Zanidatamab

FDA label, Jazz Pharmaceuticals, Inc., intravenous, effective 2026-08-24. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Boxed warning

WARNING: 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 )

Bispecific HER2-directed Antibody

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

Prepare this dose

Your numbers for zanidatamab. Take vial strength, diluent, and limits from the label below.

Dose

Basis

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Premedications and Important Administration Information 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 ] :

Administer acetaminophen, an antihistamine (such as diphenhydramine) and a corticosteroid (such as hydrocortisone). ZIIHERA in combination with fluoropyrimidine- and platinum-containing chemotherapy with or without tislelizumab-jsgr Antidiarrheal prophylaxis:

Administer loperamide 4 mg twice daily beginning on Day 1 and continue for at least 7 days during the first cycle of treatment.

If patients experience Grade 1 or higher diarrhea during the first cycle, continue prophylaxis with loperamide 4 mg twice daily for at least the first 7 days of each subsequent cycle [see Warnings and Precautions]. Fluorouracil-containing regimens:

When ZIIHERA is administered in combination with fluorouracil-containing regimens, administer fluorouracil as an intravenous infusion. Do NOT administer fluorouracil as an intravenous bolus due to the potential increase in diarrhea [see Warnings and Precautions] . Missed dose ZIIHERA in combination with fluoropyrimidine- and platinum-containing chemotherapy with or without tislelizumab-jsgr If a planned dose of ZIIHERA is delayed or missed, administer the dose as soon as possible if 7 days or fewer have passed since the scheduled time.

If more than 7 days have passed since the planned dose, withhold ZIIHERA and resume on day 1 of the next cycle. ZIIHERA as a single agent 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 2-week interval between doses.

Recommended Dosage Gastroesophageal Adenocarcinoma (GEA) Administer ZIIHERA as an intravenous infusion until disease progression or unacceptable toxicity at the recommended dosages presented in Table 1: Table 1: Dosage recommendations for patients with GEA [See table below.] Refer to the Prescribing Information of each of the individual therapeutic agents used in combination with ZIIHERA for additional dosing information.

If chemotherapy is discontinued for reasons other than disease progression, treatment with ZIIHERA, and/or tislelizumab-jsgr can continue until disease progression. Biliary Tract Cancer The recommended dosage of ZIIHERA is 20 mg/kg, administered as an intravenous infusion once every 2 weeks until disease progression or unacceptable toxicity.

Preparation and Administration Instructions Administer as an intravenous infusion after ZIIHERA is reconstituted and diluted. Reconstitution

Calculate the recommended dose based on the patient’s weight to determine the number of vials needed.

Remove the vial(s) from the refrigerator and allow the vial(s) to reach room temperature.

Reconstitute each 300 mg vial of ZIIHERA with 5.7 mL of Sterile Water for Injection by slowly directing the stream toward the inside of the wall of the vial, to obtain a concentration of 50 mg/mL in an extractable volume of 6 mL.

Swirl the vial gently until completely dissolved. Do not shake or vigorously swirl.

Allow the reconstituted vial to settle to allow bubbles to dissipate.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted product should be a colorless to light yellow, clear to slightly opalescent solution with no visible particles. Discard the reconstituted vial if any discoloration or particulate matter is observed.

The product does not contain a preservative. Use the reconstituted ZIIHERA solution immediately or store the reconstituted ZIIHERA solution for up to 4 hours, either at room temperature (18°C to 24°C [64°F to 75°F]) or in a refrigerator (2°C to 8°C [36°F to 46°F]). Dilution

Withdraw the necessary volume for the calculated dose from each vial [see Dosage and Administration] .

Slowly add the necessary dose volume to an infusion bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection to prepare an infusion solution with a final concentration between 4 mg/mL and 20 mg/mL. Use the least possible volume of diluent necessary, do not exceed a maximum volume of 500 mL.

Gently invert the infusion bag to mix. Do not shake.

The infusion solution must be a clear, colorless solution with no visible particles. Do not use if visible particles are observed or if the solution is discolored.

Discard any unused portion left in the vial(s).

Use the infusion solution immediately upon dilution or store the infusion solution at room temperature (18°C to 24°C [64°F to 75°F]) for up to 12 hours or in the refrigerator (2°C to 8°C [36°F to 46°F]) for up to 24 hours. o These time limits include the beginning of reconstitution through the duration of infusion. o If these specified times are exceeded, discontinue the current infusion bag and prepare a new bag which contains the remaining dosage of ZIIHERA to be infused.

Compatibility with intravenous administration materials and the infusion solution has been demonstrated in the following materials: o Intravenous (IV) Bag: Polyvinyl chloride (PVC), polyolefin (PO), ethyl vinyl acetate (EVA), polypropylene (PP), and ethylene-propylene copolymer. o Infusion sets: Polyvinyl chloride/ bis (2-ethylhexyl) phthalate (PVC/DEHP), Polyurethane (PUR), polyethylene-lined (PE-lined), acrylonitrile-butadiene-styrene (ABS). o Inline filters: Polyethersulfone solution filter (PES), polyvinylidene fluoride air filter (PVDF). o Closed System Transfer devices: acrylonitrile-butadiene-styrene (ABS), acrylic copolymer, polycarbonate (PC), polyisoprene (PI), polyester, polypropylene (PP) polytetrafluoroethylene (PTFE), silicone, and stainless steel (SS).

Administration

Administer ZIIHERA as an intravenous infusion with a 0.2 or 0.22 micron filter per the recommended infusion durations listed in Table 4.

Do not administer as an intravenous push or bolus.

Do not co-administer ZIIHERA and other intravenous drugs through the same intravenous line.

Administer ZIIHERA first, followed by tislelizumab-jsgr (if included in the regimen), and then chemotherapy when ZIIHERA is given in combination regimens for the treatment of GEA . [See table below.] Subsequent 60 minutes, if previous infusions were well-tolerated

No dosage modification of ZIIHERA is required.Initiate appropriate medical therapy and monitor as clinically indicated.Withhold ZIIHERA treatment until severity improves to ≤ Grade 1.Initiate or intensify appropriate medical therapy and monitor as clinically indicated.Administer subsequent ZIIHERA treatment at the same dose level or consider a dose reduction.For recurrent Grade 3 symptoms, withhold ZIIHERA treatment and ensure medical management has been optimized.Resume ZIIHERA treatment at a reduced dose after severity improves to ≤ Grade 1Permanently discontinue ZIIHERA for recurrent Grade 3 symptoms that last > 3 days despite optimized medical management.Permanently discontinue ZIIHERA. Withhold ZIIHERA for at least 4 weeks.Repeat LVEF assessment within 4 weeks.Resume ZIIHERA treatment within 4 to 8 weeks if LVEF returns to normal limits and the absolute decrease is ≤ 15% points from baseline.Permanently discontinue ZIIHERA if LVEF has not recovered to within 15% points from pre-treatment baseline.Permanently discontinue ZIIHERA.Reduce ZIIHERA infusion rate by 50%.For subsequent ZIIHERA infusions increase infusion rate gradually to the rate prior to the adverse reaction, as tolerated.Stop ZIIHERA infusion immediately.Treat with appropriate therapy.Resume ZIIHERA infusion at 50% of previous infusion rate once symptoms resolve.For subsequent ZIIHERA infusions, increase infusion rate gradually to the rate prior to the adverse reaction, as tolerated. Stop ZIIHERA infusion immediately.Promptly treat with appropriate therapy; infusion should not be restarted during the same cycle even if signs and symptoms completely resolve.Subsequent ZIIHERA infusions should be administered at 50% of previous infusion rate.Permanently discontinue ZIIHERA for recurrent Grade 3 reaction.Stop ZIIHERA infusion immediately and permanently discontinue.Promptly treat with appropriate therapy.No dosage modification is required for ZIIHERA.Initiate appropriate medical therapy and monitor as clinically indicated.Withhold ZIIHERA treatment until severity improves to ≤ Grade 1.Initiate appropriate medical therapy and monitor as clinically indicated.Administer subsequent ZIIHERA treatment at the same dose; consider dose reduction if Grade 3 symptoms recur.Permanently discontinue ZIIHERA, except as noted below.Initiate appropriate medical therapy and monitor as clinically indicated.ZIIHERA treatment may be resumed at the same dose level for Grade 4 electrolyte imbalances or laboratory abnormalities that are corrected within 3 days of onset; do not resume until symptoms improve to ≤ Grade 1.Permanently discontinue ZIIHERA for recurrent Grade 4 electrolyte imbalances or laboratory abnormalities.

Table 3: Dosage Modifications for Adverse Reactions
Adverse Reaction	Severity	Treatment Modification
Diarrhea [see Warnings and Precautions (5.1)]	Mild/Moderate (Grade 1 or 2)
	Severe (Grade 3)
	Life threatening (Grade 4)
Left Ventricular Dysfunction (LVD)[see Warnings and Precautions (5.3)]	Absolute decrease of ≥ 16% points in LVEF from pre-treatment baselineorLVEF < 50% and absolute decrease of ≥ 10% points below pre-treatment baseline
	Confirmed symptomatic congestive heart failure
Infusion-Related Reactions[see Warnings and Precautions (5.4)]	Mild (Grade 1)
	Moderate (Grade 2)
	Severe (Grade 3)
	Life threatening (Grade 4)
Other Adverse Reactions (excluding LVD, IRR and Diarrhea)[see Adverse Reactions (6.1)]	Mild/Moderate (Grades 1/2)
	Severe (Grade 3)
	Life threatening (Grade 4)

Table 4: Recommended ZIIHERA Infusion Durations
Dose	Infusion Duration
First	120 minutes
Second	90 minutes, if previous infusions were well-tolerated
Subsequent	60 minutes, if previous infusions were well-tolerated

Contraindications

None. • None. ( 4 )

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary Based on 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. Use of ZIIHERA is not recommended during pregnancy (see CLINICAL CONSIDERATIONS). Advise patients of potential risks to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Monitor women who received ZIIHERA during pregnancy or within 4 months prior to conception for oligohydramnios. If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with local standard of care.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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