Loading…
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: ). 7.1.4 Geriatrics Geriatrics (≥ 65 years of age): In patients previously untreated for metastatic colorectal cancer, patients ≥ 65 years (99 of 279 patients) receiving oxaliplatin in combination with 5-FU/LV experienced more fatigue, dehydration, diarrhea, leukopenia, and syncope than patients < 65 years, although…
Verbatim from this product's HC label. Tap a section to expand.
). 2 CONTRAINDICATIONS Oxaliplatin (Oxaliplatin Injection) 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
), during or within the hours following the 2-hour infusion, the next Oxaliplatin infusion should be administered over 6 hours. To prevent such dysesthesia, inform the patient to avoid exposure to cold and to avoid ingesting fresh/cold food or/and beverages during or within the hours following Oxaliplatin administration.
No dose adjustment is required to the 5-FU/LV regimen for neurotoxicity.
Adjuvant Stage III colon cancer:
Neurotoxicity was graded using the NCI CTC grading system (see 7 WARNINGS AND PRECAUTIONS). For patients who experience persistent grade 2 neurotoxicity (mild or moderate objective sensory loss, moderate paresthesias), the Oxaliplatin dose should be reduced to 75 mg/m2.
For patients with persistent grade 3 neurotoxicity, therapy should be discontinued.
Metastatic colorectal cancer:
In the metastatic colorectal cancer trials, neurotoxicity was graded using a study-specific neurotoxicity scale, and dose adjustments for oxaliplatin were recommended, as follows: Table 1 - Neurologic toxicity scale for oxaliplatin dose adjustments Toxicity (grade) Duration of Toxicity Persistenta Between Cycles1 – 7 Days > 7 Days Paresthesias/dysesthesiasb that do not interfere with function (grade 1) No change No change No change Paresthesias/dysesthesiasb interfering with function, but not activities of daily living (ADL) (grade 2) No change No change 65 mg/m2 Paresthesias/dysesthesiasb with pain or with functional impairment that also interfere with ADL (grade 3) No change 65 mg/m2 Stop Persistent paresthesias/dysesthesias that are disabling or life-threatening (grade 4) Stop Stop Stop Acute (during or after the 2 hour infusion) laryngopharyngeal dysesthesiasb ↑ duration of next infusion to 6 hoursc ↑ duration of next infusion to 6 hoursc ↑ duration of next infusion to 6 hoursc a Not resolved by the beginning of the next cycle.
2 Breast-feeding 05/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1. INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 9 5 OVERDOSAGE............................................................................................................
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 10 7 WARNINGS AND PRECAUTIONS ................................................................................ 18 8 ADVERSE REACTIONS ................................................................................................
35 9 DRUG INTERACTIONS ................................................................................................ 37 10 CLINICAL PHARMACOLOGY .......................................................................................
37 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 39 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 39 PART II: SCIENTIFIC INFORMATION .......................................................................................
Oxaliplatin (Oxaliplatin Injection) 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 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• 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).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
b May have been cold-induced. c May also have been pre-treated with benzodiazepines.
Renal Insufficiency:
Oxaliplatin has not been studied in patients with severe renal impairment. In patients with moderate renal impairment, treatment may be initiated at the normally recommended dose and renal function should be closely monitored. Dose should be adjusted according to toxicity (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS, Renal).
PrOxaliplatin – Product Monograph Page 8 of 64 Hepatic Insufficiency:
No increase in oxaliplatin acute toxicities was observed in the subset of patients with abnormal liver function tests at baseline. No specific dose adjustment for patients with abnormal liver function tests was performed during clinical development.
3 Reconstitution Dilution Before Infusion Only 5% glucose infusion solution is to be used to dilute the product. NEVER use sodium chloride or chloride containing solutions for dilution. Inspect visually for clarity, particulate matter, precipitate, discoloration and leakage prior to use.
Only clear solutions without particles, precipitate, discoloration or leakage should be used. The medicinal product is for single-use only. Any unused solution should be discarded. Needles or intravenous administration sets containing aluminum parts that may come in contact with Oxaliplatin should not be used for the preparation or mixing of the drug.
Aluminum has been reported to cause degradation of platinum compounds. The compatibility of Oxaliplatin solution for infusion has been tested with representative, PVC-based, administration sets. 70 mg/mL is the highest concentration in clinical practice for an oxaliplatin dose of 85 mg/m2).
0 mg/mL. After dilution in 5% glucose solution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C and 48 hours at 2°C to 8°C. From a microbiological point of view, this infusion preparation should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C unless dilution has taken place in controlled and validated aseptic conditions.
Incompatibilities - DO NOT administer undiluted. - Only 5% glucose infusion solution is to be used to dilute the product. - DO NOT reconstitute or dilute Oxaliplatin with saline or other solutions containing chloride ions (including calcium, potassium or sodium chloride).
- The diluted medicinal product should not be mixed with other medicinal products in the same infusion bag or infusion line. 4 Administration, Instructions for use with leucovorin). PrOxaliplatin – Product Monograph Page 9 of 64 - DO NOT mix with alkaline medicinal products or solutions, in particular 5-FU, leucovorin preparations containing trometamol as an excipient and trometamol salts of others active substances.
Alkaline medicinal products or solutions will adversely affect the stability of Oxaliplatin. - DO NOT use injection equipment containing aluminium. Disposal Remnants of the medicinal product as well as all materials that have been used for reconstitution, for dilution and administration must be destroyed according to hospital standard procedures applicable to cytotoxic agents in accordance with local requirements related to the disposal of hazardous waste.
4 Administration Oxaliplatin is considered moderately emetogenic. Premedication with antiemetics, including 5-HT3 blockers with or without dexamethasone, is recommended. The administration of Oxaliplatin does not require prehydration.
Oxaliplatin is administered by intravenous infusion. 3 Reconstitution, […]
40 13 PHARMACEUTICAL INFORMATION ............................................................................ 40 14 CLINICAL TRIALS ........................................................................................................
40 15 MICROBIOLOGY ........................................................................................................ 51 16 NON-CLINICAL TOXICOLOGY .....................................................................................
51 PATIENT MEDICATION INFORMATION .................................................................................. 57 PrOxaliplatin – Product Monograph Page 4 of 64 PART I: HEALTH PROFESSIONAL INFORMATION 1. INDICATIONS Oxaliplatin (Oxaliplatin […]