AVZIVI
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AVZIVI (AVZIVI).
Avizivi (avelumab) is a human IgG1 monoclonal antibody that binds to programmed death-ligand 1 (PD-L1), blocking its interaction with PD-1 and CD80 receptors. This restores anti-tumor immune responses, including T-cell activation and proliferation, by reversing PD-L1-mediated inhibition.
| Metabolism | Avelumab is a monoclonal antibody; it is expected to be degraded into small peptides and amino acids via general protein catabolic pathways. No specific metabolic enzymes are involved; renal or hepatic metabolism is not significant. |
| Excretion | Primarily renal excretion as unchanged drug (~70%) and glucuronide conjugate (~30%); biliary/fecal excretion accounts for <5%. |
| Half-life | Terminal elimination half-life is approximately 12 hours (range 10–14 h) in patients with normal renal function; prolonged to 24–48 h in moderate-to-severe renal impairment. |
| Protein binding | ~95% bound, primarily to albumin. |
| Volume of Distribution | 0.15–0.25 L/kg, indicating distribution mainly in extracellular fluid. |
| Bioavailability | Oral: 60–70% (presystemic metabolism decreases bioavailability); intravenous: 100%. |
| Onset of Action | Oral: 1–2 hours; intravenous: within 30 minutes. |
| Duration of Action | Oral: 12 hours; intravenous: 12–24 hours; extended-release formulations may provide 24-hour duration. |
IV 200 mg over 30 minutes on Day 1 of a 21-day cycle, in combination with paclitaxel and carboplatin; continue until disease progression or unacceptable toxicity.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (CrCl ≥30 mL/min). Insufficient data for severe renal impairment (CrCl <30 mL/min) or ESRD. |
| Liver impairment | No dose adjustment required for mild hepatic impairment (Child-Pugh A). Not recommended in moderate or severe hepatic impairment (Child-Pugh B or C) due to lack of data. |
| Pediatric use | Safety and efficacy not established in pediatric patients; no recommended dose. |
| Geriatric use | No specific dose adjustment recommended for patients ≥65 years. Monitor closely for adverse events, particularly diarrhea and fatigue, based on clinical trial data. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AVZIVI (AVZIVI).
| Breastfeeding | No human data; bevacizumab is detected in animal milk. M/P ratio unknown. Due to potential for adverse effects in nursing infant (e.g., impaired wound healing, bleeding), advise against breastfeeding during therapy and for at least 6 months after last dose. |
| Teratogenic Risk | AVZIVI (bevacizumab-awwb) is a VEGF inhibitor. In pregnancy, VEGF inhibition is associated with fetal vascular disruption, including malformations, growth restriction, and fetal loss. First trimester exposure carries highest risk of teratogenicity. Second and third trimester exposure may cause oligohydramnios, premature labor, and fetal renal impairment. Contraindicated in pregnancy. |
■ FDA Black Box Warning
None. Avelumab is not associated with a black box warning.
| Serious Effects |
None. There are no absolute contraindications to avelumab.
| Precautions | ["Immune-mediated adverse reactions (including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and dermatologic reactions)","Infusion-related reactions","Embryo-fetal toxicity"] |
| Food/Dietary | Grapefruit and grapefruit juice may increase systemic exposure of bevacizumab-awwb; avoid grapefruit products. No other known food interactions. Maintain adequate hydration unless contraindicated. |
| Clinical Pearls |
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| Fetal Monitoring | Monitor blood pressure regularly (risk of hypertension and preeclampsia); monitor urine protein (proteinuria); assess for vaginal bleeding or signs of preterm labor; fetal ultrasound for growth and amniotic fluid volume (oligohydramnios risk); serial monitoring of renal function and coagulation parameters. |
| Fertility Effects | May impair female fertility by inhibiting ovarian function; oligomenorrhea or amenorrhea reported. Reversibility uncertain. Animal studies show reduced fertility and ovarian failure. Advise fertility preservation counseling before treatment. |
| AVZIVI (bevacizumab-awwb) is a biosimilar to bevacizumab, indicated for metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, and epithelial ovarian cancer. Monitor for hypertension, proteinuria, bleeding, and thromboembolic events. Do not initiate for at least 28 days after major surgery or until surgical wound is fully healed. Discontinue if wound dehiscence develops. Use caution in patients with cardiovascular disease or history of arterial thromboembolism. |
| Patient Advice | Report any signs of bleeding, such as nosebleeds, easy bruising, or black tarry stools. · Monitor blood pressure regularly and report elevations. · Notify your healthcare provider if you experience severe headache, vision changes, or seizures (risk of posterior reversible encephalopathy syndrome). · Avoid pregnancy during treatment and for at least 6 months after the last dose; AVZIVI can harm a fetus. · Inform your dentist or surgeon before any procedures; surgery may need to be delayed. · Do not drive or operate machinery if you experience dizziness or fatigue. |