くすりのしおり

Self-injection
Revised: 4/2019

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 :
FORTEO s.c. injection Kit 600mcg
 Active ingredient:
Teriparatide(genetical recombination)
 Dosage form:
clear and colorless injectable preparation
 Print on wrapping:

Effects of this medicine

This medicine is recombinant human parathyroid hormone preparation. It prompts bone formation, increases bone mass that was lost due to osteoporosis and reconstructs the structure in the bones to prevent bone fracture.
It is usually used to treat patients with osteoporosis who are at high risk for bone 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 any symptoms of an elevated calcium level in the blood (hypercalcemia), kidney dysfunction, urinary stone or heart disease.
    If you have an increased risk for osteosarcoma (e.g. Paget's disease of bone or unexplained elevations of alkaline phosphatase, children or youth with open epiphyses, or prior external beam or implant radiation therapy with possible effects on the bones), bone tumors or metabolic bone diseases other than osteoporosis (e.g. hyperparathyroidism etc.).
  • 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, 20 mcg is subcutaneously administered to adults once daily. The maximum total duration of treatment should be 24 months. After the total of 24 months treatment, the 24-month course should not be repeated. Strictly follow the instructions.
  • Do not share one preparation with other people.
  • If you miss a dose, consult your doctor. You should never inject two doses at one time.
  • If you accidentally inject more than your prescribed dose, consult your doctor or pharmacist.
  • Do not stop injecting this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Please take caution when using the medicine as orthostatic hypotension or dizziness may cause accidents in the following situations.
    - Working in high places
    - Operating a motor vehicle

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, upper abdominal pain and headache. If any of these symptoms occur, consult with your doctor or pharmacist.
Since elevated levels of serum calcium may be observed, if you have any persistent symptoms related to hypercalcemia (e.g. nausea, vomiting, constipation, drowsiness, muscle weakness), contact your doctor immediately.
Shock and loss of consciousness due to transient and sudden decrease of blood pressure may occur. Keep at rest as much as possible for about 30 minutes after the injection. In addition, if you experience decreased blood pressure, dizziness, lightheadedness, palpitation (beating fast), bad feeling, nausea, pale face and cold sweat, please keep sitting down or lay down until those symptoms disappear.
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.
  • rash, breathing difficulty, decreased blood pressure  [anaphylaxis]
  • decreased consciousness [shock, loss of consciousness]
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

  • Store at 2 to 8 degrees Celsius (in refrigerator, etc.), away from light and avoid freezing.
  • Discard the remainder. Do not store them. Ask the pharmacist or the health-care provider how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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