くすりのしおり

Injection
Revised: 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 :
Arzerra for I.V. infusion 100mg
 Active ingredient:
Ofatumumab(genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine lyses tumor cells by inducing cell-damaging action, showing antitumor effect.
It is usually used to treat recurrent/refractory CD20 positive chronic lymphocytic leukemia.

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 hepatitis.
  • 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 this medicine once a week up to the 8th dose, discontinue for 4 to 5 weeks, then inject once every 4 weeks up to the 12th dose.

Precautions while taking this medicine

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include infusion reaction and infectious disease. 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.
  • rash, fever, chill [infusion reaction]
  • pain in the flank, hematuria [tumor lysis syndrome]
  • general malaise, loss of appetite, yellow discoloration of the skin/white of the eyes [liver dysfunction, jaundice, fulminant hepatitis and aggravated hepatitis caused by hepatitis B virus reactivation]
  • malaise, vomiting, lightheadedness [infection]
  • chest pain, palpitation, shortness of breath [heart disorder]
  • dizziness on standing up, dizziness, weakness [decreased blood pressure]
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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