New Lung Cancer Drug Trametinib Mekinist 2mg Lung Cancer Pill

【Drug Name】
Generic name: Trametinib tablets

Trade name: MEKINIST®

English name: Trametinib Tablets

Chinese Pinyin: Qumeitini Pian

【Indications】
BRAF V600 mutation-positive unresectable or metastatic melanoma

This product combined with dabrafenib mesylate is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

Postoperative adjuvant therapy for BRAF V600 mutation-positive melanoma

This product combined with dabrafenib mesylate is suitable for adjuvant treatment of patients with BRAF V600 mutation-positive stage III melanoma after complete resection.

【Dosage】
This product must be used in medical institutions with experience in anti-tumor treatment. Before treatment with this product in combination with dabrafenib mesylate, BRAF V600 mutation testing must be carried out through a detection method approved by the State Food and Drug Administration. Only patients confirmed to be BRAF V600 mutation positive can receive treatment with this product. This product combined with dabrafenib mesylate is not suitable for patients with BRAF wild-type melanoma.

Dosage and Administration

The recommended dose of this product is 2 mg orally once daily, and must be combined with dabrafenib mesylate until disease progression or intolerable toxicity occurs.

This product should be taken at least 1 hour before or 2 hours after a meal. This product should be taken at the same time every day.

If a dose is missed, it must be taken at least 12 hours before the next scheduled dose. If the next scheduled dose is less than 12 hours away, no make-up dose should be given.

When combined with dabrafenib mesylate, this product should be taken once daily at the same time every day, together with dabrafenib mesylate administered in the morning or evening. This product should not be chewed or crushed.

Dosage adjustment

Dose reduction, treatment interruption, or discontinuation of treatment may be necessary to manage adverse reactions (see page 3 of the package insert, Tables 1 and 2).

No dose adjustments are recommended for adverse reactions in cutaneous squamous cell carcinoma (cuSCC) or new primary melanoma.

If treatment-related toxicity occurs when dabrafenib mesylate is administered in combination with this product, both treatments should be dose reduced, interrupted, or discontinued simultaneously. For adverse reactions primarily related to dabrafenib mesylate (uveitis, noncutaneous malignancies), and adverse reactions primarily related to trametinib (retinal vein occlusion (RVO), retinal pigment

epithelial detachment (RPED), interstitial lung disease (ILD)/pneumonitis, and uncomplicated venous thromboembolism), requiring dose adjustment for only one of the treatments.

Special groups

liver damage

No dose adjustment is required in patients with mild hepatic impairment. No clinical data are available in patients with moderate or severe hepatic impairment; therefore, the potential need for initial dose adjustment cannot be determined. This product should be used with caution in patients with moderate or severe hepatic impairment.

kidney damage

No dose adjustment is required in patients with mild or moderate renal impairment. No clinical data are available in patients with severe renal impairment; therefore, the potential need for initial dose adjustment cannot be determined. This product should be used with caution in patients with severe renal impairment.

child

The safety and efficacy of this product in children and adolescents (<18 years) have not been established. No data available.

elderly

No initial dose adjustment is required in patients over 65 years of age. However, patients over 65 years of age may require more frequent dose adjustments (see page 3 of the package insert, Tables 1 and 2).

【Adverse reactions】

BRAF V600 mutation-positive unresectable or metastatic melanoma

Trametinib monotherapy

Adverse reactions leading to permanent discontinuation of the trial drug occurred in 9% of patients treated with this product. The most common adverse reactions leading to permanent discontinuation of this product are decreased LVEF, pneumonia, renal failure, diarrhea, and rash. Adverse reactions leading to dose reduction occurred in 27% of patients treated with this product. The most common reasons for dose reduction of this product are rash and decreased LVEF.

Trametinib combined with dabrafenib mesylate treatment

In patients treated with this product in combination with dabrafenib mesylate, the most common (≥ 20%) adverse reactions related to this product are fever, nausea, rash, chills, diarrhea, vomiting, hypertension, and peripheral edema.

Postoperative adjuvant therapy for BRAF V600 mutation-positive melanoma

The most common adverse reactions (≥20%) in patients treated with dabrafenib mesylate are pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia.

Adverse reactions leading to discontinuation and suspension of administration of this product occurred in 24% and 54% of patients respectively. The most common adverse reactions were fever and chills. Adverse reactions leading to dose reduction of this product occurred in 23% of patients, with the most common adverse reactions being fever and reduced ejection fraction.

【Storage】
Protect from light, airtight, store at 2-8℃. Store in original packaging, keep vial tightly closed, do not remove desiccant.

Once opened, vials can be stored for 30 days at a temperature not exceeding 30°C.