Oxaliplatin Ebewe

Oxaliplatin Ebewe



EBEWE Pharma




Mega Lifesciences
Concise Prescribing Info
Metastatic colorectal cancer & adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of primary tumor in combination w/ 5-fluorouracil & folinic acid.
Dosage/Direction for Use
Adult 85 mg/m2 as 2-6 hr IV infusion in 250-500 mL of 5% glucose soln given every 2 wk. Metastatic colorectal cancer Dose may be adjusted according to tolerability. Reduce to 65 mg/m2 if neurological symptoms occur or adverse reactions persist. Adjuvant setting Continue for 12 cycles (6 mth). May reduce to 75 mg/m2 if neurological symptoms occur or adverse reactions persist.
Hypersensitivity. Myelosuppression & peripheral sensitive neuropathy w/ functional impairment prior to starting 1st course. Severely impaired renal function (CrCl <30 mL/min). Lactation.
Special Precautions
Always administer before 5-fluorouracil. History of allergic reaction to platinum compd. Discontinue if extravasation, anaphylactic-like reaction & unexplained resp symptoms eg, non-productive cough, dyspnoea, crackles or radiological pulmonary infiltrates occur. If acute laryngopharyngeal dysaesthesia develops following the 2-hr infusion, the next dose should be administered over 6 hr. GI & haematological toxicity; Perform neurological examination & full blood count w/ white cell differential prior to & periodically thereafter. Severe renal & hepatic impairment. Pregnancy.
Adverse Reactions
Inj site reaction; fever, fatigue, allergy/allergic reaction, asthenia, pain, wt increase (adjuvant setting); peripheral sensory neuropathy, headache, sensory disturbance; diarrhea, nausea, vomiting, stomatitis/mucositis, abdominal pain, constipation, anorexia; back pain; epistaxis; infection; dyspnoea, coughing; skin disorder, alopecia; taste perversion; anemia, neutropenia, thrombocytopenia, leukopenia, lymphopenia; increased alkaline phosphatase, bilirubin, LDH & hepatic enzymes (SGPT/ALAT, SGOT/ASAT), glycemia & natriaemia abnormalities, hypokalaemia. Flushing; chest pain, wt decrease (metastatic setting); dizziness, motor neuritis, meningism; dyspepsia, gastroesophageal reflux, hiccup; dehydration; arthralgia, skeletal pain; haemorrhage nos, haematuria, deep thrombophlebitis, pulmonary embolism, rectum haemorrhage; depression, insomnia; rhinitis, upper resp tract infection; skin exfoliation, erythematous rash, rash, increased sweating, nail disorder; dysuria, micturition abnormal frequency; conjunctivitis, abnormal vision; febrile neutropenia/neutropenic sepsis; increased creatinine.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01XA03 - oxaliplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.
Oxaliplatin Ebewe lyo powd for soln for infusion 100 mg
Oxaliplatin Ebewe lyo powd for soln for infusion 50 mg
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