くすりのしおり

Injection
Published: 11/2017

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 :
DARZALEX Intravenous Infusion 100 mg
 Active ingredient:
Daratumumab(genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine is an antineoplastic injection that works as a human monoclonal antibody against CD38 antigen and is administered by infusion. It binds to CD38 and inhibits tumor growth through cytotoxic and cellular phagocytotic activities.
It is usually used to treat recurrent or 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 have chronic obstructive pulmonary disease or bronchial asthma, or a history of those.
  • 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, this medicine is administered into your vein intravenously by infusion under the following dosing schedule.
    In combination with lenalidomide and dexamethasone:
    1-week cycle (Week 1 to 8), 2-week cycle (Week 9 to 24) and 4-week cycle (Week 25 onwards)
    In combination with bortezomib and dexamethasone:
    1-week cycle (Week 1 to 9), 3-week cycle (Week 10 to 24) and 4-week cycle (Week 25 onwards)
  • Treatment duration will depend on the efficacy of the medicine after injecting it for a certain period.
  • You may be administered corticosteroids, antipyretics and antihistamines before and after each dose of this medicine to reduce the risk of infusion reactions.

Precautions while taking this medicine

  • Infusion reactions can occur with this medicine. Symptoms include anaphylaxis, nasal obstruction, coughs, chills, bronchial spasm, hypoxia and respiratory distress. Most of the infusion reactions occur at the first infusion however it can occur at the second or later infusion. If you become aware of any change in your physical condition, contact your doctor immediately.
  • Symptoms of myelosuppression such as neutropenia, thrombocytopenia, lymphopenia and febrile neutropenia may occur with this medicine. You may be instructed to have regular blood tests by your doctor.
  • You should carry your ID all the time during treatment and for 6 months after your final dose. If you ever required to have blood transfusion, you should present your ID to the doctor or other health care professionals.
  • If you or your partner has possibility to become pregnant, you should use an effective method of birth control during treatment or for certain period after your final dose.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include infusion reactions, upper respiratory infection, fatigue, coughs and respiratory distress. 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.
  • anaphylaxis, nasal obstruction, coughs, chills, shortness of breath/breathing difficulty, nausea, fever, itchiness, dizziness [infusion reactions]
  • fever, bloody stool/hematuria, bruise, bleeding tendency  [myelosuppression]
  • fever, chills, sweating, coughs/sore throat, diarrhea, pain in the body [infection]
  • decreased urine output/hematuria, fainting, convulsion [tumor lysis syndrome ]
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.

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