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美国FDA近日宣布，批准Talecris Biotherapeutics公司的免疫球蛋白产品Gamunex（immune globulin）用于慢性脱髓鞘性多发性神经炎（CIDP）的治疗。这是一种罕见的自体免疫性疾病，其代表特征是四肢进行性萎缩无力并伴有传导功能受损。
Gamunex为治疗CIDP的罕见病药物。临床研究显示，Gamunex在首次治疗后能显著起效，维持治疗肌肉功能评分较安慰剂组改善显著，随访发现疗效持续。
GAMUNEX
Manufacturer
Talecris Biotherapeutics, Inc.
Legal Classification
Rx
Pharmacological Class
IVIG.
Generic Name
Immune Globulin (human) 1g/10mL, 2.5g/25mL, 5g/50mL, 10g/100mL, 20g/200mL; soln for IV infusion; preservative- and sucrose-free.
Indications
Idiopathic Thrombocytopenic Purpura (ITP).
Adults and Children
Give by IV infusion at a rate of 1mg/kg/min for first 30 minutes, if tolerated may increase to max 8mg/kg/min. 1g/kg once daily given on 2 consecutive days or 0.4g/kg once daily given on 5 consecutive days. If adequate response after first 1g/kg dose may withhold second dose. Risk of renal dysfunction or thrombotic event: infuse at a rate <8mg/kg/min. Expanded fluid volumes: high dose regimen not recommended.
Contraindications
Severe selective IgA deficiency (serum IgA <0.05g/L) with known antibody against IgA.
Precautions
Renal insufficiency, diabetes, >65yrs, volume depletion, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure; monitor urine output, BUN before and during treatment; consider discontinuing if renal dysfunction develops. Correct hypovolemia before starting treatment. Contains human plasma; monitor for possible infection transmission. Monitor for hemolysis. Hyperviscosity (perform baseline assessment of blood viscosity). High dose (2g/kg) and/or rapid infusion may increase risk of aseptic meningitis syndrome. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Pregnancy (Cat.C).
Interactions
Avoid live viral vaccines for ≥6 months. Concomitant nephrotoxic drugs: increased risk of acute renal failure. May contain low levels of anti-Blood Group A and B antibodies of IgG4; direct antiglobin tests may be false-positive.
Adverse Reactions
Headache, ecchymosis, purpura, hemorrhage, epistaxis, petechiae, fever, GI upset, thrombocytopenia, rash, asthenia, pruritus, arthralgia, dizziness, renal dysfunction (may be fatal); rare: hemolytic anemia, aseptic meningitis syndrome, TRALI, thrombosis.
Extra Text
Note: Report all infections suspected to be transmitted by Gamunex to (800) 520-2807.
How Supplied
Vials—1
Additional Resources
• Related Prescribing Note
美国FDA批准Gamunex治疗神经疾病CIDP
美国FDA批准10％辛酸盐/色谱分离纯化人免疫球蛋白静脉注射液[（Immune Globulin Intravenous（Human），Gamunex]用）用于治疗慢性炎性脱髓鞘性多发性神经根神经病（CIDP）。CIDP是退行性神经疾病，可造成肌肉无力和乏力，导致运动技能严重损伤。
本品获准上市成为迄今唯一治疗CIDP的药品、美国迄今首个和唯一治疗神经疾病的免疫球蛋白静脉注射液。Talecris Biotherapeutics公司享有本品7年市场专卖权。
本品是含有数以千计捐血者血浆纯化的抗体免疫球蛋白静脉注射液，适用于替代治疗原发性激素免疫缺乏疾病（PI）、免疫调节治疗特发性血小板减少性紫癜（ITP）和CIDP。 |
