Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium chloride
Tromethamine
Magnesium chloride
Poloxamer 188
Hydrochloric acid
Water for injections

6.2   Incompatibilities
In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials After thawing
Once thawed, the medicinal product should not be re-frozen and may be stored refrigerated at 2°C to 8°C in the original carton for 14 days.

Once the dose volume is drawn into the syringe it must be infused within 8 hours. Discard the vector containing syringe if not infused within the 8-hour timeframe.

6.4   Special precautions for storage

Store and transport frozen (≤ -60°C).
Store in a refrigerator (2°C to 8°C) immediately upon receipt.
DO NOT REFREEZE.
Store in the original carton.
For storage conditions after thawing of the medicinal product, see section 6.3.
The date of receipt should be marked on the original carton before the product is stored in the refrigerator.
6.5   Nature and contents of container

Onasemnogene abeparvovec is supplied in a vial (10 mL polymer crystal zenith) with stopper (20 mm chlorobutyl rubber) and seal (aluminum, flip-off) with a coloured cap (plastic), in two different vial fill volume sizes, either 5.5 mL or 8.3 mL.

The dose of onasemnogene abeparvovec and exact number of vials required for each patient is calculated according to the patient’s weight (see section 4.2 and Table 6 below).

ZOL API APR24 V5                                        16                                 EU SmPC Mar2024 Table 6      Carton/kit configurations
Patient weight (kg)           5.5 mL viala             8.3 mL vialb          Total vials per carton 2.6 – 3.0                    0                        2                          2
3.1 – 3.5                    2                        1                          3 3.6 – 4.0                    1                        2                          3 4.1 – 4.5                    0                        3                          3
4.6 – 5.0                    2                        2                          4
5.1 – 5.5                    1                        3                          4 5.6 – 6.0                    0                        4                          4 6.1 – 6.5                    2                        3                          5 6.6 – 7.0                    1                        4                          5 7.1 – 7.5                    0                        5                          5 7.6 – 8.0                    2                        4                          6 8.1 – 8.5                    1                        5                          6 8.6 – 9.0                    0                        6                          6 9.1 – 9.5                    2                        5                          7 9.6 – 10.0                    1                        6                          7 10.1 – 10.5                    0                        7                          7 10.6 – 11.0                    2                        6                          8 11.1 – 11.5                    1                        7                          8 11.6 – 12.0                    0                        8                          8 12.1 – 12.5                    2                        7                          9 12.6 – 13.0                    1                        8                          9 13.1 – 13.5                    0                        9                          9 13.6 – 14.0                    2                        8                         10 14.1 – 14.5                    1                        9                         10 14.6 – 15.0                    0                       10                         10 15.1 – 15.5                    2                        9                         11 15.6 – 16.0                    1                       10                         11 16.1 – 16.5                    0                       11                         11 16.6 – 17.0                    2                       10                         12 17.1 – 17.5                    1                       11                         12 17.6 – 18.0                    0                       12                         12 18.1 – 18.5                    2                       11                         13 18.6 – 19.0                    1                       12                         13 19.1 – 19.5                    0                       13                         13 19.6 – 20.0                    2                       12                         14 20.1 – 20.5                    1                       13                         14
20.6 – 21.0                    0                       14                         14 a                                        13
Vial nominal concentration is 2 × 10 vg/mL and contains an extractable volume of not less than 5.5 mL.
b
Vial nominal concentration is 2 × 1013 vg/mL and contains an extractable volume of not less than 8.3 mL.


ZOL API APR24 V5                                     17                               EU SmPC Mar2024 6.6   Special precautions for disposal and other handling

Receipt and thawing vials

•     Vials will be transported frozen (≤ -60ºC). Upon receipt vials should be refrigerated at 2°C to 8°C immediately, and in the original carton. Onasemnogene abeparvovec therapy should be initiated within 14 days of receipt of vials.
•     Vials must be thawed before use. Do not use onasemnogene abeparvovec unless thawed.
•     For packaging configurations containing up to 9 vials, product will be thawed after approximately 12 hours in the refrigerator. For packaging configurations containing up to 14 vials, product will be thawed after approximately 16 hours in the refrigerator. Alternatively, and for immediate use, thawing may be performed at room temperature.
•     For packaging configurations containing up to 9 vials, thawing will occur from frozen state after approximately 4 hours at room temperature (20°C to 25°C). For packaging configurations containing up to 14 vials, thawing will occur from frozen state after approximately 6 hours at room temperature (20°C to 25°C)
•     Before drawing the dose volume into the syringe, gently swirl the thawed product. Do NOT shake.
•     Do not use this medicine if you notice any particles or discolouration once the frozen product has thawed and prior to administration.
•     Once thawed, the medicinal product should not be re-frozen.
•     After thawing, onasemnogene abeparvovec should be given as soon as possible. Once the dose volume is drawn into the syringe it must be infused within 8 hours. Discard the vector-containing syringe if not infused within the 8-hour timeframe.

Administration of onasemnogene abeparvovec to the patient

To administer onasemnogene abeparvovec, draw the entire dose volume into the syringe. Remove any air in the syringe before intravenous infusion through a venous catheter.

Precautions to be taken for the handling, disposal and accidental exposure to the medicinal product 
This medicinal product contains genetically-modified organisms. Appropriate precautions for the handling, disposal or accidental exposure of onasemnogene abeparvovec should be followed: 
•     The onasemnogene abeparvovec syringe should be handled aseptically under sterile conditions.
•     Personal protective equipment (to include gloves, safety goggles, laboratory coat and sleeves) should be worn while handling or administering onasemnogene abeparvovec. Personnel should not work with onasemnogene abeparvovec if skin is cut or scratched.
•     All spills of onasemnogene abeparvovec must be wiped with absorbent gauze pad and the spill area must be disinfected using a bleach solution followed by alcohol wipes. All clean up materials must be double bagged and disposed of per local guidelines for handling of biological waste.
•     Any unused medicinal product or waste material should be disposed of in accordance with local guidelines on handling of biological waste.
•     All materials that may have come in contact with onasemnogene abeparvovec (e.g. vial, all materials used for injection, including sterile drapes and needles) must be disposed of in accordance with local guidelines on handling of biological waste.
•     Accidental exposure to onasemnogene abeparvovec must be avoided. In the event of exposure to skin, the affected area must be thoroughly cleaned with soap and water for at least 15 minutes. In the event of exposure to eyes, the affected area must be thoroughly flushed with water for at least 15 minutes.


ZOL API APR24 V5                                       18                                EU SmPC Mar2024 Shedding

Temporary onasemnogene abeparvovec shedding may occur, primarily through bodily waste. Caregivers and patient families should be advised on the following instructions for the proper handling of patient bodily fluids and waste:
•     Good hand-hygiene (wearing protective gloves and washing hands thoroughly afterwards with soap and warm running water, or an alcohol-based hand sanitiser) is required when coming into direct contact with patient bodily fluids and waste for a minimum of 1 month after onasemnogene abeparvovec treatment.
•     Disposable nappies should be sealed in double plastic bags and can be disposed of in household waste.