FOR YOUR PATIENTS WITH
BRAF-MUTANT METASTATIC MELANOMA

Learn About the Clinical Data

View the results from the COLUMBUS trial.

Order BRAFTOVI + MEKTOVI

Available through a network of specialty pharmacies.

Learn About Our
$0 Co-Pay Savings Program

Available for eligible commercially-insured patients.

*In order to be eligible for the Array Co-Pay Savings Program, the patient must not have government-funded health insurance (Medicare, Medicaid, or any other federal or state program), must be taking BRAFTOVI + MEKTOVI for an FDA-approved indication, and must confirm that they meet all of the eligibility criteria and agree to the rules set forth in the terms and conditions for the program. Click here to see full terms and conditions.

Important Safety Information and Indication

The information below applies to the safety of the combination of BRAFTOVI and MEKTOVI unless otherwise noted. See full prescribing information for BRAFTOVI and for MEKTOVI for dose modifications for adverse reactions.

WARNINGS AND PRECAUTIONS

New Primary Malignancies, cutaneous and non-cutaneous malignancies can occur. In the COLUMBUS trial, cutaneous squamous cell carcinoma (cuSCC), including keratoacanthoma (KA), occurred in 2.6% and basal cell carcinoma occurred in 1.6% of patients. Median time to first occurrence of cuSCC/KA was 5.8 months. Perform dermatologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Based on its mechanism of action, BRAFTOVI may promote malignancies associated with activation of RAS through mutation or other mechanisms. Monitor patients receiving BRAFTOVI for signs and symptoms of non-cutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive non-cutaneous malignancies.

Tumor Promotion in BRAF Wild-Type Tumors: In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K mutation prior to initiating BRAFTOVI.

Cardiomyopathy, manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in ejection fraction, has been reported in patients. In the COLUMBUS trial, evidence of cardiomyopathy occurred in 7% and Grade 3 left ventricular dysfunction occurred in 1.6% of patients. The median time to first occurrence of left ventricular dysfunction (any grade) was 3.6 months. Cardiomyopathy resolved in 87% of patients. Assess LVEF by echocardiogram or MUGA scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment. The safety has not been established in patients with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal (LLN). Patients with cardiovascular risk factors should be monitored closely.

Venous Thromboembolism (VTE): In the COLUMBUS trial, VTE occurred in 6% of patients, including 3.1% of patients who developed pulmonary embolism.

Hemorrhage: In the COLUMBUS trial, hemorrhage occurred in 19% of patients and ≥ Grade 3 hemorrhage occurred in 3.2% of patients. Fatal intracranial hemorrhage in the setting of new or progressive brain metastases occurred in 1.6% of patients. The most frequent hemorrhagic events were gastrointestinal, including rectal hemorrhage (4.2%), hematochezia (3.1%), and hemorrhoidal hemorrhage (1%).

Ocular Toxicities: In the COLUMBUS trial, serous retinopathy occurred in 20% of patients; 8% were retinal detachment and 6% were macular edema. Symptomatic serous retinopathy occurred in 8% of patients with no cases of blindness. The median time to onset of the first event of serous retinopathy (all grades) was 1.2 months. In patients with BRAF mutation-positive melanoma across multiple clinical trials, 0.1% of patients experienced retinal vein occlusion (RVO). Perform ophthalmological evaluation for patient-reported acute vision loss or other visual disturbance within 24 hours. Permanently discontinue MEKTOVI in patients with documented RVO. In COLUMBUS, uveitis, including iritis and iridocyclitis was reported in 4% of patients. Assess for visual symptoms at each visit. Perform an ophthalmological evaluation at regular intervals any time a patient reports visual disturbances.

Interstitial Lung Disease (ILD): ILD, including pneumonitis occurred in 0.3% of patients with BRAF mutation-positive melanoma across multiple clinical trials. Assess new or progressive unexplained pulmonary symptoms or findings for possible ILD.

Hepatotoxicity: In the COLUMBUS trial, the incidence of Grade 3 or 4 increases in liver function laboratory tests was 6% for alanine aminotransferase (ALT), 2.6% for aspartate aminotransferase (AST), and 0.5% for alkaline phosphatase. No patient experienced Grade 3 or 4 serum bilirubin elevation. Monitor liver laboratory tests before initiation of MEKTOVI, monthly during treatment, and as clinically indicated.

Rhabdomyolysis: In the COLUMBUS trial, elevation of laboratory values of serum CPK occurred in 58% of patients. Rhabdomyolysis was reported in 0.1% of patients with BRAF mutation-positive melanoma receiving MEKTOVI with encorafenib across multiple clinical trials. Monitor CPK and creatinine levels prior to initiating MEKTOVI, periodically during treatment, and as clinically indicated.

QTc Prolongation: In the COLUMBUS trial, an increase in QTcF to > 500 ms was measured in 0.5% (1/192) of patients. Monitor patients who already have or who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QT prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc > 500 ms.

Embryo-Fetal Toxicity: BRAFTOVI or MEKTOVI can cause fetal harm when administered to pregnant women. Nonhormonal contraceptives should be used during treatment and for at least 30 days after the final dose for patients taking BRAFTOVI + MEKTOVI.

Risks Associated with BRAFTOVI as a Single Agent: There is an increased risk of certain adverse reactions compared to when BRAFTOVI is used in combination with MEKTOVI. Grades 3 or 4 dermatologic reactions occurred in 21% of BRAFTOVI single agent compared to 2% in patients treated with BRAFTOVI in combination with MEKTOVI. If MEKTOVI is temporarily interrupted or permanently discontinued, reduce the dose of BRAFTOVI as recommended.

ADVERSE REACTIONS

The most common adverse reactions (≥20%, all Grades, in the COLUMBUS trial): were fatigue (43%), nausea (41%), diarrhea (36%), vomiting (30%), abdominal pain (28%), arthralgia (26%), myopathy (23%), hyperkeratosis (23%), rash (22%), headache (22%), constipation (22%), visual impairment (20%), serous retinopathy (20%). Other clinically important adverse reactions occurring in <10% of patients in the COLUMBUS Trial were facial paresis, pancreatitis, panniculitis, drug hypersensitivity and colitis.

In the COLUMBUS Trial, the most common laboratory abnormalities (all grades) (≥ 20%) included increased creatinine (93%), increased creatine phosphokinase (58%), increased gamma glutamyl transferase (GGT) (45%), anemia (36%), increased ALT (29%), hyperglycemia (28%), increased AST (27%), and increased alkaline phosphatase (21%).

DRUG INTERACTIONS

Avoid concomitant use of strong or moderate CYP3A4 inhibitors or inducers and sensitive CYP3A4 substrates with BRAFTOVI. Modify BRAFTOVI dose if concomitant use of strong or moderate CYP3A4 inhibitors cannot be avoided.

Please see full Prescribing Information for BRAFTOVI and full Prescribing Information for MEKTOVI for additional information.

Indications AND USAGE

BRAFTOVI™ (encorafenib) and MEKTOVI® (binimetinib) are kinase inhibitors indicated for use in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test.

Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma.

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Co-Pay Savings Program Terms and Conditions

By using the Array Co-Pay Savings Program, the patient acknowledges and confirms that, at the time of usage, (s)he is currently eligible and meets the criteria set forth in the terms and conditions described.

This Co-Pay Savings Program is valid ONLY for patients with commercial (private or non-governmental) insurance who are taking the medication for a Food and Drug Administration (FDA)-approved indication. Patients using Medicare, Medicaid, or any other federal or state government-funded program to pay for their medications are not eligible. Patients who start utilizing their government coverage during their enrollment period will no longer be eligible for the program. Patients may pay as little as $0 per month and Array BioPharma will pay the remaining out-of-pocket cost up to a maximum of $25,000.00 per calendar year. Any costs exceeding the maximum of $25,000.00 are the responsibility of the patient.

This Co-Pay Savings Program is not health insurance or a benefit plan. Distribution or use of the Co-Pay Savings Program does not obligate use or continuing use of any specific product or provider. Patient or guardian is responsible for reporting the receipt of all Co-Pay Savings Program benefits or reimbursement received to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Co-Pay Savings Program, as may be required.

The Co-Pay Savings Program is not valid for medications the patient receives for free or that are eligible to be reimbursed by private insurance plans or other healthcare or pharmaceutical assistance programs that reimburse the patient in part or for the entire cost of his/her Array BioPharma medication. Patient, guardian, pharmacist, prescriber, and any other person using the Co-Pay Savings Program agree not to seek reimbursement for all or any part of the benefit received by the recipient through the offer.

The Co-Pay Savings Program will be accepted by participating pharmacies, physician offices, or hospitals. To qualify for the benefits of this Co-Pay Savings Program, the patient may be required to pay out-of-pocket expenses for each treatment. This Co-Pay Savings Program is only available with a valid prescription and cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. Use of this Co-Pay Savings Program must be consistent with all relevant health insurance requirements and payer agreements. Participating patients, pharmacies, physician offices, and hospitals are obligated to inform third-party payers about the use of the Co-Pay Savings Program as provided for under the applicable insurance or as otherwise required by contract or law. The Co-Pay Savings Program may not be sold, purchased, traded, or offered for sale, purchase, or trade. The Co-Pay Savings Program is limited to 1 per person during this offer period and is not transferable. Program eligibility period is contingent upon patient’s ability to meet and maintain all requirements as set forth by the program. Array BioPharma may periodically verify eligibility and will terminate patients without obligation to pay claims if change to status is detected. This program is not valid where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents where applicable (e.g. MA, CA).

The patient must be 18 years or older to receive Co-Pay Savings Program assistance. This Co-Pay Savings Program is (1) void if reproduced; (2) void where prohibited by law; (3) only valid in the United States and Puerto Rico; (4) only valid for FDA-approved on-label indications of Array BioPharma products; and (5) expires on 12/31/2018. Healthcare providers may not advertise or otherwise use the program as a means of promoting their services or Array BioPharma’s products to patients. Array BioPharma reserves the right to rescind, revoke, amend, or terminate the program without notice at any time.