Lafinacapsule 75mg (Dabrafenib Mesilate)

Adult dose

The recommended dose of this drug in adult patients is 150mg twice daily, regardless of body weight, for both monotherapy and combination therapy (equivalent to a total daily dose of 300mg). Dose reduction to less than 50mg twice daily is not recommended for monotherapy or combination therapy with this drug. Starting dose: 150mg twice daily First dose reduction: 100mg twice daily Second dose reduction: 75mg twice daily Third dose reduction: 50mg twice daily Further dose reduction: Permanently discontinue treatment if 50mg twice daily is not tolerated It is recommended that treatment continue unless the patient no longer benefits or unacceptable toxicity occurs. For adjuvant treatment of melanoma, treatment duration is limited to a maximum of 1 year. If a dose is missed and less than 6 hours remain until the next dose, do not take the missed dose. Dabrafenib should be taken at least 1 hour before or at least 2 hours after a meal, with approximately 12 hours between doses. This drug should be taken at about the same time each day to improve patient adherence. If vomiting occurs after taking this drug, do not take an additional dose; take the next dose according to the regular schedule. Swallow the capsules whole with water. Do not chew or crush the capsules, and do not mix them with food or liquids because of the chemical instability of dabrafenib. When this drug is used in combination with trametinib, administer trametinib once daily at the same time as the morning or evening dose of this drug. Treatment interruption, dose reduction, or treatment discontinuation may be necessary to manage adverse reactions. If the patient's adverse reactions are effectively managed, dose re-escalation may be considered using the same dose levels as for dose reduction. The dose should not exceed 150mg twice daily. Dose adjustment or treatment interruption is not recommended for adverse reactions of cutaneous squamous cell carcinoma (cuSCC) or new primary melanoma. Fever of 38℃~40℃ (at the first symptom in case of recurrence): Interrupt treatment with this drug until the fever resolves. Then resume treatment at the same or a lower dose. Fever above 40℃, or fever accompanied by complications such as rigors, hypotension, dehydration, or renal failure: Interrupt treatment with this drug until the fever resolves. Then resume treatment at a lower dose. Alternatively, permanently discontinue treatment with this drug. Intolerable Grade 2 skin toxicity, Grade 3 or 4 skin toxicity: Interrupt treatment with this drug for up to 3 weeks. If the condition improves, resume treatment at a lower dose. If it does not improve, permanently discontinue treatment. Symptomatic congestive heart failure or an absolute decrease in LVEF of 20% or more from baseline and below the institutional LLN: Interrupt treatment with this drug; if the condition improves, resume treatment at the same dose. Life-threatening pulmonary embolism: Permanently discontinue treatment with this drug. Uveitis, including iritis and iridocyclitis: In cases of mild or moderate uveitis that does not respond to ocular therapy, or severe uveitis, interrupt dabrafenib treatment for up to 6 weeks. If the condition improves to Grade 0~1, resume treatment at the same or a lower dose. If it does not improve, permanently discontinue treatment. Intolerable Grade 2 adverse reaction, or any Grade 3 adverse reaction: Interrupt treatment with this drug. If the condition improves to Grade 0~1, resume treatment at a lower dose. If it does not improve, permanently discontinue treatment. First occurrence of a Grade 4 adverse reaction: Interrupt treatment with this drug until the adverse reaction improves to Grade 0~1. Then resume treatment at a lower dose. Alternatively, permanently discontinue treatment. Recurrence of any Grade 4 adverse reaction: Permanently discontinue treatment with this drug. When adjusting the dose of concomitant trametinib for the following adverse reactions, dose adjustment of this drug is not recommended: retinal pigment epithelial detachment, retinal vein occlusion, interstitial lung disease/pneumonitis, uncomplicated deep vein thrombosis, or pulmonary embolism Continue treatment and monitor as clinically indicated when adverse reactions are Grade 1 or Grade 2 (tolerable). Permanently discontinue dabrafenib if a RAS mutation-positive noncutaneous malignancy adverse reaction occurs. If the patient's body temperature is 38℃ or higher, interrupt treatment with this drug (and with trametinib if used in combination). In case of recurrence, treatment may be interrupted at the first symptom of fever. Treatment with an antipyretic such as ibuprofen or acetaminophen (paracetamol) should be initiated. If antipyretics are inadequate, consider administering an oral corticosteroid. The patient should be assessed for signs and symptoms of infection. After the patient has been symptom-free for at least 24 hours, resume treatment with this drug (and with trametinib in the case of combination therapy) as follows. (1) Resume at the same dose (2) Or, if fever recurs or is accompanied by other severe symptoms, including dehydration, hypotension, or renal failure, resume at a dose reduced by one dose level according to Tables 1, 3, and 4

Child dose

26 – 37kg: 75mg orally twice daily 38 – 50kg: 100mg orally twice daily 51kg or more: 150mg orally twice daily The recommended dose has not been established for patients weighing less than 26kg. Recommended dose 75mg orally twice daily: starting dose 75mg orally twice daily; first dose reduction 50mg orally twice daily; second and third dose reductions: - Recommended dose 100mg orally twice daily: starting dose 100mg orally twice daily; first dose reduction 75mg orally twice daily; second dose reduction 50mg orally twice daily; third dose reduction: - Recommended dose 150mg orally twice daily: starting dose 150mg orally twice daily; first dose reduction 100mg orally twice daily; second dose reduction 75mg orally twice daily; third dose reduction 50mg orally twice daily Discontinue treatment permanently if the patient does not tolerate the third reduced dose or this medicine at 50mg twice daily.

This drug should not be administered to patients who are hypersensitive to the active ingredient or any of its components. Caution is required as various adverse reactions may occur when using this drug. In particular, symptoms such as fever, headache, nausea, vomiting, diarrhea, fatigue, rash, arthralgia, and hair loss can commonly occur. When this drug is combined with other drugs, the frequency and severity of adverse reactions may increase, so it is essential to follow the healthcare provider's guidance. During administration, liver function, heart function, and blood tests should be regularly checked to identify any abnormalities. As new lesions may develop on the skin or abnormalities resembling skin cancer may occur, regular skin examinations are necessary both before and during treatment. Heart function may decline, so monitoring left ventricular ejection fraction through echocardiography is important. If fever occurs, the healthcare provider should be notified immediately, and if necessary, medication should be stopped or dosage adjusted. Severe side effects such as pancreatitis, renal failure, and uveitis may occur, so prompt medical attention is required if symptoms arise. This drug is metabolized by liver enzymes CYP3A4 and CYP2C8, so caution is necessary when used in combination with drugs that inhibit or induce these enzymes, as drug concentrations may change. Due to the possibility of interactions with other drugs, patients should inform their healthcare provider about any medications they are taking. If there are changes in vision or pain in the eyes, immediate examination is necessary, and if severe skin adverse reactions occur, administration should be discontinued. If pregnant or planning to become pregnant, patients must consult with healthcare providers regarding the use of this drug. This drug may have a minimal effect on driving or operating machinery, so caution is advised if experiencing fatigue or dizziness. Regular check-ups and monitoring for adverse reactions during administration of this drug are vital, and any unusual symptoms should be discussed with a healthcare provider immediately.

hyperplasia, headache, fever, arthralgia, fatigue, nausea, papilloma, hair loss, rash, vomiting, chills, diarrhea, hypertension, peripheral edema, cough, nasopharyngitis, soft fibroma, skin squamous cell carcinoma, basal cell carcinoma, seborrheic keratosis, new primary melanoma, hypersensitivity reaction, decreased appetite, hypophosphatemia, hyperglycemia, uveitis, constipation, pancreatitis, actinic keratosis, skin lesions, dry skin, erythema, itching, panniculitis, myalgia, limb pain, renal failure, acute renal failure, interstitial nephritis, lethargy, influenza-like illness, decreased LVEF, QT prolongation, urinary tract infection, cellulitis, folliculitis, paronychia, pustular rash, squamous cell carcinoma in situ, increased serum alkaline phosphatase, increased gamma-glutamyl transferase, dizziness, blurred vision, visual impairment, retinal detachment, periorbital edema, bradycardia, left ventricular failure, heart failure, bleeding, hypotension, lymphedema, dyspnea, pulmonary inflammation, interstitial lung disease, gastrointestinal perforation, colitis, abdominal pain, dry mouth, stomatitis, acneiform dermatitis, diaphoresis, skin fissures, muscle cramps, elevated serum creatine phosphokinase, rhabdomyolysis, nephritis, mucosal inflammation, influenza-like syndrome, facial edema, increased alanine aminotransferase, increased aspartate aminotransferase, neutropenia, anemia, thrombocytopenia, leukopenia, chorioretinopathy, hemophagocytic lymphohistiocytosis, tumor lysis syndrome, peripheral neuropathy, Guillain-Barré syndrome, atrioventricular block, conduction block, venous thromboembolism, acute febrile neutrophilic dermatosis, Stevens-Johnson syndrome, drug reactions associated with eosinophilia and systemic symptoms, generalized exfoliative dermatitis, myocarditis, cardiomyopathy, weight gain, vascular abnormalities, pulmonary embolism, pneumonia, sepsis, pleural effusion, increased serum alkaline phosphatase, increased serum alkaline phosphatase

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is best to keep it at a temperature between 1 to 30 degrees Celsius. Therefore, it should be safely stored away from direct sunlight, high temperatures, and places with high humidity.

Appearance

Opaque dark pink capsule

Package unit

120 capsules (120 capsules/bottle packaging X 1)