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BRAFTOVI:Prescribing InformationMedication GuideMEKTOVI:Prescribing InformationMedication GuideIndicationPatient Site
Access and 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. From helping to identify financial assistance options to connecting patients to resources for emotional support, our patients’ needs are our priority.

 Access & Reimbursement Assistance

Pfizer Oncology Together is committed to supporting patients as they navigate access to prescribed Pfizer Oncology medications. We offer tools and resources to help patients receive their prescribed BRAFTOVI + MEKTOVI in a timely manner, including benefits verification and information related to prior authorizations, appeals, product distribution, and billing and coding.

 Patient Financial Assistance

Pfizer Oncology Together can help patients understand their insurance benefits and connect them with financial assistance resources (if needed), regardless of their insurance coverage.

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. Limits, terms, and conditions apply.* Patients may receive up to $25,000 per product in savings annually. There are no income requirements, forms, or faxing to enroll
ReferencesPatients 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 patients with Medicare/Medicare Part D, Medicaid, and other government insurance plans who express a financial need:

  • We can assist patients with searching for financial support from alternate funding resources, which may include 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 your patient is eligible for the Pfizer Patient Assistance Program,† which can provide prescribed Pfizer Oncology medications for free
ReferencesThe Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™. Free medicines from Pfizer are provided through the Pfizer Patient Assistance Foundation™. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct legal restrictions. Uninsured

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

  • We can check patient eligibility for Medicaid and help them understand how to apply
  • Patients who do not qualify for Medicaid may receive free medication through the Pfizer Patient Assistance Program†. Patients must be eligible and reapply as needed
ReferencesThe Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™. Free medicines from Pfizer are provided through the Pfizer Patient Assistance Foundation™. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct restrictions.Medicare/Government insured

Help identifying resources for patients with Medicare/Medicare Part D, Medicaid, and other government insurance plans who express a financial need and may be eligible:

  • We can assist patients with searching for financial support from alternate funding resources, which may include 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 your patient is eligible for the Pfizer Patient Assistance Program,† which can provide prescribed Pfizer Oncology medications for free

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.

Uninsured

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

  • We can check patient eligibility for Medicaid and help them understand how to apply
  • Patients who do not qualify for Medicaid may receive free medication through the Pfizer Patient Assistance Program† or at a savings through the Pfizer Savings Program.‡ Patients must be eligible and reapply as needed

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 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.

Medicare/Government insured

Help identifying resources for patients with Medicare/Medicare Part D, Medicaid, and other government insurance plans who express a financial need and may be eligible:

  • We can assist patients with searching for financial support from alternate funding resources, which may include 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 your patient is eligible for the Pfizer Patient Assistance Program,† which can provide prescribed Pfizer Oncology medications for free

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.

Uninsured

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

  • We can check patient eligibility for Medicaid and help them understand how to apply
  • Patients who do not qualify for Medicaid may receive free medication through the Pfizer Patient Assistance Program† or at a savings through the Pfizer Savings Program.‡ Patients must be eligible and reapply as needed

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 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.

 Personalized Patient Support

When patients and caregivers need support for their day-to-day challenges with treatment, 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.§ 
 

§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.

Personalized Patient Support

When patients and caregivers need support for their day-to-day challenges with treatment, 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.§

ReferencesSome 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.

 Emotional Support

We can connnect patients to diagnosis-specific support groups, an independent organization that offers short-term counseling, and a free app, developed by Pfizer Oncology, to help patients connect with loved ones and ask for the support they need.

 Educational Support

To help support patients’ mental well-being and physical health, we’ve created resources on topics like nutrition, stress management, and communication.

 Practical Support

If patients need assistance with transportation or lodging for treatment-related appointments, we’ll connect them to independent organizations that offer these services for free to qualifying patients.

 Getting Your Medicine Pfizer Oncology Together can help you understand your options for obtaining your prescribed BRAFTOVI + MEKTOVI. We can identify a specialty pharmacy that can fill your prescription, based on your insurance plan. Specialty pharmacies provide medicines that might not be available at typical neighborhood pharmacies. Usually, a specialty pharmacy will ship your medicine directly to your home.Visit the websiteLoadingThis Is Living With Cancer™

This Is Living With Cancer™ is a free online resource developed by Pfizer Oncology for all people living with cancer, regardless of age, income, race, location, cancer type, or stage of disease. This comprehensive program is available to anyone in the United States, whether they are on a Pfizer treatment or not, with a growing focus on those facing challenges accessing care.

 Learn moreLoadingThe free resources offered through This Is Living With Cancer™ and LivingWith® are available to anyone living with cancer and their loved ones, and are not specific to BRAFTOVI + MEKTOVI. Patient & Caregiver BrochureDownloadLoading

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IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS New Primary Malignancies: New primary malignancies, cutaneous and non-cutaneous, 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. Monitor patients for new malignancies prior to initiation of treatment, while on treatment, and after discontinuation of treatment. 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: 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. 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. Monitor liver laboratory tests before initiation of BRAFTOVI and 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.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.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. Ocular Toxicities: In the COLUMBUS trial, serous retinopathy (retinal detachment) 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 BRAFTOVI. In patients with BRAF mutation-positive melanoma receiving MEKTOVI with BRAFTOVI (n=690), 1 patient (0.1%) experienced RVO. 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. QT 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 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. 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.Embryo-Fetal Toxicity: BRAFTOVI and MEKTOVI can cause fetal harm when administered to pregnant women.
BRAFTOVI can render hormonal contraceptives ineffective. Effective, non-hormonal contraceptives should be used during treatment and for at least 30 days after the final dose for patients taking BRAFTOVI with 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. In the COLUMBUS trial, 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.Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with MEKTOVI. Refer to the prescribing information for BRAFTOVI and MEKTOVI for additional risk information.Lactation: Advise women not to breastfeed during treatment with BRAFTOVI and MEKTOVI and for 2 weeks after the final dose.Infertility: Advise males of reproductive potential that BRAFTOVI may impair fertility. ADVERSE REACTIONSThe 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 Strong or moderate CYP3A4 inhibitors: Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the BRAFTOVI dose. Strong CYP3A4 inducers: Avoid coadministration of BRAFTOVI with strong CYP3A4 inducers. Sensitive CYP3A4 substrates: Avoid the coadministration of BRAFTOVI with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. If the coadministration cannot be avoided, see the CYP3A4 substrate product labeling for recommendations.Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used
concomitantly with BRAFTOVI. Avoid coadministration of BRAFTOVI with drugs known to prolong QT/QTc interval. The information above 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. Please see full Prescribing Information for BRAFTOVI and full Prescribing Information for MEKTOVI for additional information.INDICATION AND USAGEBRAFTOVI® (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.
INDICATION 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.