くすりのしおり

Injection
Revised: 5/2014

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 :
RANMARK Subcutaneous Injection 120mg [bone lesion associated with multiple myeloma or bone metastases from solid tumors]
 Active ingredient:
Denosumab (Genetical Recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine is anti-RANKL antibody which inhibits bone resorption and suppresses progression of bone lesion from tumors.
It is usually used to treat bone lesion associated with multiple myeloma or bone metastases from solid tumors.

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 hypocalcemia, renal disorder or a potential to develop hypocalcemia.
    If you are using "PRALIA Subcutaneous Injection 60mg Syringe."
  • 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, administer by subcutaneous injection once every 4 weeks. It may be administered over a long period according to your response to the treatment.

Precautions while taking this medicine

  • In order to prevent hypocalcemia, ingest calcium and vitamin D under the instruction of your doctor. If you have difficulty in taking them orally, consult with your doctor.
  • Since hypocalcemia may occur without any symptoms, frequent blood test is needed. Keep blood test schedule under the instruction of your doctor.
  • Necrosis/osteomyelitis of the jaw bone may occur in the patients who are taking medicines for bone lesion including this medicine or similar drugs (Bisphosphonate). These adverse reactions often related to dental treatment such as tooth extraction. Receive adequate explanation about the following points from your doctor or pharmacist.
    (1) Receive dental checkup as needed, and if possible, receive dental treatment such as tooth extraction prior to taking the medicine, after consultation with your doctor.
    (2) Maintain your oral hygiene by brushing your teeth while taking this medicine.
    (3) Receive dental checkup regularly while taking the medicine.
    (4) Inform your dentist that you are taking the medicine when you see a dentist.
    (5) Avoid any treatments such as tooth extraction while taking the medicine.
    If abnormalities in teeth/jaw (jaw pain, loose teeth or swollen gums) occur, see a dentist/oral surgery specialist immediately.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include hypocalcemia, fatigue, nausea, joint pain, jaw osteonecrosis, asthenia or 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.
  • shaking limbs, muscular weakness, convulsion, numbness, arrhythmia [hypocalcemia]
  • oral pain, swelling of mouth, redness, loose teeth, numbness of jaw, heavy feeling in jaw, fever, loss of appetite [necrosis of the jaw bone, osteomyelitis of the jaw]
  • hoarse voice, swelling around eyes/lips, hives, impaired judgment, palpitation, shortness of breath, breathing difficulty, dullness, impaired mind, hot flush, decreased consciousness, lightheadedness [anaphylaxis]
  • pain of thigh or inguinal region [atypical subtrochanteric and diaphyseal femoral fractures]
  • chill, high fever, redness with local pain and fever [serious skin infection]
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

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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