donanemab

Contraindicated in:

Use Cautiously in:

Apolipoprotein E ε4 (Apo E ε4) homozygotes (15% of patients with Alzheimer disease) (↑ risk of amyloid-related imaging abnormalities)
;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Neuro: amyloid-related imaging abnormalities (ARIA) (including edema and hemosiderin deposition), headache, INTRACRANIAL HEMORRHAGE

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), infusion-related reactions

Interactions ⬆ ⬇

Drug-drug:

Anticoagulant drugs and thrombolytics may ↑ risk of intracerebral hemorrhage.

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as a monoclonal antibody directed against aggregated insoluble forms of amyloid beta.

Therapeutic effects:

Classifications ⬆ ⬇

Therapeutic Classification: anti-Alzheimers's agents

Pharmacologic Classification: monoclonal antibodies, anti amyloid monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Not widely distributed to extravascular tissues.

Metabolism/Excretion: Degraded into small peptides and amino acids via catabolic pathways.

Half-Life: 12.1 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	4 wk

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Inform patient of ↑ risk for ARIA if they are ApoE ε4 homozygote, and encourage testing for ApoE ε4 status prior to therapy initiation. Prior to testing, discuss risk of ARIA across genotypes and implications of genetic testing results.
Inform patient that symptoms of ARIA can mimic ischemic stroke and to notify a health care provider immediately of stroke symptoms (sudden weakness or numbness, difficulty speaking or understanding, visual changes, severe headache, dizziness) occur.
Advise patient to carry information that they are being treated with donanemab.
Encourage patient to enroll in registry to help further the understanding of Alzheimer disease and the impact of therapy. Call 1-800-545-5979.
Advise patient to immediately notify health care provider if signs of hypersensitivity (difficulty breathing, swelling of face) or infusion reaction occurs.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.