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Dabrafenib is a small molecule kinase inhibitor that inhibits tumor cell proliferation by targeting the activity of BRAF serine/threonine kinase and blocking abnormal activation of the MAPK signaling pathway.
1. Generic name: Dabrafenib;
2. Trade name: TAFINLAR®.
1. Single drug or combination with trametinib for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutation-positive melanoma.
2. Combined with trametinib for postoperative adjuvant treatment of BRAFV600E/K mutation-positive melanoma (after lymph node involvement and complete resection).
3. Combined with trametinib to treat BRAFV600E mutation-positive metastatic non-small cell lung cancer (NSCLC).
4. Combined with trametinib for the treatment of locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAFV600E mutation-positive disease.
5. Combined with trametinib to treat BRAFV600E mutation-positive unresectable or metastatic solid tumors in patients 6 years of age and older (requires previous treatment failure and no satisfactory alternative).
6. Combined with trametinib to treat BRAFV600E mutation-positive low-grade glioma (LGG) that requires systemic treatment in patients 1 year old and above.
7. Note: Not applicable to patients with wild-type BRAF solid tumors or colorectal cancer.
Capsule : 75mg
1. Active ingredient:dabrafenibmesylate.
2. Excipients include: Microcrystalline cellulose, colloidal silica, etc.
1. Adult : The recommended dose is 150 mg orally, twice a day (about 12 hours apart).
2. Children :Adjust the dose according to body weight (for example, 75-150mg twice a day for those ≥26kg; suspension tablet dose for those 1-25kg calculated based on body weight).
3. Medication time : Take it 1 hour before or 2 hours after a meal. Avoid taking it with food.
4. Treatment of missed doses : If the next dose is less than 6 hours away, skip it and do not take it again.
5. Vomiting treatment : Do not take additional doses after vomiting. Take the next dose as originally planned.
1. Adverse reaction adjustment : Suspend, reduce the dose or permanently discontinue the drug according to the toxicity level (suspension is required for fever, and permanent discontinuation is required for severe skin toxicity).
2. Liver insufficiency : No adjustment is required for mild to moderate, and no clear recommended dose for severe cases.
1. Risk of new malignant tumors : Regular skin examinations are required during treatment, and symptoms of non-cutaneous malignant tumors are monitored.
2. Risk of bleeding : Combination with trametinib may cause bleeding, so be alert to symptoms of intracranial or gastrointestinal bleeding.
3. Cardiotoxicity : Monitor left ventricular function before and during treatment.
4. Eye problems : See a doctor immediately if vision changes occur.
5. Fever reaction : It is common and may be serious and requires prompt symptomatic treatment.
1. Pregnant women : can cause fetal damage, effective contraception (non-hormonal) is required until 2 weeks after the last dose.
2. Lactation : Breastfeeding is prohibited within 2 weeks after stopping the drug.
3. Children : Suitable for patients with LGG ≥ 1 year old and solid tumors ≥ 6 years old. The dose needs to be adjusted according to body weight.
1. Common adverse reactions include: Fever, rash, headache, joint pain, fatigue, nausea, vomiting, diarrhea, etc.
2. Serious adverse reactions may involve:Cardiomyopathy, uveitis, severe skin toxicity, etc.
There are no clear contraindications, but it is contraindicated in patients with wild-type BRAF tumors.
1. Strong CYP3A4/CYP2C8 inhibitor (such as ketoconazole) may increase the plasma concentration of dabrafenib.
2. Dabrafenib can reduce the efficacy of CYP3A4/CYP2C9 substrates (such as warfarin), and INR needs to be monitored.
1. Capsules: Store in the original bottle and place in a dry environment at 20-25°C.
2. Desiccant : The desiccant in the bottle must be retained and do not be discarded.