くすりのしおり

Injection
Revised: 9/2019

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 :
ZOMETA for i.v. infusion 4mg/5mL [hypercalcemia]
 Active ingredient:
Zoledronic acid hydrate
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine lowers blood calcium level.
It is usually used to treat hypercalcemia associated with malignancy.

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.
    If you have recently received dental treatment such as tooth extraction or have a plan to receive it.
  • 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, administered by intravenous infusion.
  • If the next injection is needed, administer with a medicine cessation period of at least 1 week.
  • The frequency of injection depends on your response to the treatment. Ask your doctor about your frequency of injection.

Precautions while taking this medicine

  • Osteonecrosis/osteomyelitis of the jaw may occur in the patients who are using bisphosphonates including this medicine. Many of them have been associated with dental treatments such as tooth extraction, pay attention to the following points.
    - Consult with your doctor or pharmacist and receive your dental checkups before treatment of this medicine as needed. You should finish dental treatments such as tooth extraction before treatment of this medicine as much as possible.
    - Maintain your oral hygiene while injecting this medicine.
    - Receive your dental checkups regularly.
    - Inform your dentist that you are receiving this medicine.
    - Avoid dental treatments such as tooth extraction, etc. as much as possible.
    - If abnormalities in teeth/jaw (jaw pain, loose teeth or swollen gums) occur, see a dentist/oral surgeon immediately.
  • Osteonecrosis of the external auditory canal may occur in patients who are using bisphosphonates. Since some of them have been associated with ear infection or wound, see an otolaryngologist if symptoms such as otitis externa, ear discharge (fluid from the ear), ear pain, etc. persist.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include fever, nausea, dullness, headache, bone pain and joint pain. 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.
  • decreased urine output, edema, fever, shaky hands [acute renal disorder, interstitial nephritis, fanconi syndrome]
  • decline of pump-like movement in the heart, leading to stagnation of blood, breathing difficulty, general edema [congestive heart failure (swelling, breathing difficulty, pulmonary edema)]
  • loss of muscle strength, diminished muscle strength, numbness, tremoring limbs [hypocalcemia]
  • fever, dry cough, breathing difficulty [interstitial lung disease]
  • sore mouth, swollen mouth, redness, feeling of loose teeth, loose teeth, numbness of jaw, heavy feeling in the jaw, fever, loss of appetite [osteonecrosis of the jaw, osteomyelitis of the jaw]
  • ear itch, heat sensations inside the ear, strange sensations in the ear, otorrhea, ear pain [osteonecrosis of the external auditory canal]
  • pain of thigh or inguinal region [atypical subtrochanteric and proximal diaphyseal femoral fractures]
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.