"The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin "...
- Clinician Information:
Tafinlar Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tafinlar (dabrafenib) is a kinase inhibitor used to treat patients with melanoma with BRAF V600E mutation that is metastatic or unable to be removed by surgery (unresectable). Common side effects include thickening of the skin, hair loss, redness/swelling/numbness on the palms of the hands or soles of the feet, rash, headache, fever, joint pain, back pain, muscle aches, constipation, cough, or cold symptoms.
The recommended dose for Tafinlar is 150 mg orally taken twice daily, approximately 12 hours apart. Take at least 1 hour before or at least 2 hours after a meal. Tafinlar may interact with ketoconazole, nefazodone, clarithromycin, gemfibrozil, rifampin, phenytoin, carbamazepine, phenobarbital, St John's wort, proton pump inhibitors, H2-receptor antagonists, antacids, warfarin, dexamethasone, or hormonal contraceptives. Tell your doctor all medications and supplements you use. Tafinlar can cause fetal harm and is not recommended for use in pregnant women. Tell your doctor if you become pregnant during treatment. It is unknown if this drug is present in human milk. Because many drugs are present in human milk and because of the potential for serious adverse reactions from Tafinlar in nursing infants, consult your doctor before breastfeeding.
Our Tafinlar (dabrafenib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tafinlar FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in greater detail in another section of the label.
- New Primary Cutaneous Malignancies [see WARNINGS AND PRECAUTIONS]
- Tumor Promotion in BRAF Wild-Type Melanoma [see WARNINGS AND PRECAUTIONS]
- Serious Febrile Drug Reactions [see WARNINGS AND PRECAUTIONS]
- Hyperglycemia [see WARNINGS AND PRECAUTIONS]
- Uveitis and Iritis [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of TAFINLAR was evaluated in 586 patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, previously treated or untreated, who received TAFINLAR 150 mg orally twice daily as monotherapy until disease progression or unacceptable toxicity, including 181 patients treated for at least 6 months and 86 additional patients treated for more than 12 months. TAFINLAR was studied in open-label, single-arm trials and in an open-label, randomized, active-controlled trial. The median daily dose of TAFINLAR was 300 mg (range: 118 to 300 mg).
Table 3 and Table 4 present adverse drug reactions and laboratory abnormalities identified from analyses of Trial 1 [see Clinical Studies]. Trial 1, a multi-center, international, open-label, randomized (3:1), controlled trial allocated 250 patients with unresectable or metastatic BRAF V600E mutation-positive melanoma to receive TAFINLAR 150 mg orally twice daily (n = 187) or dacarbazine 1,000 mg/m² intravenously every 3 weeks (n = 63). The trial excluded patients with abnormal left ventricular ejection fraction or cardiac valve morphology ( > Grade 2), corrected QT interval ≥ 480 milliseconds on electrocardiogram, or a known history of glucose-6- phosphate dehydrogenase deficiency. The median duration on treatment was 4.9 months for patients treated with TAFINLAR and 2.8 months for dacarbazine-treated patients. The population exposed to TAFINLAR was 60% male, 99% white, and had a median age of 53 years.
The most commonly occurring adverse reactions ( ≥ 20%) in patients treated with TAFINLAR were, in order of decreasing frequency: hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, and palmar-plantar erythrodysesthesia syndrome (PPES).
The incidence of adverse events resulting in permanent discontinuation of study medication in Trial 1 was 3% for patients treated with TAFINLAR and 3% for patients treated with dacarbazine. The most frequent ( ≥ 2%) adverse reactions leading to dose reduction of TAFINLAR were pyrexia (9%), PPES (3%), chills (3%), fatigue (2%), and headache (2%).
Table 3: Selected Common Adverse Reactions Occurring
in > 10% (All Grades) or > 2% (Grades 3 or 4) of Patients Treated with
|Primary System Organ Class
N = 187
N = 59
|All Grades (%)||Grades 3 and 4b (%)||All Grades (%)||Grades 3 and 4 (%)|
|Skin and subcutaneous tissue disorders|
|Alopecia||22||NA f||2||NA f|
|Palmar-plantar erythrodysesthesia syndrome||20||2||2||0|
|Nervous system disorders|
|General disorders and administration site conditions|
|Musculoskeletal and connective tissue disorders|
|Neoplasms benign, malignant and unspecified (including cysts and polyps)|
|Respiratory, thoracic, and mediastinal disorders|
|Infections and infestations|
|a Adverse drug reactions, reported using
MedDRA and graded using CTCAE version 4.0 for assessment of toxicity.
b Grade 4 adverse reactions limited to hyperkeratosis (n=1) and constipation (n=1).
c Includes skin papilloma and papilloma.
d Includes squamous cell carcinoma of the skin and keratoacanthoma.
e Cases of cutaneous squamous cell carcinoma were required to be reported as Grade 3 per
Table 4 : Incidence of Laboratory Abnormalities
Increased from Baseline Occurring at a Higher Incidence in Patients Treated
with TAFINLAR in Trial 1 [Between Arm Difference of ≥ 5% (All
Grades) or ≥ 2% (Grades 3 or 4)]
|All Grades (%)||Grades 3 and 4 (%)||All Grades (%)||Grades 3 and 4 (%)|
|Increased Alkaline phosphatase||19||0||14||2|
|a Grade 4 laboratory abnormality limited to hypophosphatemia (n=1).|
Other clinically important adverse reactions observed in < 10% of patients (N = 586) treated with TAFINLAR were:
Gastrointestinal Disorders: Pancreatitis.
Immune System Disorders: Hypersensitivity manifesting as bullous rash.
Read the entire FDA prescribing information for Tafinlar (Dabrafenib Capsules) »
Additional Tafinlar Information
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