Generic name: avelumab 20mg in 1mL
Dosage form: injection, solution, concentrate
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Premedicate patients with an antihistamine and with acetaminophen prior to the first 4 infusions of BAVENCIO. Premedication should be administered for subsequent BAVENCIO doses based upon clinical judgment and presence/severity of prior infusion reactions [see Dosage and Administration (2.3) and Warnings and Precautions (5.7)].
The recommended dose of BAVENCIO is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
Recommended dose modifications of BAVENCIO for adverse reactions are provided in Table 1. Detailed information regarding clinical and laboratory monitoring guidelines for early detection of adverse reactions of BAVENCIO and recommended management (immunosuppressant treatment guidelines) are described in Warnings and Precautions (5).
|Treatment-Related Adverse Reaction||Severity of Adverse Reactions*||Dose Modification|
|Pneumonitis [see Warnings and Precautions (5.1)]||Grade 2 pneumonitis||Withhold BAVENCIO.
Resume BAVENCIO in patients with complete or partial resolution (Grade 0 to 1) of pneumonitis after corticosteroid taper.
|Grade 3 or 4 pneumonitis or recurrent Grade 2 pneumonitis||Permanently discontinue.|
|Hepatitis [see Warnings and Precautions (5.2)]||Aspartate aminotransferase (AST)/or alanine aminotransferase (ALT) more than 3 and up to 5 times the upper limit of normal or total bilirubin more than 1.5 and up to 3 times the upper limit of normal||Withhold BAVENCIO.
Resume BAVENCIO in patients with complete or partial resolution (Grade 0 to 1) of hepatitis after corticosteroid taper.
|AST or ALT more than 5 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal||Permanently discontinue.|
|Colitis [see Warnings and Precautions (5.3)]||Grade 2 or 3 diarrhea or colitis||Withhold BAVENCIO.
Resume BAVENCIO in patients with complete or partial resolution (Grade 0 to 1) of colitis or diarrhea after corticosteroid taper.
|Grade 4 diarrhea or colitis or recurrent Grade 3 diarrhea or colitis||Permanently discontinue.|
|Endocrinopathies (including but not limited to hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycemia) [see Warnings and Precautions (5.4)]||Grade 3 or 4||Withhold BAVENCIO.
Resume BAVENCIO in patients with complete or partial resolution (Grade 0 to 1) of endocrinopathies after corticosteroid taper.
|Nephritis and Renal Dysfunction [see Warnings and Precautions (5.5)]||Serum creatinine more than 1.5 and up to 6 times the upper limit of normal||Withhold BAVENCIO.
Resume BAVENCIO in patients with complete or partial resolution (Grade 0 to 1) of nephritis and renal dysfunction after corticosteroid taper.
|Serum creatinine more than 6 times the upper limit of normal||Permanently discontinue.|
|Other immune-mediated adverse reactions (including but not limited to myocarditis, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, bullous dermatitis, Stevens Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN), pancreatitis, rhabdomyolysis, myasthenia gravis, histiocytic necrotizing lymphadenitis, demyelination, vasculitis, hemolytic anemia, hypophysitis, iritis, and encephalitis)†[see Warnings and Precautions (5.6)]||For any of the following:
||Withhold BAVENCIO pending clinical evaluation.
Resume BAVENCIO in patients with complete or partial resolution (Grade 0 to 1) of other immune-mediated adverse reactions after corticosteroid taper.
|For any of the following:
|Infusion-related reaction [see Warnings and Precautions (5.7)]||Grade 1 or 2||Interrupt or slow the rate of infusion.|
|Grade 3 or 4||Permanently discontinue.|
Preparation and Administration
- Visually inspect vial for particulate matter and discoloration. BAVENCIO is a clear, colorless to slightly yellow solution. Discard vial if the solution is cloudy, discolored, or contains particulate matter.
- Withdraw the required volume of BAVENCIO from the vial(s) and inject it into a 250 mL infusion bag containing either 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection.
- Gently invert the bag to mix the diluted solution and avoid foaming or excessive shearing.
- Inspect the solution to ensure it is clear, colorless, and free of visible particles.
- Discard any partially used or empty vials.
Storage of diluted BAVENCIO solution
Protect from light.
Store diluted BAVENCIO solution:
- At room temperature up to 77°F (25°C) for no more than 4 hours from the time of dilution.
- Under refrigeration at 36°F to 46°F (2°C to 8°C) for no more than 24 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature prior to administration.
Do not freeze or shake diluted solution.
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- Drug class: Anti-PD-1 monoclonal antibodies