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 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). ( 2.2 ) • The recommended dosage of ZIIHERA is 20 mg/kg given as an intravenous infusion once every 2 weeks. ( 2.3 ) 2.1 Patient Selection Select patients for treatment of unresectable or metastatic biliary tract cancer based on HER2-positive (IHC 3+) tumor specimens, as detected by an FDA-approved test [see Clinical Studies ( 14 )] . Information on FDA-approved tests for HER2 protein expression in biliary tract cancers is available at: http://www.fda.gov/CompanionDiagnostics . 2.2 Premedications Premedicate all patients 30 to 60 minutes prior to each dose of ZIIHERA to reduce the risk of infusion-related reactions [see Warnings and Precautions ( 5.3 )] : • Administer acetaminophen, an antihistamine (such as diphenhydramine) and a corticosteroid (such as hydrocortisone). 2.3 Recommended Dosage Recommended Dosage and Administration The recommended dosage of ZIIHERA is 20 mg/kg, administered as an intravenous infusion once every 2 weeks until disease progression or unacceptable toxicity. Missed dose If a planned dose of ZIIHERA is delayed or missed, administer the dose as soon as possible; do not wait until the next planned dose. Adjust the administration schedule to maintain a…
Zanidatamab-Hrii side effects
The following clinically significant adverse reactions are described in greater detail in other sections of the labeling: • Embyro-Fetal Toxicity [see Warnings and Precautions ( 5.1 )] • Left Ventricular dysfunction [see Warnings and Precautions ( 5.2 )] • Infusion-Related Reactions [see Warnings and Precautions ( 5.3 )] • Diarrhea [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥ 20%) are diarrhea, infusion-related reaction, 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. The pooled safety population of ZIIHERA described in WARNINGS AND PRECAUTIONS reflect exposure in 233 patients administered ZIIHERA 20 mg/kg intravenously as a single agent in two single-arm, open-label studies (ZWI‑ZW25‑101 and HERIZON‑BTC‑01), which enrolled 109 patients with biliary tract cancer, and 124 patients with other cancers. Among 233 patients who received ZIIHERA, 39% were exposed for 6 months or longer, and 17% were exposed for greater than one year.…
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.