Zanidatamab-Hrii: uses, dosing, side effects & brands
Zanidatamab-Hrii is a medicine sold in the U.S. under one brand, for biliary tract neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Biliary Tract Neoplasms
- Available as
- Injectable
- Sold as
- Ziihera
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How zanidatamab-hrii is dosed
From the FDA label for Ziihera (application BLA761416). Other zanidatamab-hrii products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Premedicate all patients to reduce the risk of infusion-related reactions (IRRs). ( 2.2 ) • Administer loperamide during the first cycle to patients receiving ZIIHERA in combination with fluoropyrimidine- and platinum-containing chemotherapy for diarrhea prophylaxis. ( 2.2 ) Gastroesophageal Adenocarcinoma (GEA): • Patients weighing less than 70 kg: ZIIHERA 1,800 mg intravenously every 3 weeks or 1,200 mg every 2 weeks infusion in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab-jsgr. ( 2.3 ) • Patients weighing 70 kg or greater: ZIIHERA 2,400 mg intravenously every 3 weeks or 1,600 mg every 2 weeks in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab-jsgr. ( 2.3 ) Biliary Tract Cancer: ZIIHERA 20 mg/kg intravenously every 2 weeks. ( 2.3 ) 2.1 Patient Selection HER2-Positive Gastroesophageal Adenocarcinoma (GEA) Select patients for treatment of unresectable locally advanced or metastatic GEA based on HER2-positive status (IHC 3+ or IHC 2+/ISH+), as detected by FDA-authorized tests [see Clinical Studies ( 14.1 )] . Information on FDA-authorized tests for HER2 protein expression and gene amplification in gastric, gastroesophageal junction, or esophageal adenocarcinoma is available at: http://www.fda.gov/CompanionDiagnostics . Biliary Tract Cancer (BTC) Select patients for…
Zanidatamab-Hrii side effects
The following clinically significant adverse reactions are described in greater detail in other sections of the labeling: • Diarrhea [see Warnings and Precautions ( 5.1 )] • Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.2) ] • Left Ventricular Dysfunction [see Warnings and Precautions (5.3 )] • Infusion-Related Reactions [see Warnings and Precautions ( 5.4 )] • Most common adverse reactions (≥ 20%) with ZIIHERA in combination with chemotherapy and tislelizumab-jsgr were diarrhea, nausea, decreased appetite, vomiting, hypokalemia, fatigue, rash, peripheral neuropathy, and IRR. ( 6.1 ) • Most common adverse reactions (≥ 20%) with ZIIHERA in combination with chemotherapy were diarrhea, nausea, vomiting, decreased appetite, fatigue, hypokalemia, peripheral neuropathy, IRR, and rash. ( 6.1 ) • Most common adverse reactions (≥ 20%) with ZIIHERA as a single agent were diarrhea, IRR, abdominal pain, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals, Inc. at 1‑800‑520‑5568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Gastroesophageal…
Who shouldn’t take zanidatamab-hrii
None. • None. ( 4 )
Every zanidatamab-hrii product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Ziihera.
Related calculators
Frequently asked questions
What is zanidatamab-hrii?
Ziihera (Zanidatamab-Hrii) is a medication used to treat Biliary Tract Neoplasms.
Can you take zanidatamab-hrii with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run zanidatamab-hrii against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does zanidatamab-hrii come in?
Across the brands we track, zanidatamab-hrii is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic zanidatamab-hrii?
We do not currently list a generic-labelled zanidatamab-hrii product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Zanidatamab-Hrii: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/zanidatamab-hrii
- MLA
- “Zanidatamab-Hrii: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/zanidatamab-hrii.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for zanidatamab-hrii on DailyMed (NIH) ↗ — including its boxed warning in full.