Aduhelm

— THERAPEUTIC CATEGORIES —
  • Alzheimer's dementia

Aduhelm Generic Name & Formulations

General Description

Aducanumab-avwa 100mg/mL; soln for IV infusion after dilution; preservative-free

Pharmacological Class

Amyloid beta-directed antibody.

How Supplied

Single-dose vial (1.7mL, 3mL)—1

Manufacturer

Generic Availability

NO

Mechanism of Action

Aducanumab-avwa is a human, immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. Based on clinical studies, aducanumab-avwa reduces amyloid beta plaques.

Aduhelm Indications

Indications

Alzheimer's disease in mild cognitive impairment or mild dementia.

Aduhelm Dosage and Administration

Adult

See full labeling. Initiate titration based on dosing schedule. Give by IV infusion over 1hr every 4 weeks. Infusions 1 and 2: 1mg/kg. Infusions 3 and 4: 3mg/kg. Infusions 5 and 6: 6mg/kg. Infusion 7 and beyond: 10mg/kg.

Children

Not established.

Aduhelm Contraindications

Not Applicable

Aduhelm Boxed Warnings

Not Applicable

Aduhelm Warnings/Precautions

Warnings/Precautions

Risk for amyloid related imaging abnormalities (ARIA), either with edema (ARIA-E), or with hemosiderin deposition (ARIA-H). Consider testing for ApoE ε4 carrier status to determine the risk for ARIA prior to treatment initiation. Risk for intracerebral hemorrhage: prior intracerebral hemorrhage >1cm in diameter, >4 microhemorrhages, superficial siderosis, history of diffuse white matter disease. Perform clinical evaluation if ARIA symptoms occur (esp during titration), including MRI testing if indicated. Obtain recent MRI (within 1yr) prior to initiation, and prior to 5th, 7th, 9th, and 12th infusions. Discontinue if hypersensitivity reactions occur. Pregnancy. Nursing mothers.

Aduhelm Pharmacokinetics

Absorption

Steady-state concentrations were reached by 16 weeks of repeated dosing.

Distribution

The mean value for volume of distribution at steady state is 9.63 L (95% CI, 9.48–9.79).

Metabolism

Catabolic pathways.

Elimination

Half-life: 24.8 days.

Aduhelm Interactions

Interactions

Caution when considering concomitant antithrombotics or a thrombolytic agent (eg, tissue plasminogen activator).

Aduhelm Adverse Reactions

Adverse Reactions

ARIA-Edema, headache, ARIA-H microhemorrhage, ARIA-H superficial siderosis, fall; hypersensitivity reactions.

Aduhelm Clinical Trials

See Literature

Aduhelm Note

Not Applicable

Aduhelm Patient Counseling

See Literature