くすりのしおり

Injection
Published: 11/2016

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 :
EMPLICITI for I.V. INFUSION 400mg
 Active ingredient:
Elotuzumab
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medical agent is for patients with multiple myeloma, hematopoietic tumor, and belongs to the class of monoclonal antibody-medicine, humanized IgG1 monoclonal antibody. This agent is intravenously administrated by infusion, and targets specifically SLAMF7. SLAMF7 is expressed on myeloma and natural killer cell, and the pharmacological activity is caused by binding to the SLAMF7. This medical agent is approved for the patients with relapse/refractory multiple myeloma.

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 are pregnant, possibly pregnant or lactating.
  • 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))
  • It is used with lenalidomide and dexamethasone. In general, for adults, administer by intravenous infusion.
  • Each treatment cycle is 28 days. For Cycles 1 and 2, administer 4 times at an interval of every 1 week (Days 1, 8, 15, and 22). For Cycles 3 and up, administer twice at an interval of every 2 weeks (Days 1 and 15).
  • Consult with the doctor for the treatment duration.

Precautions while taking this medicine

  • Infusion reactions such as fever, chills, and hypertension may occur. Infusion reactions are reported frequently at the first injection, however, they may occur at the second injection or thereafter. If you notice any abnormality, consult with your doctor immediately.
  • Since lymphopenia may occur, periodic blood test should be performed.
  • If you or your partner have a possibility of pregnancy, avoid pregnancy while you are taking this medicine and for a certain period after you discontinue this medicine. This medicine is used in combination with lenalidomide and dexamethasone.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include fatigue, diarrhea, muscle spasm, insomnia, anemia, constipation, peripheral edema, fever, nausea and asthenia. 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, itch, increase in sweating, pimple, chills, diarrhea [infusion reaction]
  • cold-like symptom, dullness, fever, vomiting [infection]
  • fever, sore throat [lymphopenia]
  • fever, dry cough, breathing difficulty, shortness of breath [interstitial pulmonary disease]
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.