Zanidatamab-hrii

Zanidatamab-hrii
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]

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Overview

Zanidatamab-hrii is a bispecific HER2-directed antibody that is FDA approved for the treatment of ZIIHERA is a bispecific HER2-directed antibody that is FDA approved for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.. Common adverse reactions include *diarrhea,

• infusion-related reaction,
• abdominal pain, and
• fatigue..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

=====ZIIHERA==== is indicated for the 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).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Zanidatamab-hrii in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Zanidatamab-hrii in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Zanidatamab-hrii FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Zanidatamab-hrii in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Zanidatamab-hrii in pediatric patients.

Contraindications

There is limited information regarding Zanidatamab-hrii Contraindications in the drug label.

Warnings

There is limited information regarding Zanidatamab-hrii Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Zanidatamab-hrii Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Zanidatamab-hrii Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Zanidatamab-hrii Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Zanidatamab-hrii in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Zanidatamab-hrii in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Zanidatamab-hrii during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Zanidatamab-hrii in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Zanidatamab-hrii in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Zanidatamab-hrii in geriatric settings.

Gender

There is no FDA guidance on the use of Zanidatamab-hrii with respect to specific gender populations.

Race

There is no FDA guidance on the use of Zanidatamab-hrii with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Zanidatamab-hrii in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Zanidatamab-hrii in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Zanidatamab-hrii in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Zanidatamab-hrii in patients who are immunocompromised.

Administration and Monitoring

Administration

• 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 .

Information on FDA-approved tests for HER2 protein expression in biliary tract cancers is available.

• Premedications.
  • Premedicate all patients 30 to 60 minutes prior to each dose of ZIIHERA to reduce the risk of infusion-related reactions.

**Administer acetaminophen, an antihistamine (such as diphenhydramine) and a corticosteroid (such as hydrocortisone).

• 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 2-week interval between doses.

• Dosage Modifications for Adverse Reactions
  • The recommended dosage reduction of ZIIHERA for adverse reactions is 15 mg/kg as described in TABLE 1.
  • Permanently discontinue ZIIHERA in patients who cannot tolerate 15 mg/kg.

dosage modifications for advrersr reactions

File:ZIHT1B.jpg

File:ZIH1C.jpg

• Preparation and Administration Instructions.Administer only 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 final 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 8ºC [36°F to 46ºF]).
  • 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 of the diluted solution between 0.4 mg/mL and 6 mg/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 (2ºC to 8ºC [36ºF to 46ºF]) for up to 24 hours.
      • These time limits include the beginning of reconstitution through the duration of infusion.
      • 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:
      • Intravenous (IV) Bag: Polyvinyl chloride (PVC), polyolefin (PO), ethyl vinyl acetate (EVA), polypropylene (PP) and ethylene-propylene copolymer.
      • Infusion sets: Polyvinyl chloride/ bis (2-ethylhexyl) phthalate (PVC/DEHP). Polyurethane (PUR), polyethylene-lined (PE-lined) acrylonitrile-butadiene-styrene (ABS).
      • Inline filters: Polyethersulfone solution filter (PES), polyvinylidene fluoride air filter (PVDF).
      • Closed System Transfer devices: acrylonitrile-butadiene-styrene (ABS), acrylic c-polymer, 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.
  • Do not administer as an intravenous push or bolus.
  • Do not co-administer ZIIHERA and other intravenous drugs through the same intravenous line.

    File:ZIHT.png

    Recommended ZIIHERA Infusion Durations

Monitoring

There is limited information regarding Zanidatamab-hrii Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Zanidatamab-hrii and IV administrations.

Overdosage

There is limited information regarding Zanidatamab-hrii overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Zanidatamab-hrii Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Zanidatamab-hrii Mechanism of Action in the drug label.

Structure

There is limited information regarding Zanidatamab-hrii Structure in the drug label.

Pharmacodynamics

There is limited information regarding Zanidatamab-hrii Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Zanidatamab-hrii Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Zanidatamab-hrii Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Zanidatamab-hrii Clinical Studies in the drug label.

How Supplied

There is limited information regarding Zanidatamab-hrii How Supplied in the drug label.

Storage

There is limited information regarding Zanidatamab-hrii Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Zanidatamab-hrii Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Zanidatamab-hrii interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Zanidatamab-hrii Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Zanidatamab-hrii Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.