Systemic Anti-Cancer Therapy Regimen Library
GU Renal cell Metastatic - aXITinib and avelumab [flat dose]
Treatment Overview
Continue until disease progression or unacceptable toxicity (up to 2 years for avelumab).
Cycle 1 (and all further cycles) - 14 days
aXITinib: 5 mg orally TWICE daily is the starting dose—see prescribing information for dose adjustment.
avelumab: If the fourth infusion is completed without an infusion-related reaction, premedication for subsequent doses should be administered at the discretion of the physician.
Cycle details
Cycle 1 (and all further cycles) - 14 days
| Medication | Dose | Route | Days | Max Duration |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration | 1 to 14 | |
| paracetamol * | 1000 mg flat dosing | oral administration | 1 | |
| loratadine * | 10 mg | oral administration | 1 | |
| avelumab | 800 mg flat dosing | intravenous | 1 | 60 minutes |
| loperamide | 2 mg | oral administration | 1 |
aXITinib: 5 mg orally TWICE daily is the starting dose—see prescribing information for dose adjustment.
avelumab: If the fourth infusion is completed without an infusion-related reaction, premedication for subsequent doses should be administered at the discretion of the physician.
Full details
Cycle 1 (and all further cycles) - 14 days
Day: 1
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
|
| paracetamol * | 1000 mg flat dosing | oral administration |
Instructions:
ONE hour prior to avelumab. |
|
| loratadine * | 10 mg | oral administration |
Instructions:
ONE hour prior to avelumab. |
|
| avelumab | 800 mg flat dosing | intravenous | 60 minutes |
Instructions:
Administer via a sterile, non-pyrogenic, low-protein binding 0.2 micron in-line or add-on filter. |
| 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 |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Day: 3
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Day: 4
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Day: 5
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Day: 6
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Day: 7
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Day: 8
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Day: 9
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Day: 10
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Day: 11
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Day: 12
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Day: 13
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Day: 14
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| aXITinib | 5 mg Twice daily | oral administration |
Instructions:
Starting dose—see prescribing information for dose adjustment. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. |
Supportive Care Factors
| Factor | Value |
|---|---|
| Diarrhoea risk: | Anti-diarrhoeals are usually prescribed with this treatment |
| Emetogenicity: | Minimal to low |
| Hypersensitivity / Infusion related reaction risk: | High - routine premedication recommended |
Emetogenicity: Antiemetics may be required with continuous dosing of oral anti-cancer medicines with MINIMAL to LOW emetic risk; an individualised approach is appropriate.
References
Pfizer New Zealand Limited, Inlyta New Zealand Datasheet 06 February 2022 https://www.medsafe.govt.nz/profs/datasheet/i/inlytatab.pdf (accessed 30 September 2022).
Merck Serono Australia Pty Ltd Bavencio Australian Product Information 3 January 2018 https://www.tga.gov.au/sites/default/files/auspar-avelumab-190122-pi.pdf (accessed 30 September 2022).
Regimen details sometimes vary slightly from the published literature after recommendation by expert committee consensus.
* 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.