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Systemic Anti-Cancer Therapy Regimen Library

Home > SKIN Melanoma NON-Metastatic - daBRAFEnib and tRAMEtinib

SKIN Melanoma NON-Metastatic - daBRAFEnib and tRAMEtinib

Treatment Overview

Cycles 1 to 12 - 28 days

Cycle length:
28

Emetogenicity: MEDIUM to HIGH—Routine antiemetic premedication may not be required for continuous dosing of some medium to high emetic risk oral drugs; an individualised approach is appropriate.

Cycle details

Cycles 1 to 12 - 28 days

Medication Dose Route Days Max Duration
daBRAFEnib 150 mg Twice daily oral administration 1 to 28
tRAMEtinib 2 mg Once daily oral administration 1 to 28
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

Emetogenicity: MEDIUM to HIGH—Routine antiemetic premedication may not be required for continuous dosing of some medium to high emetic risk oral drugs; an individualised approach is appropriate.

Full details

Cycles 1 to 12 - 28 days

Day: 1

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.
domperidone 10 mg Three times daily oral administration
Instructions:
When required for nausea and/or vomiting. The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.
loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 2

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 3

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 4

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 5

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 6

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 7

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 8

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 9

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 10

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 11

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 12

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 13

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 14

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 15

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 16

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 17

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 18

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 19

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 20

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 21

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 22

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 23

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 24

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 25

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 26

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 27

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Day: 28

Medication Dose Route Max duration Details
daBRAFEnib 150 mg Twice daily oral administration
Instructions:
Take each dose approximately 12 hours apart on an empty stomach—one hour before OR two hours after food. ONE of the daily doses should be taken concurrently with tRAMEtinib. Take with a glass of water and swallow whole, do not crush or chew.
tRAMEtinib 2 mg Once daily oral administration
Instructions:
ONCE daily at the same time each day, concurrently with a daBRAFEnib dose. Take on an empty stomach—one hour before OR two hours after food. Take with a glass of water and swallow whole, do not crush or chew.

Supportive Care Factors

Factor Value
Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment
Emetogenicity: Medium to high

References

Maio M., K. Lewis, L. Demidov, et al. 2018. “Adjuvant vemurafenib in resected, BRAF(V600) mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial” Lancet Oncol;19(4):510-520 , PMID: 29477665

Atkinson, V., G. V. Long, A. M. Menzies, et al. 2016. "Optimizing combination dabrafenib and trametinib therapy in BRAF mutation-positive advanced melanoma patients: Guidelines from Australian melanoma medical oncologists." Asia Pac J Clin Oncol 12 Suppl 7:5-12. , PMID: 27905182

Long, G. V., A. Hauschild, M. Santinami, et al. 2017. "Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma." N Engl J Med 377(19):1813-1823 , PMID: 28891408

Hauschild, A., R. Dummer, D. Schadendorf, et al. 2018. "Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected BRAF V600–Mutant Stage III Melanoma." J Clin Oncol 36(35):3441-3449 , PMID: 30343620

Schadendorf D., A. Hauschild, M. Santinami, et al. 2019. “Patient-reported outcomes in patients with resected, high-risk melanoma with BRAF(V600E) or BRAF(V600K) mutations treated with adjuvant dabrafenib plus trametinib (COMBI-AD): a randomised, placebo-controlled, phase 3 trial.” Lancet Oncol 20(5):701-710. , PMID: 30928620

Novartis New Zealand Limited. Tafinlar New Zealand Data Sheet 17 September 2020. https://www.medsafe.govt.nz/profs/Datasheet/t/tafinlarcap.pdf (Accessed 14 June 2021).

Novartis New Zealand Limited. Mekinist New Zealand Data Sheet 17 September 2020. https://www.medsafe.govt.nz/profs/Datasheet/m/mekinisttab.pdf (Accessed 14 June 2021).

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.