长效胰岛素Basaglar(insulin glargine injection)获FDA批准上市
2015年12月16日，美国FDA批准甘精胰岛素注射液Basaglar（insulin glargine injection），这是一款长效人胰岛素类似物，在1型糖尿病成人及儿科患者及2型糖尿病成人患者中用于改善血糖控制。
据美国疾病控制与预防中心称，美国大约有2100万人确诊患有糖尿病。随着时间的推移，糖尿病会增加严重的健康并发症风险，包括心脏病、失明及神经与肾脏损伤。血糖控制的改善可以减少这些长期的并发症。
像甘精胰岛素这样的长效胰岛素产品在1型与2型糖尿病的治疗中占有重要的地位，今天的批准有望为医疗保健专业人员及患者扩展治疗选择的可用性，FDA药物评价与研究中心代谢及内分泌部门主任、医学博士Guettier称。
Basaglar是首个根据联邦食品、药品及化妆品法案，通过简化批准途径而获批的胰岛素产品。在某种程度上来说，提交的Basaglar的505(b)(2)申请基于支持 FDA批准来得时的安全性及有效性结果。
该药物申请者证明Basaglar与来得时非常类似，按科学方法证实其值得信赖，申请者还提供了Basaglar特有的数据，确立了其获批这一适应症的安全性与有效性。Basaglar的特定数据包括两项分别招募了534名与744名1型及2型糖尿病患者的临床试验。
Basaglar的用药剂量需根据个体患者的需求而定。Basaglar以皮下注射使用，每天白天用药一次，但必须在每天的同一时间用药。Basaglar不应在有低血糖发作或对甘精胰岛素或制剂中成分过敏的患者中使用。Basaglar KwikPens绝不能在患者间共用，即使更换了注射针头。患者共用会造成血液病原体传播风险。
在所有以胰岛素产品治疗的患者中，患者或照看者应对血糖进行监控。胰岛素方案调整应谨慎，并且只能根据医学监控进行调整。Basaglar可能导致低血糖，这可能是危及生命的。胰岛素剂量调整、与其它降糖药共用、餐时方案、体育活动及在肾损伤或肝脏损伤或有未觉察低血糖的患者中使用更应密切监控。
使用任何胰岛素可能会发生严重、危及生命的一般性过敏反应，包括过敏症或一般性皮肤反应、血管性水肿、支气管痉挛、低血压及休克。在临床试验中，与 Basaglar相关的最常见副作用有低血糖、过敏反应、注射部位反应、注射部位疤痕、瘙痒、皮疹、水肿及体重增加。
Insulin Glargine;100 international units/mL injection, 5x3mL cartridges;Basaglar®, Basaglar KwikPen®

FDA has approved Basaglar® (insulin glargine injection), a long–acting human insulin analog, as the first follow-on" insulin glargine product to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Dosing of Basaglar should be individualized based on the patient’s needs. Basaglar is administered subcutaneously once daily at any time of day, but at the same time every day. It should not be used during episodes of hypoglycemia or in patients with hypersensitivity to insulin glargine or one of its ingredients.
Basaglar KwikPens must never be shared between patients, even if the needle is changed. Sharing poses a risk for transmission of blood–borne pathogens. Patients or caregivers should monitor blood glucose in all patients treated with insulin products. Insulin regimens should be modified cautiously and only under medical supervision. Basaglar may cause hypoglycemia, which can be life–threatening. Patients should be monitored more closely with changes to insulin dosage, co–administration of other glucose–lowering medications, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness. Severe, life–threatening, generalized allergic reactions, including anaphylaxis, or generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin. The most common adverse reactions associated with Basaglar in clinical trials were hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, itching, rash, edema, and weight gain.
BASAGLAR Rx
Pharmacological Class:
Insulin.

Active Ingredient(s):
Insulin glargine (recombinant) 100Units/mL; for SC inj; contains m-cresol.

Company
Boehringer Ingelheim and Lilly
Indication(s):
Type 1 diabetes (in adults and children) and type 2 diabetes (in adults). Limitations of use: not for treating diabetic ketoacidosis.

Pharmacology:
Insulin and its analog lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. It inhibits lipolysis and proteolysis, and enhances protein synthesis.

Clinical Trials:
The safety and efficacy of another insulin glargine product, 100 Units/mL, given once-daily at bedtime was compared to that of once-daily and twice-daily NPH insulin in open-label, randomized, active-controlled, parallel studies of adults and pediatric patients with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus. In general, the reduction in HbA1c with this other insulin glargine product was similar to that with NPH insulin.

For more clinical trial data, see full labeling.

Legal Classification:
Rx

Contraindication(s):
During episodes of hypoglycemia.

Adults & Children:
Give by SC inj once at same time each day into abdominal, thigh, or deltoid; rotate inj sites. <6yrs: not established. ≥6yrs: individualize. Type 1: initially ⅓ of total daily insulin dose; give remainder of the total dose as short- or rapid-acting, premeal insulin. Type 2: initially 0.2 Units/kg or up to 10 Units/day. May need to adjust amount, timing of short- or rapid-acting insulins, doses of any antidiabetics. Switching from another insulin glargine 100 Units/mL: initial Basaglar dose should be the same as previous insulin glargine 100 Units/mL dose. Switching from once-daily insulin glargine 300 Units/mL: initially 80% of the previous insulin glargine 300 Units/mL dose. Switching from an intermediate- or long-acting insulin regimen (other than insulin glargine 100 Units/mL): may need to change basal insulin dose; and adjust the amount, timing of the short-acting insulins and doses of any antidiabetics. Switching from twice-daily NPH: initially 80% of the previous total NPH dose.

Warnings/Precautions:
Instruct patients on proper administration of insulin, type of insulin, and management of hypoglycemia. Do not reuse or share pens, needles, or syringes between patients. Increased risk of hyperglycemia or hypoglycemia if changes in ­physical activity, meal patterns, renal or hepatic function, insulin regimen and if acute illness occurs: monitor glucose more frequently and may need to adjust dose. Monitor potassium levels in patients at risk for hypokalemia (eg, concomitant K+-lowering or K+-sensitive drugs). Discontinue if hypersensitivity reactions occur. Pregnancy (Category C). Nursing mothers: may need to adjust dose.

Interaction(s)
Do not mix or dilute with other insulins. Potentiated by oral antidiabetic agents, ACE inhibitors, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs, sulfonamide antibiotics. Antagonized by corticosteroids, isoniazid, niacin, danazol, diuretics, phenothiazines, sympathomimetics, somatropin, thyroid hormones, estrogens, glucagon, oral contraceptives, progestogens, atypical antipsychotics, protease inhibitors. Concomitant thiazolidinediones (TZDs) may cause fluid retention and heart failure; consider dose reduction or discontinue TZDs. Variable effects with β-blockers, clonidine, lithium salts, alcohol, pentamidine. Concomitant β-blockers, clonidine, guanethidine, reserpine may mask signs of hypoglycemia.

Adverse Reaction(s)
Hypoglycemia, allergic reactions, inj site reactions, lipodystrophy, pruritus, rash, edema, weight gain; hypokalemia.

How Supplied:
Basaglar KwikPen prefilled pen (3mL)—5

LAST UPDATED:
2/26/2016