Active Ingredient: Avelumab
Avelumab is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 800 milligrams avelumab, once every 2 weeks.
The recommended dose of avelumab as monotherapy is 800 mg administered intravenously over 60 minutes every 2 weeks.
Administration of avelumab should continue according to the recommended schedule until disease progression or unacceptable toxicity.
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 | 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 | Permanently discontinue | |
| 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)
Avelumab is for intravenous infusion only. It must not be administered as an intravenous push or bolus injection.
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