Meitheal Pharmaceuticals Announces Launch of Heparin Sodium Injection, USP in the United States

Meitheal Pharma在美国推出肝素钠注射液

2019-09-16 19:30:02 BioSpace


“We are pleased to be able to provide a vital anticoagulant for patients across the country,” said Tom Shea, founding Chief Executive Officer of Meitheal Pharmaceuticals. “With increasing challenges in manufacturing and supply concerns in the global heparin market, our launch will help provide additional product for patients from a safe and dependable source. We take pride in offering a vertically integrated heparin portfolio in the US, and our operations are optimized to ensure dedicated manufacturing of heparin and consistent supply of the finished product to the US market.” Meitheal’s partner, Nanjing King-Friend Biochemical Pharmaceutical Company (NKF) is an FDA-approved manufacturer of both active pharmaceutical ingredients (API) and finished dosage form (FDF), supplying 15-20% of the finished dosage heparin market in the US. Meitheal is NKF’s exclusive commercialization arm for the US market, ensuring consistent and dedicated supply of heparin. Meitheal primarily specializes in the development, manufacture, procurement, and sale of generic injectable pharmaceuticals, with 12 FDA-approved products covering indications for anti-infective, oncolytic and intensive care. Furthermore, Meitheal has an expanding product portfolio and robust pipeline, including single and multi-dose vials, ready-to-use prefilled syringes and premixed bags. As of the end of June 2019, Meitheal, directly or in combination with its partner(s), had 49 products in the research and development phase, 24 products under review by the FDA, and 8 products to be launched in 2019. Heparin is an intravenous or subcutaneous anticoagulant derived from porcine intestinal mucosa used to decrease the clotting ability of blood and help prevent harmful clots from forming in blood vessels. It is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism. Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease. Atrial fibrillation with embolization. Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation). Prevention of clotting in arterial and cardiac surgery. Prophylaxis and treatment of peripheral arterial embolism. Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures. IMPORTANT SAFETY INFORMATION Heparin Sodium Injection, USP is contraindicated in patients with history of Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT), known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions), those whom suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals, and patients with uncontrolled active bleeding state, except when this is due to disseminated intravascular coagulation. Fatal Medication Errors: Do not use Heparin Sodium Injection as a “catheter lock flush” product. Heparin Sodium Injection is supplied in vials containing various strengths of heparin, including vials that contain a highly concentrated solution of 10,000 units in 1 mL. Fatal hemorrhages have occurred in pediatric patients due to medication errors in which 1 mL Heparin Sodium Injection vials were confused with 1 mL “catheter lock flush” vials. Carefully examine all Heparin Sodium Injection vials to confirm the correct vial choice prior to administration of the drug. Hemorrhage: Avoid using heparin in the presence of major bleeding, except when the benefits of heparin therapy outweigh the potential risks. Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis: Heparin-induced thrombocytopenia (HIT) is a serious antibody-mediated reaction. HIT occurs in patients treated with heparin and is due to the development of antibodies to a platelet Factor 4-heparin complex that induce in vivo platelet aggregation. HIT may progress to the development of venous and arterial thromboses, a condition referred to as heparin-induced thrombocytopenia with thrombosis (HITT). Thrombocytopenia: Thrombocytopenia in patients receiving heparin has been reported at frequencies up to 30%. It can occur 2 to 20 days (average 5 to 9) following the onset of heparin therapy. Obtain platelet counts before and periodically during heparin therapy. Monitor thrombocytopenia of any degree closely. If the count falls below 100,000/mm3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT and HITT, and, if necessary, administer an alternative anticoagulant. Coagulation Testing and Monitoring: When using a full dose heparin regimen, adjust the heparin dose based on frequent blood coagulation tests. If the coagulation test is unduly prolonged or if hemorrhage occurs, discontinue heparin promptly [see Overdosage (10)]. Periodic platelet counts and hematocrits are recommended during the entire course of heparin therapy, regardless of the route of administration. Heparin Resistance: Resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer, in postsurgical patients, and patients with antithrombin III deficiency. Close monitoring of coagulation tests is recommended in these cases. Adjustment of heparin doses based on anti-Factor Xa levels may be warranted. Hypersensitivity Reactions: Patients with documented hypersensitivity to heparin should be given the drug only in clearly life- threatening situations. Because Heparin Sodium Injection is derived from animal tissue, it should be used with caution in patients with a history of allergy. Benzyl Alcohol Toxicity: Use preservative-free heparin sodium in neonates and infants. The preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients. The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth weight infants may be more likely to develop toxicity. Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITT, hypersensitivity reactions, and elevations of aminotransferase levels. For additional information, please see full Prescribing Information. ABOUT MEITHEAL PHARMACEUTICALS Since 2017, Meitheal Pharmaceuticals has bridged critical gaps in the US healthcare market by supplying high quality, affordable generic injectables. Our diversified product range — from antibiotics, anticoagulants, and muscle relaxants to drugs used in chemotherapy — represents practical solutions for countless patients around the country, as well as Meitheal’s commitment to their care. Based in Chicago, Illinois, our aim each day is producing quality and ensuring affordability, using the traditional Irish guiding principle we are named for — Meitheal (Mee·hall): working together toward a common goal, for the greater good.
“我们很高兴能够为全国各地的患者提供一种至关重要的抗凝剂,”美泰制药(Meitheal Pharmaceuticals)创始首席执行官汤姆•谢(Tom Shea)说。“随着全球肝素市场在制造和供应方面面临越来越多的挑战,我们的推出将有助于从安全可靠的来源为患者提供额外的产品。我们为在美国提供垂直整合的肝素产品组合而感到自豪,我们的运营也得到了优化,以确保专门生产肝素,并向美国市场持续供应成品。” 美泰的合作伙伴南京金友生化制药有限公司(NKF)是FDA批准的活性药物成分(API)和成品剂型(FDF)制造商,供应美国成品剂量肝素市场的15-20%。美泰是NKF在美国市场的独家商业化部门,确保肝素的持续和专用供应。 美泰主要从事非专利注射剂药物的开发、制造、采购和销售,拥有12种FDA批准的产品,涵盖抗感染、溶瘤和重症监护的适应症。此外,美泰具有不断扩大的产品组合和强大的管道,包括单剂量和多剂量小瓶,即用预充注射器和预混袋。截至2019年6月底,美的塔尔直接或与合作伙伴合作,共有49种产品处于研发阶段,24种产品正在接受FDA审查,8种产品将于2019年推出。 肝素是一种从猪肠粘膜中提取的静脉或皮下抗凝剂,用于降低血液的凝血能力,帮助防止有害的血栓在血管中形成。用于: 静脉血栓和肺栓塞的预防和治疗。 预防腹部胸廓大手术患者术后深静脉血栓形成和肺栓塞,或因其他原因有发生血栓栓塞疾病风险的患者。 心房颤动伴栓塞。 急性和慢性消耗性凝血病(弥散性血管内凝血)的治疗。 预防动脉和心脏手术中的凝血。 外周动脉栓塞的防治。 在输血、体外循环和透析过程中用作抗凝剂。 重要安全信息 肝素钠注射液,USP禁止用于有肝素诱导的血小板减少(HIT)和肝素诱导的血小板减少和血栓形成(HITT)病史,已知对肝素或猪肉制品过敏(如过敏性反应),适合凝血治疗的患者。EST,如全血凝血时间、部分凝血活酶时间等,不能在适当的时间间隔内进行,并且患者处于不受控制的活动性出血状态,除非这是由于弥散性血管内凝血所致。 致命的药物错误:不要使用肝素钠注射液作为“导管锁定冲洗”产品。肝素钠注射液是以含有不同强度肝素的小瓶供应的,包括含有10000单位/1毫升高浓度溶液的小瓶。由于药物错误,1毫升肝素钠注射液小瓶会导致小儿致命性出血。e与1毫升“导管锁定冲洗”小瓶混淆。在给药之前,仔细检查所有肝素钠注射液小瓶,以确定正确的小瓶选择。 出血:避免在大出血的情况下使用肝素,除非肝素治疗的益处大于潜在风险。 肝素诱导的血小板减少和肝素诱导的血小板减少和血栓形成:肝素诱导的血小板减少(hit)是一种严重的抗体介导的反应。hit发生在接受肝素治疗的患者身上,是由于血小板因子4肝素复合物的抗体的发展引起体内血小板聚集。hit可能发展为静脉和动脉血栓形成,这种情况被称为肝素诱导的血小板减少伴血栓形成(hitt)。 血小板减少症:据报道接受肝素治疗的患者血小板减少症的发生率高达30%。在肝素治疗开始后2-20天(平均5-9天)发生。在肝素治疗之前和期间定期获取血小板计数。密切监测任何程度的血小板减少。如果计数低于100000/mm3或出现复发性血栓形成,立即停止使用肝素,评估HIT和HITT,如有必要,使用替代抗凝剂。 凝血检测与监测:使用全剂量肝素方案时,应根据频繁的凝血试验调整肝素剂量。如果凝血试验过度延长或出现出血,应立即停止使用肝素[见过量使用(10)]。在整个肝素治疗过程中,无论给药途径如何,都推荐定期血小板计数和红细胞压积。 肝素抵抗:在发热、血栓形成、血栓性静脉炎、有血栓形成倾向的感染、心肌梗死、癌症、术后患者和抗凝血酶iii缺乏症患者中,肝素抵抗经常出现。在这些情况下,建议密切监测凝血试验。可能需要根据抗因子xa水平调整肝素剂量。 过敏反应:有记录的对肝素过敏的患者只能在明显危及生命的情况下服用该药。由于肝素钠注射液来源于动物组织,有过敏史的患者应谨慎使用。 苯甲醇毒性:新生儿和婴儿使用无防腐剂肝素钠。防腐剂苯甲醇与儿科患者的严重不良事件和死亡有关。可能发生毒性的最小苯甲醇量尚不清楚。早产儿和低出生体重儿可能更容易产生毒性。 最常见的不良反应是出血、血小板减少、HIT和HITT、过敏反应和转氨酶水平升高。 有关更多信息,请参阅完整的处方信息。 关于美泰制药 自2017年以来,美泰制药通过提供高质量、价格合理的非专利注射剂,填补了美国医疗保健市场的关键空白。我们多样化的产品系列-从抗生素、抗凝剂、肌肉松弛剂到用于化疗的药物-代表了全国无数患者的实际解决方案,以及美泰对他们护理的承诺。总部位于伊利诺伊州芝加哥市,我们每天的目标是生产高质量的产品并确保价格合理,采用我们以之命名的传统爱尔兰指导原则——Meitheal(Mee·Hall):为共同的目标,为更大的利益而共同努力。