Version May 2024
Homozygous familial hypercholesterolemia, adjunct: Children ≥5 years and Adolescents: IV: 15 mg/kg/dose every 4 weeks; use in combination with other low-density lipoprotein-cholesterol (LDL-C) lowering therapies.
Altered kidney function: Children ≥5 years and Adolescents:
Mild to moderate: No dosage adjustment necessary. Observed trough concentrations were comparable between patients with mild to moderate renal function and patients with normal renal function.
Severe: There are no dosage adjustments are provided in the manufacturer's labeling (has not been studied); dosage adjustment is unlikely to be required as monoclonal antibodies are not known to be renally eliminated.
There are no dosage adjustments are provided in the manufacturer's labeling (has not been studied).
(For additional information see "Evinacumab: Drug information")
Homozygous familial hypercholesterolemia (adjunctive agent):
Note: Refer patient to a lipid specialist prior to use. Consider for use in patients with baseline low-density lipoprotein cholesterol ≥190 mg/dL who have an inadequate response to statins with or without ezetimibe and PCSK9 inhibitors (Ref).
IV: 15 mg/kg every 4 weeks.
Missed dose: Administer as soon as possible, then schedule every 4 weeks from the date of last dose.
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, dosage adjustment is unlikely to be required as monoclonal antibodies are not known to be renally eliminated.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Severe hypersensitivity reactions, including anaphylaxis, have occurred (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.
>10%: Respiratory: Nasopharyngitis (16%)
1% to 10%:
Gastrointestinal: Abdominal pain (<3%), constipation (<3%), nausea (5%)
Hypersensitivity: Severe hypersensitivity reaction (including anaphylaxis [1%]) (table 1)
|
Drug (Evinacumab) |
Placebo |
Number of Patients (Evinacumab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
1% |
0% |
81 |
54 |
Nervous system: Asthenia (4%), dizziness (6%)
Neuromuscular & skeletal: Limb pain (4%)
Respiratory: Flu-like symptoms (7%), nasal congestion (<3%), rhinorrhea (5%), upper respiratory tract infection (<3%)
Miscellaneous: Infusion-related reaction (7%)
Frequency not defined: Cardiovascular: Decreased diastolic blood pressure (transient), increased heart rate (transient)
Serious hypersensitivity (eg, anaphylaxis) to evinacumab or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylaxis, have occurred. Discontinue treatment and initiate supportive treatment in patients who develop serious allergic reaction; monitor until symptoms resolve.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Evkeeza: Evinacumab-dgnb 1200 mg/8 mL (150 mg/mL) (8 mL); Evinacumab-dgnb 345 mg/2.3 mL (150 mg/mL) (2.3 mL) [contains polysorbate 80]
No
Solution (Evkeeza Intravenous)
345MG/2.3ML (per mL): $6,084.00
1200 mg/8 mL (per mL): $6,084.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Evkeeza: 150 mg/mL (2.3 mL, 8 mL) [contains polysorbate 80]
Parenteral: IV: Must be diluted prior to administration. If diluted solution is refrigerated following preparation, allow solution to come to room temperature prior to administration. Administer IV over 60 minutes using an inline or add on 0.2-micron to 5-micron filter. Slow, interrupt, or discontinue infusion and treat as appropriate if patient develops adverse reaction or infusion reaction (eg, infusion site pruritus, pyrexia, muscular weakness, nausea, nasal congestion). Discontinue and provide emergency care if serious or life-threatening hypersensitivity reaction occurs.
Missed dose: If dose is missed, administer as soon as possible and reschedule subsequent dose from date of last dose.
IV: Do not shake. If refrigerated, allow diluted solution to come to room temperature prior to administration; otherwise administer immediately after preparation. Administer IV infusion over 60 minutes through an IV line containing a sterile, in-line or add-on, 0.2-micron to 5-micron filter. May administer without regard to timing of lipoprotein apheresis. Rate of infusion may be slowed, interrupted, or discontinued if patient develops any adverse reactions, including infusion or hypersensitivity reactions.
Store intact vial at 2ºC to 8ºC (36ºF to 46ºF). Store the vial in the original carton to protect from light. Do not freeze. Do not shake. Does not contain a preservative. If not used immediately, store the diluted solution at 2ºC to 8ºC (36ºF to 46ºF) for ≤24 hours from the time of preparation or at room temperature up to 25ºC (77ºF) for ≤6 hours from the time of infusion preparation to the end of the infusion. Do not freeze the vials or diluted solution.
Treatment of homozygous familial hypercholesterolemia, as an adjunct to other low-density lipoprotein-cholesterol lowering therapies (FDA approved in ages ≥5 years and adults).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Evaluate pregnancy status prior to use in patients who may become pregnant. Patients who may become pregnant should use effective contraception during therapy and for at least 5 months after the last evinacumab dose.
Based on data from animal reproduction studies, in utero exposure to evinacumab may cause fetal harm.
Evinacumab is a humanized monoclonal antibody (IgG4). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Assess low-density lipoprotein-cholesterol (LDL-C) when clinically appropriate; low-density lipoprotein lowering may be measured as early as 2 weeks after initiating therapy; signs/symptoms of hypersensitivity reactions; pregnancy test prior to initiation of therapy.
Evinacumab-dgnb is a recombinant human monoclonal antibody that binds to and inhibits angiopoietin-like protein 3 (ANGPTL3). ANGPTL3 inhibits lipoprotein lipase (LPL) and endothelial lipase (EL). ANGPTL3 inhibition by evinacumab results in increased lipid metabolism, leading to decreased low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), and triglycerides (TG). Evinacumab-dgnb reduces LDL-C independent of the presence of LDL receptor by promoting very low-density lipoprotein processing and clearance upstream of LDL formation. Evinacumab-dgnb blockade of ANGPTL3 lowers TG and HDL-C by rescuing LPL and EL activities, respectively.
Distribution: Vd: ~4.7 L.
Metabolism: Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Half-life elimination: Function of evinacumab serum concentration; median time of 20 weeks for serum concentration to decrease below lower quantification limit.
Excretion: Not likely to undergo renal excretion.
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