Medically reviewed by Drugs.com. Last updated on Mar 30, 2023.
- The recommended dosage of EVKEEZA is 15 mg/kg administered by intravenous (IV) infusion over 60 minutes once monthly (every 4 weeks).
- If a dosage of EVKEEZA is missed, administer as soon as possible. Thereafter, EVKEEZA should be scheduled monthly from the date of the last dosage.
- Assess LDL-C when clinically appropriate. The LDL-lowering effect of EVKEEZA may be measured as early as 2 weeks after initiation.
Preparation Instructions for Intravenous Infusion
- Calculate the dose (mg), total volume (mL) of EVKEEZA required, and the number of vials required based on the patient's current body weight.
- Visually inspect the solution for cloudiness, discoloration, and particulate matter prior to administration. EVKEEZA is a clear to slightly opalescent, colorless to pale-yellow solution. Do not administer if the solution is cloudy or discolored or contains particulate matter.
- EVKEEZA vials are single-dose containers and do not contain a preservative. Observe aseptic technique when preparing EVKEEZA.
- Do not shake the vial. Withdraw the required volume from the vial(s) of EVKEEZA and transfer into an IV infusion bag containing a maximum volume of 250 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix the diluted solution by gentle inversion; do not shake.
- The final concentration of the diluted solution should be between 0.5 mg/mL and 20 mg/mL depending on the patient's current body weight.
- Administer the diluted solution immediately after preparation and discard any unused portion left in the vial.
- If not used immediately, store the diluted solution refrigerated at 2 °C to 8 °C (36 °F to 46 °F) for no more than 24 hours from the time of preparation OR at room temperature up to 25 °C (77 °F) for no more than 6 hours from the time of infusion preparation to the end of the infusion. Do not freeze the diluted solution.
Administration Instructions for Intravenous Infusion
- If refrigerated, allow the diluted solution to come to room temperature prior to administration.
- Administer EVKEEZA diluted solution via IV infusion over 60 minutes through an IV line containing a sterile, in-line or add-on, 0.2-micron to 5-micron filter.
- Do not mix other medications with EVKEEZA or administer other medications concomitantly via the same infusion line.
- The rate of infusion may be slowed, interrupted or discontinued if the patient develops any signs of adverse reactions, including infusion or hypersensitivity reactions [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].
- EVKEEZA can be administered without regard to the timing of lipoprotein apheresis.
Frequently asked questions
- Is Evkeeza FDA approved as a high cholesterol treatment?
- Where can I find the Evkeeza FDA package insert?
- What is the mechanism of action for Evkeeza (evinacumab-dgnb)?
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