Medically reviewed by Drugs.com. Last updated on Dec 30, 2021.
The recommended dose of ASPARLAS is 2,500 units/m2 given intravenously no more frequently than every 21 days.
Premedicate patients with acetaminophen, an H-1 receptor blocker (such as diphenhydramine), and an H-2 receptor blocker (such as famotidine) 30-60 minutes prior to administration of ASPARLAS to decrease the risk and severity of both infusion and hypersensitivity reactions [see Warnings and Precautions (5.1)].
Recommended Monitoring and Dosage Modifications for Adverse Reactions
Monitor patients at least weekly, with bilirubin, transaminases, glucose and clinical examinations until recovery from the cycle of therapy. If an adverse reaction should occur, modify treatment according to Table 1.
|Infusion Reaction/ Hypersensitivity Reaction [see Warnings and Precautions (5.1)]||Grade 1||
|Grade 3 to 4||
|Thrombosis [see Warnings and Precautions (5.2)]||Uncomplicated deep vein thrombosis||
|Severe or life-threatening thrombosis||
|Pancreatitis [see Warnings and Precautions (5.3)]||Grades 3 to 4||
|Hemorrhage [see Warnings and Precautions (5.5)]||Grade 3 to 4||
|Hepatotoxicity [see Warnings and Precautions (5.6)]||Total bilirubin more than 3 times to no more than 10 times the upper limit of normal||
|Total bilirubin more than 10 times the upper limit of normal||
Preparation and Administration
ASPARLAS is a clear and colorless solution. Visually inspect parenteral drug products for particulate matter, cloudiness, or discoloration prior to administration. If any of these are present, discard the vial. Do not administer if ASPARLAS has been shaken or vigorously agitated, frozen, or stored at room temperature for more than 48 hours.
- Dilute ASPARLAS in 100 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP using sterile/aseptic technique. Discard any unused portion left in a vial.
- After dilution, administer immediately into a running infusion of either 0.9% sodium chloride or 5% dextrose, respectively.
- Administer the dose over a period of 1 hour.
- Do not infuse other drugs through the same intravenous line during administration of ASPARLAS.
- The diluted solution may be stored for up to 4 hours at room temperature (15°C to 25°C [59°F to 77°F]) or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours.
- Protect from light. Do not shake or freeze.
Frequently asked questions
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