Download Drug Information Sheet("Kusuri-no-Shiori") Injection Revised: 09

Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 09/2016
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:GRAN INJECTION 75 [for mobilization of hematopoietic
progenitor cells into peripheral blood (allogeneic
hematopoietic progenitor cell transplantation donor)]
Active ingredient:Filgrastim(genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine works for mobilization (release) of hematopoietic progenitor cells from bone marrow to blood.
It is usually used on the doner upon collection of hematopoietic progenitor cells which are required for the treatment
of a patient.
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 previously experienced rash or itch after administrating any other drugs which increase leukocytes.
Patients with the following underlying diseases may cause serious adverse effects (quotation from the guideline of
Japan Society for Hematopoietic Stem Cell Transplantation explanatory material in obtaining consent from
allogeneic peripheral blood stem cell donors):
If you have previously been told that your blood is prone to form blood clot or your blood vessels are prone to clog
(hypertension, cardiac disease, a history of cerebral infarction, diabetes mellitus or hyperlipidemia).
If you have splenomegaly; cardiac disease, lung disease or renal disease which is required to be treated; autoimmune
disease, inflammatory disease, hepatic dysfunction or neurological disorder.
If you are suspected to have bone marrow disease such as leukocytosis and thrombocytosis.
If you have interstitial pneumonia or a history of it.
If you have a history of cancer.
・If you are pregnant, may be 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, this medicine is administered subcutaneously daily, at one time or in two divided doses.
・In general, this medicine is administered for five consecutive days or daily until completion of collection of
peripheral blood progenitor cells, however, duration of administration will be determined by monitoring the effects.
Ask your doctor about the duration of administration.
・You may be administered lower dose of this medicine intradermally to check if there are any unwanted responses.
Precautions while taking this medicine
・This medicine may cause splenic rupture due to its excessive actions. Be aware of change in your blood data and
receive close observation such as receiving abdominal ultrasound examination.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include lumbar pain, headache, arthralgia, fever, bone pain (chest,
lumbar region, pelvis, etc.) and abnormal hepatic function. 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.
・chilliness, palpitation, cold sweat, grow pale [shock, anaphylaxis]
・fever, dry cough, difficult to breathe [interstitial pneumonia]
・hard to breathe, rapid breathing, lips turn blue, nails and toenails turn blue [acute respiratory distress syndrome]
・left upper quadrant pain, abdominal bloating [splenic rupture]
・sudden pressurized feeling in chest, anginal pain, cold sweat, fear of death [myocardial infarction (quotation from
the guideline of Japan Society for Hematopoietic Stem Cell Transplantation "explanatory material in obtaining
consent from allogeneic peripheral blood stem cell donors")]
・headache, feeling unwell, vomiting, decreased consciousness, hemiparesis, difficult to speak [cerebrovascular
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disorder (quotation from the guideline of Japan Society for Hematopoietic Stem Cell Transplantation "explanatory
material in obtaining consent from allogeneic peripheral blood stem cell donors")]
・hypotension, edema, rapid weight increase [capillary leak 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
・You need to be well informed that the data are being accumulated now since the long-term safety of using this
medicine for donors in mobilization of peripheral blood progenitor cells has not been established yet.
・You will be asked to participate in study (blood tests etc.) over the next few years to check long-term effects of
using this medicine.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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