ash; 5.5 1 3 4 71894-125-04
5.6 – 6.0 0 4 4 71894-126-04
6.1 – 6.5 2 3 5 71894-127-05
6.6 – 7.0 1 4 5 71894-128-05
7.1 – 7.5 0 5 5 71894-129-05
7.6 – 8.0 2 4 6 71894-130-06
8.1 – 8.5 1 5 6 71894-131-06
8.6 – 9.0 0 6 6 71894-132-06
9.1 – 9.5 2 5 7 71894-133-07
9.6 – 10.0 1 6 7 71894-134-07
10.1 – 10.5 0 7 7 71894-135-07
10.6 – 11.0 2 6 8 71894-136-08
11.1 – 11.5 1 7 8 71894-137-08
11.6 – 12.0 0 8 8 71894-138-08
12.1 – 12.5 2 7 9 71894-139-09
12.6 – 13.0 1 8 9 71894-140-09
13.1 – 13.5 0 9 9 71894-141-09
a Vial nominal concentration is 2.0 × 1013 vg/mL and contains an extractable volume of not less than 5.5 mL.
b Vial nominal concentration is 2.0 × 1013 vg/mL and contains an extractable volume of not less than 8.3 mL.
16.2 Storage and Handling
• Product is shipped and delivered frozen (≤ -60 °C [-76 °F]) in clear vials.
• Upon receipt, immediately place the kit in a refrigerator at 2°C to 8°C (36°F to 46°F).
• ZOLGENSMA is stable for 14 days from receipt when stored at 2°C to 8°C (36°F to46°F).
• DO NOT REFREEZE.
• Must use within 14 days of receipt.
17 PATIENT COUNSELING INFORMATION
Acute Serious Liver Injury and Elevated AminotransferasesInform caregivers that ZOLGENSMA could increase liver enzyme levels and cause acute seriousliver injury. Inform caregivers that patients will receive an oral corticosteroid medication beforeand after infusion with ZOLGENSMA, and will undergo regular blood tests to monitor liver function. Advise caregivers to contact their healthcare provider immediately if the patient’s skinand/or whites of the eyes appear yellowish, or if the patient misses a dose of corticosteroid orvomits it up.
Vaccination Before and After Infusion with ZOLGENSMA
Advise caregivers to consult with their healthcare provider to determine if adjustments to thepatient’s vaccination schedule are necessary during corticosteroid use. Inform caregivers thatwhere feasible, the vaccination schedule should be adjusted appropriately to accommodatetreatment with corticosteroid. Prophylaxis against respiratory syncytial virus is recommended.
Please consult your health care provider.
Caregivers should be aware that a viral respiratory infection (e.g., cold, flu, or bronchiolitis)before or after ZOLGENSMA infusion could lead to more serious complications. Advisecaregivers of the signs of a possible viral respiratory infection, such as coughing, wheezing,sneezing, runny nose, sore throat or fever. Caregivers should contact their healthcare providerimmediately if they see any of these symptoms.
Thrombocytopenia
Inform caregivers that ZOLGENSMA could decrease blood platelet count and increase the riskof bruising or bleeding. Advise caregivers to seek medical attention if the patient experiencesunexpected bruising or bleeding.
Vector Shedding
Temporary vector shedding of ZOLGENSMA occurs primarily through body waste. Advisecaregivers on the proper handling of patient feces; recommended procedures include sealingdisposable diapers in disposable trash bags and then discarding into regular trash. Provideinstructions to caregivers and family members regarding proper hand hygiene when coming intodirect contact with patient body waste. These precautions should be followed for one |
