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Drug overview for ZIIHERA (zanidatamab-hrii):
Generic name: ZANIDATAMAB-HRII
Drug class: Antineoplastic Monoclonal Antibodies
Therapeutic class: Antineoplastics
Zanidatamab-hrii, a bispecific HER2-directed antibody, is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: ZANIDATAMAB-HRII
Drug class: Antineoplastic Monoclonal Antibodies
Therapeutic class: Antineoplastics
Zanidatamab-hrii, a bispecific HER2-directed antibody, is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ZIIHERA (zanidatamab-hrii) have been approved by the FDA:
Indications:
HER2-positive biliary tract malignancy
Professional Synonyms:
None.
Indications:
HER2-positive biliary tract malignancy
Professional Synonyms:
None.
The following dosing information is available for ZIIHERA (zanidatamab-hrii):
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
*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.
*Premedicate patients with acetaminophen, an antihistamine, and a corticosteroid 30-60 minutes prior to each administration of zanidatamab-hrii infusion to prevent potential infusion-related reactions (IRRs).
*Administer as an IV infusion after reconstitution and dilution.
*The recommended dosage of zanidatamab-hrii is 20 mg/kg given as an IV infusion once every 2 weeks until disease progression or unacceptable toxicity.
*See Full Prescribing Information for additional information on preparation, administration, and dosage modifications for adverse reactions.
*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.
*Premedicate patients with acetaminophen, an antihistamine, and a corticosteroid 30-60 minutes prior to each administration of zanidatamab-hrii infusion to prevent potential infusion-related reactions (IRRs).
*Administer as an IV infusion after reconstitution and dilution.
*The recommended dosage of zanidatamab-hrii is 20 mg/kg given as an IV infusion once every 2 weeks until disease progression or unacceptable toxicity.
*See Full Prescribing Information for additional information on preparation, administration, and dosage modifications for adverse reactions.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for ZIIHERA (zanidatamab-hrii):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Nipocalimab-aahu SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3) |
IMAAVY |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Rozanolixizumab-noli SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3) DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3) |
RYSTIGGO |
The following contraindication information is available for ZIIHERA (zanidatamab-hrii):
Drug contraindication overview.
*None.
*None.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic heart failure |
| Pregnancy |
There are 0 moderate contraindications.
The following adverse reaction information is available for ZIIHERA (zanidatamab-hrii):
Adverse reaction overview.
Most common adverse reactions (>= 20%) are diarrhea, infusion-related reaction, abdominal pain, and fatigue.
Most common adverse reactions (>= 20%) are diarrhea, infusion-related reaction, abdominal pain, and fatigue.
There are 6 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Biliary obstruction Biliary tract infection Gastrointestinal obstruction Left ventricular failure Pneumonia Sepsis |
| Rare/Very Rare |
|---|
| None. |
There are 15 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Anemia Anorexia Diarrhea Fatigue Hypoalbuminemia Hypokalemia Hyponatremia Increased alkaline phosphatase Injection site sequelae Lymphopenia Nausea Skin rash Vomiting |
Increased lactate acid dehydrogenase |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ZIIHERA (zanidatamab-hrii):
Safety and efficacy of zanidatamab-hrii have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Based on mechanism of action, zanidatamab-hrii can cause fetal harm when administered to a pregnant woman. There are no human or animal data on the use of zanidatamab-hrii 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 zanidatamab-hrii is not recommended during pregnancy. 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. Monitor women who received zanidatamab-hrii 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.
Use of zanidatamab-hrii is not recommended during pregnancy. 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. Monitor women who received zanidatamab-hrii 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.
There are no data on the presence of zanidatamab-hrii in human milk, the effects on the breastfed child, or the effects on milk production. Published data suggest human IgG is present in human milk but does not enter neonatal or infant circulation in substantial amounts. Consider developmental and health benefits of breastfeeding along with the mother's clinical need for zanidatamab-hrii treatment and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. This consideration should also take into account the zanidatamab-hrii half-life of approximately 21 days and a washout period of 4 months.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Zanidatamab | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Insufficient data available; assess benefit vs. potential risk |
Of the 80 patients who received zanidatamab-hrii for unresectable or metastatic biliary tract cancer in the HERIZON-BTC-01 study, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were 65-74 years of age and 2 (3%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between these patients and younger adult patients.
The following prioritized warning is available for ZIIHERA (zanidatamab-hrii):
WARNING: Zanidatamab can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Discuss reliable forms of birth control with your doctor.
WARNING: Zanidatamab can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Discuss reliable forms of birth control with your doctor.
The following icd codes are available for ZIIHERA (zanidatamab-hrii)'s list of indications:
| HEr2-positive biliary tract malignancy | |
| C22.1 | Intrahepatic bile duct carcinoma |
| C23 | Malignant neoplasm of gallbladder |
| C24 | Malignant neoplasm of other and unspecified parts of biliary tract |
| C24.0 | Malignant neoplasm of extrahepatic bile duct |
| C24.1 | Malignant neoplasm of ampulla of vater |
| C24.8 | Malignant neoplasm of overlapping sites of biliary tract |
| C24.9 | Malignant neoplasm of biliary tract, unspecified |
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