China's Flumatinib(甲磺酸氟马替尼片):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Flumatinib

Flumatinib Mesilate Tablets was granted marketing approval via priority review and approval by the National Medical Products Administration (NMPA) in November 2019, and it is China’s first independently developed highly selective targeted agent for the treatment of chronic myeloid leukemia (CML).

Indication

This product is indicated for the treatment of adult patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML).

Overview

Generic Name

Flumatinib Mesylate Tablets,甲磺酸氟马替尼片

Brand Name

豪森昕福

Drug Type

Rx Drug

Approval No.

0.2g:国药准字H20190033;0.1g:国药准字H20190032

Active Ingredient

Flumatinib

Dosage Form

0.1g*10tablets;0.2g*10tablets

Specification

Tablets

Description

This product is a film-coated tablet, which appears white to pale yellow after the coating is removed.

Expiry Date

24 months

Manufacturer

Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

Storage

Keep sealed and store below 30℃.

Dosage and Administration

Flumatinib Mesilate Tablets should be administered under the supervision of a physician experienced in the treatment of chronic myeloid leukemia (CML).

This medication is for oral administration, with a recommended dose of 600mg once daily (qd), continued until disease progression or the occurrence of intolerable adverse reactions.

Administer on an empty stomach (no food should be consumed for 2 hours before and 1 hour after dosing). It is recommended to take the medication at approximately the same time each day, swallow the tablet whole and administer with a full glass of water; do not chew or crush the tablet.

Treatment with this product should be continued for as long as the patient derives benefit.

Contraindications

Hypersensitivity to Flumatinib Mesilate or any of its excipients.

Adverse Reactions

Blood and lymphatic system disorders: thrombocytopenia, leukopenia, neutropenia, anemia, lymphopenia; Grade ≥3 adverse reactions include thrombocytopenia, neutropenia, leukopenia, anemia, lymphopenia;

Gastrointestinal disorders: diarrhea, abdominal pain, vomiting, nausea, abdominal discomfort, toothache; Grade ≥3 adverse reaction is diarrhea;

Hepatobiliary disorders: elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated blood bilirubin, elevated gamma-glutamyl transferase; Grade ≥3 adverse reactions include elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated gamma-glutamyl transferase, elevated blood bilirubin;

Metabolism and nutrition disorders: decreased blood phosphorus, decreased blood calcium, elevated blood uric acid, elevated blood triglycerides, decreased blood potassium, elevated blood glucose, elevated blood cholesterol; Grade ≥3 adverse reactions include decreased blood phosphorus, elevated blood uric acid, decreased blood potassium, elevated blood triglycerides;

Infections and infestations: upper respiratory tract infection, pulmonary infection, urinary tract infection; Grade ≥3 adverse reaction is pulmonary infection;

General disorders: asthenia, fever, fluid retention, chest discomfort; Grade ≥3 adverse reaction is chest discomfort;

Musculoskeletal and connective tissue disorders: arthralgia, myalgia, limb pain, back pain; Grade ≥3 adverse reaction is back pain;

Skin and subcutaneous tissue disorders: rash, pruritus; No Grade ≥3 adverse reactions;

Renal and urinary disorders: elevated blood creatinine; Grade ≥3 adverse reaction is elevated blood creatinine;

Respiratory, thoracic and mediastinal disorders: cough; No Grade ≥3 adverse reactions;

Nervous system disorders: dizziness, headache; No Grade ≥3 adverse reactions;

Cardiac disorders: sinus bradycardia; No Grade ≥3 adverse reactions;

Ear and labyrinth disorders: vertigo; Grade ≥3 adverse reaction is vertigo;

Vascular and lymphatic disorders: hypertension; Grade ≥3 adverse reaction is hypertension;

Other examination abnormalities: elevated serum lipase, abnormal electrocardiogram findings, elevated serum amylase, elevated blood creatine phosphokinase, elevated blood alkaline phosphatase, elevated blood lactate dehydrogenase; Grade ≥3 adverse reactions include elevated serum lipase and elevated serum amylase.

Special Populations

Pregnancy and Lactation

Contraception

Males and females of childbearing potential should avoid conception during treatment with this product and continue to use effective contraceptive measures for 3 months after completion of treatment. The risk of decreased exposure to hormonal contraceptives cannot be excluded when co-administered 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, the use of this product in pregnant women may cause harm to the fetus.

Lactation

It is not known 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 efficacy and safety of this product in children or adolescents below 18 years of age have not been established.

Geriatric Use

In clinical studies of this product, among 283 patients treated at the 110mg dose level, 110 (38.9%) were aged ≥65 years. The incidence of adverse reactions in these patients was 80.9%, with the incidence of grade ≥3 adverse reactions being 18.2%. Current clinical study data indicate that the safety profile of geriatric patients is not significantly different from that of the overall population, and no dose adjustment is required when used under the supervision of a physician.

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