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Bavencio Generic Name & Formulations
Legal Class
Rx
General Description
Avelumab 20mg/mL; soln for IV infusion after dilution; preservative-free; contains mannitol.
Pharmacological Class
Programmed death-ligand 1 (PD-L1) blocking antibody.
How Supplied
Single-dose vial (10mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Avelumab binds to PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1, thus releasing the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses. Avelumab has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.
Bavencio Indications
Indications
First-line maintenance treatment of locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. Locally advanced or metastatic UC in patients who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In combination with axitinib for the first-line treatment of advanced renal cell carcinoma (RCC).
Bavencio Dosage and Administration
Adult
Premedicate with an antihistamine and acetaminophen prior to the first 4 infusions; then subsequent doses as clinically indicated. Give as IV infusion over 60mins. 800mg every 2 weeks until disease progression or unacceptable toxicity. RCC: give in combination with axitinib 5mg every 12hrs (may increase axitinib dose at intervals of 2 weeks or longer). Dose modifications: see full labeling.
Children
<12yrs: not established.
Bavencio Contraindications
Not Applicable
Bavencio Boxed Warnings
Not Applicable
Bavencio Warnings/Precautions
Warnings/Precautions
Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. In combination with axitinib: risk of severe and fatal cardiovascular events; consider evaluating LVEF at baseline and periodically; discontinue both drugs if Grade 3/4 events occur. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥1 month after the last dose. Pregnancy. Nursing mothers: not recommended (during and for ≥1 month after the last dose).
Bavencio Pharmacokinetics
Absorption
Steady-state concentration were reached after ~4 to 6 weeks.
Distribution
Volume of distribution: 4.72 L.
Elimination
Primary elimination mechanism: proteolytic degradation. Half-life: 6.1 days. Total systemic clearance: 0.59 L/day.
Bavencio Interactions
Interactions
Increased risk of hepatotoxicity and cardiovascular events (in combination with axitinib); monitor liver enzymes and LVEF more frequently.
Bavencio Adverse Reactions
Adverse Reactions
Fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, peripheral edema, UTI, hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, headache; other immune-mediated adverse reactions (may be fatal).
Bavencio Clinical Trials
See Literature
Bavencio Note
Not Applicable
Bavencio Patient Counseling
See Literature
Bavencio Generic Name & Formulations
Legal Class
Rx
General Description
Avelumab 20mg/mL; soln for IV infusion after dilution; preservative-free; contains mannitol.
Pharmacological Class
Programmed death-ligand 1 (PD-L1) blocking antibody.
How Supplied
Single-dose vial (10mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Avelumab binds to PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1, thus releasing the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses. Avelumab has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.
Bavencio Indications
Indications
Metastatic Merkel cell carcinoma (MCC).
Bavencio Dosage and Administration
Adult
Premedicate with an antihistamine and acetaminophen prior to the first 4 infusions; then subsequent doses as clinically indicated. Give as IV infusion over 60mins. 800mg every 2 weeks until disease progression or unacceptable toxicity. Dose modifications: see full labeling.
Children
<12yrs: not established.
Bavencio Contraindications
Not Applicable
Bavencio Boxed Warnings
Not Applicable
Bavencio Warnings/Precautions
Warnings/Precautions
Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. In combination with axitinib: risk of severe and fatal cardiovascular events; consider evaluating LVEF at baseline and periodically; discontinue both drugs if Grade 3/4 events occur. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥1 month after the last dose. Pregnancy. Nursing mothers: not recommended (during and for ≥1 month after the last dose).
Bavencio Pharmacokinetics
Absorption
Steady-state concentration were reached after ~4 to 6 weeks.
Distribution
Volume of distribution: 4.72 L.
Elimination
Primary elimination mechanism: proteolytic degradation. Half-life: 6.1 days. Total systemic clearance: 0.59 L/day.
Bavencio Interactions
Interactions
Increased risk of hepatotoxicity and cardiovascular events (in combination with axitinib); monitor liver enzymes and LVEF more frequently.
Bavencio Adverse Reactions
Adverse Reactions
Fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, peripheral edema, UTI, hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, headache; other immune-mediated adverse reactions (may be fatal).
Bavencio Clinical Trials
See Literature
Bavencio Note
Not Applicable
Bavencio Patient Counseling
See Literature
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