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Xaliptine

Xaliptine

oxaliplatin

Manufacturer:

Ebewe Pharma

Distributor:

Sandoz
Concise Prescribing Info
Contents
Oxaliplatin
Indications/Uses
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 CRC.
Dosage/Direction for Use
IV infusion Adult Adjuvant setting 85 mg/m2 repeated every 2 wk for 12 cycles (6 mth). Metastatic CRC 85 mg/m2 repeated every 2 wk until disease progression or unacceptable toxicity.
Contraindications
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). Lactation.
Special Precautions
Reports of cross reactions w/ all platinum compd. Immediately discontinue in case of extravasation. Risk of neurological symptoms (eg, paraesthesia, dysaesthesia); persistent symptoms of peripheral neuropathy after end of treatment; reversible posterior leukoencephalopathy syndrome; GI toxicity manifesting as nausea & vomiting; diarrhoea; intestinal ischaemia; heamotological toxicity; mucositis/stomatitis w/ or w/o neutropenia; haemolytic-uraemic syndrome; disseminated intravascular coagulation; QT prolongation; rhabdomyolysis; GI ulcer & potential complications eg, GI haemorrhage & perforation. Patients w/ severe & persistent myelosuppression are at high risk of infectious complications. Discontinue in case of unexplained resp symptoms until ILD or pulmonary fibrosis are excluded. Consider drug-induced vascular disorders in case of abnormal LFT results or portal HTN which does not obviously result from liver metastases. Closely monitor patients w/ mild to moderate renal impairment for adverse reactions & adjust dose according to toxicity. May impair ability to drive & use machines. May have an anti-fertility effect. Appropriate contraceptive measures must be taken during & after cessation of therapy during 4 mth for women & 6 mth for men. Not recommended during pregnancy & in women of childbearing potential not using contraceptive measures.
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 LDH, increased wt (adjuvant setting). Rhinitis, URTI, 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); fall.
Drug Interactions
Caution w/ other medicinal products known to cause QT interval prolongation; other 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.
Presentation/Packing
Form
Xaliptine conc for soln for infusion 5 mg/mL
Packing/Price
10 mL x 1's (P6,300/box);20 mL x 1's;40 mL x 1's
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