Asparaginase for injection

This product is an enzyme preparation anti-tumor drug derived from Escherichia coli. It can hydrolyze asparagine in serum into aspartic acid and ammonia. Asparagine is an amino acid necessary for cell protein synthesis and proliferation and growth. Normal cells have the function of synthesizing asparagine by themselves, while tumor cells such as acute leukemia do not have this function. Therefore, when this product is used to cause a sharp loss of asparagine, tumor cells cannot obtain enough asparagine from the blood, nor can they synthesize it by themselves, so that their protein synthesis is hindered, proliferation is inhibited, and cells are destroyed in large quantities and cannot grow and survive. This product can also interfere with the synthesis of cell DNA and RNA, and may act on the cell G1 proliferation cycle. It is a cell cycle-specific drug that inhibits cell division during this period.

Asparaginase.

This product is white freeze-dried block.

It is suitable for the treatment of acute lymphocytic leukemia (ALL), acute granulocytic leukemia, acute monocytic leukemia, chronic lymphocytic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma, melanoma, etc. This product has an inhibitory effect on the proliferation of the above-mentioned tumor cells, and has the best effect on the induction remission of acute lymphoblastic leukemia in children. Sometimes it may also be effective for patients who relapse after remission with some commonly used chemotherapy drugs, but the remission period is short when used alone, and it is easy to produce drug resistance, so it is often used in combination with other chemotherapy drugs to improve the efficacy.

The dosage of this product varies greatly according to different diseases and treatment plans. Take the induction remission plan for acute lymphoblastic leukemia as an example: the dosage can be calculated based on body surface area, with a daily dose of 500 units/m2, or 1000 units/m2, and a maximum of 2000 units/m2; a course of treatment is 10 to 20 days.

Adults seem to be more common than children. (1) The more common ones include allergic reactions, liver damage, pancreatitis, loss of appetite, and decreases in coagulation factors V, VII, VIII, IX, and fibrinogen. The main manifestations of allergic reactions are sudden onset of dyspnea, joint swelling and pain, rash, skin itching, and facial edema. In severe cases, respiratory distress, shock, and even death may occur. In late-stage childhood leukemia administered by intramuscular injection, although the incidence of mild allergic reactions is higher, there are reports that the incidence of severe allergic reactions is lower than that of intravenous injection. Allergic reactions are generally more likely to occur in patients with repeated injections, but they have occurred in patients with negative intradermal sensitivity tests (abbreviated as skin tests). In addition, some people with allergic constitutions may occasionally have allergic reactions even when injected with a skin test amount of asparaginase. Liver damage usually occurs within 2 weeks of starting treatment, and a variety of liver function abnormalities may occur, including elevated serum alanine aminotransferase [ALT (SGPT)], aspartate aminotransferase [AST (SGOT)], bilirubin, etc., and decreased serum albumin, etc. There have been cases of fatty liver lesions confirmed by liver puncture biopsy. If the patient feels severe upper abdominal pain accompanied by nausea and vomiting, acute pancreatitis should be suspected, among which fulminant pancreatitis is very serious and may even be fatal. Other symptoms include nausea, vomiting, diarrhea, etc. (2) Rare symptoms include elevated blood sugar, hyperuricemia, high fever, mental and neurotoxicity, etc. Patients with high blood sugar have symptoms of polyuria, polydipsia, and thirst. Their plasma osmotic pressure may be elevated while the blood ketone level is normal. Hyperglycemia can be alleviated or disappear by stopping this product or giving appropriate amounts of insulin and fluid replacement, but a few severe cases can be fatal. Hyperuricemia often occurs at the beginning of treatment. Due to the rapid destruction of a large number of tumor cells, the amount of uric acid released by the decomposition of nucleic acids increases. Severe cases can cause uric acid nephropathy and renal failure. Mental and neurotoxicity manifests as varying degrees of drowsiness, mental depression, mental confusion, emotional agitation, hallucinations, and occasionally Parkinson's syndrome. Other symptoms include leukopenia, immunosuppression, stomatitis, etc. (3) Rare symptoms include bleeding due to hypofibrinogenemia and decreased coagulation factors, hypolipidemia, intracranial hemorrhage or thrombosis, lower limb venous thrombosis, and bone marrow suppression. The decrease in coagulation factors is related to the inhibition of protein synthesis by this product. (4) Others: There are also high blood ammonia, hair loss, thrombocytopenia, anemia, etc. It is important to pay attention to adverse reactions and carefully analyze their nature. If there is a possibility of causing serious consequences, the product should be discontinued immediately, and appropriate treatment measures should be given based on the specific symptoms. In critical cases, active rescue should be carried out.

The following situations prohibit the use of this product: ① Those with a history of allergy to this product or a positive skin test; ② Those with a history of pancreatitis or current pancreatitis; ③ Those with current serious infections such as chickenpox and extensive herpes zoster.

(1) When prednisone, corticotropin or vincristine is used together with this product, it will enhance the hyperglycemic effect of this product and may increase the risk of neuropathy and erythropoiesis disorders caused by this product. However, there are reports that if the aforementioned drugs are used first and then this product, the toxicity seems to be lighter than using this product first or using both drugs at the same time. (2) Because this product can increase the concentration of blood uric acid, when it is used in combination with allopurinol or anti-gout drugs such as colchicine and sulfinpyrazone, the dosage of the above anti-gout drugs should be adjusted to control hyperuricemia and gout. Allopurinol is generally used as an anti-gout drug because it can prevent or reverse hyperuricemia caused by asparaginase. (3) Diabetic patients should pay attention to adjusting the dosage of oral hypoglycemic drugs or insulin when using this product and after treatment. (4) When this product is used in combination with azathioprine, chlorambucil, cyclophosphamide, cyclosporine, mercaptopurine, monoclonal antibody CD3 or radiotherapy, it can improve the efficacy, so the dose of chemotherapy drugs, immunosuppressants or radiotherapy should be reduced. (5) When this product is used together with methotrexate, it can block the anti-tumor effect of methotrexate by inhibiting cell replication. Studies have shown that if asparaginase is used 9 to 10 days before methotrexate or within 24 hours after methotrexate, it can avoid the inhibition of methotrexate's anti-tumor effect and reduce the adverse reactions of methotrexate to the gastrointestinal tract and blood system.

Keep in a dark, airtight, cool place.

5000 units