Ebewe Pharma


Concise Prescribing Info
In combination w/ 5-fluorouracil (5-FU) & folinic acid (FA) for adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of primary tumor & treatment of metastatic colorectal cancer.
Dosage/Direction for Use
IV infusion Adult Adjuvant setting 85 mg/m2 repeated every 2 wk for 12 cycles (6 mth). Metastatic colorectal cancer 85 mg/m2 repeated every 2 wk.
Hypersensitivity. Myelosuppression prior to starting 1st course as evidenced by baseline neutrophils <2 x 109/L &/or platelet count of <100 x 109/L; peripheral sensitivity neuropathy w/ functional impairment prior to 1st course. Severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation.
Special Precautions
Peripheral neuropathy. Reversible posterior leukoencephalopathy syndrome (RPLS). Discontinue if paraesthesia w/ functional impairment persists until the next cycle; intestinal ischaemia; myelosuppression; sepsis, neutropenic sepsis & septic shock; unexplained resp symptoms; at the 1st signs of microangiopathic haemolytic anaemia; disseminated intravascular coagulation; QT prolongation; rhabdomyolysis; GI ulcer. Perform neurological exam before each administration & periodically thereafter; full blood count w/ white cell differential prior to start of therapy & before each subsequent course. Closely monitor QT interval on a regular basis. Peritoneal haemorrhage when administered by intraperitoneal route. May impair ability to drive & use machines. Male patients are advised not to father a child during & up to 6 mth after treatment & seek advice on sperm conservation prior to treatment. Women should take appropriate contraceptive measures during & after cessation of therapy during 4 mth.
Adverse Reactions
Infection; anaemia, neutropenia, thrombocytopenia, leukopenia, lymphopenia; allergy/allergic reaction; anorexia, hyperglycaemia, hypokalaemia, hypernatraemia; peripheral sensory neuropathy, sensory disturbance, dysgeusia, headache; dyspnoea, cough, epistaxis; nausea, diarrhoea, vomiting, stomatitis/mucositis, abdominal pain, constipation; skin disorder, alopecia; back pain; fatigue, fever, asthenia, pain, inj site reaction; increased hepatic enzyme, blood alkaline phosphatase, blood bilirubin & blood lactate dehydrogenase, wt increase (adjuvant setting). Rhinitis, upper resp tract infection, neutropenic sepsis; febrile neutropenia; dehydration, hypocalcaemia; depression, insomnia; dizziness, motor neuritis, meningism; conjunctivitis, visual disturbance; haemorrhage, flushing, DVT, HTN; hiccups, pulmonary embolism; dyspepsia, gastrooesophageal reflux, GI & rectal haemorrhage; skin exfoliation (ie, hand & foot syndrome), rash erythematous, rash, hyperhidrosis, nail disorder; arthralgia, bone pain; haematuria, dysuria, abnormal micturition frequency, increased blood creatinine, decreased wt (metastatic setting).
Drug Interactions
Caution w/ other medicinal products known to cause QT interval prolongation. Concomitant administration w/ medicinal products associated w/ rhabdomyolysis.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01XA03 - oxaliplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.
Xaliptine concentrate for soln for infusion 5 mg/mL
10 mL x 1's (P6,300/box);20 mL x 1's;40 mL x 1's
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