くすりのしおり

Internal
Revised: 7/2021

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 :
Revlimid Capsules 5mg
 Active ingredient:
Lenalidomide hydrate
 Dosage form:
white to off-white opaque capsule, major axis: 18.0 mm, minor axis: 6.35 mm
 Print on wrapping:
(face) レブラミド 5mg, Revlimid 5mg,妊娠の可能性のある方は服用禁止, この薬は特別な管理が必要です
(back) Revlimid 5mg, レブラミド 5mg,妊娠の可能性のある方は服用禁止, この薬は特別な管理が必要です

Effects of this medicine

This medicine slows disease progression by various effects including modulating effect of cytokine production, inhibiting proliferation of hematopoietic tumor cells and inhibiting angiogenesis. It also suppresses growth of hematopoietic stem cells with chromosomal abnormality to increase the number of normal blood cells.
It is usually used to treat multiple myeloma, myelodysplastic syndrome with 5q deletion, relapsed or refractory adult T-cell leukemia-lymphoma, and relapsed or refractory follicular lymphoma and marginal zone lymphoma.

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: renal disorder, bone-marrow suppression, a risk for deep vein thrombosis, a current or past hepatitis B virus infection, previously received organ or hematopoietic stem cell transplantation.
  • 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))
  • Multiple myeloma: In general, for adults, this medicine is used in combination with dexamethasone. Repeat the cycle of taking 5 capsules (25 mg of lenalidomide) at a time, once a day for 21 days, followed by a 7-day rest.
    Myelodysplastic syndrome: In general, for adults, repeat the cycle of taking 2 capsules (10 mg of lenalidomide) at a time, once a day for 21 days, followed by a 7-day rest.
    Relapsed or refractory adult T-cell leukemia-lymphoma: In general, for adults, take 5 capsules (25 mg of lenalidomide) at a time, once a day.
    Relapsed or refractory follicular lymphoma and marginal zone lymphoma: In general, for adults, this medicine is used in combination with rituximab (genetical recombination). Repeat the cycle of taking 4 capsules (20 mg of lenalidomide) at a time, once a day for 21 days, followed by a 7-day rest for up to 12 cycles.
    In any case, the dosage may be decreased according to your symptoms. This preparation contains 5 mg of lenalidomide 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 fatigue/dizziness/somnolence/blurred vision/confusion may occur.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include constipation, fatigue, anemia, rash/itching and diarrhea. 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.
  • general malaise, fever, gum bleeding [bone-marrow suppression]
  • acute swelling/pain/numbness/redness of limbs, respiratory distress, chest pain [deep vein thrombosis, pulmonary embolism]
  • numbness, headache, language disorder [cerebral infarction, transient ischemic attack]
  • respiratory distress, swelling around the eyes/lips area, hives [hypersensitivity]
  • fever, eye bleeding, erythema/blister [mucocutaneous ocular syndrome, toxic epidermal necrolysis]
  • acute precordial pressure, breathing difficulty, syncope [myocardial infarction, heart failure, arrhythmia]
  • consciousness disorder, cognitive disorder, paralysis (paralysis on one side or of both limbs), language disorder [progressive multifocal leukoencephalopathy (PML)]
  • 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.