BYOOVIZ
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BYOOVIZ (BYOOVIZ).
BYOOVIZ (bevacizumab-maly) is a vascular endothelial growth factor (VEGF) inhibitor that binds to VEGF-A and prevents its interaction with receptors VEGFR-1 and VEGFR-2, thereby inhibiting angiogenesis and tumor growth.
| Metabolism | Bevacizumab-maly is a monoclonal antibody; metabolism is primarily via catabolic pathways (proteolysis). No specific CYP450 or other drug-metabolizing enzyme involvement. Clearance may be influenced by tumor burden and renal function. |
| Excretion | Bevacizumab (BYOOVIZ) is eliminated primarily via proteolytic catabolism, not renal or biliary excretion. No significant intact drug is excreted in urine or feces. |
| Half-life | 20 days (range 11–50 days) in patients; supports every-2- or 3-week dosing. Longer half-life in bevacizumab compared to other monoclonal antibodies due to FcRn-mediated recycling. |
| Protein binding | Negligible specific binding to plasma proteins; monoclonal antibody, not bound to albumin or other proteins to a significant extent (<1%). |
| Volume of Distribution | 2.9–3.9 L (approximately 0.04–0.06 L/kg) in typical adult; small Vd consistent with primarily intravascular distribution, limited extravascular penetration. |
| Bioavailability | Intravenous: 100% (only approved route). Subcutaneous or oral bioavailability not applicable; not absorbed via GI tract. |
| Onset of Action | Intravenous: Anti-angiogenic effect begins within hours; clinical tumor response may be seen within 2–4 weeks after first dose. |
| Duration of Action | Persists for duration of dosing (e.g., 2–3 weeks per cycle); therapeutic effect wanes as drug is cleared, requiring repeated administration for sustained VEGF inhibition. |
0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection once every 4 weeks (monthly). Dose adjustment is not recommended.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required based on renal function. Safety and efficacy not established in patients with severe renal impairment. |
| Liver impairment | No dose adjustment required based on hepatic function. Safety and efficacy not established in patients with severe hepatic impairment. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established. No dosing recommendations available. |
| Geriatric use | No dose adjustment required in elderly patients. Clinical studies included patients aged ≥65 years, and no overall differences in safety or efficacy were observed. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BYOOVIZ (BYOOVIZ).
| Breastfeeding | It is unknown if bevacizumab-awwb is excreted in human milk; however, human IgG antibodies are known to be present in breast milk. The molecular size makes transfer likely. Potential for absorption and harm to the infant is uncertain, but due to the long half-life and pharmacodynamic effects, breastfeeding is not recommended during treatment and for at least 6 months after the last dose. No M/P ratio is available. |
| Teratogenic Risk | BYOOVIZ (bevacizumab-awwb) is a vascular endothelial growth factor (VEGF) inhibitor. Based on mechanism of action and findings from animal studies, there is a risk of fetal harm. In pregnant animals, VEGF inhibition resulted in teratogenic effects including reduced fetal weight, increased resorption, and skeletal abnormalities. In humans, use during pregnancy is not recommended, especially during the second and third trimesters, as it may impair angiogenesis essential for fetal development. First trimester exposure may carry risks; however, data are limited. The drug should be avoided during pregnancy unless the potential benefit outweighs the risk. |
■ FDA Black Box Warning
WARNING: GASTROINTESTINAL PERFORATIONS, SURGICAL WOUND COMPLICATIONS, AND HEMORRHAGE. Bevacizumab-maly can cause gastrointestinal perforations, wound dehiscence, and serious or fatal hemorrhage. Therapy should be discontinued if any of these occur. Avoid surgery within 28 days of administration.
| Serious Effects |
["Known hypersensitivity to bevacizumab-maly or any excipients","Recent major surgery (within 28 days)","Uncontrolled hypertension","History of serious hemorrhage (e.g., hemoptysis, gastrointestinal bleeding)","Active bleeding or coagulopathy","Pregnancy (based on mechanism of action, known to cause fetal harm)","Lactation (discontinue breast-feeding due to potential harm to infant)"]
| Precautions | ["Gastrointestinal perforations","Surgical wound dehiscence and impaired wound healing","Hemorrhage (including pulmonary hemorrhage)","Arterial thromboembolic events (including stroke, myocardial infarction)","Venous thromboembolic events","Hypertension","Posterior reversible encephalopathy syndrome (PRES)","Proteinuria and nephrotic syndrome","Congestive heart failure","Ovarian failure and infertility","Infusion-related reactions","Increased risk of severe neutropenia and infections when used with chemotherapy"] |
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| Fetal Monitoring | Monitor for signs of preeclampsia, hypertension, proteinuria, and fetal growth restriction via ultrasound. Assess blood pressure and urine protein at each visit. For patients inadvertently exposed during pregnancy, fetal ultrasound should be performed to assess growth and amniotic fluid volume. |
| Fertility Effects | Based on its antiangiogenic mechanism, bevacizumab-awwb may impair female fertility. Animal studies have shown reduced ovarian function and fertility. In humans, ovarian failure has been reported in premenopausal women, with potential for reversible amenorrhea and reduced fertility. Male fertility effects are unknown but may occur. |
| Food/Dietary |
| No specific food interactions. Maintain adequate hydration. Avoid grapefruit juice if taking concomitant CYP3A4 substrates (not a direct interaction with bevacizumab). |
| Clinical Pearls | BYOOVIZ (bevacizumab-bzbz) is a biosimilar to Avastin. Monitor for hypertension, proteinuria, and bleeding. Do not initiate within 28 days of major surgery. Contraindicated in patients with untreated CNS metastases. Administer as IV infusion, not IV push or bolus. |
| Patient Advice | Report any signs of bleeding or unusual bruising immediately. · Monitor blood pressure regularly and report elevated readings. · Inform your doctor if you are pregnant or planning to become pregnant; BYOOVIZ can harm an unborn baby. · Avoid activities that increase risk of bleeding; use soft toothbrush and electric razor. · You may need to stop treatment before surgery; discuss with your surgeon. |