Indications
Bavencio SC Injection is used for:
Monotherapy for metastatic Merkel cell carcinoma (MCC).
Adult Dose
Merkel Cell Carcinoma
Indicated in adults with metastatic Merkel cell carcinoma (MCC)
800 mg IV every 2 Weeks
Continue until disease progression or unacceptable toxicity
Urothelial Carcinoma
Indicated for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy
Also, indicated for locally advanced or metastatic UC in patients 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
800 mg IV every 2 Weeks
Continue until disease progression or unacceptable toxicity
Renal Cell Carcinoma
Indicated in combination with axitinib for first-line treatment in patients with advanced renal cell carcinoma (RCC)
Avelumab 800 mg IV every 2 Weeks in combination with
Axitinib 5 mg PO BID
Continue until disease progression or unacceptable toxicity
When axitinib is used in combination with avelumab, consider dose escalation of axitinib above the initial 5-mg dose at ?2-week intervals
Refer also to prescribing information for axitinib dosing information
Child Dose
Merkel Cell Carcinoma
Indicated for metastatic Merkel cell carcinoma (MCC) in adults and pediatric patients aged >12 yr
<12 years: Safety and efficacy not established
>12 years: 800 mg IV every 2 Weeks
Continue until disease progression or unacceptable toxicity
Renal Dose
Nephritis and Renal Dysfunction
Serum creatinine >1.5 and up to 6 times the upper limit of normal
Withhold Avelumab. Resume Avelumab in patients with complete or partial resolution (Grade 0 to 1) of nephritis and renal dysfunction after corticosteroid taper.
Serum creatinine >6 times the upper limit of normal
Permanently discontinue.
Administration
IV Preparation
Visually inspect vial for particulate matter and discoloration; should appear as a clear, colorless to slightly yellow solution
Discard vial if solution is cloudy, discolored, or contains particulate matter
Withdraw required dosage volume and inject it into a 250-mL infusion bag containing either 0.9% or 0.45% NaCl
Gently invert bag to mix diluted solution and avoid foaming or excessive shearing
Inspect admixture solution to ensure it is clear, colorless, and free of visible particles
Discard any partially used or empty vials
IV Administration
Infuse IV over 60 minutes through an IV line containing a sterile, nonpyrogenic, low protein-binding inline filter (pore size of 0.2 micron)
Do not coadminister other drugs through the same IV line
Premedication
Premedicate with an antihistamine and acetaminophen before the first 4 infusions
Based clinical judgment, premedicate for subsequent doses and presence/severity of prior infusion reactions
Contra Indications
Precautions
Immune-mediated pneumonitis: Withhold for moderate pneumonitis; permanently discontinue for severe, life-threatening or recurrent moderate pneumonitis.
Immune-mediated hepatitis: Monitor for changes in liver function.
Withhold for moderate hepatitis; permanently discontinue for severe or life-threatening hepatitis.
Immune-mediated colitis: Withhold for moderate or severe colitis; permanently discontinue for life-threatening or recurrent severe colitis.
Immune-mediated endocrinopathies: Withhold for severe or life-threatening endocrinopathies
Immune-mediated nephritis and renal dysfunction: Withhold for moderate or severe nephritis and renal dysfunction; permanently discontinue for life-threatening nephritis or renal dysfunction.
Infusion-related reactions: Interrupt or slow the rate of infusion for mild or moderate infusion-related reactions. Stop the infusion and permanently discontinue Avelumab for severe or life-threatening infusion-related reactions.
Major adverse cardiovascular events: Optimize management of cardiovascular risk factors. Discontinue Avelumab in combination with who: axitinib for Grade 3-4 events.
Embryo-fetal toxicity: Avelumab can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.
Monitoring Parameters
Monitor patients for signs & symptoms of infusion-related reactions.
Monitor for signs & symptoms of immune-related pneumonitis, & rule out causes other than immune-related pneumonitis.
Monitor for changes in liver function & symptoms of immune-related hepatitis, & rule out causes other than immune-related hepatitis.
Monitor for signs & symptoms of immune-related colitis & rule out causes other than immune-related colitis.
Monitor for clinical signs & symptoms of endocrinopathies.
Monitor for elevated serum creatinine prior to & periodically during treatment.
Pregnancy-Lactation
Pregnancy
Based on its mechanism of action, fetal harm may occur when administered to a pregnant woman
Animal studies demonstrated that PD-1/PD-L1 pathway inhibition can lead to increased risk of immune-mediated rejection of the developing fetus, resulting in fetal death
Human IgG1 immunoglobulins (IgG1) are known to cross the placenta; therefore, transmission may potentially occur from the mother to the developing fetus
Advise patient of the potential risk to a fetus
Contraception
Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose
Lactation
Unknown if distributed in human breast milk
Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose, owing to the potential for serious adverse reactions in breastfed infants
Interactions
Adverse Effects
Side effects of Avelumab :
>10%
Fatigue (50%)
Musculoskeletal pain (32%)
Diarrhea (23%)
Nausea (22%)
Infusion-related reaction (22%)
Rash (22%)
Peripheral edema (20%)
Decreased appetite (20%)
Cough (18%)
Constipation (17%)
Abdominal pain (16%)
Arthralgia (16%)
Decreased weight (15%)
Dizziness (14%)
Vomiting (13%)
Hypertension (13%)
Dyspnea (11%)
1-10%
Pruritus (10%)
Headache (10%)
Thyroid disorders (6%)
Hypertension, Grade 3 or 4 (6%)
Decreased appetite, Grade 3 or 4 (2%)
Abdominal pain, Grade 3 or 4 (2%)
Musculoskeletal pain, Grade 3 or 4 (2%)
Fatigue, Grade 3 or 4 (2%)
Colitis (1.5%)
Pneumonitis (1.2%)
Constipation, Grade 3 or 4 (1%)
Arthralgia, Grade 3 or 4 (1%)
<1%
Hepatitis
Adrenal insufficiency
Type 1 diabetes mellitus
Nephritis
Mechanism of Action
Anti-PD-L1 IgG1 monoclonal antibody
PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the antitumor immune response in the tumor microenvironment
Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen-presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production
Avelumab binds PD-L1 and blocks interaction between PD-L1 and its receptors PD-1 and B7.1; therefore, inhibiting PD-L1, resulting in restoration of immune responses, including antitumor immune responses
Note
Bavencio 20 mg/ml SC Injection manufactured by Janata Traders. Its generic name is Avelumab. Bavencio is availble in Bangladesh.
DIMS information on Bavencio SC Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.