30 Tablets Dabrafenib 2mg PHOTRAME 2 Lung Cancer Meds BRAF V600

【Drug Name】
Generic name: Dabrafenib mesylate capsules

Product name: Tafinlar®

English name: Dabrafenib mesylate Capsules

Chinese Pinyin: Jiahuangsuan Dalafeini Jiaonang

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

This product combined with trametinib 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 trametinib 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 trametinib, 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 trametinib is not suitable for patients with BRAF wild-type melanoma.

Dosage and Administration

The recommended dose of this product is 150 mg twice daily (equivalent to a total daily dose of 300 mg). This product needs to be treated in combination with trametinib until disease progression or intolerable toxicity occurs.

This product should be taken at least 1 hour before or at least 2 hours after a meal, with an interval of approximately 12 hours between doses. This product should be taken at the same time every day.

If a dose of this product is missed, it should not be taken if it is less than 6 hours before the next dose.

When trametinib is administered in combination with trametinib, trametinib should be taken once daily at the same time each day, together with trametinib administered in the morning or evening. Do not open, crush or break this product.

Dosage adjustment

Two strengths of this product, 50 mg and 75 mg, can be used to effectively manage the need for dose adjustment.

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

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

If treatment-related toxicity occurs when administering this product in combination with trametinib, both treatments should be dose reduced, interrupted, or discontinued simultaneously. For adverse reactions mainly related to dabrafenib mesylate (uveitis, non-cutaneous malignancies), and adverse reactions mainly related to trametinib (retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED) ), interstitial lung disease (ILD)/pneumonitis, and uncomplicated venous thromboembolism), dose adjustments are required for only one of the treatments.

Special groups

liver damage

No dose adjustment is required in patients with mild hepatic impairment. Clinical data in patients with moderate to severe hepatic impairment are not available to determine the potential need for dose adjustments. Hepatic metabolism and bile secretion are the major elimination pathways of dabrafenib mesylate and its metabolites, and exposure may be increased in patients with moderate to severe hepatic impairment. 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. Clinical data in patients with severe renal impairment are not available to determine the potential need for dose adjustments. This product should be used with caution in patients with severe renal impairment.

child

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

elderly

No initial dose adjustment is required in patients over 65 years of age.

【Adverse reactions】
BRAF V600 mutation-positive unresectable or metastatic melanoma

Dabrafenib mesylate monotherapy

The most common adverse reactions (≥20%) in patients treated with this product, in descending order of incidence, are: keratoderma, headache, pyrexia, arthralgia, papilloma, alopecia, and palmoplantar erythrodysesthesia syndrome (PPES)

Dabrafenib mesylate combined with trametinib treatment

Among patients treated with this product in combination with trametinib: 11% of patients experienced adverse reactions that led to the discontinuation of this product, the most common being fever (1.9%); 26% of patients experienced adverse reactions that led to a reduction in the dose of this product. Adverse reactions, the most common of which were pyrexia (14%), neutropenia (1.9%), rash (1.9%), and chills (1.9%); 56% of patients experienced adverse reactions leading to dose interruption of this product , the most common were fever (35%), chills (11%), vomiting (7%), nausea (5%), and reduced ejection fraction (5%).

Postoperative adjuvant therapy for BRAF V600 mutation-positive melanoma

The most common adverse reactions (≥20%) in patients treated with this product in combination with trametinib are fever, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia and myalgia.

Adverse reactions leading to discontinuation, dose reduction, or dose interruption of this product occurred in 25%, 35%, and 66% of patients, respectively; the most common adverse reactions were pyrexia and chills.

【Storage】
Shade, seal, and store in a dry place below 30°C.