Active Ingredient: Avelumab
Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 800 milligrams avelumab, once every 2 weeks.
The recommended dose of avelumab in combination with axitinib is 800 mg administered intravenously over 60 minutes every 2 weeks and axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity.
For information on the posology of axitinib, please refer to the axitinib product information.
Patients have to be premedicated with an antihistamine and with paracetamol prior to the first 4 infusions of 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.
Dose escalation or reduction is not recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability; see table.
Guidelines for withholding or discontinuation of avelumab:
| Treatment-related adverse reaction | Severity* | Treatment modification |
|---|---|---|
| Infusion-related reactions | Grade 1 infusion-related reaction | Reduce infusion rate by 50% |
| Grade 2 infusion-related reaction | Withhold until adverse reactions recover to Grade 0-1; restart infusion with a 50% slower rate | |
| Grade 3 or Grade 4 infusion-related reaction | Permanently discontinue | |
| Pneumonitis | Grade 2 pneumonitis | Withhold until adverse reactions recover to Grade 0-1 |
| Grade 3 or Grade 4 pneumonitis or recurrent Grade 2 pneumonitis | Permanently discontinue | |
| Hepatitis For avelumab in combination with axitinib, see below | Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN | Withhold until adverse reactions recover to Grade 0-1 |
| AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN | Pe | |
| Colitis | Grade 2 or Grade 3 colitis or diarrhoea | Withhold until adverse reactions recover to Grade 0-1 |
| Grade 4 colitis or diarrhoea or recurrent Grade 3 colitis | Permanently discontinue | |
| Pancreatitis | Suspected pancreatitis | Withhold |
| Confirmed pancreatitis | Permanently discontinue | |
| Myocarditis | Suspected myocarditis | Withhold |
| Confirmed myocarditis | Permanently discontinue | |
| Endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycaemia) | Grade 3 or Grade 4 endocrinopathies | Withhold until adverse reactions recover to Grade 0-1 |
| Nephritis and renal dysfunction | Serum creatinine more than 1.5 and up to 6 times ULN | Withhold until adverse reactions recover to Grade 0-1 |
| Serum creatinine more than 6 times ULN | Permanently discontinue | |
| Skin reactions | Grade 3 rash | Withhold until adverse reactions recover to Grade 0-1 |
| Grade 4 or recurrent Grade 3 rash or confirmed Stevens–Johnson syndrome (SJS) or Toxic epidermal necrolysis (TEN) | Permanently discontinue | |
| Other immune-related adverse reactions (including myositis, hypopituitarism, uveitis, myasthenia gravis, myasthenic syndrome, Guillain-Barré syndrome) | For any of the following: • Grade 2 or Grade 3 clinical signs or symptoms of an immune-related adverse reaction not described above | Withhold until adverse reactions recover to Grade 0-1 |
| For any of the following: • Life threatening or Grade 4 adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy) • Recurrent Grade 3 immune-related adverse reaction • Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks • Persistent Grade 2 or Grade 3 immune-mediate adverse reactions lasting 12 weeks or longer | Permanently discontinue |
* Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.03)
If ALT or AST ≥3 times ULN but <5 times ULN or total bilirubin ≥1.5 times ULN but <3 times ULN, both avelumab and axitinib should be withheld until these adverse reactions recover to Grades 0-1. If persistent (greater than 5 days), corticosteroid therapy with prednisone or equivalent followed by a taper should be considered. Rechallenge with avelumab or axitinib or sequential rechallenge with both avelumab and axitinib after recovery should be considered. Dose reduction according to the axitinib product information should be considered if rechallenging with axitinib.
If ALT or AST ≥5 times ULN or >3 times ULN with concurrent total bilirubin ≥2 times ULN or total bilirubin ≥3 times ULN, both avelumab and axitinib should be permanently discontinued and corticosteroid therapy should be considered.
When avelumab is administered in combination with axitinib, please refer to the axitinib product R/9608 | R/9609information for recommended dose modifications for axitinib.
Avelumab is for intravenous infusion only. It must not be administered as an intravenous push or bolus injection.
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