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L-Asgen 10,000 IU should be prescribed and administered by physicians and healthcare personnel experienced in the use of antineoplastic products. It should only be given in a hospital setting where appropriate resuscitation equipment is available.
Posology: L-Asgen 10,000 IU is usually employed as part of combination chemotherapy protocols with other antineoplastic agents (see also Interactions).
Adults and children older than 1 year: The recommended intravenous dose of asparaginase is 5,000 units per square metre (U/m2) body surface area (BSA) given every third day.
Treatment may be monitored based on the trough serum asparaginase activity measured three days after administration of L-Asgen 10,000 IU. If asparaginase activity values fail to reach target levels, a switch to a different asparaginase preparation could be considered (see Precautions).
Children 0-12 months old: Based on limited data, the recommended dose in infants is as follows: age less than 6 months: 6,700 U/m2 BSA; age 6-12 months: 7,500 U/m2 BSA.
Data on efficacy and safety of L-Asgen 10,000 IU in adults are limited.
Data on efficacy and safety of L-Asgen 10,000 IU in the post-induction treatment phases are very limited.
Special populations: Renal impairment: No dose adjustment is necessary in patients with renal impairment.
Hepatic impairment: No dose adjustment is necessary in patients with mild to moderate hepatic impairment. However, L-Asgen 10,000 IU should not be used in patients with severe hepatic impairment (see Contraindications).
Elderly: Limited data are available for the treatment of patients older than 65 years of age.
Method of administration: L-Asgen 10,000 IU is for administration by intravenous infusion only.
The daily amount of L-Asgen 10,000 IU needed per patient can be diluted in a final volume of 50-250 mL sodium chloride 9 mg/mL (0.9%) solution for infusion. The diluted solution of asparaginase may be infused over 0.5 to 2 hours.
Asparaginase must not be administered as a bolus dose.
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