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Bavencio Dosage

Generic name: avelumab 20mg in 1mL
Dosage form: injection, solution, concentrate

Medically reviewed on October 30, 2017.

Premedication

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)].

Recommended Dosage

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.

Dose Modifications

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).

Table 1: Recommended Dose Modifications of BAVENCIO for Adverse Reactions
Treatment-Related Adverse Reaction Severity of Adverse Reactions* Dose Modification
*
Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events. Version 4.0 (NCI CTCAE v4)
Observed with BAVENCIO or with other anti-PD-1/PD-L1 monoclonal antibodies
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:
  • Moderate or severe clinical signs or symptoms of an immune-mediated adverse reaction not described above
  • Grade 3 or 4 endocrinopathies
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:
  • Life-threatening adverse reaction (excluding endocrinopathies)
  • Recurrent severe immune-mediated adverse reaction
  • Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks
  • Persistent Grade 2 or 3 immune-mediate adverse reactions lasting 12 weeks or longer
Permanently discontinue.
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

Preparation

  • 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.

Or

  • 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.

Administration

  • Administer the diluted solution over 60 minutes through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size of 0.2 micron).
  • Do not co-administer other drugs through the same intravenous line.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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