Safety illustration

SAFETY

Choose a treatment with a favourable safety profile^3,6

Less than 1 in 5 patients discontinued due adverse events (AE)³

Adverse events occuring in ≥10% of patients in the BRAFTOVI^® + MEKTOVI^® arm^a,3

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Adverse events: all grades and grade 3-4

	BRAFTOVI^® + MEKTOVI^® (n=192)		Vemurafenib (n=186)
	All grades	Grade 3/4	All grades	Grade 3/4
Total	98%	70%	100%	66%

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

GO TO SUPPORT AND RESOURCES

Gastrointestinal and nutrition disorders

	BRAFTOVI^® + MEKTOVI^® (n=192)		Vemurafenib (n=186)
	All grades	Grade 3/4	All grades	Grade 3/4
Nausea	44%	2%	35%	2%
Diarrhoea	39%	3%	34%	3%
Vomiting	33%	3%	16%	1%
Constipation	26%	0%	7%	1%
Abdominal pain	19%	4%	8%	1%
Upper abdominal pain	13%	1%	11%	1%
Decreased appetite	10%	0%	19%	1%

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

GO TO SUPPORT AND RESOURCES

General and nervous system disorders

	BRAFTOVI^® + MEKTOVI^® (n=192)		Vemurafenib (n=186)
	All grades	Grade 3/4	All grades	Grade 3/4
Fatigue	30%	2%	31%	2%
Headache	27%	2%	20%	1%
Asthenia	22%	2%	19%	4%
Pyrexia	21%	4%	29%	0%
Dizziness	17%	2%	4%	0%
Peripheral oedema	13%	2%	11%	1%

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

GO TO SUPPORT AND RESOURCES

Skin and subcutaneous tissue disorders

	BRAFTOVI^® + MEKTOVI^® (n=192)		Vemurafenib (n=186)
	All grades	Grade 3/4	All grades	Grade 3/4
Rash	20%	2%	37%	7%
Dry skin	17%	0%	23%	0%
Hyperkeratosis	15%	1%	29%	0%
Alopecia	15%	0%	38%	0%
Pruritus	14%	1%	22%	1%

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

GO TO SUPPORT AND RESOURCES

Muskuloskeletal disorders

	BRAFTOVI^® + MEKTOVI^® (n=192)		Vemurafenib (n=186)
	All grades	Grade 3/4	All grades	Grade 3/4
Arthralgia	33%	1%	47%	6%
Myalgia	16%	0%	18%	1%
Back pain	16%	1%	7%	2%
Muscle spasms	14%	1%	2%	1%
Pain in extremity	13%	1%	15%	1%

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

GO TO SUPPORT AND RESOURCES

Vascular, blood and lymphatic disorders

	BRAFTOVI^® + MEKTOVI^® (n=192)		Vemurafenib (n=186)
	All grades	Grade 3/4	All grades	Grade 3/4
Anaemia	19%	6%	10%	3%
Hypertension	17%	7%	13%	4%

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

GO TO SUPPORT AND RESOURCES

Laboratory test disorders

	BRAFTOVI^® + MEKTOVI^® (n=192)		Vemurafenib (n=186)
	All grades	Grade 3/4	All grades	Grade 3/4
Increased blood creatine phosphokinase	27%	8%	2%	0%
Increased gamma-glutamyl transferase	16%	9%	11%	3%
Increased ALT	11%	5%	8%	2%

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

GO TO SUPPORT AND RESOURCES

Other disorders

	BRAFTOVI^® + MEKTOVI^® (n=192)		Vemurafenib (n=186)
	All grades	Grade 3/4	All grades	Grade 3/4
Blurred vision^a	16%	0%	2%	0%
Nasopharyngitis^b	14%	0%	11%	0%
Cough^c	13%	1%	9%	1%
Insomnia^d	10%	0%	8%	0%

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

GO TO SUPPORT AND RESOURCES

^aEye disorders. ^bInfections and infestations. ^cRespiratory disorders. ^dPsychiatric disorders.

In the BRAFTOVI^® + MEKTOVI^® arm^a :

Pyrexia: Dose adjustments or interruptions were uncommon, occurring in 6% of patients

Ocular toxicity: Discontinuation occurred in only one patient

Some sites adopted amendment 6 prior to the data cut-off of September 2020. Following the adoption date, only Grade ≥3 and all serious AEs are recorded at those sites. AE, adverse event; ALT, alanine transaminase. ^aAdapted from Dummer et al. 2022.³

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

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

▼ These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

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 internationally. 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-BRH-03-22-2200003 V2.0

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. © 2022, Pierre Fabre all rights reserved