The medicine may be moved into semen. Male patients should make sure to avoid pregnancy with reliable methods from the starting day of this medicine to 4 weeks after withdrawal of this medicine. If your partner is pregnant, avoid sexual relations.
  • Do not make donation of blood/sperm/semen or breastfeed from the starting day of this medicine to 4 weeks after withdrawal of this medicine.
  • Avoid performing dangerous operations such as driving a car or operating machinery since drowsiness or dizziness may occur.
  • Periodical kidney function test may be performed. In that case, receive the test on your designated date and time.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, fever, constipation, fatigue, anemia, diarrhea and peripheral sensory neuropathy (sensory paralysis, numbness of limbs, pain of limbs). 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.
  • acute swelling/pain/numbness/redness of limbs, respiratory distress, chest pain [deep vein thrombosis, pulmonary embolism]
  • sudden paralysis of one side of the limbs/face, numbness, conscious disorder [cerebral infarction]
  • general malaise, fever, gum bleeding [bone-marrow suppression]
  • cough, phlegm, fever [infection]
  • fever, dry cough, respiratory distress [interstitial pulmonary 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.
  • Pay close attention to storage, not to lose this medicine. If you lose it, inform your prescribing hospital immediately. Do not share this medicine with your family or any other person (even if he/she has same symptoms as you) or give the medicine to them.
  • You can store this medicine in a dedicated RevMate kit which is distributed by medical institutions.
  • If you miss a dose, inform the number of the missed dose(s) on your next visit. Your doctor or pharmacist will confirm the remaining number of the medicine.
  • Return the remainder to your hospital or pharmacist. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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