BAVENCIO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BAVENCIO (BAVENCIO).
Avelumab is a human IgG1 monoclonal antibody that binds to programmed death ligand 1 (PD-L1) and blocks its interaction with PD-1 and B7.1, removing PD-L1-mediated inhibition of T-cell activation, resulting in an anti-tumor immune response.
| Metabolism | Avelumab is a monoclonal antibody that is expected to be degraded into small peptides and amino acids via general protein catabolism; no specific metabolic pathways or enzymes are involved. |
| Excretion | Avelumab is a monoclonal antibody (IgG1) that undergoes catabolism into small peptides and amino acids. Renal excretion of intact drug is negligible (<1%). Fecal elimination of intact drug is not a major route; catabolized components are recycled or excreted in urine as amino acids. No specific percentage for biliary excretion. |
| Half-life | Avelumab has a terminal half-life of approximately 6.1 days (range 4.5–8.3 days) at steady state, supporting a 2-week dosing interval. |
| Protein binding | Avelumab is an immunoglobulin G1 lambda monoclonal antibody; it is not bound to plasma proteins in a classical sense, but the fraction unbound is >99%. No specific protein binding partners. |
| Volume of Distribution | Volume of distribution at steady state is approximately 4.4 L (range 3.3–9.1 L), which is close to plasma volume, indicating limited extravascular distribution. In L/kg, assuming 70 kg: ~0.063 L/kg. |
| Bioavailability | Only intravenous administration is used; bioavailability is 100% by IV route. No other routes are approved. |
| Onset of Action | Intravenous administration; tumor response may be observed as early as the first imaging assessment (typically 6–8 weeks after initiation), though delayed responses are common. |
| Duration of Action | Drug exposure persists for approximately 5 half-lives (~30 days) after last dose. Clinical effect (anti-tumor activity) may last beyond drug clearance due to immune memory; duration is variable and not precisely defined. |
10 mg/kg intravenously over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment recommended for mild to moderate renal impairment (GFR >=30 mL/min). Insufficient data for severe renal impairment (GFR <30 mL/min). |
| Liver impairment | No dose adjustment recommended for mild hepatic impairment (Child-Pugh A). Not studied in moderate to severe hepatic impairment (Child-Pugh B or C). |
| Pediatric use | Safety and efficacy not established in pediatric patients under 18 years. No recommended dose. |
| Geriatric use | No specific dose adjustment required. Elderly patients (>=65 years) may have increased adverse reactions; monitor closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BAVENCIO (BAVENCIO).
| Breastfeeding | It is not known whether avelumab is excreted in human milk or absorbed systemically after ingestion. However, human IgG is excreted in breast milk, and avelumab is a human IgG1 antibody. Because of the potential for adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for at least 1 month after the last dose. No M/P ratio is available. |
| Teratogenic Risk | BAVENCIO (avelumab) is a human IgG1 monoclonal antibody targeting PD-L1. Based on its mechanism of action, there is a potential risk of fetal harm when administered to pregnant women. Human IgG antibodies are known to cross the placental barrier; the transfer increases as pregnancy progresses, with the largest amount transferred during the third trimester. In animal studies, administration of avelumab during gestation resulted in increased fetal loss and neonatal mortality. There are no adequate and well-controlled studies in pregnant women. Therefore, avelumab should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception during treatment and for at least 1 month after the last dose. |
■ FDA Black Box Warning
None
| Serious Effects |
["None"]
| Precautions | ["Immune-mediated adverse reactions: pneumonitis, colitis, hepatitis, endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus), nephritis, dermatologic reactions, and other immune-mediated reactions","Infusion-related reactions (severe or life-threatening)","Embryofetal toxicity: can cause fetal harm when administered to a pregnant woman"] |
| Food/Dietary | No specific food interactions have been identified with avelumab. Patients should maintain a balanced diet. Grapefruit and other CYP450 modulators are unlikely to interact as avelumab is not metabolized by cytochrome P450 enzymes. Alcohol does not have known interactions. |
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| Fetal Monitoring | Pregnancy status should be verified in women of childbearing potential before initiating BAVENCIO. During pregnancy, fetal monitoring should include serial ultrasound assessments for fetal growth and development, amniotic fluid volume, and placental health. Additionally, monitoring for maternal adverse effects such as immune-related complications (e.g., thyroiditis, pneumonitis) is essential. After delivery, neonates should be monitored for potential immune-related effects. |
| Fertility Effects | There are no specific data on the effects of avelumab on human fertility. However, based on its mechanism of action (PD-L1 blockade), there is a potential for immune-mediated effects on reproductive organs, which could impact fertility. In animal studies, no fertility studies have been conducted. Therefore, the effect on female and male fertility is unknown. |
| Clinical Pearls | BAVENCIO (avelumab) is a PD-L1 inhibitor indicated for Merkel cell carcinoma (MCC) and advanced urothelial carcinoma. Infusion-related reactions are common; premedicate with antihistamines and acetaminophen. Monitor for immune-mediated adverse events (e.g., pneumonitis, colitis, hepatitis, endocrinopathies). Do not administer as an intravenous push or bolus; infuse over 60 minutes via a 0.2-micron in-line filter. Dose modification is not recommended; withhold or discontinue for severe or life-threatening immune-related reactions. |
| Patient Advice | You may experience infusion reactions (fever, chills, flushing) during or after your infusion; tell your healthcare provider immediately. · This drug can cause your immune system to attack healthy organs, leading to serious side effects such as lung inflammation, colitis, liver damage, or hormonal problems. · Report any new or worsening symptoms like cough, chest pain, shortness of breath, severe diarrhea, abdominal pain, yellowing of skin or eyes, or extreme fatigue. · Avoid live vaccines during treatment and for a period after therapy as directed by your doctor. · Do not breastfeed while taking this medication and for at least 1 month after the last dose. |