Cytosor IV Injection

Cytosor IV Injection is used for: Acute myeloid leukaemia, acute lymphocytic leukaemia (ALL), lymphomas, Leukaemic meningitis

Acute Nonlymphocytic Leukemia IV administration for remission induction 100-200 mg/sq.meter/day for 5-10 days; begin second course in 2-4 weeks after initial therapy if necessary OR 100 mg/sq.meter for 7 days OR 100 mg/sq.meter/dose 12 hourly for 7 days Intrathecal (IT) administration for remission induction 5-75 mg/sq.meter every 2-7 days until CNS findings normalize IV administration for remission maintenance 70-200 mg/sq.meter/day for 2-5 days at monthly intervals IM administration for remission maintenance 1-1.5 mg/kg single dose for maintenance at 1- 4 week intervals Meningeal Leukemia IT administration 30 mg/sq.meter intrathecal (IT) every 4Days until CSF findings normal plus one additional dose Refractory Leukemia IV administration 3 g/sq.meter IV (infusion over 1-3 hours) 12 hourly x 4-12 doses Repeat every 2-3Weeks

IV Administration Rapid IV, infusion over 1-3 hr, or SC intrathecal Has been administered by IM & continuous SC infusion IT: Patient should lie flat for 1 hour after lumbar puncture Liposomal: To reduce incidence of arachnoiditis, administer dexamethasone concurrently IV Preparation Reconstitute vials in BWI containing benzyl alcohol 0.945% as follows (CAUTION: Do not use benzyl alcohol for intrathecal inj) 100 mg vial: add 5 mL diluent to 20 mg/mL 500 mg vial: add 10 mL diluent to 50 mg/mL 1 g vial: add 10 mL diluent to 100 mg/mL 2 g vial: add 20 mL diluent to 100 mg/mL

Hypersensitivity; pregnancy and lactation.

Only physicians experienced in cancer chemotherapy should administer Physician must judge possible benefit to patient against known toxic effects in considering advisability of therapy For induction therapy, administer in facility with lab and supportive resources sufficient to monitor drug tolerance and protect and maintain patient if compromised by drug toxicity Main toxic effect is bone marrow suppression with leukopenia, thrombocytopenia, and anemia Less serious toxicity includes nausea, vomiting, diarrhea, abdominal pain, oral ulceration, and hepatic dysfunction Cautions Do not use benzyl alcohol-containing solutions IT or in neonates This drug is a potent bone marrow suppressant; therapy should be started cautiously in patients with pre-existing drug-induced bone marrow suppression; patients receiving this drug must be under close medical supervision and, during induction therapy, should have leucocyte and platelet counts performed daily Bone marrow examinations should be performed frequently after blasts have disappeared from the peripheral blood; facilities should be available for management of complications, possibly fatal, of bonemarrow suppression (infection resulting from granulocytopenia and other impaired body defenses, and hemorrhage secondary to thrombocytopenia) Case of anaphylaxis resulting in acute cardiopulmonary arrest and required resuscitation reported; occurred immediately after intravenous administration of injection Severe and at times fatal CNS, GI, and pulmonary toxicity (different from that seen with conventional therapy regimens of cytarabine injection) reported following some experimental dose schedules for cytarabine injection; these reactions include reversible corneal toxicity, and hemorrhagic conjunctivitis, which may be prevented or diminished by prophylaxis with a local corticosteroid eye drop Cerebral and cerebellar dysfunction, including personality changes, somnolence, and coma, usually reversible; severe gastrointestinal ulceration, including pneumatosis, cystoides intestinalis leading to peritonitis; sepsis and liver abscess; pulmonary edema, liver damage with increased hyperbilirubinemia; bowel necrosis; and necrotizing colitis Rarely, severe skin rash, leading to desquamation reported; complete alopecia is more commonly seen with experimental high-dose therapy than with standard treatment programs using cytarabine injection Cases of cardiomyopathy with subsequent death reported following experimental high-dose therapy with cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation A syndrome of sudden respiratory distress, rapidly progressing to pulmonary edema and radiographically pronounced cardiomegaly reported following experimental high-dose therapy with cytarabine used for treatment of relapsed leukemia; the outcome of this syndrome can be fatal The human liver apparently detoxifies a substantial fraction of an administered dose; in particular, patients with renal or hepatic function impairment may have higher likelihood of CNS toxicity after high-dose cytarabine injection treatment Use the drug with caution and possibly at reduced dose in patients whose liver or kidney function is poor; periodic checks of bone marrow, liver, and kidney functions should be performed in patients receiving cytarabine injection Like other cytotoxic drugs, this drug may induce hyperuricemia secondary to rapid lysis of neoplastic cells; the clinician should monitor the patient’s blood uric acid level and be prepared to use such supportive and pharmacologic measures as might be necessary to control this problem Acute pancreatitis reported to occur in a patient receiving injection by continuous infusion and in patients being treated who have had prior treatment with L-asparaginase MONITORING PARAMETERS Haematological monitoring: Cytarabine is a potent myelosuppressant and requires careful haematological monitoring. Patients receiving therapy must be monitored closely; frequent platelet and leucocyte counts and bone marrow examinations are mandatory.

Pregnancy Therapy can cause fetal harm when administered to a pregnant woman There are no adequate and well-controlled studies in pregnant women Women of childbearing potential should be advised to avoid becoming pregnant; a review of the literature has shown 32 reported cases where cytarabine injection was given during pregnancy, either alone or in combination with other cytotoxic agents; eighteen normal infants were delivered; four of these had first-trimester exposure; five infants were premature or of low birth weight; twelve of the 18 normal infants were followed up at ages ranging from six weeks to seven years, and showed no abnormalities; one apparently normal infant died at 90 days of gastroenteritis Two cases of congenital abnormalities reported, one with upper and lower distal limb defects, and the other with extremity and ear deformities; both of these cases had first-trimester exposure There were seven infants with various problems in the neonatal period, including pancytopenia, transient depression of WBC, hematocrit or platelets; electrolyte abnormalities; transient eosinophilia; and one case of increased lgM levels and hyperpyrexia possibly due to sepsis; six of the seven infants were also premature The child with pancytopenia died at 21 days of sepsis; therapeutic abortions were done in five cases; four fetuses were grossly normal, but one had an enlarged spleen and another showed Trisomy C chromosome abnormality in chorionic tissue Because of potential for abnormalities with cytotoxic therapy, particularly during first trimester, a patient who is or who may become pregnant while on therapy should be apprised of potential risk to fetus and advisability of pregnancy continuation There is a definite, but considerably reduced risk if therapy is initiated during second or third trimester; although normal infants delivered to patients treated in all three trimesters of pregnancy, follow-up of such infants would be advisable Animal data Cytarabine causes abnormal cerebellar development in neonatal hamster and is teratogenic to rat fetus Lactation Not known whether this drug is excreted in human milk; because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from this drug, a decision should be made whether to discontinue nursing or to discontinue drug,taking into account importance of drug to the mother

May reduce efficacy of gentamicin, digoxin and flucytosine. Potentially Fatal: Potentiates bone marrow depression with radiotherapy and other myelotoxic drugs. Contraindicated (0) Serious (14) adenovirus types 4 and 7 live, oral axicabtagene ciloleucel brexucabtagene autoleucel cedazuridine ciltacabtagene autoleucel etrasimod idecabtagene vicleucel influenza virus vaccine quadrivalent, adjuvanted influenza virus vaccine trivalent, adjuvanted lisocabtagene maraleucel palifermin ropeginterferon alfa 2b tisagenlecleucel tofacitinib

Side effects of Cytarabine : 1-10% Anorexia,Nausea,Vomiting,Diarrhea,Oral/anal inflammation,Thrombophlebitis,Bleeding,Myelosuppression,Rash,Fever,Hepatic dysfunction Frequency Not Defined Headache,Neuropathy,Chest pain,Pericarditis,Pneumonia,Anemia,Bleeding,Leukopenia,Thrombocytopenia,Kidney disease,Infectious disease,Sepsis,"Cytarabine syndrome": fever, myalgia, bone pain, rash, conjunctivitis, malaise,Skin ulcers,Cellulitis,Urinary retention,Neuritis,Jaundice,Anaphylaxis Potentially Fatal: Convulsions. Cerebellar dysfunction, respiratory distress syndrome, GI perforation, bone marrow suppression.

Cytarabine acts by interfering with DNA synthesis specifically at the S-phase of the cell cycle. It is a potent myelosuppressant and requires careful haematological monitoring during its use. It also has antiviral property.

Cytosor 500mg/5ml IV Injection manufactured by Eskayef Pharmaceuticals Ltd.. Its generic name is Cytarabine. Cytosor is availble in Bangladesh. Farmaco BD drug index information on Cytosor IV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.