Ctrl

K

Zenocutuzumab

Class
Targeted therapy
Subclass
Anti-HER2 / HER3 bispecific monoclonal antibodies
Substance name
Zenocutuzumab, zenocutuzumab-zbco
Brand names
Bizengri®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Non-small cell lung cancer in patients with NRG1 fusion • Unresectable or metastatic, progression on or after prior systemic therapy
•
750 mg IV q2 weeks until disease progression or unacceptable toxicity
Administer over 4 hours via a peripheral or central line. Do not infuse concomitantly through the same intravenous line as other agents.
Pancreatic adenocarcinoma in patients with NRG1 fusion • Unresectable or metastatic, progression on or after prior systemic therapy
•
750 mg IV q2 weeks until disease progression or unacceptable toxicity
Administer over 4 hours via a peripheral or central line. Do not infuse concomitantly through the same intravenous line as other agents.
Indications for use
Labeled indications
Adults
•
Treatment of non-small cell lung cancer in patients with NRG1 fusion (unresectable or metastatic, progression on or after prior systemic therapy)
•
Treatment of pancreatic adenocarcinoma in patients with NRG1 fusion (unresectable or metastatic, progression on or after prior systemic therapy)
Safety risks
Boxed warnings
Fetal toxicity
•
Do not use in pregnant patients.
Warnings and precautions
ILD, pneumonitis
•
Maintain a high level of suspicion, as zenocutuzumab can cause life-threatening ILD/pneumonitis. Monitor patients for new or worsening pulmonary symptoms. If ILD/pneumonitis occurs, interrupt zenocutuzumab until recovery and consider corticosteroids as clinically indicated. For Grade 2 or higher severity, permanently discontinue zenocutuzumab and promptly initiate corticosteroid treatment.
Infusion-related reactions, anaphylaxis
•
Maintain a high level of suspicion, as zenocutuzumab can cause serious and life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis. Premedicate before the first infusion with a corticosteroid (e.g., dexamethasone 10 mg PO/IV), an H1 antihistamine (e.g., dexchlorpheniramine 5 mg PO/IV), and an antipyretic (e.g., acetaminophen 1,000 mg PO). For subsequent infusions, corticosteroid premedication is optional unless the patient has had a prior Grade ≤3 infusion-related reaction, where it is recommended. Continue H1 antihistamine and antipyretic premedication for all infusions. Monitor during infusion and for at least 1 hour post-infusion. For Grade ≤3 reactions, interrupt and resume at 50% of the prior rate after resolution. Permanently discontinue for Grade 4 or life-threatening reactions.
LV dysfunction
•
Maintain a high level of suspicion, as zenocutuzumab can cause LV dysfunction. Assess LVEF (LVEF) before initiating treatment and monitor at regular intervals as clinically indicated. If LVEF is <45%, or <50% with an absolute decrease from baseline of ≥10%, interrupt therapy and repeat assessment within 3 weeks. Permanently discontinue zenocutuzumab if LVEF remains <45% or does not recover to within 10% of baseline, or in cases of symptomatic congestive HF.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 30 mL/min
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
No guidance available.
Child-Pugh C (severe)
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Do not use. Evidence of fetal harm in humans. Evidence of fetal harm in humans. Verify pregnancy status in females of reproductive potential before initiating treatment. Advise patients to use effective contraception during treatment and for 2 months after the final dose.
Breastfeeding
Do not use during breastfeeding.
•
During treatment with zenocutuzumab and for 2 months after the last dose.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Abdominal distension, bleeding, anemia, ↓ WBC count, ↓ serum albumin, ↓ platelet count, ↓ serum magnesium, ↓ serum phosphate, ↓ serum potassium, ↓ serum sodium, edema, ↑ serum ALP, ↑ serum ALT, ↑ serum AST, ↑ serum TBIL, ↑ serum gamma-glutamyltransferase, infusion-related reactions, cough, constipation, diarrhea, dyspnea, abdominal pain, fatigue, loss of appetite, musculoskeletal pain, nausea, skin rash, vomiting
Common 1-10%
•
↓ LVEF, heart failure, pneumonitis, interstitial lung disease, fever, anxiety, skin dryness, stomatitis
Interactions
Drug(s)
Check Interactions
Reset

What did you think about this content?

Create free account

Sign up for free to access the full drug resource