Tunlametinib Capsules are the world's first and only approved targeted drug for advanced melanoma with NRAS mutation that has failed anti-PD-1/PD-L1 therapy, featuring convenient oral administration, controllable safety and definite efficacy.
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Privacy As a highly selective mitogen-activated protein kinase kinase 1and2(MEK1/2) inhibitor, Tunlametinib Capsules feature a novel core structure and independent intellectual property rights, with invention patents authorized in China, the United States, Europe and other countries.
Tunlametinib Capsules are indicated for the treatment of patients with advanced melanoma harboring NRAS mutation who have failed prior anti-PD-1/PD-L1 therapy.
This product has been granted conditional approval for marketing based on surrogate endpoints. Clinical endpoint data have not yet been obtained, and its efficacy and safety are to be further confirmed in post-marketing studies.
Tunlametinib Capsules must be administered under the guidance of a physician experienced in antineoplastic therapy.
Prior to treatment with this product, the presence of NRAS mutation in the patient’s tumor sample must be confirmed. A validated detection method should be used to determine the patient’s NRAS mutation status. Only patients confirmed to harbor NRAS mutation based on test results from hospitals or laboratories are eligible for treatment with this product. The test result shall be reviewed once by an independent third party designated by Shanghai Kechow Pharma, Inc., using an investigational companion diagnostic assay to confirm the presence of NRAS mutation before the patient can continue treatment.
The recommended dosage of this product is 12 mg per dose, twice daily (approximately every 12 hours) for oral administration, which can be taken with or without food. The capsules must not be chewed, dissolved or opened.
If a dose is missed, the missed dose can be taken up to 8 hours before the next scheduled dose. If less than 8 hours remain until the next dose, it is not recommended to take the missed dose.
Patients with hypersensitivity to the active substance or any of the excipients of Tunlametinib Capsules are prohibited from using this product.
The most common all-grade adverse drug reactions (ADR) (incidence ≥ 20%) include diarrhea, rash, facial edema, peripheral edema, anemia, fatigue, acneiform dermatitis and hypoalbuminemia; the most common grade 3 ADR (incidence ≥ 5%) include anemia, acneiform dermatitis, fatigue and rash.
Pregnancy
There are currently no available data to assess the drug-related risks of Tunlametinib use in pregnant women.
Pregnant women should not take this product.
Lactation
Data on the presence of Tunlametinib in human milk, as well as the effects of Tunlametinib on breastfed infants or lactation, have not been obtained. Since breastfed infants may experience serious adverse reactions when their mothers are taking this product, women are advised not to breastfeed during the treatment with this product and for 30 days after the last dose.
Contraception
Females: Women of childbearing potential are advised to use contraceptive measures during the treatment with this product and until 30 days after the last dose. If this product is used during pregnancy or if a patient becomes pregnant while taking this product, the patient should be informed of the potential hazards of Tunlametinib to the fetus.
Males: Males are advised to use highly effective contraceptive measures during the treatment with this product and until 30 days after the last dose.
Fertility
The effects of this product on male and female fertility remain unknown.
The safety and efficacy of this product in pediatric patients and adolescents (under 18 years of age) have not been established, and the use of this product is not recommended.
No initial dose adjustment is required for subjects aged 65 years and above.
For more detailed drug information, please consult the official package leaflet.
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Trametinib is a MEK inhibitor, primarily indicated for the treatment of advanced solid tumors with specific gene mutations, such as melanoma, non-small cell lung cancer (NSCLC), etc.
Trametinib is generally taken orally, once daily. It can be administered on an empty stomach or with food, but must be taken at a fixed time each day.
Store Trametinib below 25°C and protected from light, and keep it out of the reach of children.
Trametinib can be mailed in compliance with relevant regulations. Orders require a valid prescription, and the medication will be delivered in full accordance with standard pharmaceutical distribution requirements.
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