Zolgensma Caution For Usage

Special precautions for disposal and other handling: Receipt and thawing vials: Vials will be transported frozen (≤ -60°C). 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 any particles or discolouration are noticed 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.
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.
Incompatibilities: In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.