Asparaginase
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From MedlinePlus, U.S. National Library of Medicine
Asparagine-specific Enzyme
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation and Administration Instructions Ensure that medical support is available to appropriately manage anaphylactic reactions when administering RYLAZE [see Warnings and Precautions] . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
If particulate matter, cloudiness, or discoloration are present, discard the vial.
Use aseptic technique.
Determine the dose, total volume of RYLAZE solution required, and the number of RYLAZE vials needed based on the individual patient’s BSA. More than one vial may be needed for a full dose.
Withdraw the indicated injection volume of RYLAZE into the syringe for injection. o Do not shake the vial. o Limit the volume of RYLAZE at a single injection site to 2 mL. o If the volume to be administered is greater than 2 mL, divide the doses equally into multiple syringes, one for each injection site. o Discard the remaining unused RYLAZE in the single-dose vial.
Administer RYLAZE by intramuscular injection. o Rotate injection sites. o Do not inject RYLAZE into scar tissue or areas that are reddened, inflamed, or swollen.
If the prepared dose is not used immediately, store the syringe(s) at room temperature 15°C to 25°C (59°F to 77°F) for up to 8 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours. The syringe does not need to be protected from light during storage.
Contraindications
4 CONTRAINDICATIONS RYLAZE is contraindicated in patients with: • History of serious hypersensitivity reactions to Erwinia asparaginase , including anaphylaxis [see Warnings and Precautions ( 5.1 )] ; • History of serious pancreatitis during previous asparaginase therapy [see Warnings and Precautions ( 5.2 )] ; • History of serious thrombosis during previous asparaginase therapy [see Warnings and Precautions ( 5.3 )] ; • History of serious hemorrhagic events during previous asparaginase therapy [see Warnings and Precautions ( 5.4 )] ; • Severe hepatic impairment [ see Warnings and Precautions ( 5.5 ) ].
RYLAZE is contraindicated in patients with: • History of serious hypersensitivity reactions to RYLAZE, including anaphylaxis. ( 4 ) • History of serious pancreatitis during previous L-asparaginase therapy. ( 4 ) • History of serious thrombosis during previous L-asparaginase therapy. ( 4 ) • History of serious hemorrhagic events during previous L-asparaginase therapy. ( 4 ) • Severe hepatic impairment. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ALikelihood score A: Well known cause of clinically apparent liver injury.
Asparaginase is a bacterial enzyme that is used as an antineoplastic agent, largely in the therapy of acute lymphocytic leukemia (ALL). Asparaginase has many side effects, one of which is hepatic injury that is characterized by inhibition of hepatic protein synthesis, marked cholestasis and steatosis, which is usually reversible but can be severe and lead to death from hepatic failure.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal reproduction studies, RYLAZE can cause fetal harm when administered to a pregnant woman. There are no available data on RYLAZE use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproductive and developmental toxicity studies, intramuscular administration of asparaginase Erwinia chrysanthemi to pregnant rats and rabbits during organogenesis resulted in structural abnormalities and embryo-fetal mortality ( see Data ) at exposures below those in patients at the recommended human dose. Advise pregnant women of the potential risk to a fetus.
In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal Data Animal reproductive and developmental toxicity studies have not been conducted with RYLAZE. In embryofetal development studies, asparaginase Erwinia chrysanthemi was administered intramuscularly every other day during the period of organogenesis to pregnant rats (at 3, 6, or 12 mg/m 2 ) and rabbits (at 0.12, 0.30, or 0.48 mg/m 2 ).
In rats given 12 mg/m 2 (approximately 0.48 times the maximum recommended human dose), maternal toxicity of decreased body weight gain was observed, as was a fetal finding of increased incidence of partially undescended thymic tissue. In rabbits, maternal toxicity consisting of decreased body weight was observed at 0.48 mg/m 2 (approximately 0.02 times the maximum recommended human dose).
Increased post-implantation loss, a decrease in the number of live fetuses, and gross abnormalities (e.g., absent kidney, absent accessory lung lobe, additional subclavian artery, and delayed ossification) were observed at doses of ≥ 0.12 mg/m 2 (approximately 0.005 times the maximum recommended human dose).
Breastfeeding (LactMed)
No information is available on the use of asparaginase during breastfeeding. Because aspariginase is a large protein molecule with a molecular weight of about 140,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. However, the manufacturer recommends that breastfeeding be discontinued during asparaginase therapy and for 1 week after the final dose.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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