MEKTOVI® Other (binimetinib) | Pfizer Medical Information - US

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

Distributed by:
Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc.
3200 Walnut Street
Boulder, CO 80301

© 2020 Array BioPharma Inc. All rights reserved.
MEKTOVI® is a registered trademark of Array BioPharma Inc. in the United States and various other countries.
Patented. See www.arraybiopharma.com/patents

LAB-1426-1.0

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

MEKTOVI® Quick Finder

Pfizer samples (for eligible HCPs)

Requests for samples of prescription medications can be made by contacting Pfizer for Professionals at 1-800-505-4426 or by visiting the PfizerPro website www.pfizerpro.com.
Report an adverse event or concern about the quality of a Pfizer product

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly by visiting www.fda.gov/medwatch or by calling (800)-332-1088.
Assistance programs (for eligible patients)

Pfizer RxPathways connects eligible patients to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. Patients and physicians can contact RxPathways at (866) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com.
Resources

Show All Hide All

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

Read more

Did you find an answer to your question? Yes No

1 INDICATIONS AND USAGE

MEKTOVI® is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected...

Read more

Did you find an answer to your question? Yes No

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

Confirm the presence of a BRAF V600E or V600K mutation in tumor specimens prior to initiating MEKTOVI...

Read more

Did you find an answer to your question? Yes No

3 DOSAGE FORMS AND STRENGTHS

Tablets: 15 mg, yellow/dark yellow, unscored biconvex oval film-coated tablets debossed with a stylized "A" on one side and "15" on the other side.

Read more

Did you find an answer to your question? Yes No

4 CONTRAINDICATIONS

None.

Read more

Did you find an answer to your question? Yes No

5 WARNINGS AND PRECAUTIONS

5.1 Cardiomyopathy

Cardiomyopathy, manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in...

Read more

Did you find an answer to your question? Yes No

6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in the labeling:

Cardiomyopathy [see Warnings and Precautions (5.1)]

Read more

Did you find an answer to your question? Yes No

7 DRUG INTERACTIONS

No clinically important drug interactions have been observed with MEKTOVI.

Read more

Did you find an answer to your question? Yes No

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from...

Read more

Did you find an answer to your question? Yes No

10 OVERDOSAGE

Since binimetinib is 97% bound to plasma proteins, hemodialysis is likely to be ineffective in the treatment of overdose with MEKTOVI.

Read more

Did you find an answer to your question? Yes No

11 DESCRIPTION

Binimetinib is a kinase inhibitor. The chemical name is 5-[(4-bromo-2-fluorophenyl)amino]-4-fluoro-N-(2-hydroxyethoxy)-1-methyl-1H-benzimidazole-6-carboxamide. The molecular formula is C17...

Read more

Did you find an answer to your question? Yes No

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Binimetinib is a reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2...

Read more

Did you find an answer to your question? Yes No

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies with binimetinib have not been conducted. Binimetinib was...

Read more

Did you find an answer to your question? Yes No

14 CLINICAL STUDIES

MEKTOVI in combination with encorafenib was evaluated in a randomized, active-controlled, open-label, multicenter trial (COLUMBUS; NCT01909453). Eligible patients were required to have BRAF V600E or V600K...

Read more

Did you find an answer to your question? Yes No

16 HOW SUPPLIED/STORAGE AND HANDLING

MEKTOVI (binimetinib) is supplied as 15 mg yellow/dark yellow, unscored biconvex oval film-coated tablets debossed with a stylized "A" on one side and "15" on the other side, available in...

Read more

Did you find an answer to your question? Yes No

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform patients of the following:

...

Read more

Did you find an answer to your question? Yes No

Distributed by:
Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc.
3200 Walnut Street
Boulder, CO 80301

© 2020 Array BioPharma Inc. All...

Read more

Did you find an answer to your question? Yes No

Did you find an answer to your question? Yes No

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985^*

*Contact Medical Information.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.