BIZENGRI
Generic Name/API: zenocutuzumab-zbco
Manufacturer: Merus N.V.
Packaging & Strength & Form:
Injection: 375 mg/18.75 mL (20 mg/mL) in a single-dose vial.
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.
BIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for
the treatment of:
• Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease
progression on or after prior systemic therapy.* (1.1)
• Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with
disease progression on or after prior systemic therapy.* (1.2)
*This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
WARNINGS AND PRECAUTIONS ——————–
• Infusion-Related Reactions (IRR)/Hypersensitivity/Anaphylactic Reactions:
Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor for signs and symptoms of IRR. Interrupt infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms.
Immediately stop the infusion and permanently discontinue BIZENGRI for
Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis. (5.1)
• Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Permanently discontinue BIZENGRI in patients with ≥ Grade 2 ILD/pneumonitis. (5.2)
• Left Ventricular Dysfunction: Assess LVEF before initiating BIZENGRI and at regular intervals during treatment as clinically indicated. Manage through treatment interruption or discontinuation. Permanently discontinue
BIZENGRI in patients with symptomatic congestive heart failure (CHF). (5.3)
*The contents of this site are for reference only. We do not offer drug procurement service. All information must not be used for any commercial purpose.
