くすりのしおり

Self-injection
Revised: 9/2018

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 :
TALTZ Subcutaneous Injection 80 mg syringe
 Active ingredient:
Ixekizumab (genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine inhibits interleukin(IL)-17A, which is one of the causes of inflammatory response that plays a role in the development of psoriasis, and psoriatic arthritis.
It is usually used to treat plaque psoriasis, psoriatic arthritis, pustular psoriasis and erythrodermic psoriasis with inadequate response to conventional therapies.

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/suspected of infections.
  • If you have active tuberculosis or a history of tuberculosis.
  • If you have inflammatory bowel disease (Crohn's Disease or ulcerative colitis).
  • If you are scheduled for vaccination with a live vaccine.
  • If you are 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, inject 2 syringes (160 mg of the active ingredient) subcutaneously at the first time, followed by one syringe(80 mg) every 2 weeks for 12 weeks. After 12 weeks, inject one syringe (80 mg) every 4 weeks. Strictly follow the injection instructions.
  • If the effect is insufficient at week 12 of treatment, injection may be continued every 2 weeks. If an effect of treatment is observed with every 2 weeks injection after 12 weeks, the frequency of injection may be changed to every 4 weeks.
  • After start of the treatment, self-injection is allowed when your doctor confirms that you are able to self-inject.
  • Depending on your response to the treatment, whether or not the treatment will continue is to be determined.
  • Inject the whole content of the syringe at once.
  • Allow this medicine to reach room temperature before use.
  • Do not inject into areas where the skin is sensitive, painful, bruised, red, or hard or where the patient have scars or stretch marks or psoriasis. Do not inject within 3 cm of the navel.
  • Inject this medicine into the thighs, abdomen, or outer upper arms. Change the injection site every time.
  • Do not rub the injected site after giving the injection.
  • If you missed an injection, or were unable to inject on the scheduled date, consult with your doctor. You should never inject two doses at one time.
  • If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop injecting this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Preventing from any infections such as common cold or influenza, washing hands and gargling is important to keep your health condition better.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include injection site reaction (erythema, pain etc.), nasopharyngitis, and upper respiratory tract infection. 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.
  • fever, cold-like symptoms, general malaise [serious infections]
  • fever, hives, swelling around the lips, breathing difficulty [serious hypersensitivity reaction]
  • fever, sore throat [neutropenia]
  • abdominal pain, chronic diarrhea, feces with mucus or blood [inflammatory bowel disease (Crohn's disease, ulcerative colitis) ]
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

  • Keep out of the reach of children. Store at 2 to 8 degrees Celsius and avoid light and freezing.
  • Discard the remainder. Do not store them. Ask the pharmacist and the medical institution how to discard them.
  • This medicine has immuno-suppressive effect, avoid receiving live vaccines during the treatment.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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