Dabrafenib Mesylate Application Scope

Dabrafenib Mesylate is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

It is commonly administered in combination with Trametinib (a MEK inhibitor) to improve therapeutic efficacy and delay resistance.

Dabrafenib Mesylate Characteristics

Ingredients:
Dabrafenib Mesylate

Properties:
Oral kinase inhibitor targeting mutated BRAF proteins, interfering with MAPK pathway signaling to inhibit tumor growth.

Packaging Specification:
Capsules of 50 mg and 75 mg

Storage:
Store in a cool, dry place at 20°C to 25°C, protected from moisture and light.

Expiry Date:
Refer to packaging label

Executive Standard:
Over-the-counter OTC

Approval Number:
H20190067

Date of Revision:
2019

Manufacturer:
Novartis Pharma Stein AG (Novartis Pharmaceuticals, Switzerland)

Packaging Enterprise:
Novartis Pharmaceuticals (Beijing) Co., Ltd.

Guidelines for the Use of Dabrafenib Mesylate

Dosage and Administration:
- Recommended Dose: 150 mg orally twice daily, approximately 12 hours apart, taken on an empty stomach (at least 1 hour before or 2 hours after a meal). Capsules should be swallowed whole without chewing, opening, or crushing.
  
  In combination therapy with Trametinib, Dabrafenib dosing remains the same. Trametinib is administered once daily at 2 mg orally, also on an empty stomach.
Adverse Reactions:
- Common Adverse Reactions (≥5% and >3% higher than placebo):
  - Skin and subcutaneous tissue disorders: alopecia, rash (erythema, papules, commonly on head, neck, trunk), palmar-plantar erythrodysesthesia syndrome (redness, swelling, pain in palms and soles)
  - Metabolic abnormalities: hypophosphatemia, hyperglycemia
  - General symptoms: fever, chills, fatigue, headache
  - Gastrointestinal: nausea, vomiting, diarrhea, abdominal pain
- Serious Adverse Reactions:
  - Cutaneous squamous cell carcinoma and keratoacanthoma (approx. 25% incidence, mainly within first 6 months)
  - Hemorrhage (e.g., epistaxis, hemoptysis, gastrointestinal bleeding)
  - Venous thromboembolism (pulmonary embolism, deep vein thrombosis)
  - Cardiomyopathy (may lead to heart failure)
  - Ocular toxicities (uveitis, iritis)
Contraindications: Known hypersensitivity to dabrafenib or its ingredients.
Precautions:
- Regular skin examinations to detect skin malignancies early
- Monitor for bleeding symptoms; suspend treatment if severe bleeding occurs
- Advise effective contraception during treatment and for a period after discontinuation due to fetal risk
- Regular cardiac monitoring (ECG and function tests), especially in patients with cardiovascular risk
- Periodic ophthalmologic examinations
- Liver and kidney function tests during treatment

Dabrafenib Mesylate Interactions

Dabrafenib is primarily used in combination with Trametinib for synergistic effect in treating BRAF V600 mutation-positive cancers.
Drug interactions may occur via CYP3A4 metabolic pathway; caution with concomitant medications is advised.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.