Bavencio

Bavencio

avelumab

Manufacturer:

Merck

Distributor:

Apex Pharma Marketing
Concise Prescribing Info
Contents
Avelumab
Indications/Uses
Monotherapy for metastatic Merkel cell carcinoma (MCC).
Dosage/Direction for Use
IV infusion 10 mg/kg over 60 min every 2 wk.
Special Precautions
Not to be administered as IV push or bolus inj. Monitor for signs & symptoms of infusion-related reactions. Discontinue treatment if Grade 3 or 4 infusion-related reactions occur. For Grade 1 infusion-related reactions, decrease infusion rate by 50%. For Grade 2 infusion-related reactions, temporarily discontinue infusion until Grade 1 or resolved, then restart infusion w/ 50% slower infusion rate. Perform adequate evaluation to confirm aetiology or exclude other causes for suspected immune-related AR. Consider other systemic immunosuppressants in patients whose immune-related AR could not be controlled w/ corticosteroid. Monitor for signs & symptoms of immune-related pneumonitis, & rule out causes other than immune-related pneumonitis. Confirm suspected pneumonitis w/ radiographic imaging. Administer corticosteroids for Grade ≥2 events in immune-related pneumonitis, immune-related hepatitis & immune-related colitis. W/hold treatment for Grade 2 immune-related pneumonitis until resolution, & permanently discontinue for Grade 3, Grade 4 or recurrent Grade 2 immune-related pneumonitis. Monitor for changes in liver function & symptoms of immune-related hepatitis, & rule out causes other than immune-related hepatitis. W/hold treatment for Grade 2 immune-related hepatitis until resolution, & permanently discontinue for Grade 3 or 4 immune-related hepatitis. Monitor for signs & symptoms of immune-related colitis & rule out causes other than immune-related colitis. W/hold treatment for Grade 2 or 3 immune-related colitis until resolution & permanently discontinue for Grade 4 or recurrent Grade 3 immune-related colitis. Risk of immune-related thyroid disorders, immune-related adrenal insufficiency, & type 1 DM. Monitor for clinical signs & symptoms of endocrinopathies. W/hold treatment for Grade 3 or 4 endocrinopathies until resolution. Immune-related nephritis. Monitor for elevated serum creatinine prior to & periodically during treatment. Administer corticosteroids for Grade ≥2 nephritis. W/hold treatment for Grade 2 or 3 nephritis until resolution to Grade ≤1 & permanently discontinue for Grade 4 nephritis. Myocarditis including fatal cases, myositis, hypopituitarism, uveitis, & Guillain-Barre syndrome. W/hold treatment & administer corticosteroids based on severity of AR; resume treatment when immune-related AR returns to Grade ≤1 following corticosteroid taper. Permanently discontinue for any recurrent Grade 3 immune-related AR & for Grade 4 immune-related AR. Use caution when driving or operating machinery. Severe renal impairment. Moderate or severe hepatic impairment. Women of childbearing potential should use effective contraception during treatment & for at least 1 mth after the last dose. Not recommended to use avelumab during pregnancy unless clinical condition requires treatment. Advise not to breast-feed during treatment & for at least 1 mth after the last dose due to potential serious AR in infants. Childn & adolescent <18 yr.
Adverse Reactions
Anaemia; decreased appetite; cough, dyspnoea; nausea, diarrhoea, constipation, vomiting, abdominal pain; back pain, arthralgia; fatigue, pyrexia, peripheral oedema; decreased wt; infusion-related reaction. Lymphopenia; hypothyroidism; headache, dizziness, peripheral neuropathy; HTN, hypotension; pneumonitis; dry mouth; rash, pruritus, maculo-papular rash, dry skin; myalgia; asthenia, chills, influenza-like illness; increased γ-glutamyl transferase, blood alkaline phosphatase, amylase, lipase & blood creatinine.
ATC Classification
L01XC31 - avelumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Bavencio conc for soln for infusion 200 mg/10 mL
Packing/Price
1's
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