くすりのしおり

Injection
Revised: 1/2018

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 :
Teribone Inj. 56.5 mcg
 Active ingredient:
Teriparatide acetate
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine is a synthetic human parathyroid hormone preparation. It enhances the function of cells that make bone, and increases bone mass, thereby reducing the risk of fracture.
It is usually used to treat osteoporosis at high risk of fracture.

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 high risk of osteosarcoma [Paget's disease of bone, increased blood alkaline phosphatase of unknown origin, pediatric and young adult patients with open epiphyses (currently, growth in stature), previously received radiotherapy that may affect the bone], hypercalcemia, primary or metastatic malignant bone tumors, metabolic bone diseases other than osteoporosis, such as hyperparathyroidism.
  • 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, for adults, this medicine is injected subcutaneously once a week. The total treatment period should not exceed 24 months. The total treatment period with this medicine should not exceed 24-month (104-week) even when the therapy is temporarily discontinued and subsequently resumed. A 24-month (104-week) therapy with this medicine should not be repeated after the first 24-month (104-week) therapy.

Precautions while taking this medicine

  • From immediately to few hours after injection, this medicine may cause unconsciousness/convulsion/fall due to shock or transient rapid reduction of blood pressure. These symptoms may appear for the first time after few months have passed from the initial injection. Pay attention to the following points when receiving this injection.
    -Observe your condition for 30 minutes after the injection. Go home after confirming that there are no symptoms in the case of outpatient.
    -If reduction of blood pressure, dizziness, dizziness on standing up, palpitation, feeling unwell, nausea, facial pallor or cold sweat has occurred after injection, lie down or sit down until your symptoms subside.
  • This medicine may cause dizziness, dizziness on standing up or unconsciousness due to transient reduction of blood pressure. Pay attention when performing dangerous operations such as working at heights or driving a car.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, vomiting, headache, malaise, stomach discomfort, dizziness, rash, hives, allergic conjunctivitis, allergic rhinitis and itch. 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, see your doctor immediately.
  • respiratory distress, hives, redness (the skin becomes congested and reddened) with itch of the whole body, swollen eye and lip [anaphylaxis]
  • facial pallor, cold sweat, dizziness on standing up, dizziness, shortness of breath [shock, unconsciousness]
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

  • This medicine is injected in a medical institution. This is not a self-injection agent.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.