EVKEEZA

2 Recommended Dose and Dosage Adjustment • The recommended dose for Evkeeza is 15 mg/kg administered by intravenous (IV) infusion over 60 minutes every 4 weeks. • Evkeeza should be administered by a health professional only. • The rate of infusion may be slowed, interrupted, or discontinued if the patient develops any signs of adverse reactions, including infusion-associated symptoms.

• Evkeeza can be administered without regard to lipoprotein apheresis. 3 Preparation Evkeeza is supplied as single-use only and does not contain a preservative; aseptic technique must be observed. EVKEEZA® (evinacumab) Product Monograph Page 5 of 28 Unclassified / Non classifié • Visually inspect the drug product for cloudiness, discolouration, or particulate matter prior to administration.

• Evkeeza is a clear to slightly opalescent, colourless to pale yellow solution. • Discard the vial if the solution is cloudy or discoloured or contains particulate matter. • Do not shake the vial. 9%) or dextrose 50 mg/mL (5%) for infusion.

Mix diluted solution by gentle inversion. 5 mg/mL and 20 mg/mL. • Do not freeze or shake the solution. • Discard any unused portion left in the vial. • Once infusion is prepared, the diluted solution should be administered immediately (see 11 STORAGE, STABILITY, AND DISPOSAL).

4 Administration • If refrigerated, allow the solution to come to room temperature (up to 25°C) prior to administration. • Evkeeza is for intravenous (IV) infusion only. 2 micron to 5 micron filter. Do not administer Evkeeza as an IV push or bolus.

• Do not mix other medicinal products with Evkeeza or administer concomitantly via the same infusion line. • Once the infusion is prepared, the diluted solution should be administered immediately (see 11 STORAGE, STABILITY, AND DISPOSAL).

• The rate of infusion may be slowed, interrupted, or discontinued if the patient develops any signs of adverse reactions, including infusion-associated symptoms. • Dispose of any unused medicinal product or waste material in accordance with local requirements.

5 Missed Dose If a dose of Evkeeza is missed, administer as soon as possible. Thereafter, Evkeeza should be scheduled every 4 weeks from the date of the last dose.

3 Pharmacokinetics and 14 CLINICAL TRIALS).

Pediatrics (< 6 months):

The safety and efficacy of Evkeeza in pediatric patients less than 6 months of age has not been established; therefore, Health Canada has not authorized an indication for pediatric patients less than 6 months of age. 3 Pharmacokinetics and 14 CLINICAL TRIALS).

2 CONTRAINDICATIONS Evkeeza is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING.

2 Recommended Dose and Dosage Adjustment • The recommended dose for Evkeeza is 15 mg/kg administered by intravenous (IV) infusion over 60 minutes every 4 weeks. • Evkeeza should be administered by a health professional only. • The rate of infusion may be slowed, interrupted, or discontinued if the patient develops any signs of adverse reactions, including infusion-associated symptoms.

• Evkeeza can be administered without regard to lipoprotein apheresis. 3 Preparation Evkeeza is supplied as single-use only and does not contain a preservative; aseptic technique must be observed. EVKEEZA® (evinacumab) Product Monograph Page 5 of 28 Unclassified / Non classifié • Visually inspect the drug product for cloudiness, discolouration, or particulate matter prior to administration.

• Evkeeza is a clear to slightly opalescent, colourless to pale yellow solution. • Discard the vial if the solution is cloudy or discoloured or contains particulate matter. • Do not shake the vial. 9%) or dextrose 50 mg/mL (5%) for infusion.

Mix diluted solution by gentle inversion. 5 mg/mL and 20 mg/mL. • Do not freeze or shake the solution. • Discard any unused portion left in the vial. • Once infusion is prepared, the diluted solution should be administered immediately (see 11 STORAGE, STABILITY, AND DISPOSAL).

, infusion site pruritus), have been reported with Evkeeza. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Evkeeza, treat according to the standard of care, and monitor until signs and symptoms resolve (see 2 CONTRAINDICATIONS).

1 Pregnant Women). Fertility No human data on the effect of Evkeeza on fertility are available. Teratogenic Risk Human IgG antibodies are known to cross the placenta barrier; therefore, Evkeeza has the potential to be transmitted from the mother to the developing fetus.

Evkeeza may cause fetal harm when administered to a pregnant woman and it is not recommended during pregnancy and in women of childbearing potential not using effective contraception. 1 Pregnant Women There is a limited amount of data from the use of Evkeeza in pregnant women.

Evkeeza may cause fetal harm when administered to a pregnant woman based on studies in animals demonstrating teratogenicity and maternal toxicity at maternal exposures below the human exposure at the maximum recommended human dose (MRHD) of 15 mg/kg every 4 weeks (see 16 NON-CLINICAL TOXICOLOGY).

Human IgG antibodies are known to cross the placenta barrier; therefore, Evkeeza has the potential to be transmitted from the mother to the developing fetus. Animal studies have shown the presence of evinacumab in fetal sera, indicating that evinacumab crosses the placental barrier (see 16 NON-CLINICAL TOXICOLOGY).

Evkeeza is not recommended during pregnancy and in women of childbearing potential not using effective contraception. Before initiating treatment with Evkeeza in women of childbearing potential, determine pregnancy status. Women of childbearing potential should use effective contraception during treatment with Evkeeza and for at least 5 months after the last dose of Evkeeza.

2 Breastfeeding There is no information regarding the presence of Evkeeza in human milk, the effects on the breastfed infant, or the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Evkeeza and any potential adverse effects on the breastfed infant from Evkeeza or from the underlying maternal condition.

Evkeeza is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING.