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Screen for hepatitis B virus in all cancer patients starting systemic treatment. Find out more about hepatitis B virus screening and management.

Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.


( a VEL ue mab )
New Drug Funding Program
  • Avelumab - Metastatic Merkel Cell Carcinoma
  • Avelumab - Maintenance Treatment for Unresectable Locally Advanced or Metastatic Urothelial Carcinoma
Other Name(s): Bavencio™
Appearance: solution mixed into larger bags of fluids
A - Drug Name



B - Mechanism of Action and Pharmacokinetics


Avelumab is a fully human monoclonal antibody (IgG1) that inhibits the suppressive effects of PD-L1 on cytotoxic T cells, thereby restoring the anti-tumour immune response. 


Time to reach steady state4 to 6 weeks (2 to 3 cycles) when administered every 2 weeks


Avelumab is distributed mainly in the systemic circulation, with less distribution to the extracellular space. 

Avelumab exposure increases proportionally to dose in the range of 10-20 mg/kg every 2 weeks. 




Monoclonal antibodies are degraded into small peptides and amino acids via catabolic pathways. 



6.1 days (terminal) 

C - Indications and Status
Health Canada Approvals:
  • Merkel cell carcinoma (MCC)
  • Urothelial carcinoma (UC)

(Includes conditional approvals)
Refer to the product monograph for a full list and details of approved indications.

D - Adverse Effects

Emetogenic Potential:  



Extravasation Potential:   None


The following table lists adverse effects that occurred in ≥ 1% of patients in an unresectable locally advanced or metastatic urothelial carcinoma (UC) study, where higher incidences were observed in the avelumab arm. Adverse effects marked with “†” were reported in previously untreated Merkel cell carcinoma. It also includes severe, life-threatening and post-marketing adverse effects from other indications.


CardiovascularHypertension (10%) †E
 Hypotension (2%)E
 Myocarditis (rare)E  D
DermatologicalErythema multiforme (rare)E
 Rash, pruritus (20%) (1% severe)E
GastrointestinalAbdominal pain (13%) †E
 Anorexia, weight loss (14%)E
 Constipation (16%)E
 Diarrhea (17%) (may be severe, 2% colitis)E  D
 Nausea, vomiting (16%)E
GeneralEdema (13%)E
 Fatigue (36%)E
 Fever, chills (15%)I
HematologicalAnemia (16%) †E  D
Hepatobiliary↑ LFTs (5%) (2% severe; 1% autoimmune hepatitis)E  D
 Pancreatitis (rare, in combination with axitinib)E
HypersensitivityHypersensitivity (2%)I  E
 Infusion related reaction (10%) (may be severe)I
ImmuneAntibody response (4%)E  D
Metabolic / EndocrineAdrenal insufficiency (2%)E  D
 Hyperglycemia (4%) ; diabetes mellitus (type 1; rare)E  D
 Hyperthyroidism (6%)E  D
 Hypothyroidism (12%)E  D
MusculoskeletalMusculoskeletal pain (24%)E
 Other - Rheumatoid arthritis (rare)E
Nervous SystemGuillain-Barre syndrome (rare)E
 Myasthenia gravis (rare)E
 Myositis (<1%)E  D
OphthalmicUveitis (rare)E
RenalNephrotoxicity (2%) (nephritis - rare)E  D
RespiratoryCough, dyspnea (14%)E
 Pneumonitis (3%)E  D
UrinaryUrinary tract infection (20%)E

* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.

** I = immediate (onset in hours to days)     E = early (days to weeks)
D = delayed (weeks to months)      L = late (months to years)

The most common side effects for avelumab include fatigue, musculoskeletal pain, rash/pruritus, diarrhea, anemia, constipation, nausea/vomiting, fever, chills, anorexia/weight loss, cough/dyspnea.

Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions of Immune-related toxicities and their management.

Presentation of immune-mediated reactions may be different compared to other anti-cancer agents and early diagnosis and appropriate management is critical.

Immune-mediated reactions such as rash, pneumonitis, colitis, hepatitis,  nephritis, endocrinopathies and neuropathies were reported in patients who received avelumab and may be severe or fatal.

Anti-drug antibodies have been reported, but did not appear to impact the risk of infusion-related reactions.

E - Dosing

Refer to protocol by which patient is being treated. 

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.

Avoid the use of corticosteroids or immunosuppressants before starting treatment.

Premedication with an antihistamine and acetaminophen prior to the first 4 infusions is recommended. Consider for subsequent infusions based on clinical judgement and prior infusion reactions. 


Avelumab 10 mg/kg IV every 2 weeks until disease progression or unacceptable toxicity 

Dosage with Toxicity:

Healthcare professionals should also consult the most recent avelumab product monograph for additional information.

Dose reductions are not recommended for avelumab . Doses may be delayed or discontinued based on toxicity.


Summary of Principles of Management of Immune-Related Adverse Effects (irAEs):

  • Immune-related adverse effects (irAEs) are different in their presentation, onset and duration compared to conventional chemotherapy. Patient and provider education is essential.

  • Initial irAEs presentation can occur months after completion of treatment and affect multiple organs.

  • Dose escalation or reduction is not recommended.

  • If no other cause can be identified (such as infection), any new symptom should be considered immune-related and prompt treatment initiated.

  • Organ-specific system-based toxicity management is recommended.

Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions of Immune-related toxicities and their management.


Infusion-related reactions:

Toxicity GradeAction
1Slow infusion rate by 50%
2Interrupt infusion until ≤ grade 1; restart at 50% lower infusion rate.


Dosage with Hepatic Impairment:

Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions for immune-related hepatic toxicity management.

Hepatic impairmentAvelumab dose
Mild (bilirubin ≤ ULN and AST > ULN OR bilirubin 1-1.5 x ULN)no change
Moderate (bilirubin 1.5-3 x ULN)
Severe (bilirubin > 3 x ULN)no data 



Dosage with Renal Impairment:

Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions for immune-related renal toxicity management.

Creatinine clearance (ml/min)Avelumab dose
≥ 60no change

Dosage in the elderly:

Metastatic Merkel Cell Carcinoma:
Differences in safety or efficacy between patients aged 65 and older compared to younger patients have not been evaluated

Locally Advanced or Metastatic Urothelial Carcinoma:
No overall differences in safety or efficacy were reported between elderly patients and younger patients. There is limited safety data in patients ≥ 75 years of age in maintenance treatment after first-line platinum-based chemotherapy.


Safety and efficacy in pediatric patients have not been established. 

F - Administration Guidelines
  • DO NOT administer as an IV push or bolus.

  • Dilute avelumab with 0.9% or 0.45% saline solution (preferably 250 mL) prior to infusion. It must not be mixed with other products or diluents.

  • Mix the diluted solution by gentle inversion; do not shake.

  • Infuse over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micrometer in-line or add-on filter.

  • Do not co-administer with other drugs through the same IV line; flush the line with 0.9% or 0.45% saline after administration.

  • Avelumab is compatible with polyethylene, polypropylene and ethylene vinyl acetate infusion bags, glass bottles, polyvinyl chloride infusion sets and in-line filters with polyethersulfone membranes and pore sizes of 0.2 micrometer.
  • Avelumab vials should be stored at 2-8oC; do not freeze.

  • Store in the original container and protect from light.

G - Special Precautions


  • Patients who have a hypersensitivity to this drug or any components of the formulation.



Other Warnings/Precautions:


  • Use with caution and monitor closely in patients with pre-existing conditions such as colitis, hepatic impairment, respiratory or endocrine disorders, such as hypo or hyperthyroidism or diabetes mellitus.

  • Avelumab may cause fatigue; patients should be advised not to drive or operate machinery/tools until they are sure of feeling well.


Other Drug Properties:


  • Carcinogenicity: Unknown



Pregnancy and Lactation:
  • Crosses placental barrier: Yes
  • Fetotoxicity: Likely

    Avelumab may cause fetal harm and is not recommended for use in pregnancy.  Adequate contraception should be used by both sexes during treatment, and for at least 1 month after the last dose.

  • Excretion into breast milk: Likely

    Breastfeeding is not recommended during treatment and for at least 1 month after the last dose. 

  • Fertility effects: Unknown
H - Interactions


No formal pharmacokinetic drug-drug interaction studies have been conducted. Avelumab is mainly metabolized through catabolic pathways; it is not expected that avelumab will have drug-drug interactions with other medications.

Use of systemic corticosteroids or immunosuppressants should be avoided prior to starting avelumab because of the potential for interference with avelumab's efficacy. They can be used to treat immune-mediated reactions after starting the drug.

Acetaminophen may affect the response to immune checkpoint inhibitors. Further clinical studies are needed to determine the exact mechanism and the appropriate clinical management (Bessede et al, 2022).


I - Recommended Clinical Monitoring


Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.


Recommended Clinical Monitoring
Monitor TypeMonitor Frequency


Baseline, before each dose and as clinically indicated

Liver function tests

Baseline, before each dose and as clinically indicated; frequent with severe toxicity

Renal function tests

Baseline, periodically during treatment and as clinically indicated; frequent with severe toxicity

Thyroid function tests

Baseline and before each dose, or at least once monthly

Blood glucose

Baseline, periodically during treatment and as clinically indicated

Clinical toxicity assessment for infusion-related reactions, fatigue, immune-mediated reactions, including GI, skin, respiratory, neurologic, cardiac, ophthalmic and endocrine toxicities

At each visit and as clinically indicated

Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Supplementary Public Funding

New Drug Funding Program (NDFP Website )

  • Avelumab - Metastatic Merkel Cell Carcinoma
  • Avelumab - Maintenance Treatment for Unresectable Locally Advanced or Metastatic Urothelial Carcinoma


K - References


Avelumab (Bavencio®) product monograph, EMD Serono, January 2021.

Bessede A, Marabelle A, Guegan JP, et al. Impact of acetaminophen on the efficacy of immunotherapy in cancer patients. Ann Oncol 2022;33(9):909-15.

D'Angelo SP, Lebbé C, Mortier L, et al. First-line avelumab in a cohort of 116 patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200): primary and biomarker analyses of a phase II study. J Immunother Cancer 2021 Jul;9(7):e002646.

Kaufman HL, Russell J, Hamid O, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385.

Patel MR, Ellerton J, Infante JR, et al. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol 2018;19:51–64.

Powles T, Park SH, Voog E, et al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N Engl J Med . 2020 Sep 24;383(13):1218-30.



February 2023 Updated Interactions section

L - Disclaimer

Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.

The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.

Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.

While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.

CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.