Initial US Approval:
2024
Key Clinical Studies:
HERIZON-BTC-01 (NCT04466891)
Drug Class/Description:
Bispecific HER2-directed antibody
Indications and Usage:
Treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
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)
Dosage Administration:
- Premedicate patients with acetaminophen, an antihistamine and a corticosteroid, 30-60 minutes prior to each administration of ZIIHERA infusion to prevent potential infusion-related reactions (IRRs).
- The recommended dosage of ZIIHERA is 20 mg/kg given as an intravenous infusion once every 2 weeks.
Dosage Forms and Strengths:
For injection: 300 mg lyophilized powder in a single-dose vial.
Contraindications:
None.
Warnings and Precautions:
Left Ventricular Dysfunction: Assess left ventricular ejection fraction (LVEF) prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold or permanently discontinue ZIIHERA based on severity.
Infusion-Related Reactions (IRRs): Premedicate before each infusion of ZIIHERA. Interrupt the infusion, decrease the infusion rate, and/or permanently discontinue ZIIHERA based on severity.
Diarrhea: ZIIHERA can cause severe diarrhea. Administer antidiarrheal treatment as clinically indicated. Withhold or permanently discontinue ZIIHERA based on severity.
Adverse Reactions:
Most common adverse reactions (≥ 20%) are diarrhea, infusion-related reaction, abdominal pain, and fatigue.
Use in Specific Populations:
- Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of ZIIHERA
Adapted from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761416s000lbl.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
