Oxaliplatin concentrated solution for injection
Consumer Medicine Information
Please read this leaflet before you are given this medicine.
What is in this leaflet
This leaflet answers some common questions about Oxaliplatin SUN injection. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of using Oxaliplatin SUN against the benefits it is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
What Oxaliplatin SUN is used for
Oxaliplatin SUN is used to treat cancer of the large intestine and rectum (colorectal cancer). Oxaliplatin SUN is used with two other anti-cancer drugs, fluorouracil (FU), and folinic acid. The active ingredient in Oxaliplatin SUN is called oxaliplatin.
Cancer cells are normal cells which have changed so that they grow in an uncontrolled way. Oxaliplatin works by interfering with cancer cell growth. Because of the similarities between cancer cells and normal cells, anti-cancer drugs often have unwanted effects on the body.
Your doctors have decided to treat you with Oxaliplatin SUN because they believe that the benefit of Oxaliplatin SUN treatment will be greater than the unwanted effects.
Many of the side effects from anti-cancer drugs are predictable and can be prevented or lessened. Your doctor and other staff will take all of the precautions needed to reduce the unwanted effects of treatment.
Oxaliplatin SUN is only available on a prescription from your doctor.
Before you are given Oxaliplatin SUN
When you must not receive it
You should not be given Oxaliplatin SUN if you are allergic to the active ingredient 'oxaliplatin'. If you have had an allergic reaction to oxaliplatin before, you should not receive it again.
You must not receive Oxaliplatin SUN if you are pregnant or breastfeeding. Oxaliplatin may cause birth defects if you are being treated with it at the time of conception or it is given to women who are already pregnant. Adequate contraception is required during treatment with oxaliplatin. You should discuss this with your doctor. Nursing mothers are advised not to breastfeed while receiving oxaliplatin, as the effect of breast milk from such patients is unknown.
You must not receive Oxaliplatin SUN if you have severe kidney disease.
What you should tell your doctor
You must tell your doctor if:
- you have had a reaction to any other platinum compound
- you have severe kidney disease
- you have nerve damage (neuropathy)
- you have any other medical condition that he or she is not aware of
- you are taking any other medicines, including medicines that you have bought without a prescription from a pharmacy, supermarket or health food shop.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
How Oxaliplatin SUN is given
Oxaliplatin SUN will be given to you as an infusion into one of your veins (this is called an intravenous infusion). The infusion will be given over 2-6 hours.
The dose of Oxaliplatin SUN is calculated according to your body surface area, which is calculated from your weight and height.
The usual dose is 85mg/m2 every two weeks. Your doctor may change the dose in some circumstances.
Each course of treatment is called a cycle; your doctor will tell you how many cycles you will receive.
Oxaliplatin SUN will be used with fluorouracil (FU) and folinic acid.
Oxaliplatin SUN is not recommended in children.
While you are being given Oxaliplatin SUN
Things you must do
Avoid cold foods and drinks and cover skin prior to exposure to cold during or within 48 hours following being given oxaliplatin, since neurological effects may be brought on or worsened by exposure to cold.
Contact your doctor immediately if you develop fever, particularly in association with persistent diarrhoea or evidence of infection since this may indicate low blood count.
Contact your doctor if persistent vomiting, diarrhoea, signs of dehydration, cough or breathing difficulties or signs of allergic reaction occur.
Visual disturbance is a rare side effect of Oxaliplatin SUN. Contact your doctor if this happens to you, and do not drive or use machinery until your vision is clear.
Tell your doctor or nurse as soon as possible if you do not feel well while Oxaliplatin SUN is being given to you. You should also tell your doctor if you do not feel well between courses of Oxaliplatin SUN. All medicines can have side effects.
It is important to understand the side effects that Oxaliplatin SUN may cause, even though you may not experience them. As well as the predictable side effects of Oxaliplatin SUN, there are other effects that occur much more rarely.
If you have any side effects or notice anything unusual it is important to inform your doctor before your next treatment.
Your doctor will decide whether such effects are because of your treatment, and what action needs to be taken.
This section explains the side effects of Oxaliplatin SUN, and some of the checks made before each treatment to prevent excessive side effects.
- Physical Condition. Before each treatment with Oxaliplatin SUN you will be examined for any condition that may be affected by chemotherapy (for example, infection, or loss of feeling). This will include those conditions caused by previous treatment, those caused by your disease, and those caused by other things.
- Loss of Feeling. Oxaliplatin SUN can affect nerves in the hands and feet. This is common soon after treatment and can appear as tingling or numbness in the fingers or toes, and may be made worse by cold temperatures or by contact with cold water or other cold objects. These symptoms often go away between treatments, but may last longer and get worse with repeated treatment. In some patients the limbs may become weak or painful. However, in most patients these symptoms improve after treatment is stopped. Tell your doctor if any of these things happen. Your doctor will examine you before treatment to see if you are affected.
- Nausea and Vomiting. Severe nausea and vomiting is uncommon with Oxaliplatin SUN. Mild nausea and vomiting is more common. Medication to prevent the sickness caused by Oxaliplatin SUN will be given before treatment, and may sometimes be continued after treatment.
- Diarrhoea. Severe diarrhoea may occur during treatment with Oxaliplatin SUN.
If you suffer from persistent or severe diarrhoea or vomiting, contact your doctor urgently for treatment advice.
- Low Blood Counts. Oxaliplatin SUN can affect the body's ability to make blood cells. There are three types of blood cells checked before each treatment; platelets, which help control bleeding; white blood cells, which help fight infection; and red blood cells which move oxygen around the body. If your blood count is too low, your treatment may be postponed, or the dose reduced.
Tell your doctor if you notice any bruising or abnormal bleeding, or have an infection. These may be signs of a low blood count.
- Difficulty Swallowing. Some patients may experience a sudden, temporary feeling of difficulty with swallowing or breathing. This sensation, if it occurs, usually happens during the infusion or within hours after the infusion. It may be triggered by swallowing a cold drink. Although unpleasant, this feeling does not last long, and goes away by itself.
Tell your doctor if this happens to you.
Other known side effects of Oxaliplatin SUN are:
- mucositis (sore lips or mouth ulcers)
- changes to liver function
- mild hair loss (alopecia)
- inflammation around the injection site
- skin rash
- allergic reactions
- altered taste
- abnormal tongue sensation
- nose bleeds
- feeling of chest pressure
- voice disturbance (rare)
- loss of hearing (rare)
- lung disorders (rare)
- visual disturbance (rare)
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
If you receive too much (overdose)
Your doctor will decide what dose of Oxaliplatin SUN you need, and this will be given under close supervision, usually in a hospital setting. The risk of an overdosage in these circumstances is low. In the event of an overdose occurring, your doctor will decide on the treatment necessary.
If you need to store Oxaliplatin SUN before you take it with you to hospital, make sure it is stored in a cool dry place where the temperature does not exceed 25 degrees C. Protect from light. Do not freeze.
Do not use it after the expiry date (EXP) printed on the vial.
This is not all the information that is available on Oxaliplatin SUN. If you have any more questions or are not sure about anything ask your doctor or pharmacist.
Oxaliplatin SUN comes as a concentrated solution in a glass vial.
A box contains 1 vial.
Each Oxaliplatin SUN vial contains the active ingredient, oxaliplatin 50mg, 100mg or 200mg.
The concentrated solution for injection also contains lactose monohydrate and water for injections.
Oxaliplatin SUN is supplied in Australia by:
Sun Pharmaceutical Ind. Australia Pty Ltd.
1053 Burwood Highway
FERNTREE GULLY VIC 3156
Tel: (03) 9753-5762
Fax: (03) 9753-5768
Oxaliplatin SUN 50mg/10mL concentrated solution for injection: AUSTR 173346
Oxaliplatin SUN 100mg/20mL concentrated solution for injection: AUSTR 173348
Oxaliplatin SUN 200mg/40mL concentrated solution for injection: AUSTR 173350
This leaflet was prepared in June 2011.
Published by MIMS January 2015