Dosing illustration

DOSING

BRAFTOVI MEKTOVI packaging

Presentation

BRAFTOVI^®️ and MEKTOVI^®️ are available in packs of:

*BRAFTOVI^®️ 75 mg**	42 x 1 hard capsules
*BRAFTOVI^®️^ 75 mg**	168 x 1 hard capsules
MEKTOVI^®️15 mg	84 film-coated tablets

^{*Not all pack sizes may be marketed}

For patients undergoing dose reduction BRAFTOVI^®️ is also available in 50mg capsules

Recommended dosing

Recommended dosing

Treatment with BRAFTOVI^®️ + MEKTOVI^®️ should be continued until the patient no longer derives benefit or the development of unacceptable toxicity.

^a For patients with mild hepatic impairment, administration of BRAFTOVI should be undertaken with caution at a reduced dose. In the absence of clinical data, BRAFTOVI is not recommended in patients with moderate to severe hepatic impairment.¹

Recommended dose adjustments

BRAFTOVI^® + MEKTOVI^® are indicated to be taken in combination.

The management of ARs may require dose reduction, temporary interruption, or treatment discontinuation.

Dose adjustments

Dose modifications are recommended to manage certain adverse reactions.

^aThere are limited data for dose reduction to 100 mg QD. If unable to tolerate 100 mg QD, permanently discontinue BRAFTOVI.¹
^bIf unable to tolerate 30 mg BID, permanently discontinue MEKTOVI.¹ BID, twice daily; QD, once daily.

Patient monitoring is recommended prior, during and after the treatment. For more information on safety, explore our Therapy Management Guide, on the Support and Resources page.

GO TO SUPPORT AND RESOURCES

Dose interruption and discontinuation

When temporarily interrupting or permanently discontinuating BRAFTOVI or MEKTOVI, please adapt the other drug's posology according to the table below.

dose interruption and discontinuation

For complete information, please refer to the Summaries of Product Characteristics.

HealthCare Professionals

This is an international website for BRAFTOVI® + MEKTOVI® dedicated to Healthcare professionals

IMPORTANT: the information on this website is based on the European Summary of Product Characteristics. Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.

I certify that:

I am Healthcare Professional outside the US and I have read the information above.

Patients

This is an international website for BRAFTOVI^® + MEKTOVI^® dedicated to Healthcare Professionals.

I am a patient outside the US.

https://www.pierre-fabre.com/en

REFERENCES

1. BRAFTOVI^® Summary of Product Characteristics. Pierre Fabre Médicament.
2. MEKTOVI^® Summary of Product Characteristics. Pierre Fabre Médicament.
3. Dummer R, et Al. COLUMBUS 5-Year Update: A randomized, open-label, phase III trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAFV600–mutant melanoma. J. Clin. Oncol. (2022). DOI: 10.1200/JCO.21.026595-year publication.
4. Dummer R, Ascierto PA, Gogas HJ et al. Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, Phase 3 trial. Lancet Oncol 2018;19(10):1315–1327.
5. Ascierto PA, Dummer R, Gogas HJ et al. Update on tolerability and overall survival in COLUMBUS: landmark analysis of a randomised Phase 3 trial of encorafenib plus binimetinib vs vemurafenib or encorafenib in patients with BRAF^V600-mutant melanoma. Eur J Cancer 2020;126:33–44.
6. Gogas HJ, Flaherty KT, Dummer R et al. Adverse events associated with encorafenib plus binimetinib in the COLUMBUS study: incidence, course and management. Eur J Cancer 2019;119:97–106.
7. Gogas HJ, Dummer R, Ascierto PA et al. Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: results from a multicentre, open-label, randomised, Phase III study (COLUMBUS). Eur J Cancer 2021;152:116–128.
8. Musoro JZ, Bottomley A, Coens C et al. Interpreting European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 scores as minimally importantly different for patients with malignant melanoma. Eur J Cancer 2021;104:169–181.
9. Trojaniello C, Festino L, Vanella V et al. Encorafenib in combination with binimetinib for unresectable metastatic melanoma with BRAF mutation. Expert Rev Clin Pharmacol 2019;12(3):259–266.
10. Heinzerling L, Elgentler TK, Fluck M et al. Tolerability of BRAF/MEK inhibitor combinations: adverse event evaluation and management. ESMO Open 2019;4(3):e000491.
11. Dummer R, Ascierto PA, Gogas HJ et al. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised Phase 3 trial. Lancet Oncol 2018;19(5):603–615.
12. Lebbe C, Lorigan P, Ascierto PA et al. Treatment patterns and outcomes among patients diagnosed with unresectable stage III or IV melanoma in Europe: a retrospective, longitudinal survey (MELODY study). Eur J Cancer 2012;48(17):3205–3214.
13. Gogas HJ, et al. Updated Quality of Life (QoL) of encorafenib + binimetinib (COMBO450) versus (vs) vemurafenib (VEM) from COLUMBUS Part 1 Phase III study in BRAF-mutant melanoma. Presented at the 16th International Congress of the Society for Melanoma Research (SMR). November 20–23, 2019, Salt Lake City, Utah. USA.

This is an international website for BRAFTOVI^®+MEKTOVI^®. IMPORTANT: the information on this website is based on the European Summaries of Product Characteristics . Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.

HQ-MEK-09-23-2300001 Last update: September 2023

Pierre Fabre

BRAFTOVI® is a trademark of Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc. MEKTOVI® is a trademark of Array BioPharma Inc. a wholly owned subsidiary of Pfizer Inc. © 2023, Pierre Fabre all rights reserved