Safety Profile of BAVENCIO® (avelumab)

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Safety and tolerability profile of BAVENCIO® (avelumab) in mMCC

Summary of warnings and precautions

BAVENCIO can cause immune-mediated pneumonitis, including fatal cases

  • Monitor patients for signs and symptoms of pneumonitis and evaluate suspected cases with radiographic imaging

  • Administer corticosteroids for Grade 2 or greater pneumonitis

  • Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis

  • Pneumonitis occured in 1.2% (21/1738) of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3

BAVENCIO can cause immune-mediated hepatitis, including fatal cases

  • Monitor patients for abnormal liver tests prior to and periodically during treatment

  • Administer corticosteroids for Grade 2 or greater hepatitis

  • Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis

  • Immune-mediated hepatitis was reported in 0.9% (16/1738) of patients, including two (0.1%) patients with Grade 5 and 11 (0.6%) with Grade 3

BAVENCIO can cause immune-mediated colitis

  • Monitor patients for signs and symptoms of colitis

  • Administer corticosteroids for Grade 2 or greater colitis

  • Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or Grade 3) colitis and permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon re-initiation of BAVENCIO

  • Immune-mediated colitis was reported in 1.5% (26/1738) of patients, including seven (0.4%) with Grade 3

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus

  • Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate

  • Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency

    Adrenal insufficiency was reported in 0.5% (8/1738) of patients, including one (0.1%) with Grade 3

  • Thyroid disorders can occur at any time during treatment

  • Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation

    Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management

    Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders

    Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis were reported in 6% (98/1738) of patients, including three (0.2%) with Grade 3

  • Type 1 diabetes mellitus, including diabetic ketoacidosis

  • Monitor patients for hyperglycemia or other signs and symptoms of diabetes

    Withhold BAVENCIO and administer anti-hyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved

    Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% (2/1738) of patients, including two cases of Grade 3 hyperglycemia

BAVENCIO can cause immune-mediated nephritis and renal dysfunction

  • Monitor patients for elevated serum creatinine prior to and periodically during treatment

  • Administer corticosteroids for Grade 2 or greater nephritis

  • Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower

  • Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis

  • Immune-mediated nephritis occurred in 0.1% (1/1738) of patients

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation

  • For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes

  • Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy if appropriate

  • Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper

  • Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction

  • The following clinically significant immune-mediated adverse reactions occured in less than 1% of 1738 patients treated with BAVENCIO: myocarditis with fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic inflammatory response

BAVENCIO can cause severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions

  • Patients should be premedicated with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions

  • Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria

  • Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions

  • Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions

  • Infusion-related reactions occurred in 25% (439/1738) of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3

BAVENCIO can cause fetal harm when administered to a pregnant woman

  • Advise patients of the potential risk to a fetus including the risk of fetal death

  • Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO

  • It is not known whether BAVENCIO is excreted in human milk

  • Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants