BRAFTOVI:

MEKTOVI:

Access & patient support​​​​​​​

Making your patients’ support needs a priority. Together.

At Pfizer Oncology Together, patient support is at the core of everything we do. We've gathered resources and developed tools to help patients and their loved ones throughout BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) treatment.

Personalized patient support

When your patients need support for their day-to-day challenges, we want to be a place they can turn to for help. At Pfizer Oncology Together, our Care Champions, who have social work experience, can connect patients prescribed BRAFTOVI + MEKTOVI to resources that may help with some of their daily needs.*
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  • Connections to emotional support resources such as diagnosis-specific support groups, an independent organization’s helpline, and a free app to connect with loved ones
  • Connections to independent organizations that help eligible patients find free rides and lodging for treatment-related appointments
  • Educational information about physical and mental health, nutrition, and BRAFTOVI + MEKTOVI
  • Information to help patients prepare for leaving or returning to work

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LivingWith® helps take care of the small details so patients can focus on the big picture

Help your patients and their caregivers stay connected and get organized by telling them about LivingWith®, a free app developed by Pfizer Oncology, designed to help manage life with cancer.

Download LivingWith® for free. Available in English and Spanish.

 
Learn more
The LivingWith® app is available to anyone living with cancer and their loved ones, and is not specific to BRAFTOVI + MEKTOVI.

  *Some services are provided through third-party organizations that operate independently and are not controlled by Pfizer. Availability of services and eligibility requirements are determined solely by these organizations.

BRAFTOVI + MEKTOVI is available through specific specialty pharmacies​​​​​​​

To help your patients access the medication you’ve prescribed, we can provide a list of specialty pharmacies.

Visit PfizerOncologyTogether.com to see the complete list of specialty pharmacies in the BRAFTOVI + MEKTOVI distribution network.

Visit the website

Patient financial assistance

Commercially insured

Resources for eligible patients with commercial, private, employer, or state health insurance marketplace coverage:

  • Co-pay assistance: Eligible, commercially insured patients may pay as little as $0 per month for BRAFTOVI + MEKTOVI. Patients may receive up to $25,000 per product in savings annually. Limits, terms, and conditions apply† There are no income requirements, forms, or faxing to enroll.

  Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico. Patients may receive up to $25,000 per product in savings annually. The offer will be accepted only at participating pharmacies. This offer is not health insurance. No membership fees apply. Pfizer reserves the right to rescind, revoke, or amend this offer without notice. For full Terms and Conditions, please see PfizerOncologyTogether.com/terms. For any questions, please call 1-877-744-5675, visit PfizerOncologyTogether.com/terms or write: Pfizer Oncology Together Co-Pay Savings Program, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560.

Medicare/Government insured

Help identifying resources for eligible patients with Medicare/Medicare Part D, Medicaid, and other government insurance plans:

  • Assistance for patients with searching for financial support that may be available from alternate funding resources. These resources include independent charitable foundations which exist independently of Pfizer and have their own eligibility criteria and application processes. Availability of support from the foundations is determined solely by the foundations
  • Financial assistance through Extra Help, a Medicare Part D Low-Income Subsidy (LIS) program
  • If support from alternate funding resources or Medicare Extra Help is not available, Pfizer Oncology Together will see if you’re eligible for the Pfizer Patient Assistance Program, which can provide your prescribed Pfizer Oncology medicine for free

Uninsured

Help identifying resources for eligible patients without any form of healthcare coverage:

  • Help finding coverage.
  • Free medicine through the Pfizer Patient Assistance Program for up to 1 year, for eligible patients who do not qualify for Medicaid and reapply annually​​​​​​​
  • Medicine at a savings through the Pfizer Savings Program,§ for patients who meet the eligibility requirements and reapply annually

  ‡The Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct legal restrictions.

  §The Pfizer Savings Program is not health insurance. For more information, call the toll-free number: 1-877-744-5675. There are no membership fees to participate in this program. Estimated savings are 50% and depend on such factors as the particular drug purchased, amount purchased, and the pharmacy where purchased.

Resources

  • Access & patient support
  • Patient & caregiver resources
  • Oncologist resources
  • Peer-to-peer insights
  • APP & Nurse Center

Patient & Caregiver Brochure

Download

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. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Dose modification is not recommended for new primary cutaneous malignancies. 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 using an FDA-approved test 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 left ventricular ejection fraction (LVEF) by echocardiogram or multi-gated acquisition (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. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. 

Venous Thromboembolism (VTE): In the COLUMBUS trial, VTE occurred in 6% of patients, including 3.1% of patients who developed pulmonary embolism. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hemorrhage: Hemorrhage can occur when BRAFTOVI is administered in combination with MEKTOVI. In the COLUMBUS trial, hemorrhage occurred in 19% of patients and ≥ Grade 3 hemorrhage occurred in 3.2% of patients. The most frequent hemorrhagic events were gastrointestinal, including rectal hemorrhage (4.2%), hematochezia (3.1%), and hemorrhoidal hemorrhage (1%). Fatal intracranial hemorrhage in the setting of new or progressive brain metastases occurred in 1.6% of patients. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

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. Retinal vein occlusion (RVO) is a known class-related adverse reaction of MEK inhibitors and may occur in patients treated with MEKTOVI in combination with encorafenib. In patients with BRAF mutation-positive melanoma receiving MEKTOVI with BRAFTOVI (n=690), 1 patient experienced RVO (0.1%). The safety of MEKTOVI has not been established in patients with a history of RVO or current risk factors for RVO including uncontrolled glaucoma or a history of hyperviscosity or hypercoagulability syndromes. 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 treated with MEKTOVI in combination with BRAFTOVI. Assess for visual symptoms at each visit. Perform an ophthalmological evaluation at regular intervals and for new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. 

Interstitial Lung Disease (ILD): ILD, including pneumonitis occurred in 0.3% (2 of 690 patients) with BRAF mutation-positive melanoma receiving MEKTOVI with BRAFTOVI. Assess new or progressive unexplained pulmonary symptoms or findings for possible ILD. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. 

Hepatotoxicity: Hepatotoxicity can occur when MEKTOVI is administered in combination with BRAFTOVI. 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. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. 

Rhabdomyolysis: Rhabdomyolysis can occur when MEKTOVI is administered in combination with BRAFTOVI. In the COLUMBUS trial, elevation of laboratory values of serum CPK occurred in 58% of patients. Rhabdomyolysis was reported in 0.1% (1 of 690 patients) with BRAF mutation-positive melanoma receiving MEKTOVI with BRAFTOVI. Monitor CPK and creatinine levels prior to initiating MEKTOVI, periodically during treatment, and as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

QTc Prolongation: BRAFTOVI is associated with dose-dependent QTc interval prolongation in some patients. In the COLUMBUS trial, an increase in QTcF to > 500 ms was measured in 0.5% (1/192) of patients who received BRAFTOVI in combination with MEKTOVI. 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 and MEKTOVI can cause fetal harm when administered to pregnant women. BRAFTOVI can render hormonal contraceptives ineffective. 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 patients treated with 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) for BRAFTOVI and MEKTOVI compared to vemurafenib were: fatigue (43% vs. 46%), nausea (41% vs. 34%), diarrhea (36% vs. 34%), vomiting (30% vs. 16%), abdominal pain (28% vs. 16%), arthralgia (26% vs. 46%), myopathy (23% vs. 22%), hyperkeratosis (23% vs. 49%), rash (22% vs. 53%), headache (22% vs. 20%), constipation (22% vs. 6%), visual impairment (20% vs. 4%), serous retinopathy/RPED (20% vs. 2%). 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%) for BRAFTOVI and MEKTOVI compared to vemurafenib included increased creatinine (93% vs. 92%), increased creatine phosphokinase (58% vs. 3.8%), increased gamma glutamyl transferase (GGT) (45% vs. 34%), anemia (36% vs. 34%), increased ALT (29% vs. 27%), hyperglycemia (28% vs. 20%), increased AST (27% vs. 24%), and increased alkaline phosphatase (21% vs. 35%).

DRUG INTERACTIONS

Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors (including grapefruit juice) or CYP3A4 inducers and use caution with sensitive CYP3A4 substrates. Avoid coadministration of BRAFTOVI with hormonal contraceptives.

Modify BRAFTOVI dose if coadministration with a strong or moderate CYP3A4 inhibitor cannot be avoided.

Avoid coadministration of BRAFTOVI with drugs known to prolong QT/QTc interval.

Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI.

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

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.

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.