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OXALIPLATIN is a brand name for Oxaliplatin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Both 5-FU and oxaliplatin are associated with gastrointestinal and hematologic adverse events. When oxaliplatin is administered in combination with 5-FU, the incidence of these events is increased. The most common adverse reactions in patients treated with oxaliplatin in combination with 5- FU in the adjuvant colon and metastatic colorectal cancer trials were peripheral sensory neuropathies, fatigue, thrombocytopenia, anemia, neutropenia, nausea, vomiting, diarrhea, stomatitis and increase in hepatic enzymes and alkaline phosphatase (see WARNINGS AND PRECAUTIONS).
Blood and Lymphatic System Disorders:
Anemia, neutropenia and thrombocytopenia were reported with the combination of oxaliplatin and infusional 5-FU/LV (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions). 7% in the oxaliplatin plus 5-FU/LV arm. The incidence of febrile neutropenia in the patients previously untreated for metastatic colorectal cancer was 15% (3% of cycles) in the irinotecan plus 5-FU/LV arm and 4% (less than 1% of cycles) in the oxaliplatin plus 5-FU/LV arm.
The incidence of febrile neutropenia in the previously treated patients was 1% in the 5- FU/LV arm and 5% (less than 1% of cycles) in the oxaliplatin plus 5-FU/LV combination arm. In adjuvant patients the incidence of thrombocytopenia (all grades) was 77% vs.
19% (oxaliplatin plus 5-FU/LV vs. 7% vs. 4%. 3%). The incidence of thrombocytopenia in patients previously untreated for metastatic colorectal cancer was higher in the oxaliplatin plus 5-FU/LV arm vs irinotecan plus 5-FU/LV arm (all grade thrombocytopenia: 70% vs.
26%; grade 3 and 4: 5% vs 2%). However, bleeding events in the oxaliplatin plus 5- FU/LV arm were infrequent and included: epistaxis, rectal bleeding, melena, vaginal bleeding, hematuria, and hemoptysis. The incidence of thrombocytopenia in patients previously treated for metastatic colorectal cancer was higher in the oxaliplatin plus 5-FU/LV arm vs.
the 5-FU/LV arm (all grade thrombocytopenia: 67% vs 21%; grade 3 and 4: 6% vs. 0%). Hemolytic Uremic Syndrome has been rarely reported with the use of oxaliplatin.
Gastrointestinal Disorders:
Anorexia, nausea, vomiting, diarrhea, stomatitis/mucositis and abdominal pain were commonly reported in the adjuvant treatment of patients with colon cancer and the previously untreated and Page 14 of 65 treated patients for metastatic colorectal cancer (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions).
Oxaliplatin Injection USP should not be administered to patients: • with a history of known allergy to oxaliplatin or other platinum compounds or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.
• who have a pre-existing peripheral sensitive neuropathy with functional impairment. • who are breast-feeding. • who are pregnant. • with severe renal impairment (creatinine clearance Clcr < 30 mL/min). WARNINGS AND PRECAUTIONS Serious Warnings and Precautions • Oxaliplatin Injection USP should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
• Anaphylactic Reactions – See WARNINGS AND PRECAUTIONS, Immune and Cardiovascular sections. • Cardiovascular – QT prolongation and Torsade de Pointes (including fatalities) – See WARNINGS AND PRECAUTIONS, Cardiovascular section. • Gastrointestinal - duodenal ulcer, duodenal hemorrhage, duodenal perforation and intestinal ischemia (including fatalities) – See WARNINGS AND PRECAUTIONS, Gastrointestinal section.
• Hepatotoxicity – See WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic section. • Musculoskeletal – rhabdomyolysis (including fatalities) – See WARNINGS AND PRECAUTIONS, Musculoskeletal section. • Myelosuppression – Neutropenia/febrile neutropenia and Thrombocytopenia.
See WARNINGS AND PRECAUTIONS, Hematologic section. • Sepsis (including fatalities). See WARNINGS AND PRECAUTIONS, Infections and Infestations. • Neuropathy – Sensory and Motor - See WARNINGS AND PRECAUTIONS, Neurologic section; ADVERSE REACTIONS, Adverse Drug Reactions Overview, Other Clinical Trial Adverse Drug Reactions and Post-Market Adverse Drug Page 5 of 65 Reactions, Nervous System Disorders.
• Respiratory – Interstitial lung disease (including fatalities) has been reported with oxaliplatin use. See WARNINGS AND PRECAUTIONS, Respiratory section; ADVERSE REACTIONS, Other Clinical Trial Adverse Drug Reactions, Respiratory, Thoracic and Mediastinal Disorders.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dehydration, hypokalemia, metabolic acidosis, ileus, intestinal obstruction and renal disorders may be associated with severe diarrhea or vomiting, particularly when oxaliplatin is combined with 5-FU (see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS, Other Clinical Trial Adverse Drug Reactions).
General Disorders and Administration Site Conditions:
Fever and rigors (tremors) either from infection (with or without febrile neutropenia) or possibly from immunological mechanism were reported in the adjuvant treatment of patients with colon cancer and in the previously untreated and treated patients for metastatic colorectal cancer (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions).
Injection Site Injection site reactions, including local pain, redness, swelling and thrombosis have been reported (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions). In the literature, tissue necrosis has been reported with oxaliplatin extravasation (see REFERENCES: De Lemos 2005).
Immune System Disorders:
Allergic reactions such as: skin rash (particularly urticaria), conjunctivitis, rhinitis and anaphylactic reactions were reported (see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions).
Musculoskeletal and Connective Tissue Disorders:
Back pain was reported in patients receiving oxaliplatin plus 5-FU/LV as adjuvant therapy and in the previously treated patients for metastatic colorectal cancer. In case of such adverse reaction, hemolysis (as part of Hemolytic Uremic Syndrome) which has been rarely reported should be investigated (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions).
Arthralgia was also reported (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions).
Nervous System Disorders:
Oxaliplatin is frequently associated with acute and chronic sensory peripheral neuropathy. There have been very rare reports of symptoms compatible with a diagnosis of Guillain-Barre Syndrome, for which a causal relationship has not been established (see ADVERSE REACTIONS, Other Clinical Trial Adverse Drug Reactions).
Peripheral sensory neuropathy was reported in adjuvant patients treated with the oxaliplatin combination with a frequency of 92% (all grades) and 13% (grade 3). In patients previously untreated for metastatic colorectal cancer, neuropathy was reported in 82% (all grades) and 19% Page 15 of 65 (grade 3/4), and in the previously treated patients in 79% (all grades) and 11% (grade 3/4) events.
Peripheral Sensory Neuropathy Acute sensory neuropathy These symptoms usually develop at the end of the 2-hour oxaliplatin infusion or within a few hours, abate spontaneously within the next hours or days, and frequently recur with further cycles.
They may be precipitated or exacerbated by exposure to cold temperatures or objects. They usually present as transient paresthesia, dysesthesia and hypoesthesia. An acute syndrome of pharyngolaryngeal dysesthesia (grades 3/4) characterized by subjective sensations of dysphagia or dyspnea, feeling of suffocation, without any evidence of respiratory distress (no cyanosis or hypoxia) or of laryngospasm or bronchospasm (no stridor or wheezing) occurs in 1- 2% of the patients.
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General Do not use Oxaliplatin Injection USP intraperitoneally. Peritoneal hemorrhage may occur when oxaliplatin is administered by intraperitoneal route (not an approved route of administration) (see SUMMARY PRODUCT INFORMATION, Route of Administration).
No studies on the effects on the ability to drive and operate machinery have been performed. However Oxaliplatin Injection USP treatment resulting in an increased risk of dizziness, nausea and vomiting, and neurologic gait and balance disorders may have influence on the ability to drive and operate machinery.
Vision abnormalities, in particular transient vision loss (reversible following therapy discontinuation), were reported with oxaliplatin administration (see Other Clinical Trial Adverse Drug Reactions and Post-Market Adverse Drugs Reactions, Eye Disorders).
Transient blindness episodes lasting for periods of seconds or minutes may recur repeatedly during the event duration (usually hours to days). Therefore, patients should be warned of the potential effect of these events on the ability to drive or operate machinery.
Carcinogenesis and Mutagenesis Oxaliplatin was shown to be mutagenic and clastogenic in mammalian test systems in vitro and in vivo. The teratogenic potential of oxaliplatin was manifested by the embryonic mortality, decreased fetal weight and delayed ossifications in rats at doses up to 12 mg/m2/day.
This daily dose is approximately one-sixth of the recommended human dose. Related compounds with similar mechanism of action and genotoxicity profiles have been reported to be teratogenic. Oxaliplatin may increase the risk of genetic defects or fetal malformations.
Oxaliplatin Injection USP is contraindicated in pregnancy, and males are advised not to father a child during treatment and up to 6 months thereafter. Because Oxaliplatin Injection USP may cause irreversible infertility, men are advised to seek counseling on sperm storage before starting treatment (see TOXICOLOGY).
Carcinogenicity studies have not been performed with oxaliplatin. However given that oxaliplatin is genotoxic, it should be considered a human carcinogen, which should be taken into consideration for the overall risk/benefit in the adjuvant setting.
Cardiovascular Cases of QT prolongation and Torsade de Pointes have been reported. QT prolongation may lead to an increased risk for ventricular arrhythmias including Torsade de Pointes, which can be fatal. Page 6 of 65 Caution should be exercised in patients with a history or a predisposition for prolongation of QT, those who are taking medicinal products known to prolong QT interval, and those with electrolyte disturbances such as hypokalemia, hypocalcaemia, or hypomagnesaemia.
In case of QT prolongation, oxaliplatin treatment should be discontinued (see ADVERSE REACTIONS, Post-Market Adverse Drugs Reactions and DRUG INTERACTIONS). No formal clinical cardiac safety studies have been carried out. Preclinical data are limited.
No standard hERG or Purkinje fibre tests have been done. Cardiotoxicity was observed in dogs (see TOXICOLOGY). No formal clinical QT studies with oxaliplatin were done. The effect of oxaliplatin in combination with 5-HT3 blocker antiemetics (given as pre-medication in clinical studies) on QTc has not been formally studied.
g. bradycardia, tachycardia, hypotension, hypertension) ECG monitoring should be done. Gastrointestinal Gastrointestinal toxicity, which manifests as nausea and vomiting, warrants prophylactic and/or therapeutic antiemetic therapy (see ADVERSE REACTIONS).
Dehydration, ileus, intestinal obstruction, hypokalemia, metabolic acidosis, and even renal disorders, may be associated with severe diarrhea/emesis, particularly when combining oxaliplatin with 5-FU. In rare cases, colitis, including Clostridium difficile […]