lek-AN-e-mab
Therapeutic Classification: anti-Alzheimers's agents
Pharmacologic Classification: monoclonal antibodies, anti amyloid monoclonal antibodies
Absorption: IV administration results in complete bioavailability.
Distribution: Not widely distributed to extravascular tissues.
Half-Life: 5–7 days.
Contraindicated in:
Use Cautiously in:
Apolipoprotein E ε4 homozygotes (15% of patients with Alzheimer disease) (↑ risk of amyloid-related imaging abnormalities)
;GI: diarrhea
Hemat: lymphopenia
Neuro: amyloid-related imaging abnormalities (ARIA) (including edema and hemosiderin deposition), headache, INTRACRANIAL HEMORRHAGE, SEIZURES
Resp: cough
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), infusion-related reactions
Drug-drug:
Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the 1st 14 wk of therapy.
May cause amyloid related imaging abnormalities edema (ARIA-E) and hemosiderin deposition (ARIA-H). For patients with ARIA-E severity on MRI: If asymptomatic and mild severity, continue dosing. If asymptomatic and moderate or severe severity, suspend dosing. If symptoms are mild (discomfort noticed, but no disruption of normal daily activity) with mild severity, may continue dosing based on clinical judgment. If symptoms are mild with moderate or severe severity, suspend dosing. If symptoms are moderate (discomfort sufficient to reduce or affect normal daily activity) or severe (incapacitating, with inability to work or to perform normal daily activity), suspend dosing. Suspend until MRI demonstrates radiographic resolution and symptoms, if present, resolve; consider a follow-up MRI to assess for resolution 2–4 mo after initial identification. Use clinical judgement when considering resumption of dosing.
For patients with ARIA-H severity on MRI: If asymptomatic and mild severity, continue dosing. If asymptomatic and moderate or severe severity, suspend dosing. If symptomatic, suspend dosing. For mild or moderate severity, suspend until MRI demonstrates radiographic stabilization and symptoms resolve; use clinical judgement regarding resumption of dosing; consider a follow-up MRI to assess for stabilization 2–4 mo after initial identification. For severe ARIA-H severity on MRI, suspend until MRI demonstrates radiographic stabilization and symptoms resolve; use clinical judgment in considering whether to continue or permanently discontinue therapy.
If patient develops an intracerebral hemorrhage >1 cm in diameter during therapy, suspend dosing until MRI demonstrates radiographic stabilization and symptoms resolve. Use clinical judgment in considering whether to continue or permanently discontinue therapy.
Lab Test Considerations:
IV Administration:
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.
NDC Code