Skip to Content

Avelumab Dosage

Applies to the following strength(s): 20 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Merkel Cell Carcinoma

10 mg/kg IV over 60 minutes every 2 weeks

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-Patients should be premedicated with an antihistamine and acetaminophen prior to the first 4 infusions; premedication should be administered for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions.

Uses:
-For metastatic Merkel cell carcinoma (MCC)
-For the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who: Have disease progression during or following platinum-containing chemotherapy OR have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Usual Adult Dose for Urothelial Carcinoma

10 mg/kg IV over 60 minutes every 2 weeks

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-Patients should be premedicated with an antihistamine and acetaminophen prior to the first 4 infusions; premedication should be administered for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions.

Use: For the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who:
-Have disease progression during or following platinum-containing chemotherapy
-Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Usual Pediatric Dose for Merkel Cell Carcinoma

12 years and older:
10 mg/kg IV over 60 minutes every 2 weeks

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-Patients should be premedicated with an antihistamine and acetaminophen prior to the first 4 infusions; premedication should be administered for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions.

Uses:
-For metastatic Merkel cell carcinoma (MCC)
-For the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who: Have disease progression during or following platinum-containing chemotherapy OR have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Pneumonitis:
-Grade 2: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of pneumonitis after corticosteroid taper
-Grade 3 or 4 or recurrent Grade 2: Permanently discontinue therapy

Hepatitis:
-Aspartate aminotransferase (AST)/or alanine aminotransferase (ALT) more than 3 and up to 5 times the upper limit of normal (ULN) or total bilirubin more than 1.5 and up to 3 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of hepatitis after corticosteroid taper
-AST or ALT more than 5 x ULN or total bilirubin more than 3 X ULN: Permanently discontinue therapy

Colitis:
-Grade 2 or 3 diarrhea or colitis: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy 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 therapy

Endocrinopathies (including but not limited to hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycemia):
-Grade 3 or 4: Withhold therapy; administer corticosteroids as appropriate for adrenal insufficiency; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of endocrinopathies after corticosteroid taper

Nephritis and Renal Dysfunction:
-Serum creatinine more than 1.5 and up to 6 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of colitis or diarrhea after corticosteroid taper
-Serum creatinine more than 6 x ULN: Permanently discontinue therapy

Other Immune-Mediated Adverse Reactions (e.g., myocarditis, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barre syndrome, bullous dermatitis, Stevens Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN), pancreatitis, rhabdomyolysis, myasthenia gravis, histiocytic necrotizing lymphadenitis, demyelination, vasculitis, hemolytic anemia, hypophysitis, iritis, encephalitis):
-For moderate or severe signs of an immune-mediated adverse reaction not previously described: Withhold therapy; administer high dose corticosteroids, and if appropriate, initiate hormone replacement; resume therapy in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper
-For any of the following: Life threatening adverse reaction (excluding endocrinopathies); recurrent severe immune-mediated adverse reactions; requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks; persistent Grade 2 or 3 immune-mediated adverse reactions lasting 12 weeks or longer: Permanently discontinue therapy

Infusion-Related Reactions:
Grade 1 or 2: Interrupt or slow the rate of infusion
Grade 3 or 4: Permanently discontinue therapy

Precautions

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Do not freeze or shake diluted solution.
-Administer the diluted solution over 60 minutes through an IV line containing a sterile, nonpyrogenic, low protein binding in-line filter (pore size of 0.2 micron).
-Do not coadminister other drugs through the same IV line.

Storage requirements:
-Store diluted solution at room temperature up to 77F (25C) for no more than 4 hours from the time of dilution or under refrigeration at 36F to 46F (2C to 8C) 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.

Reconstitution/preparation techniques:
-Visually inspect vial for particulate matter and discoloration; it should be a clear, colorless to slightly yellow solution. Discard vial if the solution is cloudy, discolored, or contains particulate matter.
-Withdraw the required volume of drug 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.

IV compatibility:
-This drug may be used with 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection.

Hide