Recoxali

In combination w/ 5-fluorouracil (5-FU) & folinic acid for metastatic CRC; adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of primary tumor.

IV Administer as 2-6 hr infusion via central venous line or peripheral vein before fluoropyrimidines eg, 5-fluorouracil. Adult Adjuvant treatment Oxaliplatin 85 mg/m² every 2 wk for 12 cycles (6 mth). Metastatic CRC 85 mg/m² every 2 wk until disease progression or unacceptable toxicity.

History of hypersensitivity. Myelosuppression prior to starting 1st course w/ baseline neutrophils <2 x 10⁹/L &/or platelet count of <100 x 10⁹/L; peripheral sensitive neuropathy w/ functional impairment prior to 1st course. Severe renal impairment (CrCl <30 mL/min). Lactation.

Interrupt treatment immediately in case of anaphylactic manifestations. Stop infusion immediately in case of extravasation. Discontinue use if paraesthesia w/ functional impairment persists until next cycle; if sepsis, neutropenic sepsis & septic shock occur; at 1st signs of any evidence of microagiopathic haemolytic anaemia eg, rapidly falling Hb w/ concomitant thrombocytopenia, elevation of serum bilirubin, creatinine, BUN, or LDH; if disseminated intravascular coagulation is present; in case of QT prolongation; if signs of rhabdomyolysis (eg, muscle pain & swelling, in combination w/ weakness, fever or darkened urine) occur; in case of intestinal ischemia; in case of unexplained resp symptoms eg, non-productive cough, dyspnoea, crackles or radiological pulmonary infiltrates, until further pulmonary investigations exclude ILD; if rhabdomyolysis is confirmed; in case of GI ulcer. Postpone next course of therapy if haematological toxicity occurs (neutrophils <1.5 x 10⁹/L or platelets <50 x 10⁹/L), until haemotological values return to acceptable levels. Delay next treatment until recovery from mucositis/stomatitis to ≤ grade 1 &/or until neutrophil count is ≥1.5 x 10⁹/l, if mucositis/stomatitis occurs w/ or w/o neutropenia. Peritoneal hemorrhage may occur when administered by intraperitoneal route. Peripheral neuropathy; reversible posterior leukoencephalopathy syndrome; nausea, vomiting, diarrhoea, dehydration & haematological changes; cross reactions; haemolytic-uraemic syndrome; QT prolongation that may lead to increased risk for ventricular arrhythmias including Torsades de Pointes; GI ulcer & complications eg, GI haemorrhage & perforation. Risk of diarrhoea/emesis, mucositis/stomatitis & neutropenia. Patients w/ severe & persistent myelosuppression; history of allergic manifestations to other products containing platinum; history or predisposition for QT prolongation, those who are taking medicinal products known to prolong QT interval, & w/ electrolyte disturbances eg, hypokalemia, hypocalcaemia or hypomagnesaemia. Carefully monitor neurological toxicity of oxaliplatin, especially when co-administered w/ other medicinal products w/ specific neurological toxicity. Perform FBC w/ white cell differential prior to start of therapy & before each subsequent course; neurological exam before each administration & periodically thereafter. Administer next oxaliplatin infusion over 6 hr in patients who develop acute laryngopharyngeal dysaesthesia during or w/in the hr following 2-hr infusion. Adjust dosage based on duration & severity if neurological symptoms (paraesthesia, dysaesthesia) last >7 days & are troublesome or if paraesthesia w/o functional impairment persists until the next cycle (reduce subsequent oxaliplatin dose from 85 to 65 mg/m² in metastatic setting or 75 mg/m² in adjuvant setting). Possible persistent peripheral sensory neuropathy symptoms after end of treatment; localized moderate paresthesias or paresthesias that may interfere w/ functional activities can persist after up to 3 yr following treatment cessation in adjuvant setting. Causes increased risk of dizziness, nausea & vomiting, & other neurologic symptoms that affect gait & balance; vision abnormalities, particularly transient vision loss which may affect ability to drive & use machines. Closely monitor adverse reactions in patients w/ mild to moderate renal impairment. Drug-induced hepatic vascular disorders. May have irreversible infertility effect. Appropriate contraceptive measures must be taken during & after cessation of therapy during 4 mth for women & 6 mth for men. Male patients should not father a child during & up to 6 mth after treatment & should seek advice on sperm conservation prior to treatment. Women should not become pregnant & should use effective contraception method during treatment. Not recommended during pregnancy & in women of childbearing potential not using contraceptive measures. No relevant use in childn. Elderly ≤65.

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, bilirubin & lactate dehydrogenase, increased wt (adjuvant setting). Rhinitis, URTI, neutropenic sepsis; febrile neutropenia; dehydration, hypocalcaemia; depression, insomnia; dizziness, motor neuritis, meningism; haemorrhage, flushing, DVT, HTN; hiccups, pulmonary embolism; dyspepsia, gastro-esophageal reflux, GI & rectal haemorrhage; skin exfoliation (ie, hand & foot syndrome), erythematous rash, rash, hyperhidrosis, nail disorder; arthralgia, bone pain; haematuria, dysuria, abnormal micturition frequency; increased blood creatinine, decreased wt (metastatic setting); fall.

Concomitant use w/ medicinal products known to cause QT interval prolongation or rhabdomyolysis.

Cytotoxic Chemotherapy

L01XA03 - oxaliplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.

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