Evolocumab
REPATHA
Pronunciation: e-voe-LOK-yoo-mab (ri-PATH-a)
“Evil lookin’ mab Re-paths a (pesky K-9)”
Pesky K-9 → PCSK9, which targets LDL receptors for destruction
What it isPCSK9-binding monoclonal antibody that increases LDL-receptor recycling; hyperlipidemia and ASCVD risk reduction.
Why this oneUnlike response-titrated alirocumab, its standard hyperlipidemia regimens use fixed, clinically equivalent dosing options.
What limits itInjection-site reactions are usually mild; cost, access and the need for ongoing injections are the main reasons treatment fails.
FDA-approved for
- hyperlipidemia / ASCVD risk reduction (2015)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Primary hyperlipidemia / CV risk reduction | Adults | 140 mg q2wk or 420 mg monthly SC | 140 mg q2wk or 420 mg monthly SC | |
| HeFH | Adults & peds ≥10 yr | 140 mg q2wk or 420 mg monthly SC | 140 mg q2wk or 420 mg monthly SC | |
| HoFH | Adults & peds ≥10 yr | 420 mg monthly SC | may ↑ to 420 mg q2wk if inadequate response at 12 wk | 420 mg q2wk |
Titration HoFH: may increase to 420 mg q2wk only if inadequate response after 12 wk
Renal No adjustment needed
Hepatic No adjustment for mild–moderate (Child-Pugh A/B); no data in severe
Instructions
- Inject SC into abdomen, thigh, or upper arm; rotate sites
- Allow to warm to room temperature ≥30 min before use
- Give the 420 mg dose as 3 injections consecutively within 30 min
- If switching regimens, give first dose of new regimen on next scheduled date of prior regimen
- Missed dose: give within 7 days and resume schedule; if >7 days, for q2wk wait for next scheduled dose, for monthly give dose and start new schedule
Available strengths
- inj 140 mg/mL
Cautions
- Hypersensitivity reactions including angioedema — discontinue if serious reaction occurs
- Some autoinjector/syringe presentations have dry natural rubber (latex) in needle cover — caution if latex-sensitive
Adverse reactions
- Nasopharyngitis
- Upper respiratory tract infection
- Influenza
- Back pain
- Injection site reactions
- Diabetes mellitus / new-onset diabetes (in CV disease patients)
Pregnancy Insufficient data; IgG crosses placenta (increasingly near term) and may transmit to fetus
Lactation No information on presence in human milk; breast-milk antibodies unlikely to enter infant circulation in substantial amounts
Cost
| Strength | #/mo | generic $/unit | brand $/unit | CostPlus | |
|---|---|---|---|---|---|
| 140 mg/mL | inj | per unit | — | $281.88/mL | not offered |
Generic entry2037 est. (biosimilar)
NO BOXED WARNINGS
Principal riskInjection-site reactions
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityInjection-site and hypersensitivity reactions; systemic acute toxicity is minimal.
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Memory aids: interaction avatars
