くすりのしおり

Injection
Revised: 6/2019

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 :
Romiplate for s.c. injection 250 mcg
 Active ingredient:
Romiplostim(Genetical Recombination)
 Dosage form:
Injection
 Print on wrapping:

Effects of this medicine

This medicine acts on cells that produce platelets and increases or maintains the number of platelets.
It is usually used to treat chronic idiopathic thrombocytopenic purpura, aplastic anemia which conventional treatments showed insufficient results.

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 a history of brain infarction, myocardial infarction and lung infarction.
    If you have renal or hepatic disease.
  • 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, inject this medicine subcutaneously, once a week.
  • This medicine may be used for a long period of time depending on your response to treatment.
  • Before and during use of this medicine, blood tests will be performed regularly to investigate the number and shape of various types of blood cells.

Precautions while taking this medicine

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include headache, malaise, back pain, joint pain, vertigo, nausea, fatigue, musculoskeletal stiffness, pain of the limbs, injection site reaction, muscle spasms, muscle pain. 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.
  • breathing difficulty/chest pain, edema/pain of lower limbs, feeling of suddenly compressed chest [thrombosis/thromboembolism]
  • bone marrow fibrosis, hematopoietic disorder when bone marrow fibrosis becomes severe (general malaise caused by anemia, bleeding tendency)/splenomegaly(fullness, left upper quadrant pain) [increase in bone marrow reticulin]
  • bleeding after withdrawal of this medicine [bleeding]
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

  • Stopping the use of this medicine may result in higher risks of worsening of thrombocytopenia or bleeding compared to those before the use of this medicine. The patient's status will be carefully observed, and attention will be paid to platelet count for at least 4 weeks after discontinuation. Blood tests will thus be performed frequently.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.