くすりのしおり

Injection
Published: 11/2018

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 :
GAZYVA for I.V. Infusion 1000mg
 Active ingredient:
Obinutuzumab(genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine binds to CD20, a protein found only on the surfaces of malignant B lymphocytes and normal B lymphocytes at the specific maturation stage. Thereafter, it inhibits proliferation of cancer cells by cellular cytotoxic and phagocytic activities.
It is usually used to treat CD20 positive follicular lymphoma.

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 bacterial/viral infection or myelosuppression.
    If you have hepatitis or have a history of it.
    If you cardiac/pulmonary dysfunctions of have a history of them.
    If you have previously been told that you have a large tumor mass.
  • 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, administer by intravenous infusion once a day on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycle 2 and subsequent cycles as induction therapy. As maintenance therapy after induction therapy, administer by intravenous infusion once every 2 months for up to 2 years.
  • The treatment frequency may vary by other concomitant medication.

Precautions while taking this medicine

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include infusion reaction, nausea, infection, fatigue and fever. 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, see your doctor immediately.
  • respiratory distress, consciousness disorder, swelling of eyelids/lips/tongue, fever, chills, vomiting, cough, dizziness, palpitation [infusion reaction]
  • decreased consciousness, impaired mind, impaired judgement, decreased urine output, breathing difficulty, shortness of breath [tumor lysis syndrome]
  • fever, sore throat [decreased neutrophils, decreased leukocytes]
  • nose bleeding, gum bleeding, bruise, subcutaneous bleeding, prolonged bleeding [decreased platelets]
  • cold-like symptom, dullness, fever, vomiting [infection]
  • dullness, fever, decreased consciousness, impaired mind, headache, yellowing of the white of eyes, nausea, vomiting, loss of appetite, flapping tremor, yellowing of skin, dark urine, impaired judgement, loss of consciousness [fulminant hepatitis and aggravated hepatitis caused by hepatitis B virus]
  • loss of consciousness, slurred speech, memory loss, paralysis of limbs, impaired mind, focus disorder [progressive multifocal leukoencephalopathy (PML)]
  • dizziness, palpitation, chest pain, syncope, palpitation after exercise, cold sweat, chest tightness, feeling of pressure on chest, anginal pain, breathing difficulty, dullness, generalized edema, easier breathing in upright position than when lying down, shortness of breath [cardiac disorder]
  • nausea, vomiting, severe abdominal pain [perforation of the digestive tract]
  • fever, dry cough, breathing difficulty, shortness of breath [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

  • Periodic blood tests will be performed during taking this medicine, since the medicine may cause blood disorder (decreased neutrophils/leukocytes/platelets, etc.).
  • Consult with your doctor or pharmacist when you receive a vaccination.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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