Consumer medicine information

Oxaliplatin Accord 50 mg/10 mL Concentrate for infusion

Oxaliplatin

BRAND INFORMATION

Brand name

Oxaliplatin Accord

Active ingredient

Oxaliplatin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Oxaliplatin Accord 50 mg/10 mL Concentrate for infusion.

1. Why am I being given Oxaliplatin Accord?


Oxaliplatin Accord contains the active ingredient oxaliplatin. Oxaliplatin Accord is used to treat cancer of the large intestine and rectum (colorectal cancer). It is used in combination with other anti-cancer drugs; fluorouracil and folinic acid. Oxaliplatin Accord is not recommended in children.
For more information, see Section 1. Why am I using Oxaliplatin Accord? in the full CMI.

2. What should I know before I am given Oxaliplatin Accord?


Do not use if you have ever had an allergic reaction to Oxaliplatin, any of the ingredients listed at the end of the CMI or other platinum compound.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am given Oxaliplatin Accord? in the full CMI.

3. What if I am taking other medicines?


Some medicines and Oxaliplatin may interfere with each other and may affect how well each medicine works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How will I be given Oxaliplatin Accord?


Oxaliplatin Accord will be given to you by a doctor or a nurse as an infusion into one of your veins.
More instructions can be found in Section 4. How will I be given Oxaliplatin Accord? in the full CMI.

5. What should I know while being given Oxaliplatin Accord?

Things you should do
  • Be sure to keep all your doctor's appointments
  • Tell your doctor if you do not feel well between courses of oxaliplatin
  • If you suffer from persistent or severe diarrhoea or vomiting, contact your doctor urgently for treatment advice
  • Tell your doctor if you notice any bruising or abnormal bleeding
  • Avoid cold foods and drinks and cover skin prior to exposure to cold during or within 48 hours following being given oxaliplatin
  • Tell your doctor immediately if you become pregnant while you are being given oxaliplatin
Driving or using machinesBe careful driving or operating machinery until you know how Oxaliplatin Accord affects you. Visual disturbance is a rare side effect of Oxaliplatin Accord. Contact your doctor if this happens to you, and do not drive or use machinery until your vision is clear.

For more information, see Section 5. What should I know while being given Oxaliplatin Accord? in the full CMI.

6. Are there any side effects?


All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
Some of the very serious side effects are:

  • allergic reactions - swelling of the face, lips, mouth, touch or throat; a wheezing or whistling sound when inhaling; difficulty breathing; shortness of breath and looking pale; rash, itching or hives o the skin
  • chest pain or feeling of chest pressure
  • coughing
  • abnormal changes to your heart rate
  • feeling lightheaded or dizzy
  • breakdown of muscle tissue causing muscle fibres to be released into the blood. Symptoms include dark, red urine, decreased urine output, muscle stiffness or aching
  • serious lung infections. Symptoms include fever, chills, shortness of breath, and a cough which produces yellow-green phlegm and occasionally blood
  • convulsions, fits or seizures
  • vomiting blood or material that looks like coffee grounds
  • bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea

Tell your doctor immediately even if they occur even if this is several months or years after stopping treatment with Oxaliplatin Accord.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Oxaliplatin Accord

Active ingredient

Oxaliplatin

Schedule

S4

 

1 Name of Medicine

Oxaliplatin.

2 Qualitative and Quantitative Composition

Oxaliplatin Accord, concentrated injection is presented in vials containing 50 mg/10 mL and 100 mg/20 mL oxaliplatin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Oxaliplatin Accord, concentrated injection is a clear, colourless solution in a clear glass vial.

4 Clinical Particulars

4.9 Overdose

There is no known antidote to oxaliplatin. In cases of overdose, exacerbation of adverse effects can be expected. Monitoring of haematological parameters should be initiated and symptomatic treatment given.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia) or the national Poisons Centre, 0800 POISON or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Oxaliplatin was shown to be mutagenic and clastogenic in mammalian test systems in vitro and in vivo.
Carcinogenicity. The carcinogenic potential of oxaliplatin has not been studied, but compounds with similar mechanisms of action and genotoxicity profiles have been reported to be carcinogenic. Oxaliplatin should be considered a probable carcinogen.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical Names: [SP-4-2]-(1R,2R)-(cyclohexane-1,2-diamine-k2N,N'(oxalato(2-)-k2O1,O2]platinum (II) or (SP-4-2)-[(1R,2R)-Cyclohexane-1,2-diamine-kN,kN1] [ethanedioato (2-)-kO1,kO2]platinum.
The empirical formula of oxaliplatin is C8H14N2O4Pt and its molecular weight is 397.3.
Oxaliplatin is a white to off-white crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and practically insoluble in ethanol.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSOXALIP.gif CAS number. 61825-94-3.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/OXAACCST.gif