英文药名：SOLIQUA 100/33(insulin glargine and lixisenatide injection)

中文药名：甘精胰岛素和利西拉肽复方注射笔

生产厂家：Sanofi
药品介绍
Soliqua(甘精胰岛素和利西拉肽) – 以前iGlarLixi
为治疗：2型糖尿病
批准日期：2016年11月21日；公司：Sanofi
SOLIQUA™ 100/33(甘精胰岛素[insulin glargine]和利西拉肽[lixisenatide]注射液)，为皮下使用
美国初次批准：2016
作用机制
SOLIQUA 100/33
SOLIQUA 100/33是甘精胰岛素，一个基础胰岛素类似物，和利西拉肽，一个GLP-1受体激动剂的组合。
甘精胰岛素
胰岛素的主要活性，包括甘精胰岛素，葡萄糖代谢的调节。胰岛素及其类似物通过刺激外周葡萄糖摄取减低血糖，尤其是通过骨骼肌和脂肪，和通过抑制肝葡萄糖生成。胰岛素抑制脂解和蛋白水解，和增强蛋白质合成。
利西拉肽
利西拉肽是一个GLP-1受体激动剂增加葡萄糖依赖胰岛素释放，减低胰高血糖素分泌，和减慢胃排空。
适应证和用途
SOLIQUA 100/33是一种长效人胰岛素类似物与一种胰高血糖素-样肽-1(GLP-1)受体激动剂的组合适用为对饮食和运动辅助改善血糖控制在有2型糖尿病成年中用基础胰岛素不适当地控制(低于60单位每天)或利西拉肽。
使用的限制：
● 在原因不明的胰腺炎史患者未曽研究。在胰腺炎史患者中考虑其他抗糖尿病治疗。
● 建议不与任何含利西拉肽或另一个GLP-1受体激动剂其他产品联用。
● 不为1型糖尿病或糖尿病酮症酸中毒的治疗。.
● 建议不为有胃轻瘫患者的使用。
● 尚未研究与餐前胰岛素[prandial insulin]联合。
剂量和给药方法
● SOLIQUA 100/33的开始前终止用利西拉肽或基础胰岛素。
● 在用基础胰岛素低于30单位或用利西拉肽不适当地控制患者，起始剂量是15单位(15单位甘精胰岛素/5 µg利西拉肽)给予皮下每天1次.
● 在用基础胰岛素的30至60单位不适当地控制患者中，起始剂量是30单位(30单位甘精胰岛素/10 µg利西拉肽)给予皮下每天1次。
● 注射一天1次在当天首次餐前小时内。
● 最大每天剂量是60单位(甘精胰岛素的60单位和利西拉肽20µg)。
● SOLIQUA 100/33笔输送剂量从15至60单位与每次注射。
● 用另外抗糖尿病产品如患者需要一个SOLIQUA 100/33每天剂量低于15单位或超过60单位。
● 见完整处方资料对滴定调整建议。
● 在大腿，上臂，或腹部皮下注射。
● 不要静脉地，肌肉内地，或通过一个输注泵给药。
● 不要与任何其他胰岛素产品或溶液稀释或混合。
剂型和规格
注射液：100单位甘精胰岛素每mL和33 µg利西拉肽每mL在一个3mL单个-患者使用笔。
禁忌证
● 低血糖的发作期间。
● 超敏性对SOLIQUA 100/33或活性药物物质(甘精胰岛素或利西拉肽)，或其任何赋形剂。用利西拉肽和甘精胰岛素两者曽发生超敏性反应包括过敏反应。
● 过敏反应和严重超敏性反应：用SOLIQUA 100/33中任一组分可能发生。指导患者终止如一个反应发生和及时寻求医学关注。
● 胰腺炎：及时地终止如怀疑胰腺炎。如胰腺炎被确证不要再开始。
● 患者间永不共享一个SOLIQUA 100/33预装笔，即使针头被更换。
● 高血糖或低血糖与在SOLIQUA 100/33方案中变化：在严密医学监督下进行。
● 由于药物错误而过量：SOLIQUA 100/33含两种药物。指导患者在每次注射前总是核对标签因为可能发生与含胰岛素产品意外混合。不要超过最大剂量或与其他GLP-1受体激动剂使用。
● 低血糖：可能是危及生命。葡萄糖监视增加频数随变化：胰岛素剂量，共同给药的葡萄糖降低药物，餐模式，身体活动；和in患者有肾或肝受损和不知道低血糖。
● 急性肾损伤：在有肾受损和in患者有严重GI不良反应患者中监视肾功能。在有肾病终末期患者中建议不使用。
● 免疫原性：患者可能发生对甘精胰岛素和利西拉肽抗体。如有血糖控制恶化或对实现目标血糖控制失败，显著注射部位反应或过敏反应，应考虑另外抗糖尿病治疗。
● 低钾血症：可能是危及生命。在处于低钾血症风险患者监视钾水平和如适应治疗。
● 液体潴留和心衰与噻唑烷二酮类(TZDs)的使用：观察心衰的体征和症状;如心衰发生考虑剂量减低或终止。
● 大血管结局：用SOLIQUA 100/33临床研究未显示大血管风险减低。
不良反应
用SOLIQUA 100/33常伴随不良反应包括低血糖，过敏反应，恶心，鼻咽炎，腹泻，上呼吸道感染，头痛。
药物相互作用
● 影响葡萄糖代谢药物：可能需要SOLIQUA 100/33剂量的调整；严密监视血糖(7.1)
● 抗肾上腺素能药物(如，β-阻断剂，可乐定，胍乙啶[guanethidine],和利血平[reserpine])：低血糖体征和症状可能减低。
● 延迟胃排空对口服药物的影响：利西拉肽延迟胃排空可能影响同时给予口服药物的吸收。口服避孕药和其他药物例如抗菌素和对乙酰氨基酚[acetaminophen]应在SOLIQUA 100/33前至少1小时前或11小时后给药。
特殊人群中使用
● 妊娠：妊娠期间仅如潜在的获益胜过对胎儿潜在风险时才应使用SOLIQUA 100/33。
供应/贮存和处置
如何供应
SOLIQUA 100/33是一种注射以一个无菌，清澈，无色至几乎无色溶液在一个3mL预装，可遗弃的，单个-患者使用笔注射器供应。

不包括针头。仅使用与SOLIQUA 100/33预装笔匹配针头。
贮存
首次使用前，SOLIQUA 100/33笔应在冰箱贮存，36°F-46°F(2°C-8°C)。不要冻结。避光保护。在超出标签有效期后遗弃。
SOLIQUA 100/33不应贮存在冻结器和不应允许被冻结。如它已被冻结遗弃SOLIQUA 100/33。
使用后，贮存在室温低于86°F(30°C)，每次使用后放上笔帽避光。.
首次使用后14天遗弃笔14。
在每次注射后总是移去针和在不附着针贮存SOLIQUA 100/33笔。这防止污染和/或感染，或SOLIQUA 100/33笔的渗漏，和将确保准确给药。对每次注射总是使用新针头以预防污染。

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Lantus Solostar Pen is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

Lantus Solostar Pen is used to improve blood sugar control in adults and children with diabetes mellitus. This medicine is used to treat type 1 or type 2 diabetes in adults, and type 1 diabetes children who are at least 6 years old.

Some brands of this medicine are for use only in adults. Carefully follow all instructions for the brand of Lantus Solostar Pen you are using.

Lantus Solostar Pen may also be used for purposes not listed in this medication guide.

Never share an injection pen or syringe with another person, even if the needle has been changed.

You should not use this medicine if you are allergic to insulin, or if you are having an episode of hypoglycemia(low blood sugar).

Lantus Solostar Pen is not approved for use by anyone younger than 6 years old, and should not be used to treat type 2 diabetes in a child of any age.

To make sure Lantus Solostar Pen is safe for you, tell your doctor if you have:

·         liver or kidney disease;

·         low levels of potassium in your blood (hypokalemia); or

·         diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Follow your doctor's instructions about using insulin if you are pregnant or breast-feeding a baby.Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

The Toujeo brand of Lantus Solostar Pen contains 3 times as much insulin per milliliter (mL) as the Lantus or Basaglar brands. There are 300 units of insulin in 1 mL of Toujeo, and 100 units in 1 mL of Lantus or Basaglar.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change.

Insulin is injected under the skin. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Lantus Solostar Pen must not be given with an insulin pump, or mixed with other insulins. Do not inject this medicine into a vein or a muscle.

Lantus Solostar Pen is usually injected once per day at the same time each day. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Your care provider will show you the best places on your body to inject Lantus Solostar Pen. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

If you use an injection pen, use only the injection pen that comes with Lantus Solostar Pen. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen or syringe with another person, even if the needle has been changed.Sharing these devices can allow infections or disease to pass from one person to another.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your insulin dose or schedule.

Lantus Solostar Pen is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Basaglar or Lantus:

·         Refrigerate and use until expiration date; or

·         Store at room temperature and use within 28 days.

Storing unopened (not in use) Toujeo:

·         Refrigerate and use until expiration date.

Storing opened (in use) Basaglar or Lantus:

·         Store the vial in a refrigerator or at room temperature and use within 28 days.

·         Store the injection pen at room temperature (do not refrigerate) and use within 28 days.

Storing opened (in use) Toujeo:

·         Store the injection pen at room temperature (do not refrigerate) and use within 42 days.

Do not store an injection pen with the needle attached.

Do not use the medicine if it looks cloudy, has changed colors, or has any particles in it. Call your pharmacist for new medicine.

Wear a diabetes medical alert tag in case of emergency. Any medical care provider who treats you should know that you have diabetes.

Call your doctor for instructions if you miss a dose of Lantus Solostar Pen. You should not use more than one dose in a 24-hour period unless your doctor tells you to.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

·         fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or

·         low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

·         low blood sugar;

·         itching, mild skin rash; or

·         thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.