碧康替西帕肽tirzepatide替尔泊肽tirza说明书

Tirza(Tirzepatide) Injection-Beacon 替西帕肽/替尔帕肽最新型“一针瘦”减肥产品/胜过司美格鲁肽Semaglutide
Tirza(Tirzepatide) Injection-Beacon 替西帕肽/替尔帕肽可作为饮食和运动的辅助药物，以改善 2 型糖尿病成人患者的血糖控制。最新型“一针瘦”减肥产品，胜过司美格鲁肽Semaglutide。

适应症：
Tirza 可作为饮食和运动的辅助药物，以改善 2 型糖尿病成人患者的血糖控制。
使用限制：
1、尚未在有胰腺炎病史的患者中进行研究。
2、不适用于 1 型糖尿病患者。

药理：
Tirzepatide 是一种 GIP 受体和 GLP-1 受体激动剂。 它是一种 39 个氨基酸修饰的肽，具有 C20 脂肪二酸部分，能够与白蛋白结合并延长半衰期。 它选择性地结合并激活 GIP 和 GLP-1 受体，即天然 GIP 和 GLP-1 的靶标。 它以葡萄糖依赖性方式增强第一相和第二相胰岛素分泌并降低胰高血糖素水平

剂量与给药：
给药途径：替西帕肽应以皮下注射的方式给药。
剂量说明-
推荐起始剂量为2.5 mg，每周皮下注射一次。 2.5 mg 剂量用于开始治疗，并非用于控制血糖。
4周后，将剂量增加至5毫克，每周一次。 如果需要额外的血糖控制，请在当前剂量至少 4 周后以 2.5 mg 增量增加剂量。 最大剂量为每周一次皮下注射 15 mg。“如果漏服一剂，指导患者在漏服后 4 天内（96 小时）尽快补服。如果超过 4 天，则跳过漏服，并在定期安排的日期补服下一剂 在每种情况下，患者都可以恢复每周一次的常规给药方案。
如有必要，每周给药的日期可以更改，只要两次给药之间的时间间隔至少为 3 天（72 小时）。
准备和给药-
预充式注射器的针头套含有干燥的天然橡胶（乳胶的衍生物），可能会引起过敏反应。不要冻结。 不要使用已冷冻的替泽帕肽。
.保护预充式注射器避光。
.注射用药物产品在给药前应目视检查颗粒物和变色情况。 请勿使用任何出现颗粒物和变色的预充式注射器。
小心处理。如果预充式注射器掉落在坚硬的表面上，请勿使用。
不要稀释替西帕肽，也不要与其他药物溶液一起给药。
使用说明-
每周一次，一天中的任何时间，随餐或空腹服用。
“ 在腹部、大腿或上臂皮下注射。每次剂量轮换注射部位。与胰岛素一起使用时，分开注射，切勿混合注射。可以在同一身体部位注射替泽帕肽和胰岛素，但注射剂不能同时注射。 不应彼此相邻。

相互作用：
药物相互作用：考虑减少同时服用的胰岛素促分泌剂（例如磺酰脲类）或胰岛素的剂量，以降低低血糖的风险。
Tirza 会延迟胃排空，从而有可能影响同时服用的口服药物的吸收。 根据疗效阈值浓度监测服用口服药物的患者以及同时服用治疗指数较窄的患者（例如华法林）。建议使用口服激素避孕药的患者在开始使用后 4 周以及每次剂量递增后 4 周内改用非口服避孕方法或添加屏障避孕方法。非口服的激素避孕药不应受到影响。

禁忌症：
已知对替泽帕肽或本产品任何其他成分过敏的患者禁用替泽帕肽。有甲状腺髓样癌 (MTC) 个人史或家族史的患者或多发性内分泌肿瘤综合征 2 型 (MEN 2) 患者也禁用。

副作用：
最常见的副作用是恶心、腹泻、食欲下降、呕吐、便秘、消化不良和腹痛。

怀孕及哺乳期：
妊娠期糖尿病控制不良会给母亲和胎儿带来风险。 仅当潜在益处证明对胎儿存在潜在风险时，才应在怀孕期间使用替泽帕肽。 应考虑母乳喂养的发育和健康益处以及母亲对替泽帕肽的临床需求以及替泽帕肽或潜在母亲状况对母乳喂养婴儿的任何潜在不利影响。

注意事项和警告：
向患者提供关于使用 Tirza 的 MTC 潜在风险的咨询，并告知他们甲状腺肿瘤的症状。开始后，仔细观察患者是否有胰腺炎的体征和症状。 如果怀疑胰腺炎，请停用 Tirza 并开始适当的治疗。 低血糖的风险可以通过减少磺酰脲（或其他同时施用的胰岛素促分泌剂）或胰岛素的剂量来降低。 如果发生过敏反应，请停止使用 Tirza； 按照护理标准及时治疗并监测，直至体征和症状消失。 对报告有严重胃肠道不良反应的肾功能不全患者开始或增加剂量时应监测肾功能。 有糖尿病视网膜病变病史的患者应监测糖尿病视网膜病变的进展情况。 如果怀疑胆石症，胆囊诊断研究和表明了适当的临床随访。

特殊人群的使用：
儿童和青少年使用：尚未确定 Tirza 在 18 岁以下患者中的安全性和有效性。

过量效应：
应根据患者的临床体征和症状开始适当的支持治疗。 考虑到 Tirza 的半衰期约为 5 天，可能需要对这些症状进行一段时间的观察和治疗。

药物类别：GLP-1受体激动剂

储存条件：
远离孩子可以触及的地方。 储存于2℃至8℃冰箱中。 请勿冷冻并避光保存。 如果已冻结，请勿使用。 只能根据注册医生的处方服用和销售。

Tirza Tirzepatide Injection

Beacon Pharmaceuticals Ltd.

Indications
Tirza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of use:
. It has not been studied in patients with a history of pancreatitis.
. It is not indicated for use in patients with type 1 diabetes mellitus

Pharmacology
Tirzepatide is a GIP receptor and GLP-1 receptor agonist. It is a 39-amino-acid modifed peptide with a C20 fatty diacid moiety that enables albumin binding and prolongs the half-life. lt selectively binds to and activates both the GIP and GLP-1 receptors, the targets for native GIP and GLP-1. It enhances frst and second-phase insulin secretion and reduces glucagon levels, both in a glucose dependent manner

Dosage & Administration
Route of administration: Tirzepatide should be administered as a subcutaneous injection.
Dosing instructions-
.The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. The 2.5 mg dosage is for treatment initiation and is not intended for glycemic control.
.After 4 weeks, increase the dosage to 5 mg once weekly. lf additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. The maximum dosage is 15 mg injected subcutaneously once weekly.
" lf a dose is missed, instruct patients to administer it as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
.The day of weekly administration can be changed, if necessary, as long as the time between the two doses is at least 3 days (72 hours).
Preparation and administration-
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Do not freeze. Do not use Tirzepatide that has been frozen
.Protect pre-filled syringes from light.
.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any pre-filled syringes exhibiting particulate matter and discoloration.
Handle it carefully. If the pre-filled syringe dropped on a hard surface, do not use it.
Do not dilute Tirzepatide and do not administer in conjunction with other drug solutions.
Administration instructions-
.Administer once weekly, any time of day, with or without meals.
" Inject it subcutaneously in the abdomen, thigh or upper arm. Rotate injection sites with each dose. When using with insulin, administer as separate injections and never mix. It is acceptable to inject Tirzepatide and insulin in the same body region, but the injections should not be adjacent to each other.

Interaction
Drug interaction with medication:Consider reducing the dose of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia.
Tirza delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation with it.
Hormonal contraceptives that are not administered orally should not be affected.

Contraindications
Tirzepatide is contraindicated in patients with known hypersensitivity to tirzepatide or any other components of this product. It is also contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2).

Side Effects
The most common side effects are nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia and abdominal pain.

Pregnancy & Lactation
There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. Tirzepatide should be used during pregnancy only if the potential beneft justifies the potential risk to the fetus. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tirzepatide and any potential adverse effects on the breastfed infant from tirzepatide or from the underlying maternal condition.

Precautions & Warnings
Counsel patients regarding the potential risk for MTC with the use of Tirza and inform them of symptoms of thyroid tumors. After initiation, observe patients carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, discontinue Tirza and initiate appropriate management. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. If hypersensitivity reactions occur, discontinue use of Tirza; treat promptly per standard of care and monitor until signs and symptoms resolve. Monitor renal function when initiating or escalating doses in patients with renal impairment reporting severe gastrointestinal adverse reactions. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy. lf cholelithiasis is suspected, gallbladder diagnostic studies and
appropriate clinical follow-up are indicated.

Use in Special Populations
Use in children and adolescents: Safety and effectiveness of Tirza have not been established in patients under 18 years of age.

Overdose Effects
Appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms. A period of observation and treatment for these symptoms may be necessary, taking into account the half-life of Tirza is approximately 5 days.

Therapeutic Class
GLP-1 receptor agonists

Storage Conditions
Keep out of the reach and sight of children. Store in a refrigerator at 2℃ to 8C. Do not freeze and protect from light. Do not use if it has been frozen. To be taken and sold only on the prescription of a registered physician.