Matters needing attention of cytarabine for injection

This product uses benzyl alcohol as solvent, and intramuscular injection in children is prohibited. Only doctors who are experienced in tumor chemotherapy can use cytarabine. Patients should have enough laboratories and auxiliary equipment to monitor patients' tolerance to drugs during induction treatment, so as to ensure that patients are free from toxic damage of drugs. The main toxic reaction of cytarabine is bone marrow suppression, which is characterized by leukopenia, thrombocytopenia and anemia. Mild toxic reactions include nausea, vomiting, diarrhea and abdominal pain, oral ulcer and abnormal liver function. When considering the application of this product, doctors must consider the possible curative effect and toxic reaction of the drug. Doctors must be familiar with the following when considering the application or starting to use it. Effect on blood system cytarabine is a powerful bone marrow inhibitor. The severity of myelosuppression depends on the dosage and regimen of drugs. Patients with bone marrow suppression caused by drugs in the past must be cautious when starting to use drugs. Patients must accept strict medical supervision when taking medicine, and white blood cells and platelet counts must be detected every day during induction treatment. Bone marrow examination should be carried out frequently after the original cells of peripheral blood picture disappear. When the drug causes bone marrow suppression and the platelet count is lower than 50,000/mm3 or the polymorphonuclear granulocyte count is lower than 65,438+0,000/mm3, the drug should be stopped or the treatment scheme should be changed. The number of visible components in peripheral blood may further decrease after drug withdrawal, reaching the lowest value 12-24 days after drug withdrawal. When necessary, when there is definite bone marrow recovery, the treatment can be started again. It is necessary to have the conditions to deal with bone marrow suppression (infection caused by impaired defense function such as granulocytopenia and bleeding caused by thrombocytopenia) that may lead to death. There is allergic reaction to cytarabine treatment. There are reports of cardiac arrest and respiratory arrest caused by allergic reaction, and cardiopulmonary resuscitation is needed. The above situation occurred immediately after intravenous cytarabine injection. It has been reported in high-dose regimen that high-dose (2-3g/m2) cytarabine can cause serious or even fatal toxic reactions in central nervous system, gastrointestinal tract and lung (different from those caused by conventional regimen of cytarabine). These reactions include reversible corneal poisoning and hemorrhagic conjunctivitis. Preventive topical application of steroid eye drops can prevent or alleviate symptoms. Dysfunctions of the brain and cerebellum, including personality changes, lethargy, convulsions and coma, are usually reversible. Severe gastrointestinal ulcer, including peritonitis, septicemia and liver abscess caused by cystic pneumatosis in intestinal wall; Pulmonary edema, liver injury with hyperbilirubinemia; Intestinal necrosis; And necrotizing colitis. Severe or even fatal pulmonary toxicity, adult respiratory distress syndrome and pulmonary edema may occur after high-dose cytarabine treatment. It has been reported that patients with recurrent leukemia suddenly developed respiratory distress syndrome after experimental high-dose cytarabine treatment, which quickly progressed to pulmonary edema. X-ray films showed obvious cardiac hypertrophy. There are reports about the secondary death of cardiomyopathy wells after pretreatment with experimental high-dose cytarabine and cyclophosphamide before bone marrow transplantation. This may depend on the treatment plan. Adult patients with acute non-lymphoblastic leukemia developed peripheral motor and sensory neuropathy after receiving high-dose cytarabine, daunorubicin and asparaginase consolidation therapy. Because irreversible neuropathy can be avoided by changing the dose and course of treatment, patients who use cytarabine in large doses should observe neuropathy. Rare report of desquamation caused by severe rash. Compared with the standard treatment scheme of this product, complete alopecia is more common in high-dose treatment. Diluents containing benzyl alcohol should not be used if large doses of treatment are used. The diluent of this product contains benzyl alcohol. It is reported that benzyl alcohol is related to the fatal "wheezing syndrome" of premature infants. If intrathecal medication is used, the diluent of ancient benzyl alcohol shall not be used. Many doctors use 0.9% sodium chloride solution without preservatives to prepare injections and apply them immediately. Patients often feel nauseous and may vomit for several hours after rapid intravenous injection of this product in large doses. If this product is given intravenously, the degree of nausea and vomiting is mild. It has been reported in the conventional dose regimen that patients who received the conventional dose of cytarabine combined with other drugs developed abdominal tenderness (peritonitis) and colitis, and the stool was occult blood positive, accompanied by neutropenia and thrombocytopenia. Relieved after non-surgical treatment. It is reported that children with acute myeloid leukemia developed fatal delayed progressive paralysis after intrathecal and intravenous injection of cytarabine and other drugs. Liver and/or renal function The liver of a human body can detoxify most given drugs. In particular, patients with impaired renal function or liver function are more likely to have central nervous system toxicity after receiving high-dose cytarabine treatment. For patients with hepatic or renal insufficiency, this product should be used with caution to reduce the dose. Patients receiving cytarabine therapy should have regular bone marrow, liver and kidney function tests. Tumor lysis syndrome is similar to other cytotoxic drugs, and this product can cause hyperuricemia secondary to the rapid dissolution of tumor cells. Clinicians should observe the patient's blood uric acid level and make preparations, and if necessary, adopt supportive treatment and drug treatment to control the disease. It is reported that patients who received cytarabine combined with other drugs developed acute pancreatitis. Immune rejection effect/increased susceptibility to infection For patients with immune impairment caused by chemotherapy drugs (including cytarabine), vaccination with live or attenuated live vaccine may lead to serious or fatal infection. Patients who are receiving cytarabine therapy should avoid vaccination with live vaccine. Dead or inactivated vaccines can be inoculated, but the immune response to these vaccines may be reduced. Do not use diluent containing benzyl alcohol when preparing cytarabine in sheath. Intrathecal application of this product can cause systemic toxicity, so it is necessary to carefully monitor the hematopoietic system. Antileukemia treatment may need to be adjusted. Rare serious toxic reaction. If cytarabine is used for intrathecal and intravenous injection within a few days, the risk of spinal cord toxicity will increase. However, if the condition is serious and life-threatening, the attending doctor should decide whether to use cytarabine both intravenously and intrathecally. Focal lesions of central nervous system leukemia may not respond to intrathecal injection of this product, and radiotherapy may be more effective. Contraindications to drug compatibility: cytarabine can be compatible with the following drugs for 8 hours in a specific concentration of 5% glucose aqueous solution: cytarabine 0.8 mg/ml, cefotaxime sodium1.0 mg/ml; Cytarabine 0.4 mg/ml, prednisolone sodium phosphate 0.2 mg/ml; Cytarabine 16 μ g/ml, vincristine sulfate 4 μ g/ml. Cytarabine is also physically compatible with methotrexate. In addition to the above drugs, cytarabine should not be mixed with other drugs. Compatibility should be ensured before mixing with any other drugs. Aromatic polyamides are physically incompatible with heparin, insulin, 5- fluorouracil, penicillins such as oxacillin and penicillin G, and methylprednisolone sodium succinate. The chemical and physical stability of cytarabine in intravenous infusion showed that this product was mixed with water for injection, 5% glucose injection or 0.9% sodium chloride injection and packed in intravenous infusion glass bottles and plastic bags, and it could remain stable for seven days at room temperature. Similarly, this product is mixed with 5% glucose injection, 5% glucose 0.2% sodium chloride injection or 0.9% sodium chloride injection to prepare an infusion with a concentration of 8-32 mg/ml, which can be stored stably at room temperature, -20℃ and 4℃ in glass bottles and plastic bags for intravenous injection for seven days. At room temperature, cytarabine can remain stable for 8 days in 5% glucose aqueous solution or 0.9% sodium chloride solution containing 50 mg /500 ml potassium chloride with a concentration of 2 mg/ml. At room temperature or refrigeration temperature (8℃), cytarabine with a concentration of 0.2- 1.0 mg/ml can be kept stable for seven days in 5% glucose aqueous solution or 5% glucose 0.2% sodium chloride solution containing 50 eq/L sodium bicarbonate in Travenol glass bottles or Viaflex soft bags. Cytarabine injection and intravenous infusion prepared with this injection do not contain antibacterial drugs. Therefore, it is recommended to further dilute the solution before use and start infusion as soon as possible after preparation. Infusion should be completed within 24 hours after solution preparation, and the remaining liquid should be discarded.