Kanuma Sebelipase Alfa Instructions
- June 12, 2024
- Kanuma
Table of Contents
**Kanuma Sebelipase Alfa Instructions
**
INSTRUCTION
The following information is intended for healthcare professionals only:
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Each vial of KANUMA is intended for single use only. KANUMA has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique. The diluted solution should be administered to patients using a low-protein binding infusion set equipped with an in-line, low-protein binding 0.2 μm filter, with a surface area of greater than 4.5 cm2 as available in order to avoid filter occlusion
Preparation of the sebelipase alfa infusion
KANUMA should be prepared and used according to the following steps. Aseptic technique should be used
a. The number of vials to be diluted for infusion should be determined
based on the patient’s weight and prescribed dose.
b. It is recommended to allow KANUMA vials to reach a temperature between
15 °C and 25 °C prior to dilution to minimise the potential for the formation
of sebelipase alfa protein particles in solution. The vials should not be left
outside the refrigerator longer than 24 hours prior to dilution for infusion.
The vials should not be frozen, heated or microwaved and should be protected
from light.
c. The vials should not be shaken. Prior to dilution, the concentrate in
the vials should be inspected visually; the concentrate should be clear to
slightly opalescent, colourless to slightly coloured (yellow). Due to the
proteinaceous nature of the medicinal product, slight flocculation (e.g., thin
translucent fibres) may be present in the vial concentrate and is acceptable
for use.
d. Do not use if the concentrate is cloudy, or if foreign particulate
matter is present.
e. Up to 10 ml of concentrate should be slowly withdrawn from each vial
and diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion. See
Table 1 for recommended total infusion volumes by weight range. The solution
should be mixed gently, and not be shaken.
**Table 1: Recommended infusion volumes***
| 1 mg/kg dose| 3 mg/kg dose| 5 mg/kg dose**
---|---|---|---
Weight range (kg)| Total infusion volume (ml)| Total Infusion
Volume (mL)| Total Infusion Volume (mL)
1-2.9| 4| 8| 12
3-5.9| 6| 12| 20
6-10.9| 10| 25| 50
11-24.9| 25| 50| 150
25-49.9| 50| 100| 250
50-99.9| 100| 250| 500
100-120.9| 250| 500| 600
The infusion volume should be based on the prescribed dose and should be
prepared to a final sebelipase alfa concentration of 0.1-1.5 mg/ml.
For patients with LAL Deficiency presenting within the first 6 months of life
who do not achieve an optimal clinical response with a dose of 3 mg/kg
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.