Ziihera (zanidatamab-hrii)

If adverse events occur during zanidatamab-hrii therapy, temporary interruption of therapy, dosage reduction, and/or discontinuance of the drug may be necessary. In general, if dosage reduction is necessary, the recommended dosage is 15 mg/kg. If a dosage of 15 mg/kg is not tolerated, zanidatamab-hrii should be permanently discontinued.

Administer zanidatamab-hrii via IV infusion in a dedicated line with a low protein-binding 0.2-micron in-line filter. Do not administer via rapid IV bolus injection.

Zanidatamab-hrii is available as a 300-mg single-dose vial of preservative-free lyophilized powder that must be reconstituted and diluted prior to IV infusion.

Do not administer in the same IV line with other medications.

Store vials of zanidatamab-hrii refrigerated at 2-8degreesC in original carton. Do not freeze.

Zanidatamab-hrii is compatible with 0.9% sodium chloride injection and 5% dextrose injection.

No dosing information is available for this tab.

No formal drug interaction studies have been conducted to date with zanidatamab-hrii.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Igg Antibodies And Derivatives/Efgartigimod-Alfa

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) Efgartigimod-alfa 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 efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)

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)

Moderate Interaction: Assess the risk to the patient and take action as needed.

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)

*None.

There are no contraindication contraindications for this drug.

• Chronic heart failure
• Pregnancy

There are no moderate contraindications for this drug.

The most common adverse reactions (incidence >=20%) reported with zanidatamab-hrii in clinical studies were diarrhea, infusion-related reaction, abdominal pain, and fatigue.

Less Frequent

• Biliary obstruction
• Biliary tract infection
• Gastrointestinal obstruction
• Left ventricular failure
• Pneumonia
• Sepsis

More Frequent

• Acute abdominal pain
• Anemia
• Anorexia
• Diarrhea
• Fatigue
• Hypoalbuminemia
• Hypokalemia
• Hyponatremia
• Increased alkaline phosphatase
• Injection site sequelae
• Lymphopenia
• Nausea
• Skin rash
• Vomiting

Less Frequent

• Increased lactate acid dehydrogenase

No enhanced messaging available.

Safety and efficacy of zanidatamab-hrii have not been established in pediatric patients <18 years of age.

There are no human or animal data on zanidatamab-hrii use in pregnant women. However, based on its mechanism of action, zanidatamab-hrii can cause fetal harm when administered to a pregnant woman. Oligohydramnios, fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death have been reported in women receiving an anti-HER2 antibody during pregnancy in postmarketing experience.

Verify the pregnancy status of females of reproductive potential prior to the initiation of zanidatamab-hrii. Advise pregnant women and females of reproductive potential that exposure to zanidatamab-hrii 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 zanidatamab-hrii and for 4 months following the last dose of zanidatamab-hrii.

In women who received zanidatamab during pregnancy or within 4 months prior to conception, monitor for oligohydramnios. If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with local standard of care.

It is not known whether zanidatamab-hrii is distributed into human milk. Effects of the drug on breastfed infants or milk production are also not known. However, published data suggest that human IgG is present in human milk but does not enter neonatal or infant circulation in substantial amounts. Consider the 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 zanidatamab-hrii or the underlying maternal condition. The half-life of zanidatamab-hrii of approximately 21 days, and the washout period of 4 months should also be taken into consideration.

The manufacturer makes no specific recommendations for geriatric patients.

In clinical studies, 49% of 80 patients were >=65 years of age; 3% were >=75 years of age. No overall differences in safety or efficacy were observed between geriatric patients (>=65 years of age) and younger adults (<65 years of age).