e 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.
DAIICHI SANKYO COMPANY, LIMITEDInjection
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. |
