Oxaliplatin


Full Prescribing Info
Dosage/Direction for Use

Intravenous
Adjuvant therapy in stage III colon cancer
Adult: Combination therapy w/ fluorouracil (FU)/folinic acid (FA): 85 mg/m2 every 2 wk, given via infusion over 2-6 hr for 12 cycles. Dose may be reduced to 75 mg/m2, according to tolerability.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<30Contraindicated.

Reconstitution:
Dilute the required dose w/ 250-500 mL of dextrose 5% in water, to provide a soln containing 0.2-0.7 mg/mL.
Incompatibility:
Incompatible w/ Cl-containing solutions. Alkaline agents or soln (e.g. 5-FU, trometamol) negatively affect the stability. Needles and IV admin sets containing Al can cause degradation of platinum compd.

Intravenous
Metastatic colorectal cancer
Adult: Combination therapy w/ FU/FA: 85 mg/m2 every 2 wk, given via infusion over 2-6 hr for 12 cycles. Dose may be reduced to 65 mg/ m2, according to tolerability.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<30Contraindicated.

Reconstitution:
Dilute the required dose w/ 250-500 mL of dextrose 5% in water, to provide a soln containing 0.2-0.7 mg/mL.
Incompatibility:
Incompatible w/ Cl-containing solutions. Alkaline agents or soln (e.g. 5-FU, trometamol) negatively affect the stability. Needles and IV admin sets containing Al can cause degradation of platinum compd.
Contraindications
Hypersensitivity to oxaliplatin and other platinum agents. Myelosuppression, peripheral sensory neuropathy w/ functional impairment, congenital long QT prolongation. Severe renal impairment (CrCl <30 mL/min). Lactation. Concomitant use w/ live vaccines.
Special Precautions
Patient w/ history of or risk for QT prolongation, electrolyte disturbances. Pregnancy. Patient Counselling This drug may cause dizziness, nausea, vomiting, vision abnormalities and other neurological symptoms that affect gait and balance, if affected, do not drive or operate machinery. Monitoring Parameters Monitor CBC w/ differential, ALT/AST, bilirubin, creatinine, electrolyte, K, Mg levels. Monitor neurological status, QT interval, hypersensitivity, resp effects and toxicity.
Adverse Reactions
Significant: QT prolongation, ventricular arrhythmias, hypersensitivity reactions (e.g. burning sensations, pruritus, erythema, rashes/urticaria, flushing, diaphoresis, diarrhoea, shortness of breath, chest pain, syncope, disorientation; rarely, bronchospasm, hypotension); hepatotoxicity (e.g. peliosis, nodular regenerative hyperplasia or sinusoidal alterations, perisinusoidal fibrosis, veno-occlusive lesions; rarely, hepatitis, hepatic failure, hepatic vascular disorder); peripheral sensory neuropathy; reversible posterior leukoencephalopathy syndrome; neurological toxicity (e.g. acute laryngopharyngeal dysaesthesia; pulmonary symptoms (e.g. non-productive cough, dyspnoea, crackles, radiological pulmonary infiltrates); extravasation; GI toxicity (e.g. nausea, vomiting, severe diarrhoea/emesis, ulcer); haematological toxicity (e.g. neutropenia, thrombocytopenia). Nervous: Meningism, motor neuritis, depression, insomnia, fatigue, asthenia, rigors, dizziness, headache. CV: DVT, haemorrhage, peripheral oedema, flushing, thromboembolism, HTN. GI: Abdominal pain, constipation, anorexia, stomatitis, dyspepsia, flatulence, GERD, GI/rectal haemorrhage, dysgeusia, anorexia, mucositis, dysphagia. Resp: Coughing, epistaxis, hiccups, pulmonary embolism, rhinitis, URTI. Hepatic: Increased blood bilirubin, ALT/AST and alkaline phosphatase levels. Genitourinary: Dysuria, abnormal micturition frequency, haematuria, increased creatinine. Endocrine: Hyperglycaemia, wt gain/loss, increased blood lactate dehydrogenase. Haematologic: Anaemia, leukopenia, lymphopenia. Musculoskeletal: Arthralgia, back pain. Ophthalmologic: Conjunctivitis, visual disturbance, abnormal lacrimation. Dermatologic: Skin/nail disorder, alopecia, palmar-plantar erythrodysesthesia, exfoliation, hyperhidrosis. Immunologic: Infection. Others: Fever, hypocalcaemia, hypokalaemia, hypernatraemia, dehydration, inj site reactions (e.g. pain, redness, swelling and thrombosis).
Potentially Fatal: Anaphylaxis; bone marrow suppression (e.g. sepsis, neutropenic sepsis, septic shock); torsade de pointes; pulmonary fibrosis, interstitial lung disease; intestinal ischaemia, duodenal ulcer haemorrhage and perforation; haemolytic uraemic syndrome, disseminated intravascular coagulation; rhabdomyolysis.
Overdosage
Symptoms: Hypersensitivity reaction, myelosuppression, anaemia, neurotoxicity, grade 4 thrombocytopenia, sensory neuropathy (e.g. paraesthesia, dysaesthesia, laryngospasm and facial muscle spasms), GI disorders (e.g. nausea, vomiting, stomatitis, flatulence, enlarged abdomen, grade 4 intestinal obstruction), grade 4 dehydration, dyspnoea, wheezing, chest pain, resp failure, severe bradycardia. Management: Supportive treatment.
Drug Interactions
May enhance adverse effect of live vaccines.
Potentially Fatal: May diminish the therapeutic effect of vaccines. Increased risk of torsade de pointes w/ QT interval prolonging drugs.
Action
Oxaliplatin is a platinum-containing antineoplastic drug which forms several transient reactive complexes including monoaquo and diaquo diaminocyclohexane platinum. These complexes covalently bind to DNA base sequences to form inter and intra-strand cross-links thereby inhibiting replication, transcription and cell division leading to cell death.
Distribution: Widely distributed throughout the body. Volume of distribution: 440 L. Plasma protein binding: >90%, mainly to albumin and γ globulin.
Metabolism: Undergoes rapid and extensive nonenzymatic metabolism into inactive and active metabolites.
Excretion: Mainly via urine (approx 54%); faeces (approx 2%). Terminal elimination half-life: 391 hr.
Storage
Intravenous: Store between 20-25°C. Do not freeze. Protect from light. Reconstituted soln: Store between 2-8°C for up to 24 hr. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, admin, and disposal. Any unused portions should be disposed of in accordance w/ local requirements.
ATC Classification
L01XA03 - oxaliplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.
Disclaimer: This information is independently developed by CIMS based on oxaliplatin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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