EVKEEZA® is a 60-minute IV infusion, every 4 weeks1
The dosage for EVKEEZA should be calculated using the patient’s weight at 15 mg/kg.
The recommended dose is 15 mg/kg administered by intravenous (IV) infusion over 60 minutes every 4 weeks. 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.
No dosage adjustment is required for:
- Elderly patients
- Patients with renal impairment*
- Patients with hepatic impairment*
- Pediatric patients aged 5 to 17 years
Women of childbearing potential should use effective contraception during treatment with EVKEEZA and for at least 5 months after the last dose of EVKEEZA.
Patients should maintain their usual low-fat or heart-healthy diet while on EVKEEZA.
* No data is available in patients with hepatic impairment or patients with severe renal impairment
Example calculation for the amount of EVKEEZA (mL) recommended if your patient weighs 100 kg
100 kg (patient’s weight)
x 15 mg/kg (dose)
150 mg/mL
(concentration)
10 mL
(1500 mg)
of EVKEEZA
required
Missed dose
If a dose is missed, it should be administered as soon as possible. Thereafter, treatment with EVKEEZA should be scheduled every 4 weeks from the date of the last dose.
Overdose
There is no specific treatment for EVKEEZA overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures should be instituted as required. For management of a suspected drug overdose, contact your regional poison control centre.
Preparation1
- Calculate dose and number of vials required. EVKEEZA is preservative-free and is supplied as a single use only. During preparation and reconstitution, a strictly aseptic technique must be used.
- Visually inspect the medicinal 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.
- Withdraw the required volume of EVKEEZA 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 and 20 mg/mL. Do not freeze or shake the solution. Discard any unused portion left in the vial.
- Once prepared, administer the diluted solution immediately. 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.
Administration1
- If refrigerated, allow the solution to come to room temperature (up to 25°C) prior to administration.
- Administer EVKEEZA over 60 minutes by intravenous (IV) infusion only through an intravenous line containing a sterile, in-line or add-on 0.2-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.
- 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.
Reference:
- EVKEEZA Product Monograph. Ultragenyx Pharmaceutical, Inc. 2023.
