EVKEEZA Concentrate for solution for infusion Ref.[27942] Active ingredients: Evinacumab

Before treatment initiation of evinacumab the patient should be on optimal LDL-C lowering regimen.

Treatment with evinacumab should be initiated and monitored by a physician experienced in the treatment of lipid disorders.

Posology

The recommended dose is 15 mg/kg administered by intravenous infusion over 60 minutes once monthly (every 4 weeks).

If a dose is missed, it should be administered as soon as possible. Thereafter, treatment with evinacumab should be scheduled monthly from the date of the last dose.

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.

Elderly

No dosage adjustment is required for elderly patients (see sections 5.1 and 5.2).

Renal impairment

No dose adjustment is required in patients with renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is required in patients with hepatic impairment (see section 5.2).

Paediatric population

No dose adjustment is required for paediatric patients aged 5 to 17 years (see sections 4.8, 5.1 and 5.2). The safety and efficacy of Evkeeza in children aged less than 5 years have not been established. No data are available.

No data are available.

Method of administration

Evkeeza is for intravenous infusion use only.

Administration:

• If refrigerated, allow the solution to come to room temperature (up to 25ºC) prior to administration.
• Evinacumab should be administered over 60 minutes by intravenous infusion through an intravenous line containing a sterile, in-line or add-on 0.2-micron to 5-micron filter. Do not administer evinacumab as an intravenous push or bolus.
• Do not mix other medicinal products with evinacumab or administer 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-associated symptoms.

For instructions on dilution of the medicinal product before administration, see section 6.6.

There is no specific treatment for evinacumab overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.

Unopened vial:

3 years.

After dilution:

From a microbiological point of view, the product should be used immediately. If not used immediately, it is the responsibility of the user to follow the in-use storage times and conditions prior to use.

If the diluted solution is not administered immediately, it may be stored temporarily either:

• under refrigeration at 2°C to 8°C for no more than 24 hours from the time of infusion preparation to the end of the infusion

or

• at room temperature up to 25°C for no more than 6 hours from the time of infusion preparation to the end of the infusion.

Unopened vial:

Store in a refrigerator (2°C-8°C).
Store in the original carton to protect from light.
Do not freeze.
Do not shake.

For storage conditions after dilution of the medicinal product, see section 6.3.

2.3 ml of concentrate in a 3 ml clear Type 1 glass vial with a grey chlorobutyl stopper with coating and a seal cap with a flip-off button containing 345 mg of evinacumab. Pack size of 1 vial.

8 ml of concentrate in a 20 ml clear Type 1 glass vial, with a grey chlorobutyl stopper with coating and a seal cap with a flip-off button containing 1 200 mg of evinacumab. Pack size of 1 vial.

Not all pack sizes may be marketed.

Preparation of solution

Evkeeza is supplied as a single use vial only. During preparation and reconstitution a strictly aseptic technique should be used.

• Visually inspect the medicinal product for cloudiness, discolouration or particulate matter prior to administration.
• Discard the vial if the solution is cloudy or discoloured or contains particulate matter.
• Do not shake the vial.
• Withdraw the required volume of evinacumab from the vial(s) based on patient’s weight and transfer into an intravenous infusion bag containing sodium chloride 9 mg/ml (0.9%) or dextrose 50 mg/ml (5%) for infusion. Mix the diluted solution by gentle inversion.
• The final concentration of the diluted solution should be between 0.5 mg/ml to 20 mg/ml.
• Do not freeze or shake the solution.
• Discard any unused portion left in the vial.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.