, 18, 24 and 30.
16 HOW SUPPLIED/STORAGE AND HANDLING
ASPARLAS injection is supplied as a clear, colorless, preservative-free sterile solution in single-dosevials containing 3,750 units of calaspargase pegol-mknl per 5 mL solution (NDC 72694-515-01).
Store ASPARLAS refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Do not shake or freeze product. Unopened vials may be stored at room temperature (15°C to 25°C [59°Fto 77°F]) for no more than 48 hours.
17 PATIENT COUNSELING INFORMATION
Advise Patients/Caregivers of the following risks of ASPARLAS:
Hypersensitivity
Inform patients on the possibility of serious allergic reactions, including anaphylaxis. Instruct thepatient on the symptoms of allergic reactions and to seek medical advice immediately if they experiencesuch symptoms [see Warnings and Precautions (5.1)].
Pancreatitis
Instruct patients on the signs and symptoms of pancreatitis and to seek immediate medical attentionif they experience severe abdominal pain [see Warnings and Precautions (5.2)].
Instruct patients on the risk of hyperglycemia and glucose intolerance. Advise patients to seekmedical advice if they experience excessive thirst or any increase in the volume or frequency of urination[see Dosage and Administration (2.2)].
Thrombosis
Instruct patients on the risk of thrombosis and to seek medical advice immediately if they experiencesevere headache, arm or leg swelling, shortness of breath, or chest pain [see Warnings and Precautions(5.3)].
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761102s000lbl.pdf
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