China's Socazolimab(索卡佐利单抗注射液):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Socazolimab

As the only PD-L1 monoclonal antibody approved for the indication of cervical cancer in China, Socazolimab Injection has filled the clinical application gap of PD-L1 monoclonal antibodies in the immunotherapy of cervical cancer in China, and also provided a new treatment option for patients with malignant tumors such as small cell lung cancer.

Indications

Socazolimab Injection is indicated for the treatment of patients with recurrent or metastatic cervical cancer who have failed previous platinum-containing chemotherapy.

This product has been conditionally approved for marketing based on surrogate endpoints. Clinical endpoint data have not yet been obtained, and its efficacy and safety are to be further confirmed after marketing. The full approval of this indication will depend on whether the ongoing confirmatory clinical trials can demonstrate the clinical benefit of socazolimab treatment.

Overview

Generic Name

Socazolimab Injection,索卡佐利单抗注射液

Brand Name

善克钰

Drug Type

Rx Drug

Approval No.

国药准字S20230071

Active Ingredient

Socazolimab

Dosage Form

100mg(4ml)/vial

Specification

Injection

Description

Colorless to pale yellow liquid, may be slightly opalescent.

Expiry Date

36 months

Manufacturer

WuXi Biologics(Wuxi)Co., Ltd.

Storage

Store and transport protected from light at 2-8℃.

Dosage and Administration

Socazolimab Injection must be administered under the supervision of a physician experienced in malignant tumor treatment.

Recommended Dosage

This product is administered via intravenous infusion at a recommended dosage of 5 mg/kg, once every 2 weeks, until the occurrence of disease progression or unacceptable toxicity.

Atypical responses may be observed (e.g., temporary tumor enlargement or the appearance of new lesions within the first few months, followed by tumor regression). If a patient's clinical symptoms are stable or continuously alleviated, even in the presence of preliminary radiological evidence of disease progression, continuation of treatment with this product may be considered based on the evaluation of overall clinical benefit, until confirmed disease progression occurs.

Contraindications

This product is contraindicated in patients with known hypersensitivity to socazolimab or any of its excipients.

Adverse Reactions

Adverse reactions with an incidence of ≥10% include: hypothyroidism, decreased white blood cell count, elevated alanine aminotransferase, anemia.

Most adverse reactions reported with socazolimab treatment are Grade 1 or 2 in severity. The incidence of Grade 3 or higher adverse reactions is 9.6%, and those with an incidence of ≥1% include: decreased neutrophil count, decreased white blood cell count, elevated alanine aminotransferase. The incidence of serious adverse reactions is 6.3%, and those with an incidence of ≥1% include: decreased white blood cell count, decreased neutrophil count, abnormal liver function.

Special Populations

Pregnancy and Lactation

Pregnancy

There are no data on the use of this product in pregnant women. Based on its mechanism of action and pharmacology and toxicology, the use of this product during pregnancy is not recommended unless the clinical benefit outweighs the potential risk.

Lactation

It is currently unknown whether this product is excreted in human breast milk, as well as its effects on breastfed infants and breast milk production. Since human IgG is excreted in breast milk, this product may pose potential risks to breastfed infants. Therefore, it is recommended that lactating women discontinue breastfeeding during the treatment with this product and for at least 3 months after the last dose.

Contraception

Women of childbearing potential should use effective contraceptive measures during the treatment with this product and for at least 3 months after the last dose.

Fertility

No studies on the effects of this product on fertility in both sexes have been conducted, so the impact of this product on male and female fertility is unknown.

Pediatric Use

The safety and efficacy of this product in patients under 18 years of age have not been established.

Geriatric Use

In the current cervical cancer clinical trials of this product, patients aged ≥65 years accounted for 0.3% of all patients, and no Grade 3 or higher adverse drug reactions were observed. No specific dosage adjustment was made for geriatric patients in the clinical trials. Due to the limited number of geriatric patients in the current clinical trials, it is recommended that geriatric patients use this product with caution under the guidance of a physician. If use is necessary, no dosage adjustment is required.

For more detailed drug information, please consult the official package leaflet.