China's Rilertinib(甲磺酸瑞厄替尼片):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Rilertinib

Rilertinib Mesylate Tablets is China’s first third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) with a unique molecular structure, and it holds patents in multiple countries including China and the United States.

Indications

This product 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 deletions or exon 21 (L858R) substitution mutations.

Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after prior treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and are confirmed positive for the EGFR T790M mutation by testing.

Overview

Generic Name

Rilertinib Mesylate Tablets,甲磺酸瑞厄替尼片

Brand Name

圣瑞沙

Drug Type

Rx Drug

Approval No.

国药准字H20240020

Active Ingredient

Rilertinib Mesylate

Dosage Form

100mg*20tablets

Specification

Tablets

Description

Rilertinib is a pale yellow to dark yellow film-coated tablet, which appears off-white to pale yellow after the coating is removed.

Expiry Date

36 months

Manufacturer

Nanjing Sanhome Pharmaceutical Co., Ltd.

Storage

Protect from light, hermetically sealed, store below 25℃. Keep out of the reach of children.

Dosage and Administration

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

Prior to treatment with Rilertinib, it is first necessary to confirm the epidermal growth factor receptor (EGFR) mutation status. The presence of EGFR exon 19 deletions, exon 21 (L858R) substitution mutations, or EGFR T790M mutations must be identified using an approved detection method (see Precautions for details).

Dosage and Administration Route

The recommended dose of Rilertinib is 200 mg, taken orally once daily, until disease progression or intolerable toxicity occurs.

Rilertinib may be taken with or without food. It is recommended to take the medication at approximately the same time each day, swallow the tablet whole with a full glass of water, and do not chew or crush it. If a dose of this product is missed, the missed dose should be taken if the interval until the next scheduled dose is more than 12 hours.

Dose Modification

Treatment may be temporarily suspended or the dose reduced based on the individual patient's safety and tolerability. If dose reduction is required, the dose should be reduced to 100 mg taken orally once daily.

Contraindications

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

Adverse Reactions

At the recommended dose, common adverse reactions include gastrointestinal disorders (diarrhea, nausea), blood and lymphatic system disorders (anemia), and skin and subcutaneous tissue disorders (rash).

Some patients experienced serious adverse reactions.

Adverse reactions led to treatment interruption in some patients, with the associated adverse reactions including elevated blood creatine phosphokinase, diarrhea, nausea and vomiting. A small number of patients required dose reduction due to adverse reactions, and all such adverse reactions were infrequent. A small number of patients permanently discontinued the medication due to adverse reactions.

Common abnormal laboratory findings included elevated blood creatine phosphokinase, decreased white blood cell count, elevated serum creatinine, elevated aspartate aminotransferase, elevated alanine aminotransferase, elevated blood creatine phosphokinase MB and decreased platelet count.

Use in Special Populations

Use in Pregnant and Lactating Women

Contraception

Men and women of childbearing potential should avoid conception during treatment with this product and continue to use effective contraceptive measures for 3 months after the completion of treatment. The risk of decreased exposure to hormonal contraceptives cannot be ruled out when such contraceptives are used concomitantly with this product.

Pregnancy

No data are available 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, administration of this product in pregnant women may cause harm to the fetus.

Lactation

It is unknown 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

In clinical studies of this product, a certain proportion of elderly patients (aged ≥65 years) were enrolled. Available clinical study data indicate that the safety profile of elderly patients is not significantly different from that of the overall population, and no dose adjustment is required when the product is used under the guidance of a physician.

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