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Systemic Anti-Cancer Therapy Regimen Library

Home > CRC Metastatic - CETUximab [Q1W], biNIMEtinib and encorafenib

[Superseded] CRC Metastatic - CETUximab [Q1W], biNIMEtinib and encorafenib

THIS REGIMEN HAS BEEN SUPERSEDED BY CRC Metastatic - CETUximab [Q2W] and encorafenib

Treatment Overview

Cycle 1 - 7 days - Loading dose

Cycle length:
7

Cycle 2 (and all further cycles) - 7 days - Maintenance dose

Cycle length:
7

Cycle details

Cycle 1 - 7 days - Loading dose

Medication Dose Route Days Max Duration
doxycycline * 100 mg Once daily oral administration 0
hydrocortisone * 1 % Once daily topical administration 0
cetostearyl alcohol + paraffin liquid + paraffin soft white 50 g Once daily topical administration 0
avobenzone + homosalate + octisalate + octocrilene + oxybenzone 50 g topical administration 0
dexamethasone * 8 mg oral administration 1
loratadine * 10 mg oral administration 1
CETUximab * 400 mg/m² intravenous 1 120 minutes
biNIMEtinib 45 mg Twice daily oral administration 1 to 7
encorafenib 300 mg Once daily oral administration 1 to 7
cycliZINE 50 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

Cycle 2 (and all further cycles) - 7 days - Maintenance dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1
loratadine * 10 mg oral administration 1
CETUximab * 250 mg/m² intravenous 1 60 minutes
biNIMEtinib 45 mg Twice daily oral administration 1 to 7
encorafenib 300 mg Once daily oral administration 1 to 7
cycliZINE 50 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

Full details

Cycle 1 - 7 days - Loading dose

Day: 0

Medication Dose Route Max duration Details
doxycycline * 100 mg Once daily oral administration
Instructions:
  • To prevent rash.
  • Commence taking the day before CETUximab and continue for 6 weeks or as per institutional policy. If no rash develops after 6 weeks, consider stopping.
  • Take each dose with food and a large glass of water. Swallow whole, do not crush or chew. Remain sitting upright or standing for at least 30 minutes afterwards. Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine. Protect yourself from too much natural or artificial sunlight while being treated with this medicine.
hydrocortisone * 1 % Once daily topical administration
Instructions:
  • To prevent rash.
  • Apply to the face, hands, feet, neck, back and chest at bedtime or as directed by your oncologist.
  • If no rash develops after 6 weeks, consider stopping.
cetostearyl alcohol + paraffin liquid + paraffin soft white 50 g Once daily topical administration
Instructions:
  • Apply as a moisturiser to the face, hands, feet, neck, back and chest each morning or as directed by your oncologist.
  • Whilst this is a subsidised preparation, other moisturisers may also be suitable.
  • Quantity is approximate only, prescriber discretion required.
avobenzone + homosalate + octisalate + octocrilene + oxybenzone 50 g topical administration
Instructions:
  • SPF 50+ Sunscreen—apply to skin 30 minutes before going outdoors as directed by your oncologist.
  • Certified condition for subsidy. Whilst this is the subsidised preparation, alternative SPF 50+ sunscreen preparations may also be suitable.
  • Quantity is approximate only, prescriber discretion required.

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONE hour prior to CETUximab with food.
loratadine * 10 mg oral administration
Instructions:

ONE hour prior to CETUximab.
CETUximab * 400 mg/m² intravenous 120 minutes
Instructions:
  • Maximum rate of 5 mg/min for initial loading dose.
  • Doses above 600 mg will have a longer infusion duration than 120 minutes.
  • An observation period of 60 minutes post-infusion is recommended.
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.
cycliZINE 50 mg Three times daily oral administration
Instructions:

When required for nausea and/or vomiting.

  • Warning: may cause drowsiness.
  • Consider starting dose at 25 mg and increasing as tolerated/required.
  • The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics. Note: domperidone is not recommended in combination with encorafenib due to potential risk of QT prolongation.
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
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.

Day: 3

Medication Dose Route Max duration Details
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.

Day: 4

Medication Dose Route Max duration Details
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.

Day: 5

Medication Dose Route Max duration Details
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.

Day: 6

Medication Dose Route Max duration Details
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.

Day: 7

Medication Dose Route Max duration Details
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.

Cycle 2 (and all further cycles) - 7 days - Maintenance dose

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONE hour prior to CETUximab with food.
loratadine * 10 mg oral administration
Instructions:

ONE hour prior to CETUximab.
CETUximab * 250 mg/m² intravenous 60 minutes
Instructions:

Maximum rate of 10 mg/min for maintenance dose.

An observation period of 60 minutes post-infusion is recommended.
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.
cycliZINE 50 mg Three times daily oral administration
Instructions:

When required for nausea and/or vomiting.

  • Warning: may cause drowsiness.
  • Consider starting dose at 25 mg and increasing as tolerated/required.
  • The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics. Note: domperidone is not recommended in combination with encorafenib due to potential risk of QT prolongation.
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
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.

Day: 3

Medication Dose Route Max duration Details
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.

Day: 4

Medication Dose Route Max duration Details
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.

Day: 5

Medication Dose Route Max duration Details
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.

Day: 6

Medication Dose Route Max duration Details
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.

Day: 7

Medication Dose Route Max duration Details
biNIMEtinib 45 mg Twice daily oral administration
Instructions:
Swallow whole, do not crush or chew.
encorafenib 300 mg Once daily oral administration
Instructions:

Swallow whole, do not crush or chew. Avoid grapefruit and its juice.

Supportive Care Factors

Factor Value
Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment
Emetogenicity: Medium to high
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended

Emetogenicity: MEDIUM to HIGH—Routine antiemetic premedication may not be required for continuous dosing of oral anti-cancer medicines with MEDIUM to HIGH emetic risk; an individualised approach is appropriate. 

References

Matsuda, A., T. Yamada, S. Jamjittrong, et al. 2020. "Comparison Between Biweekly and Weekly Cetuximab in Patients With Metastatic Colorectal Cancer: A Meta-analysis." Anticancer Res 40(6):3469-3476., PMID: 32487646

Healthcare Logistics Ltd. Erbitux New Zealand Data Sheet 4 September 2018. https://www.medsafe.govt.nz/profs/Datasheet/e/Erbituxinf.pdf (Accessed 26 November 2020).

Tabernero, J., A. Grothey, E. Van Cutsem, et al. 2021. "Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study." J Clin Oncol 39(4):273-284., PMID: 33503393

Hofheinz RD, Deplanque G, Komatsu Y, et al. Recommendations for the Prophylactic Management of Skin Reactions Induced by Epidermal Growth Factor Receptor Inhibitors in Patients With Solid Tumors. Oncologist. 2016;21(12):1483-1491. doi:10.1634/theoncologist.2016-0051, PMID: 27449521

Lacouture ME, Anadkat MJ, Bensadoun RJ, Bryce J, Chan A, Epstein JB, Eaby-Sandy B, Murphy BA; MASCC Skin Toxicity Study Group. Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Support Care Cancer. 2011 Aug;19(8):1079-95. doi: 10.1007/s00520-011-1197-6. Epub 2011 Jun 1., PMID: 21630130

Deplanque G, Gervais R, Vergnenegre A, Falchero L, Souquet PJ, Chavaillon JM, Taviot B, Fraboulet G, Saal H, Robert C, Chosidow O. Doxycycline for prevention of erlotinib-induced rash in patients with non-small-cell lung cancer (NSCLC) after failure of first-line chemotherapy: A randomized, open-label trial. Journal of the American Academy of Dermatology. 2016 Jun 1;74(6):1077-85. , PMID: 26946985

Dika, E., & Patrizi, A. (2017). Prevention of erlotinib-induced folliculitis with doxycycline. Dermatologic therapy, 30(1), https://doi.org/10.1111/dth.12419, PMID: 27592506

* 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.