Table 2.
Current biopharmaceutical formulations for L-Asparaginase (ASNase).
| Approved Biopharmaceuticals | Pharmaceutical form/aspect | Route of administration | Composition | References |
|---|---|---|---|---|
| ASNase amidohydrolase | Lyophilized white crystalline powder, water soluble (225 IU/mg) | Intravenous/intramuscular | Mannitol (80 mg in 10,000 IU of the enzyme) | Merck, 2000 |
| ASNase from Dickeya chrysanthemi (Erwinia chrysanthemi) (Erwinase®) | Lyophilized white powder, water soluble (10,000 Units) | Intravenous/intramuscular | 5 mg glucose per bottle < 1 mmol sodium (23 mg) per dose, i.e., essentially sodium-free | Medicines Evaluation Board, 2015 |
| Recombinant ASNase from Escherichia coli (Spectrila®) | Lyophilized white powder, water soluble (10,000 Units) | Intravenous | Sucrose | European Medicines Agency, 2015 |
| Pegylated ASNase amidohydrolase (Oncaspar®) | Clear, colorless, preservative-free, isotonic sterile solution (3,750 IU/5 mL) | Intravenous/intramuscular | Phosphate buffer (1.20 mg monobasic sodium phosphate, 5.58 mg dibasic sodium phosphate, and 8.50 mg sodium chloride per mL of water for injection) | European Medicines Agency, 2016 |