Donanemab-azbt
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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Black Box Warning
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AMYLOID RELATED IMAGING ABNORMALITIES
See full prescribing information for complete Boxed Warning.
Condition Name: (Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities (ARIA), as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). ARIA is usually asymptomatic, although serious and life-threatening events can rarely occur. Serious intracerebral hemorrhages >1 cm have occurred in patients treated with this class of medications. ARIA-E can cause focal neurologic deficits that can mimic ischemic stroke. )
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Overview
Donanemab-azbt is an amyloid beta-directed antibody that is FDA approved for the treatment of Alzheimer's disease.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include ARIA-E, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and headache..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
KISUNLA is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease.
- Confirm the presence of amyloid beta pathology prior to initiating treatment.
- The recommended dosage of KISUNLA is 700 mg administered as an intravenous infusion over approximately 30 minutes every four weeks for the first three doses, followed by 1400 mg every four weeks.
- Consider stopping dosing with KISUNLA based on reduction of amyloid plaques to minimal levels on amyloid PET imaging.
- Obtain a recent baseline brain MRI prior to initiating treatment.
- Obtain an MRI prior to the 2nd, 3rd, 4th, and 7th infusions. If radiographically observed ARIA occurs, treatment recommendations are based on type, severity, and presence of symptoms.
- Dilution to a final concentration of 4 mg/mL to 10 mg/mL with 0.9% Sodium Chloride Injection, is required prior to administration.
- Injection: 350 mg/20 mL (17.5 mg/mL) in a single-dose vial.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Donanemab-azbt in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Donanemab-azbt in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Donanemab-azbt 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 Donanemab-azbt in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Donanemab-azbt in pediatric patients.
Contraindications
KISUNLA is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or to any of the excipients. Reactions have included anaphylaxis.
Warnings
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AMYLOID RELATED IMAGING ABNORMALITIES
See full prescribing information for complete Boxed Warning.
Condition Name: (Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities (ARIA), as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). ARIA is usually asymptomatic, although serious and life-threatening events can rarely occur. Serious intracerebral hemorrhages >1 cm have occurred in patients treated with this class of medications. ARIA-E can cause focal neurologic deficits that can mimic ischemic stroke. )
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There is limited information regarding Donanemab-azbt Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Donanemab-azbt Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Donanemab-azbt Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Donanemab-azbt Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Donanemab-azbt in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Donanemab-azbt in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Donanemab-azbt during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Donanemab-azbt in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Donanemab-azbt in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Donanemab-azbt in geriatric settings.
Gender
There is no FDA guidance on the use of Donanemab-azbt with respect to specific gender populations.
Race
There is no FDA guidance on the use of Donanemab-azbt with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Donanemab-azbt in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Donanemab-azbt in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Donanemab-azbt in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Donanemab-azbt in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Donanemab-azbt Administration in the drug label.
Monitoring
There is limited information regarding Donanemab-azbt Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Donanemab-azbt and IV administrations.
Overdosage
There is limited information regarding Donanemab-azbt 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 Donanemab-azbt Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Donanemab-azbt Mechanism of Action in the drug label.
Structure
There is limited information regarding Donanemab-azbt Structure in the drug label.
Pharmacodynamics
There is limited information regarding Donanemab-azbt Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Donanemab-azbt Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Donanemab-azbt Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Donanemab-azbt Clinical Studies in the drug label.
How Supplied
There is limited information regarding Donanemab-azbt How Supplied in the drug label.
Storage
There is limited information regarding Donanemab-azbt 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 Donanemab-azbt Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Donanemab-azbt 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 Donanemab-azbt Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Donanemab-azbt 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.