HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciTram safely and effectively. See full prescribing information for LuciTram.

INDICATIONS AND USAGE

LuciTram is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA approved test.

LuciTram is indicated, in combination with dabrafenib, for:

• the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

• the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.

• the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.

• the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

• the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

• the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

DOSAGE AND ADMINISTRATION

The recommended dosage of LuciTram in adult patients is 2 mg orally once daily. The recommended dosage for LuciTram in pediatric patients is based on body weight. Take LuciTram at least 1 hour before or at least 2 hours after a meal.

DOSAGE FORMS AND STRENGTHS

Tablets: 2 mg×30 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• New Primary Malignancies, Cutaneous and Non-Cutaneous: Can occur when LuciTram is used with dabrafenib. Monitor patients for new malignancies prior to, or while on therapy, and following discontinuation of treatment.

• Hemorrhage: Major hemorrhagic events can occur. Monitor for signs and symptoms of bleeding.

• Colitis and Gastrointestinal Perforation: Colitis and gastrointestinal perforation can occur in patients receiving LuciTram.

• Venous Thromboembolic Events: Deep vein thrombosis (DVT) and pulmonary embolism (PE) can occur in patients receiving LuciTram.

• Cardiomyopathy: Assess left ventricular ejection fraction (LVEF) before treatment, after one month of treatment, then every 2 to 3 months thereafter.  

• Ocular Toxicities: Perform ophthalmological evaluation for any visual disturbances. For Retinal Vein Occlusion (RVO), permanently discontinue LuciTram.

• Interstitial Lung Disease (ILD)/Pneumonitis: Withhold LuciTram for new or progressive unexplained pulmonary symptoms. Permanently discontinue LuciTram for treatment-related ILD or pneumonitis.

• Serious Febrile Reactions: Can occur when LuciTram is used with dabrafenib.

• Serious Skin Toxicities: Monitor for skin toxicities and for secondary infections. Permanently discontinue LuciTram for intolerable Grade 2 or for Grade 3 or 4 rash not improving within 3 weeks despite interruption of LuciTram. Permanently discontinue for severe cutaneous adverse reactions (SCARs).

• Hyperglycemia: Monitor serum glucose levels in patients with preexisting diabetes or hyperglycemia.

• Hemophagocytic Lymphohistiocytosis (HLH): Interrupt treatment for suspected HLH. Discontinue treatment if HLH is confirmed.

• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

Most common adverse reactions (≥ 20%) for LuciTram as a single agent include rash, diarrhea, and lymphedema.

Most common adverse reactions (≥ 20%) for LuciTram in combination with dabrafenib include:

• Unresectable or metastatic melanoma: pyrexia, nausea, rash, chills, diarrhea, vomiting, hypertension, and peripheral edema.

• Adjuvant treatment of melanoma: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia.

• NSCLC: pyrexia, fatigue, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea.

• Adult patients with solid tumors: pyrexia, fatigue, nausea, rash, chills, headache, hemorrhage, cough, vomiting, constipation, diarrhea, myalgia, arthralgia, and edema.

• Pediatric patients with solid tumors: pyrexia, rash, vomiting, fatigue, dry skin, cough, diarrhea, dermatitis acneiform, headache, abdominal pain, nausea, hemorrhage, constipation, and paronychia.

• Pediatric patients with LGG: pyrexia, rash, headache, vomiting, musculoskeletal pain, fatigue, diarrhea, dry skin, nausea, hemorrhage, abdominal pain, and dermatitis acneiform.

USE IN SPECIFIC POPULATIONS

• Lactation: Do not breastfeed.  

• Females and Males of Reproductive Potential: May impair fertility. Counsel patients on pregnancy planning and prevention.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.