China's Befotertinib(甲磺酸贝福替尼胶囊):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Befotertinib

Befotertinib Mesylate Capsules is a national Class 1 innovative drug independently researched and developed by Betta Pharmaceuticals Co., Ltd. with complete independent intellectual property rights. As a domestic third-generation, highly selective oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), it was approved for marketing by the National Medical Products Administration (NMPA) in 2023.

Indications

Befotinib is indicated for:

First-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation.

Treatment of adult patients with locally advanced or metastatic NSCLC who have experienced disease progression during or after prior treatment with an EGFR tyrosine kinase inhibitor (TKI) and have a confirmed positive EGFR T790M mutation status upon detection.

Overview

Generic Name

Befotertinib Mesylate Capsules,甲磺酸贝福替尼胶囊

Brand Name

赛美纳

Drug Type

Rx Drug,targeted drug

Approval No.

25mg:国药准字H20230011;50mg:国药准字H20230012

Active Ingredient

Befotertinib Mesylate

Dosage Form

25mg*40capsules;50mg*20capsules

Specification

Capsules

Description

The contents of the capsule are a white or off-white powder.

Expiry Date

36 months

Manufacturer

Betta Pharmaceuticals Co., Ltd.

Storage

Store in a sealed container at a temperature not exceeding 25°C. Keep out of the reach and sight of children.

Dosage and Administration

This product should be administered under the supervision of an oncologist with extensive clinical experience.

Prior to treatment with this product, the presence of EGFR exon 19 deletion, exon 21 (L858R) substitution mutation, or EGFR T790M mutation must be confirmed using an approved detection method. Physicians must conduct a COMPASS-CAT score assessment for patients before drug administration: for high-risk patients (score ≥7), the risk-benefit profile of treatment with this product should be evaluated and relevant risks informed to the patients; if this product is prescribed, prophylactic anticoagulant therapy may be administered.

Dosage and Administration Route

Administer orally, once daily, starting with an initial dose of 75mg for a continuous 21-day course. If no severe adverse reactions occur, or there is no Grade ≥2 thrombocytopenia and/or no Grade ≥2 headache, the dose may be adjusted to 100mg once daily after 21 days, until disease progression or unacceptable toxicity occurs.

This product may be taken on an empty stomach or with food. It is recommended to take the medication at approximately the same time each day. If a single dose is missed, the missed dose should be taken if more than 12 hours remain before the next scheduled dose.

Contraindications

Patients with hypersensitivity to Befotertinib Mesylate or any of its excipients.

Adverse Reactions

Among patients, some experienced treatment interruption due to adverse reactions. The adverse reactions leading to treatment interruption included thrombocytopenia, other venous thromboembolism and thrombotic events, and pulmonary embolism.

Some patients required dose reduction due to adverse reactions, with the relevant adverse reactions including thrombocytopenia, other venous thromboembolism and thrombotic events, pulmonary embolism, and rash. Some patients discontinued treatment permanently due to adverse reactions, and the adverse reactions leading to permanent treatment discontinuation included thrombocytopenia, interstitial lung disease, other venous thromboembolism and thrombotic events, and pulmonary embolism.

Some patients experienced serious adverse reactions. The serious adverse reactions included pulmonary embolism, other venous thromboembolism and thrombotic events, thrombocytopenia, and interstitial lung disease.

Special Populations

Pregnancy and Lactation

Contraception

Males and females of childbearing potential should avoid conception during treatment with this product and use effective contraceptive measures for 3 months after completion of treatment. The risk of reduced exposure to hormonal contraceptives cannot be ruled out when co-administered with this product.

Pregnancy

There are no available data on the use of this product in pregnant women, and the potential safety risks to the fetus are currently unknown. Based on its mechanism of action, the use of this product in pregnant women may cause harm to the fetus.

Lactation

It is not yet clear whether this product or its metabolites are excreted in human milk. It is recommended that breastfeeding be discontinued during treatment with this product and for at least 3 months after the last dose.

Pediatric Use

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

Geriatric Use

Current clinical study data and population pharmacokinetic analyses indicate that no adjustment of the initial dose is required for elderly patients when the product is used under the supervision of a physician.