Oxaliplatin Hospira

Oxaliplatin Hospira





Zuellig Pharma


Concise Prescribing Info
In combination w/ fluorouracil & folinic acid for metastatic colorectal cancer & as adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumour.
Dosage/Direction for Use
IV Metastatic colorectal cancer in combination w/ fluorouracil & folinic acid 85 mg/m2 repeated every 2 wk. Adjuvant treatment of stage III (Duke's C) colon cancer in combination w/ fluorouracil & folinic acid 85 mg/m2 repeated every 2 wk for 12 cycles (6 mth).
Hypersensitivity. Myelosuppression prior to starting 1st course (baseline neutrophils <1.5 x 109/L &/or platelet count <75 x 109/L); peripheral sensory neuropathy w/ functional impairment prior to 1st course; severely impaired renal function (CrCl <30 mL/min). Pregnancy & lactation.
Special Precautions
Discontinue infusion immediately & initiate usual local symptomatic treatment in case of oxaliplatin extravasation. Monitor for allergic symptoms in patients w/ a history of allergic reactions to platinum compd; discontinue immediately in case of an anaphylactic-type reaction. Avoid vaccination w/ live or live attenuated vaccine. Perform neurological exam before initiation of each administration & periodically thereafter. Avoid exposure to cold & ingesting cold food &/or beverages during or w/in 48 hr following administration. Signs & symptoms of reversible posterior leukoencephalopathy syndrome. Risk of GI toxicity (eg, nausea & vomiting) which warrants prophylactic anti-emetic therapy, including 5-HT3 antagonists & corticosteroids); risk of severe diarrhoea/emesis particularly when combined w/ fluorouracil. Discontinue & initiate appropriate measures in case of intestinal ischaemia. Monitor haematological toxicity w/ a full blood count & white cell differential count prior to starting therapy & before each subsequent course; idiosyncratic haematological toxicity may occur in patients previously receiving myelotoxic treatment. Possibe sepsis, neutropenic sepsis & septic shock. Discontinue if disseminated intravascular coagulation is present. Discontinue treatment in case of unexplained resp symptoms eg, non-productive cough, dyspnoea, crackles or radiologic pulmonary infiltrates until further pulmonary investigations exclude an interstitial lung disease or pulmonary fibrosis. Discontinue at the 1st signs of any evidence of microangiopathic haemolytic anaemia (eg, rapidly falling haemoglobin w/ concomitant thrombocytopenia, elevation of serum blirubin, creatinine, BUN or lactate dehydrogenase). Reactions related to liver sinusoidal obstruction syndrome, including nodular regenerative hyperplasia. Increased risk for ventricular arrhythmias, including Torsade de pointes. Interrupt or discontinue treatment based on the individual benefit-risk assessment in case of acute coronary syndrome. Discontinue if rhadbomyolysis, duodenal ulcer occurs. Not to be used intraperitoneally. Hepatic & renal impairment. Not recommended in childn.
Adverse Reactions
Primarily sensory peripheral neuropathy (eg, loss of deep tendon reflexes, dysaesthesia, paraesthesia Lhermitte’s sign), dysgeusia, neuritis; epistaxis; anaemia (all grades), neutropenia (all grades), thrombocytopenia (all grades); diarrhoea, nausea, vomiting, stomatitis, abdominal pain, mucositis, dehydration, ileus, intestinal obstruction, hypokalemia, metabolic acidosis, constipation; anorexia, hyperglycaemia; elevation of transaminases & alkaline phosphatases activities; back pain, arthralgia; skin rash (particularly urticaria), conjunctivitis, rhinitis, inj site reactions, cough; infections, fever, rigors (tremors), fatigue, asthenia; sensory peripheral neuropathy; taste perversion; alopecia, rash. Pharyngolaryngeal dysaesthesia, jaw spasm, abnormal tongue sensation, feeling of chest pressure; DVT, thromboembolic events, HTN; neutropenic sepsis, including fatal outcomes; febrile neutropenia; GI haemorrhage; hypocalcaemia; bronchospasm, chest pain sensation, angioedema, hypotension, anaphylactic shock; altered renal function; hiccups; dyspepsia; conjunctivitis; rhinitis, dyspnoea.
Drug Interactions
Increased fluorouracil plasma conc. Incompatible w/ chloride-containing soln & basic soln (including fluorouracil); not to be mixed or administered simultaneously via same IV line. Co-administration w/ other known QT interval-prolonging medicinal products. Concomitant use w/ other known rhabdomyolysis-associated medicinal products.
ATC Classification
L01XA03 - oxaliplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.
Oxaliplatin Hospira soln for infusion 50 mg/10 mL
Oxaliplatin Hospira soln for infusion 200 mg/40 mL
Oxaliplatin Hospira soln for infusion 100 mg/20 mL
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