くすりのしおり

Injection
Revised: 8/2021

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 :
DARZQURO Combination Subcutaneous Injection
 Active ingredient:
Daratumumab(genetical recombination)
Vorhyaluronidase alfa(genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine is an combination preparation of human anti-CD38 monoclonal antibody (antineoplastic agent) and hyaluronic acid-degrading enzyme, which is used as a subcutaneous injection. It increases subcutaneous tissue permeability by hydrolyzing hyaluronic acid, and binds to human CD38 to inhibit tumor growth through cytotoxic and cellular phagocytotic activities.
It is usually used to treat multiple myeloma, systemic AL amyloidosis.

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 or have a history of chronic obstructive pulmonary disease or bronchial asthma.
    If you are hepatitis B virus carrier, or negative for HBs antigen and positive for HBc antibody or HBs antibody.
    If you weigh less than 65 kg.
  • 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, in consideration of dose interval of other concomitant anti-malignant tumor medicine, for adults, this medicine is administered by subcutaneous injection under either of the following dosing schedule. This medicine is always used in combination with other anti-malignant tumor medicine.
    -in the order of 1-week cycle, 2-week cycle and 4-week cycle
    -in the order of 1-week cycle, 3-week cycle and 4-week cycle
  • Treatment duration will depend on the efficacy of the medicine after using 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 may occur with this medicine. Symptoms include anaphylaxis, nasal congestion, coughs, chills, bronchial spasm, hypoxia and breathing difficulty. Most of the infusion reactions occur at the first injection however it can occur at the second or later injection. 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 Patient ID Card all the time during treatment and for 6 months after your final dose. If you are ever required to have blood transfusion, you should present your Patient ID Card 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 a certain period after your final dose.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include upper respiratory infection, anemia, diarrhea, fever, fatigue and injection site reaction. 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 congestion, cough, chills, shortness of breath/respiratory distress, nausea, fever, itching, dizziness [infusion reaction]
  • fever, bloody stool/bloody urine, bruise, bleeding tendency [myelosuppression]
  • fever, cough, phlegm, shortness of breath, loss of appetite, general malaise, nausea, vomiting, jaundice [infection]
  • decreased urine output/bloody urine, decreased consciousness, convulsion [tumor lysis syndrome ]
  • fever, dry cough, breathing difficulty, fatigue [interstitial lung 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.

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