部份中文瑞莎珠单抗处方资料（仅供参考）
英文名：Risankizumab
商品名：瑞莎珠单抗预充式注射剂
中文名：Skyrizi
生产商：艾伯维制药
药品简介
新型抗炎药Skyrizi获欧盟批准，3个月注射一次治疗斑块型银屑病。
近日，欧盟委员会（EC）批准其白细胞介素-23（IL-23）单抗Skyrizi（risankizumab），用于治疗中度至重度斑块状银屑病成人患者。
用药方面，Skyrizi在第0、4周分别用药一次，之后每3个月（12周）用药一次，剂量为150mg（2针75mg），皮下注射。
作用机理
Risankizumab是一种人源化免疫球蛋白G1（IgG1）单克隆抗体，可与人白介素23（IL-23）细胞因子的p19亚基选择性高亲和性结合，而与IL-12结合并抑制其与IL-23受体复合物的相互作用。 IL-23是一种细胞因子，参与炎症反应和免疫反应。通过阻止IL-23与其受体结合，risankizumab抑制了IL-23依赖性细胞信号传导和促炎细胞因子的释放。
适应症
Skyrizi可以用于治疗全身性成年人的中度至重度斑块状牛皮癣。
用法与用量
推荐剂量是在第0周，第4周以及此后每12周通过皮下注射给药150mg（两次75 mg注射）。
治疗16周后仍无反应的患者应考虑中止治疗。一些最初具有部分反应的患者随后可通过继续治疗超过16周而有所改善。
错过的剂量
如果错过剂量，应尽快给药。此后，应在正常的预定时间恢复加药。
特殊人群
老年人（65岁以上）
无需调整剂量。
年龄≥65岁的受试者的信息有限。
肾或肝功能不全
没有进行专门的研究来评估肝或肾功能不全对Skyrizi药代动力学的影响。通常预期这些条件不会对单克隆抗体的药代动力学产生任何重大影响，并且认为无需调整剂量。
小儿
Skyrizi在6至18岁的儿童和青少年中的安全性和疗效尚未确定。无可用数据。
Skyrizi在6岁以下儿童中没有相关用途，可用于指示中度至重度斑块状牛皮癣。
超重患者
无需调整剂量。
给药方法
Skyrizi通过皮下注射给药。对于每种剂量，应在不同的解剖位置（例如大腿或腹部）注射，而不应注射到皮肤变软，青肿，红斑，硬结或受牛皮癣影响的区域。Skyrizi在上臂的管理只能由医护人员或护理人员执行。
接受皮下注射技术培训后，患者可以自行注射Skyrizi。应指导患者注射2个预填充注射器，以完整的150 mg剂量注射，并在给药前阅读包装说明书中提供的“使用说明”。
禁忌症
对活性物质或所列的任何赋形剂过敏。
临床上重要的活动性感染（例如活动性结核）。
保质期
2年
特殊的储存注意事项
存放在冰箱（2°C-8°C）中。 不要冻结。
将预填充的注射器保持在外部纸箱中，以避光。
容器的性质和内容
带有固定针头和针头盖的预装玻璃注射器，安装在自动针头保护器中。 每个预先填充的注射器均包含0.83ml的75mg risankizumab。
Skyrizi的包装中包含2个预装注射器和2个酒精垫。

部份中文瑞莎珠单抗处方资料（仅供参考）
英文名：Risankizumab
商品名：瑞莎珠单抗预充式注射剂
中文名：Skyrizi
生产商：艾伯维制药
药品简介
新型抗炎药Skyrizi获欧盟批准，3个月注射一次治疗斑块型银屑病。
近日，欧盟委员会（EC）批准其白细胞介素-23（IL-23）单抗Skyrizi（risankizumab），用于治疗中度至重度斑块状银屑病成人患者。
用药方面，Skyrizi在第0、4周分别用药一次，之后每3个月（12周）用药一次，剂量为150mg（2针75mg），皮下注射。
作用机理
Risankizumab是一种人源化免疫球蛋白G1（IgG1）单克隆抗体，可与人白介素23（IL-23）细胞因子的p19亚基选择性高亲和性结合，而与IL-12结合并抑制其与IL-23受体复合物的相互作用。 IL-23是一种细胞因子，参与炎症反应和免疫反应。通过阻止IL-23与其受体结合，risankizumab抑制了IL-23依赖性细胞信号传导和促炎细胞因子的释放。
适应症
Skyrizi可以用于治疗全身性成年人的中度至重度斑块状牛皮癣。
用法与用量
推荐剂量是在第0周，第4周以及此后每12周通过皮下注射给药150mg（两次75 mg注射）。
治疗16周后仍无反应的患者应考虑中止治疗。一些最初具有部分反应的患者随后可通过继续治疗超过16周而有所改善。
错过的剂量
如果错过剂量，应尽快给药。此后，应在正常的预定时间恢复加药。
特殊人群
老年人（65岁以上）
无需调整剂量。
年龄≥65岁的受试者的信息有限。
肾或肝功能不全
没有进行专门的研究来评估肝或肾功能不全对Skyrizi药代动力学的影响。通常预期这些条件不会对单克隆抗体的药代动力学产生任何重大影响，并且认为无需调整剂量。
小儿
Skyrizi在6至18岁的儿童和青少年中的安全性和疗效尚未确定。无可用数据。
Skyrizi在6岁以下儿童中没有相关用途，可用于指示中度至重度斑块状牛皮癣。
超重患者
无需调整剂量。
给药方法
Skyrizi通过皮下注射给药。对于每种剂量，应在不同的解剖位置（例如大腿或腹部）注射，而不应注射到皮肤变软，青肿，红斑，硬结或受牛皮癣影响的区域。Skyrizi在上臂的管理只能由医护人员或护理人员执行。
接受皮下注射技术培训后，患者可以自行注射Skyrizi。应指导患者注射2个预填充注射器，以完整的150 mg剂量注射，并在给药前阅读包装说明书中提供的“使用说明”。
禁忌症
对活性物质或所列的任何赋形剂过敏。
临床上重要的活动性感染（例如活动性结核）。
保质期
2年
特殊的储存注意事项
存放在冰箱（2°C-8°C）中。 不要冻结。
将预填充的注射器保持在外部纸箱中，以避光。
容器的性质和内容
带有固定针头和针头盖的预装玻璃注射器，安装在自动针头保护器中。 每个预先填充的注射器均包含0.83ml的75mg risankizumab。
Skyrizi的包装中包含2个预装注射器和2个酒精垫。

Skyrizi  

Generic Name: Risankizumab-rzaa  
Class: Skin and Mucous Membrane Agents, Miscellaneous
Chemical Name: propan-2-ol
Molecular Formula: C3H8O
CAS Number: 3979-51-9

Introduction

Risankizumab-rzaa, a recombinant DNA-derived humanized immunoglobulin G1 (IgG1) monoclonal antibody, is an antipsoriatic agent.1

Uses for Skyrizi

Risankizumab-rzaa has the following uses:

Risankizumab-rzaa is an interleukin-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.1

Skyrizi Dosage and Administration

General

Risankizumab-rzaa is available in the following dosage form(s) and strength(s):

· Injection: 75 mg/0.83 mL in each single-dose prefilled syringe.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

· 150 mg (two separate 75 mg injections) administered by subcutaneous injection at Week 0, Week 4 and every 12 weeks thereafter.1

· For each dose, administer the injections at different anatomic locations (e.g., thighs, abdomen) avoiding skin that is tender, bruised, erythematous, indurated, or affected by psoriasis.1

· Intended for use under the guidance and supervision of a healthcare professional.1

Cautions for Skyrizi

Contraindications

· None.1

Warnings/Precautions

Infections

Risankizumab-rzaa may increase the risk of infections. In clinical studies, infections occurred in 22.1% of the risankizumab-rzaa group compared to 14.7% of the placebo group through 16 weeks of treatment. Upper respiratory tract infections and tinea infections occurred more frequently in the risankizumab-rzaa group than in the placebo group. Subjects with known chronic or acute infections were not enrolled in clinical studies.1

The rate of serious infections for the risankizumab-rzaa group and the placebo group was ≤ 0.4%. Treatment with risankizumab-rzaa should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.1

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing risankizumab-rzaa. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer risankizumab-rzaa until the infection resolves.1

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with risankizumab-rzaa. Across the Phase 3 psoriasis clinical studies, of the 72 subjects with latent TB who were concurrently treated with risankizumab-rzaa and appropriate TB prophylaxis during the studies, none developed active TB during the mean follow-up of 61 weeks on risankizumab-rzaa. Two subjects taking isoniazid for treatment of latent TB discontinued treatment due to liver injury. Of the 31 subjects from the IMMHANCE study with latent TB who did not receive prophylaxis during the study, none developed active TB during the mean follow-up of 55 weeks on risankizumab-rzaa. Consider anti-TB therapy prior to initiating risankizumab-rzaa in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after risankizumab-rzaa treatment. Do not administer risankizumab-rzaa to patients with active TB.1

Immunizations

Prior to initiating therapy with risankizumab-rzaa, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with risankizumab-rzaa. No data are available on the response to live or inactive vaccines.1

Specific Populations

Pregnancy

Risk Summary: Limited available data with risankizumab-rzaa use in pregnant women are insufficient to evaluate a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome. Human IgG is known to cross the placental barrier; therefore, risankizumab-rzaa may be transmitted from the mother to the developing fetus.1

In an enhanced pre- and post-natal developmental toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of 5 and 50 mg/kg risankizumab-rzaa once weekly during the period of organogenesis up to parturition. At the 50 mg/kg dose [20 times the maximum recommended human dose (MRHD); 2.5 mg/kg based on administration of a 150 mg dose to a 60 kg individual], increased fetal/infant loss was noted in pregnant monkeys. No risankizumab-rzaa-related effects on functional or immunological development were observed in infant monkeys from birth through 6 months of age. The clinical significance of these findings for humans is unknown.1

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.1

Animal Data: An enhanced pre- and post-natal developmental toxicity study was conducted in cynomolgus monkeys. Pregnant cynomolgus monkeys were administered weekly subcutaneous doses of risankizumab-rzaa of 5 or 50 mg/kg from gestation day 20 to parturition and the cynomolgus monkeys (mother and infants) were monitored for 6 months after delivery. No maternal toxicity was noted in this study. There were no treatment-related effects on growth and development, malformations, developmental immunotoxicology or neurobehavioral development. However, a dose-dependent increase in fetal/infant loss was noted in the risankizumab-rzaa-treated groups (32% and 43% in the 5 mg/kg and 50 mg/kg groups, respectively) compared to the vehicle control group (19%). The increased fetal/infant loss in the 50 mg/kg group was considered to be related to risankizumab-rzaa treatment. The no observed adverse effect level (NOAEL) for maternal toxicity was identified as 50 mg/kg (20 times the MRHD, based on mg/kg comparison) and the NOAEL for developmental toxicity was identified as 5 mg/kg (2 times the MRHD, based on mg/kg comparison). In the infants, mean serum concentrations increased in a dose-dependent manner and were approximately 17-86% of the respective maternal concentrations. Following delivery, most adult female cynomolgus monkeys and all infants from the risankizumab-rzaa-treated groups had measurable serum concentrations of risankizumab-rzaa up to 91 days postpartum. Serum concentrations were below detectable levels at 180 days postpartum.1

Lactation

Risk Summary: There are no data on the presence of risankizumab-rzaa in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for risankizumab-rzaa and any potential adverse effects on the breastfed infant from risankizumab-rzaa or from the underlying maternal condition.1

Pediatric Use

The safety and efficacy of risankizumab-rzaa in pediatric patients less than 18 years of age have not yet been established.1

Geriatric Use

Of the 2234 subjects with plaque psoriasis exposed to risankizumab-rzaa, 243 subjects were 65 years or older and 24 subjects were 75 years or older. No overall differences in risankizumab-rzaa exposure, safety or effectiveness were observed between older and younger subjects who received risankizumab-rzaa. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.1

Common Adverse Effects

Most common adverse reactions (≥ 1%) are upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Avoid use of live vaccines in patients treated with risankizumab-rzaa.1

Actions

Mechanism of Action

Risankizumab-rzaa is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds to the p19 subunit of human interleukin 23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.1

Risankizumab-rzaa inhibits the release of pro-inflammatory cytokines and chemokines.1

Advice to Patients

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) before starting risankizumab-rzaa therapy and to reread the Medication Guide each time the prescription is renewed. Advise patients of the potential benefits and risks of risankizumab-rzaa.1

Infections

Inform patients that risankizumab-rzaa may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection.1

Administration Instructions

Instruct patients or caregivers to perform the first self-injected dose under the supervision and guidance of a qualified healthcare professional for training in preparation and administration of risankizumab-rzaa, including choosing anatomical sites for administration, and proper subcutaneous injection technique.1

Instruct patients or caregivers to administer two 75 mg single-dose syringes to achieve the 150 mg dose of risankizumab-rzaa.1

Instruct patients or caregivers in the technique of needle and syringe disposal.1

Additional Information

AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.