Evkeeza

• The recommended dosage of EVKEEZA is 15 mg/kg administered by intravenous (IV) infusion once monthly (every 4 weeks). (
  2.1 Recommended Dosage

  • 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.
  )
• See the Full Prescribing Information for preparation instructions for the intravenous infusion. (
  2.2 Preparation Instructions for Intravenous Infusion

  • Calculate the dosage (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, discolored, or contains particulate matter.
  • EVKEEZA is supplied as single-dose vials and does not contain a preservative. Prepare the diluted infusion using aseptic technique.
  • Do not shake the vial. Withdraw the required volume from the vial(s) of EVKEEZA and transfer into an IV infusion bag of 0.9% Sodium Chloride Injection or 5% Dextrose Injection. Discard any unused portion left in the vials. Mix the diluted solution by gentle inversion; do not shake. Maximum diluent volume by patient weight is summarized in Table 1.
  • Table 1: Maximum Diluent Volume by Patient Weight

    Patient Weight	Maximum Diluent Volume
    3 kg to less than 26 kg	5 mL/kg
    26 kg to less than 45 kg	150 mL
    45 kg and greater	250 mL

  • 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 administered 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 preparation to the end of the infusion. Do not freeze the diluted solution.
  )
• Administer the 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. (
  2.3 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 through an IV line containing a sterile, in-line or add-on, 0.2-micron to 5-micron filter over 60 minutes.
  • 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.
  )
• Do not mix other medications with EVKEEZA or administer other medications concomitantly via the same infusion line. (
  2.3 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 through an IV line containing a sterile, in-line or add-on, 0.2-micron to 5-micron filter over 60 minutes.
  • 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.
  )
• The rate of infusion may be slowed, interrupted or discontinued if the patient develops any signs of adverse reactions, including infusion or hypersensitivity reactions. (
  2.3 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 through an IV line containing a sterile, in-line or add-on, 0.2-micron to 5-micron filter over 60 minutes.
  • 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.
  )

EVKEEZA is a clear to slightly opalescent, colorless to pale yellow solution available as follows:

• Injection: 345 mg/2.3 mL (150 mg/mL) and 1,200 mg/8 mL (150 mg/mL) in single-dose vials.

Based on data from animal reproduction studies, EVKEEZA may cause fetal harm when administered to pregnant patients. Available human data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Evinacumab-dgnb is a human IgG4 monoclonal antibody

Subcutaneous administration of evinacumab-dgnb to pregnant rabbits during the period of organogenesis resulted in fetal malformations (domed head, hydrocephalus, and flexed limbs) at doses below the maximum recommended human dose (MRHD). No adverse embryofetal effects were observed with subcutaneous administration of evinacumab-dgnb to pregnant rats during the period of organogenesis at doses below the MRHD. Measurable evinacumab-dgnb serum concentrations were observed in fetal rabbit and rat sera at birth, indicating that evinacumab-dgnb, like other IgG antibodies, crosses the placental barrier

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

If a patient becomes pregnant while receiving EVKEEZA, healthcare providers should report EVKEEZA exposure by calling 1-833-385-3392.