2021年3月12日，协和麒麟株式会社宣布，G-CSF（粒细胞-克隆刺激因子）G-Lasta®[pegfilgrastim（基因重组）]的持续时间形式的核准适应症，用于动员造血干细胞进入外周血3月11日在日本进行同种异体造血干细胞移植（适应症）。
本申请基于Kyowa Kirin进行的临床试验结果，该试验旨在评估G-Lasta对健康志愿者外周血造血干细胞动员的影响。临床试验结果将在欧洲血液和骨髓移植组织（EBMT）第47届年会上公布，该年会将于3月14日至17日（中欧时间）在线举行。
G-Lasta是一种长效G-CSF制剂，由麒麟Amgen*2授权，自2014年起在日本上市，用于降低接受癌症化疗患者的发热性中性粒细胞减少症的发病率。
“尽管异基因外周血干细胞移植是一种供体负担相对较低的移植方法，但使用G-CSF产品将造血干细胞动员到外周血中需要几天的药物治疗、医院就诊和住院治疗，”Kyowa Kirin战略产品规划部主任执行官Tomohiro Sudo说道。“通过在G-Lasta（G-CSF产品的一种持续时间形式）中添加适应症，我们希望能够减轻造血干细胞移植中捐献者的负担。”
完整资料附件：https://www.info.pmda.go.jp/go/pack/3399410G1020_1_06/
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G-LASTA Subcutaneous Injection 3.6mg（Pegfilgrastim[Genetical recombination]）
Brand name :G-LASTA Subcutaneous Injection 3.6mg
Active ingredient:Pegfilgrastim(Genetical recombination)
Dosage form:
injection
Print on wrapping:
Effects of this medicine
This medicine increases leukocytes (neutrophils) which play an important role for protection against infection.
It is usually used to treat leukopenia (neutropenia) attributed to anticancer agents.
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 medicines which increases leukocytes (neutrophils).
If you have myeloid leukemia(including myelodysplastic syndrome)with insufficient decrease of leukemic cells in the bone marrow or presence of leukemic cells in the blood.
If you have been administered an anticancer agent within 24 hours.
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, this medicine is administered subcutaneously once per chemotherapy course, on or after the next day of treatment completion with anticancer agent.
Duration of administration will be determined by monitoring the effects. Ask your doctor about the duration of administration.
Precautions while taking this medicine
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include back pain, fever, arthralgia, malaise, headache, muscle pain and rash. 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 lung disease]
hard to breathe, rapid breathing, lips turn blue, nails and toenails turn blue [acute respiratory distress syndrome]
shortness of breath, fever, general malaise, easy to bleed, dizziness[increase of blasts]
left upper quadrant pain, shoulder pain, abdominal bloating [splenomegaly, splenic rupture]
hypotension, edema, rapid weight increase[capillary leak syndrome]
fever, raised red rash with pain[Sweet's syndrome]
fever, bruise, blood blister[cutaneous vasculitis]
fever, general malaise, headache, dizziness[large vessel vasculitis(inflammation of aorta, common carotid artery, subclavian artery, etc)]
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.
Injection
Revised: 6/2018
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. |
