Oxaliplatin Alphapharm
contains the active ingredient oxaliplatin
CONSUMER MEDICINE INFORMATION
 

What is in this leaflet

This leaflet answers some common questions about Oxaliplatin Alphapharm.
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 you taking Oxaliplatin Alphapharm against the benefits expected for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.

What Oxaliplatin Alphapharm is used for

Oxaliplatin Alphapharm is used to treat advanced cancer of the large intestine and rectum (colorectal cancer). Oxaliplatin Alphapharm is used with two other anti-cancer drugs, fluorouracil (FU), and folinic acid. The active ingredient in Oxaliplatin Alphapharm 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 Alphapharm because they believe that the benefit of this 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 Alphapharm is only available on a prescription from your doctor.
Ask your doctor if you have any questions about why Oxaliplatin Alphapharm has been prescribed for you.

Before you take Oxaliplatin Alphapharm

When you must not take it

Do not take Oxaliplatin Alphapharm if you are allergic to the active ingredient "oxaliplatin" or any of the ingredients listed at the end of this leaflet.
If you have had an allergic reaction to oxaliplatin before, you should not take it again.
You must not receive Oxaliplatin Alphapharm 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 Alphapharm if you have severe kidney disease.
Do not take Oxaliplatin Alphapharm after the expiry date (EXP.) printed on the pack.
If you take this medicine after the expiry date, it may not work as well.
Do not take Oxaliplatin Alphapharm if the packaging shows signs of tampering or the powder does not look quite right.

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 Alphapharm is given

Oxaliplatin Alphapharm 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 Alphapharm is calculated according to your body surface area, which is calculated from your weight and height.
The usual dose is 85 mg/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 Alphapharm will be used with fluorouracil (FU) and folinic acid.
Oxaliplatin Alphapharm is not recommended in children.

While you are being given Oxaliplatin Alphapharm

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.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while Oxaliplatin Alphapharm is being given to you. You should also tell your doctor if you do not feel well between courses of Oxaliplatin Alphapharm.
All medicines can have side effects. It is important to understand the side effects that Oxaliplatin Alphapharm may cause, even though you may not experience them. As well as the predictable side effects of Oxaliplatin Alphapharm, 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 Alphapharm, and some of the checks made before each treatment to prevent excessive side effects.
Physical Condition.
Before each treatment with Oxaliplatin Alphapharm 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 Alphapharm 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 Alphapharm. Mild nausea and vomiting is more common. Medication to prevent the sickness caused by Oxaliplatin Alphapharm will be given before treatment, and may sometimes be continued after treatment.
Diarrhoea.
Severe diarrhoea may occur during treatment with Oxaliplatin Alphapharm.
If you suffer from persistent or severe diarrhoea or vomiting,contact your doctor urgently for treatment advice.
Low Blood Counts.
Oxaliplatin Alphapharm 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 Alphapharm are;
mucositis (sore lips or mouth ulcers)
abdominal pain
constipation
anorexia
changes to liver function
mild hair loss (alopecia)
fever
inflammation around the injection site
tiredness
skin rash
allergic reactions
conjunctivitis
altered taste
abnormal tongue sensation
nose bleeds
feeling of chest pressure
voice disturbance (rare)
loss of hearing (rare)
lung disorders (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 Alphapharm 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.

Storage

If you need to store Oxaliplatin Alphapharm before you take it with you to hospital, make sure it is stored in a cool dry place where the temperature does not exceed 30 degrees Celsius.
Do not use it after the expiry date (EXP) printed on the vial.
This is not all the information that is available on Oxaliplatin Alphapharm. If you have any more questions or are not sure about anything ask your doctor or pharmacist.

Product Description

Oxaliplatin Alphapharm comes as a powder for injection in a glass vial.
A box contains 1 vial.
Each Oxaliplatin Alphapharm vial contains the active ingredient, oxaliplatin 50 mg or 100 mg.

Manufacturer

Oxaliplatin Alphapharm is supplied in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Chase Building 2
Wentworth Park Road
Glebe NSW 2037
Phone: (02) 9298 3999
www.alphapharm.com.au
Medical Information
Phone: 1800 028 365
Australian registration number:
Oxaliplatin Alphapharm 50 mg - AUST R 130848
Oxaliplatin Alphapharm 100 mg - AUST R 130854
This leaflet was prepared on
07 October 2008.