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 occurred in 1.2% (21/1738) of patients.
BAVENCIO can cause immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests. 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 across clinical trials, and in 2% (2/88) of patients with metastatic MCC in the JAVELIN Merkel 200 trial.
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 (Grade 2) or severe (Grade 3) colitis and permanently discontinue for life-threatening (Grade 4) or recurrent Grade 3 colitis upon re-initiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% (26/1738) of patients across clinical trials and in 2% (2/88) of patients with metastatic MCC in the JAVELIN Merkel 200 trial.
BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus with diabetic ketoacidosis. Monitor patients for signs and symptoms of adrenal insufficiency, hyperglycemia, and changes in thyroid function prior to, periodically during, and after treatment. Manage hypothyroidism with hormone replacement therapy, hyperthyroidism with medical management, and adrenal insufficiency with corticosteroids. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency or thyroid disorders. Withhold BAVENCIO and administer antihyperglycemics for Grade 3 or greater hyperglycemia, and resume treatment when metabolic control is achieved.
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 for life-threatening (Grade 4) nephritis. Immune-mediated nephritis leading to permanent discontinuation of BAVENCIO 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 a severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. Other clinically significant, immune-mediated adverse reactions including myocarditis with fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic inflammatory response have occurred in less than 1% of 1738 patients treated with BAVENCIO.
BAVENCIO can cause severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Patients should be premedicated with an antihistamine and acetaminophen for 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 have been reported in 25% (439/1738) of patients across clinical trials, including 0.7% (12/1738) of patients with Grade 3 or 4 events. A Grade 1 or 2 infusion-related reaction occurred in 22% (19/88) of patients with metastatic MCC in the JAVELIN Merkel 200 trial.
BAVENCIO can cause fetal harm when administered to pregnant women. 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 lactating women 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.
The most common adverse reactions (≥ 20%) in patients with metastatic MCC were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reactions (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%). The most common adverse reaction requiring dose interruption was anemia.
Selected treatment-emergent Grade 3-4 laboratory abnormalities (≥ 2%) in patients with metastatic MCC were lymphopenia (19%), anemia (9%), hyperglycemia (7%), increased alanine aminotransferase (5%), and increased lipase (4%).
BAVENCIO is indicated for the treatment of adolescent and adult patients with metastatic Merkel cell carcinoma (MCC).
This indication is approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Please see full Prescribing Information.
Reference: 1. U.S. National Library of Medicine. DailyMed: Advanced Search. Indication And Usage Section (34067-9). https://dailymed.nlm.nih.gov/dailymed/advanced-search.cfm. Accessed February 22, 2017.
