China's Tafolecimab(托莱西单抗注射液):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Tafolecimab

Tafolecimab Injection, as the first and only innovative fully humanized PCSK9 monoclonal antibody with independent intellectual property rights in China, was selected as a project of the National Major Science and Technology Project for Major New Drug Creation, and has broken the monopoly of imported drugs in this field.

Indications

On the basis of dietary control, this product is used in combination with statins alone, or in combination with statins plus other lipid-lowering therapies, for adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia who fail to achieve the target low-density lipoprotein cholesterol (LDL-C) level despite treatment with moderate or higher doses of statins. It is indicated for reducing the levels of low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and apolipoprotein B (ApoB).

Overview

Generic Name

Tafolecimab Injection,托莱西单抗注射液

Brand Name

信必乐

Drug Type

Rx Drug

Approval No.

国药准字S20230043

Active Ingredient

Tafolecimab

Dosage Form

150mg/prefilled auto-injection pen

Specification

Injection

Description

Tafolecimab Injection is a clear to slightly opalescent, colorless to slightly yellow liquid, free of foreign particles.

Expiry Date

12 months

Manufacturer

Innovent Biologics (Suzhou) Co., Ltd.

Storage

Store and transport at 2-8℃ protected from light. Do not freeze or shake vigorously.If special storage is required, prior to use, the product may be stored in its original packaging at room temperature (20℃-25℃) for 30 days, and must not be returned to refrigerated storage (2-8℃) thereafter; protection from light is required throughout this period. If the product is not used within 30 days under such conditions, or if the storage temperature exceeds 25℃, it shall be discarded.

Dosage and Administration

Administration

Administer by subcutaneous injection in the abdomen using a disposable prefilled auto-injection pen.

It is recommended to rotate injection sites.

Do not administer this product at sites with active skin diseases or lesions (e.g., sunburn, rash, inflammation, or skin infection).

Do not simultaneously inject this product and other injectable drugs at the same injection site.

No compatibility studies have been conducted; therefore, do not mix this product with other medicinal products.

Prior to use, provide appropriate training to patients and/or caregivers on how to prepare and inject this product in accordance with the Instructions for Use, including aseptic technique. Instruct patients and/or caregivers to read and follow the Instructions for Use before each administration.

Before administration, visually inspect for particulate matter or discoloration. Do not use if the solution is discolored or contains visible particulate matter.

Before use, allow the prefilled auto-injection pen to reach room temperature by leaving it at room temperature for at least 30 minutes.

After use, place the prefilled auto-injection pen in a puncture-resistant container and dispose of it in accordance with local (national) regulations. Do not reuse the container. Keep the container out of the reach of children.

Instruct patients and/or caregivers not to reuse the prefilled auto-injection pen and provide guidance on the safe disposal method after use.

Dosage

The recommended dosage of this product is 150 mg once every 2 weeks, 450 mg once every 4 weeks, or 600 mg once every 6 weeks.

Contraindications

Known hypersensitivity to the active ingredient of tafolecimab or any of its excipients.

Adverse Reactions

Mild reactions may include: minor bleeding, skin redness, and muscle aches at the injection site;

Common reactions include: raised red wheals on the skin (i.e., urticaria)。

Use in Special Populations

Use in Pregnant and Lactating Women

Pregnancy

No data are available on the use of this product in pregnant women. The use of this product during pregnancy is not recommended unless the woman’s clinical condition necessitates treatment with tafolecimab.

Combination Therapy with Statins

Statins are contraindicated in pregnant women. Refer to the current prescribing information for each respective agent.

Lactation

It is not known whether tafolecimab is excreted in human milk. Human immunoglobulin G (IgG) is excreted in human milk, particularly in colostrum; the use of this product in lactating women during this period is not recommended. Exposure is expected to be low during the remainder of the lactation period. In Sprague-Dawley (SD) rat perinatal toxicity studies, detectable levels of tafolecimab were found in the milk of maternal rats approximately 24 hours after administration on lactation day 14, indicating that the drug can cross into milk and be excreted via milk in maternal rats. Since the effects of tafolecimab on breastfed infants are unknown, consideration should be given to discontinuing breastfeeding or discontinuing the product during this period.

Combination Therapy with Statins

Statins are contraindicated in lactating women. Refer to the current prescribing information for each respective agent.

Pediatric Use

The safety and efficacy of tafolecimab in pediatric patients have not been established.

Geriatric Use

In three phase III randomized controlled clinical trials, 188 patients treated with tafolecimab were aged ≥ 65 years, and 658 patients were aged <65 years. No significant differences in overall safety and efficacy were observed between patients aged ≥65 years and those aged <65 years. Therefore, no dose adjustment is required for geriatric patients.

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