Peg L Asparaginase injection Product Specifications
Adult Women Suitable For All Ages
Store in Cool
3750 IU/5ml Milliliter (mL)
Peg L Asparaginase injection Trade Information
Per Day
30-60 Days
Sample costs shipping and taxes has to be paid by the buyer
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USFDA
Product Description
Warnings:
Contraindications
Hypersensitivity
History of (with prior L-asparaginase treatment): pancreatitis; hemorrhagic events; serious thrombosis
Cautions:
No more than 2ml should be administered at any one injection site
Anaphylaxis or serious allergic reactions may occur, monitor patient for 1 hr after administration; discontinue with serious allergic reactions
Glucose intolerance reported (irreversible in some cases); monitor serum glucose
Hepatotoxicity and abnormal liver function, including elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin (direct and indirect), and depression of serum albumin, and plasma fibrinogen may occur; monitor
Discontinue if pancreatitis occurs; evaluate patients with abdominal pain for pancreatitis
Serious thrombotic events, including sagittal sinus thrombosis reported; discontinue if this occurs
Increased prothrombin time, increased PTT and hypofibrinogenemia may occur; monitor for coagulopathy
Pregnancy & Lactation
Pregnancy Category: C
Lactation: not known if excreted in breast milk
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
Pharmacology
Mechanism of Action
Modified version of L-asparaginase depletes asparagine, the aminoacid required for protein synthesis, and in turn kills leukemic cells
Pharmacokinetics
Half-Life: 5-5.6 days
Onset: Asparagine depleted within 4 days (IM)
Duration: 21 days (IM); 2-4 weeks (IV in asparaginase naive adults)
Vd: 1.5 L/m (IM in children); 2.4 L/m (IV in adults)
Metabolism: Systemically
Peak plasma time: 3-4 days (IM)
Excretion: Urine (trace amounts)
Warnings:
Refrigerate
Do not use if cloudy or if precipitate is present
Do not freeze
Specification
Brand Name
Peg L-Asparkay
Best Before
24 months from Manufacture date
Form Of Medicine
Injection
Grade
Medicine Grade
Storage
Store in cool and dry place
Packaging Size
5 ml
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