ziihera
Ziihera (Zanidatamab-Hrii) is a medication used to treat Biliary Tract Neoplasms.
Zanidatamab-Hrii · by Jazz
Key facts
- Active ingredient
- Zanidatamab-Hrii
- Form
- Injectable
- Strength
- ZANIDATAMAB-HRII 300MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- biliary tract neoplasms
- Manufacturer
- Jazz
- FDA application
- BLA761416
- FDA boxed warning
- Yes — see the boxed warning
What is Ziihera?
From the FDA label:Zanidatamab‑hrii is a humanized, IgG1-like, bispecific HER2-directed antibody. Zanidatamab‑hrii is produced in mammalian (Chinese hamster ovary) cell culture via recombinant DNA technology and has a molecular weight of 124.8 kDa. ZIIHERA (zanidatamab‑hrii) for injection is supplied as a sterile, preservative free, white lyophilized powder that requires reconstitution and dilution for intravenous use. Each single-dose vial of reconstituted product contains 300 mg of zanidatamab‑hrii and the inactive ingredients: polysorbate 20 (0.63 mg), sodium succinate (4.3 mg), succinic acid (4.3 mg), and sucrose (567 mg). Following reconstitution with 5.7 mL Sterile Water for Injection, a solution containing 50 mg/mL zanidatamab‑hrii is produced with a deliverable volume of 6 mL, with pH of 4.6. The resulting solution is diluted and administered by intravenous infusion.
How to use
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…
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…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
DIARRHEA AND EMBRYO-FETAL TOXICITY ZIIHERA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab-jsgr, can cause severe diarrhea, including life threatening and fatal cases. Use antidiarrheal prophylaxis during the first cycle when ZIIHERA is given in combination with these drugs. Manage with antidiarrheals and supportive measures as clinically indicated. Interrupt, reduce the dose or discontinue ZIIHERA based on severity [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.5 )] . Embryo-Fetal Toxicity: Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 , 8.3 )] . WARNING: DIARRHEA and EMBRYO‑FETAL TOXICITY See full prescribing information for complete boxed warning. • ZIIHERA, in combination with fluoropyrimidine- and platinum-containing chemotherapy with or without tislelizumab-jsgr can cause severe diarrhea, including life threatening, and fatal cases. Use antidiarrheal prophylaxis during the first cycle when ZIIHERA is given in combination with these drugs. Manage with antidiarrheals and supportive measures as clinically indicated. Interrupt, reduce the dose or discontinue ZIIHERA based on severity. ( 2.4 , 5.1 , 8.5 ) • Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception. ( 5.2 )
Warnings
Important safety information
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. ( 2.4 , 5.3 ) • 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. ( 2.2 , 2.4 , 5.4 ) 5.1 Diarrhea ZIIHERA can cause severe diarrhea. When ZIIHERA is used in combination with fluoropyrimidine- and platinum-containing chemotherapy with or without tislelizumab-jsgr, severe, life threatening, and fatal cases of diarrhea can occur despite loperamide prophylaxis [see Adverse Reactions ( 6.1 ), Use in Specific Populations ( 8.5 )] . The risk of severe and life threatening diarrhea is higher when ZIIHERA is administered with chemotherapy and tislelizumab-jsgr, with a higher risk in patients aged 65 years or older compared to younger patients [see Geriatric Use ( 8.5 )] . Advise patients to increase oral fluids, begin antidiarrheals, and notify their healthcare provider immediately if diarrhea occurs [see Patient Counseling Information ( 17 )] . Administer antidiarrheal prophylaxis with loperamide in cycle 1 for all patients receiving ZIIHERA in combination with fluoropyrimidine- and platinum-containing chemotherapy with or without tislelizumab-jsgr. Begin loperamide at the first loose stool when ZIIHERA is administered in combination with chemotherapy or as a single agent. Administer fluids, electrolytes, and additional antidiarrheal agents as necessary. When ZIIHERA was used in combination with chemotherapy with or without tislelizumab-jsgr, 9% of patients had a dose reduction of ZIIHERA due to diarrhea and concomitant agents were dose reduced in 22% of patients. Before modifying the dose of ZIIHERA, evaluate, modify or discontinue drug(s) contributing to diarrhea in accordance with their respective prescribing information. Withhold, reduce the dose, or permanently discontinue ZIIHERA based on severity [see Dosage and Administration ( 2.2 , 2.4 )] . In a Phase 2 study evaluating ZIIHERA in combination with FOLFOX in patients with GEA, 57% of patients who received a fluorouracil bolus without loperamide prophylaxis (N=14), experienced Grade 3 diarrhea, while 30% of patients who did not receive a fluorouracil bolus but received loperamide prophylaxis (N=10) experienced Grade 3 diarrhea. If treating patients with ZIIHERA in combination with FOLFOX, do not administer the fluorouracil bolus. Gastroesophageal Adenocarcinoma (GEA) In Combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab: When ZIIHERA was used in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr, diarrhea was reported in 85% of 330 patients treated in clinical studies, including Grade 4 (2.1%), Grade 3 (24%), and Grade 2 (31%) events. Fatal outcomes resulting from diarrhea occurred in 1.5% of patients. Diarrhea leading to dose reduction of ZIIHERA occurred in 10% of patients, and permanent discontinuation of ZIIHERA occurred in 3.9% of patients. In cycle 1, diarrhea at Grade 4 severity occurred in 1.5% and Grade 3 severity occurred in 15% of patients despite use of loperamide prophylaxis. The median time to onset for cycle 1 diarrhea was 6 days and median time to resolution was 18 days. In Combination with fluoropyrimidine- and platinum-containing chemotherapy: When ZIIHERA was used in combination with fluoropyrimidine- and platinum-containing chemotherapy , diarrhea was reported in 81% of 395 patients treated in clinical studies, including Grade 4 (1.3%), Grade 3 (20%) and Grade 2 (33%). Diarrhea leading to dose reduction of ZIIHERA occurred in 10% of patients, and permanent discontinuation of ZIIHERA occurred in 1.8% of patients. In cycle 1, diarrhea at Grade 4 severity occurred in 0.8% and Grade 3 severity occurred in 14% of patients despite use of loperamide prophylaxis. The median time to onset for cycle 1 diarrhea was 6 days and median time to resolution was 18 days. Biliary Tract Cancer (BTC) When ZIIHERA was used as a single agent, diarrhea was reported in 49% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). Grade 3 diarrhea occurred in 2.6% of patients during cycle 1 of treatment. Of all diarrhea events occurring during the first cycle of treatment, median time to onset was 4 days and median time to resolution was 21 days. 5.2 Embryo-Fetal Toxicity Based on the mechanism of action, ZIIHERA can cause fetal harm when administered to a pregnant woman. There are no human or animal data on the use of ZIIHERA in pregnancy. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception while receiving ZIIHERA and for 4 months following the last dose of ZIIHERA. 5.3 Left Ventricular Dysfunction (LVD) ZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions [see Dosage and Administration ( 2.4 )] . The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50% [see Dosage and Administration ( 2.4 )] . Gastroesophageal Adenocarcinoma (GEA) In patients who received ZIIHERA in combination with chemotherapy and tislelizumab-jsgr, LVEF decrease (an absolute decline in LVEF of more than 10%, resulting in a final value below 50%) was observed in 9% of 330 patients. LVD leading to permanent discontinuation of ZIIHERA was reported in 3% of patients. Fatal outcomes due to LVD occurred in one patient (0.3%). The median time to first occurrence of LVD was 6.9 months (range: 1.2 to 29.1 months). Left ventricular dysfunction resolved in 78% of patients. In patients who received ZIIHERA in combination with chemotherapy, LVEF decrease was observed in 5% of 395 patients. LVD leading to permanent discontinuation of ZIIHERA was reported in 1.0% of patients. The median time to first occurrence of left ventricular dysfunction was 6.0 months (range: 1.4 to 15.0 months). Left ventricular dysfunction resolved in 70% of patients. Biliary Tract Cancer (BTC) In patients who received ZIIHERA as a single agent, LVEF decrease was observed in 4.3% of 233 patients. LVD leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of left ventricular dysfunction was 5.6 months (range: 1.6 to 18.7 months). LVD resolved in 70% of patients. 5.4 Infusion-Related Reactions ZIIHERA can cause infusion-related reactions (IRRs). Prior to each dose of ZIIHERA, administer premedication to prevent potential IRRs [see Dosage and Administration ( 2.2 )] . Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use. If an IRR occurs, slow or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs [see Dosage and Administration ( 2.4 )] . Gastroesophageal Adenocarcinoma (GEA) An IRR was reported in 22% of 330 patients treated with ZIIHERA and chemotherapy with…
Who should not take Ziihera
None. • None. ( 4 )
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Ziihera treat?
- Ziihera (Zanidatamab-Hrii) may be used to treat biliary tract neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Ziihera?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ziihera. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ziihera?
- Ziihera is marketed by Jazz. You can see Jazz's full profile, rating, and other products on pharmaranks.
- Is Ziihera a brand-name or generic drug?
- Ziihera is a brand-name product with the active ingredient Zanidatamab-Hrii.
- Is Ziihera available over the counter?
- No. Ziihera is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ziihera come in?
- Ziihera is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Ziihera FDA-registered?
- Ziihera is on record with the U.S. FDA under application number BLA761416. You can verify this on its official FDA label.
- Is Ziihera safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Ziihera. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Ziihera?
- Ziihera's side effects are taken directly from its FDA label. From the label: 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… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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