Eloxatin (Oxaliplatin)
Eloxatin 5 mg/ml concentrate for solution for infusion
Oxaliplatin
1. What Eloxatin is and what it is used for
The active ingredient of Eloxatin is oxaliplatin.
Eloxatin is used to treat cancer of the large bowel (treatment of stage III colon cancer after complete resection of primary tumour, metastatic cancer of colon and rectum). Eloxatin is used in combination with other anticancer medicines called 5 fluorouracil and folinic acid.
Eloxatin is an antineoplastic or anticancer drug and contains platinum.
2. Before you use Eloxatin
- You should not be given Eloxatin if
- You are allergic to oxaliplatin,
- You are breast-feeding,
- You already have a reduced number of blood cells,
- You already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes,
- You have severe kidney problems.
Take special care with Eloxatin
- If you have ever suffered an allergic reaction to platinum-containing medicines such as carboplatin, cisplatin,
- If you have moderate kidney problems,
- If you have any liver problems,
- Oxaliplatin may have an anti-fertility effect, which could be irreversible. Male patients are therefore advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment. Male patients should take appropriate contraceptive measures during and after cessation of therapy continuing for 6 months.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
• It is not recommended that you become pregnant during treatment with oxaliplatin and must use an effective method of contraception. Female patients should take appropriate contraceptive measures during and after cessation of therapy continuing for 4 months.
If you are pregnant or planning a pregnancy it is very important that you discuss this with your doctor before you receive any treatment. If you get pregnant during your treatment, you must immediately inform your doctor.
• You must not breast-feed while you are treated with Oxaliplatin.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Oxaliplatin treatment may result in an increased risk of dizziness, nausea and vomiting, and other neurological symptoms that affect walking and balance. If this happens you should not drive or operate machinery. If you have vision problems while taking Eloxatin, do not drive, operate heavy machines, or engage in dangerous activities.
3. How to use Eloxatin
Eloxatin is intended only for adults. For single use only.
Dosage
The dose of Eloxatin is based on your body surface area. This is calculated from your height and weight.
The usual dose for adults including the elderly is 85 mg/m2 of body surface area. The dose you receive will also depend on results of blood tests and whether you have previously experienced side effects with Eloxatin.
Method and route of administration
• Eloxatin will be prescribed for you by a specialist in cancer treatment.
• You will be treated by a healthcare professional, who will have made up the required dose of Eloxatin.
• Eloxatin is given by slow injection into one of your veins (an intravenous infusion) over a 2 to 6 hour period.
• Eloxatin will be given to you at the same time as folinic acid and before the infusion of 5 fluorouracil.
Frequency of administration
You should usually receive your infusion once every 2 weeks.
Duration of treatment
The duration of the treatment will be determined by your doctor.
Your treatment will last a maximum of 6 months when used after complete resection of your tumour.
If you use more Eloxatin than you should
As this medicine is administered by a healthcare professional it is highly unlikely that you will be given too much or too little.
In case of overdose, you may experience increased side effects. Your doctor may give you appropriate treatment for these side effects.
If you have any questions about your treatment, ask your doctor, nurse or pharmacist.
4. Possible side effects
Like all medicines, Eloxatin can cause side effects, although not everybody gets them.
If you experience any side effect it is important that you inform your doctor before your next treatment.
You will find described below the side effects that you could experience.
Tell your doctor immediately if you notice any of the following:
• Abnormal bruising, bleeding, or signs of infection such as a sore throat and high temperature,
• Persistent or severe diarrhoea or vomiting,
• Presence of blood or dark brown coffee-coloured granules in your vomit,
• Stomatitis/mucositis (sore lips or mouth ulcers),
• Unexplained respiratory symptoms such as dry cough, difficulties in breathing or crackles.
Other known side effects of Eloxatin are:
Very common (affects more than 1 person in 10)
• Eloxatin can affect the nerves (peripheral neuropathy). You may feel a tingling and/or numbness in the fingers, toes, around the mouth or in the throat, which may sometimes occur in association with cramps.
These effects are often triggered by exposure to cold e.g. opening a refrigerator or holding a cold drink.
You may also have difficulty in performing delicate tasks, such as buttoning clothes. Although in the majority of cases these symptoms resolve themselves completely there is a possibility of persistent symptoms of peripheral sensory neuropathy after the end of the treatment.
Some people have experienced a tingling, shock-like sensation passing down the arms or trunk when the neck is flexed.
• Eloxatin can sometimes cause an unpleasant sensation in the throat, in particular when swallowing, and give the sensation of shortness of breath. This sensation, if it happens, usually occurs during or within hours of the infusion and may be triggered by exposure to the cold.
Although unpleasant, it will not last long and goes away without the need for any treatment.
Your doctor may decide to alter your treatment as a result.
• Eloxatin may cause diarrhoea, mild nausea (feeling sick) and vomiting (being sick); however medication to prevent the sickness is usually given to you by your doctor before treatment and may be continued after treatment.
• Eloxatin causes temporary reduction in the number of blood cells. The reduction of red cells may cause anaemia (a reduction of red cells), abnormal bleeding or bruising (due to a reduction in platelets).
The reduction in white blood cells may make you prone to infections. Your doctor will take blood to check that you have sufficient blood cells before you start treatment and before each subsequent course.
• Sensation of discomfort close to or at the injection site during the infusion,
• Fever, rigors (tremors), mild or severe tiredness, body pain,
• Weight changes, loss or lack of appetite, taste disorders, constipation,
• Headache, back pain,
• Swelling of the nerves to your muscles, neck stiffness, abnormal tongue sensation possibly altering speech, stomatitis/mucositis (sore lips or mouth ulcers),
• Stomach pain,
• Abnormal bleeding including nose bleeds,
• Coughing, difficulty in breathing,
• Allergic reactions, skin rash which may be red and itchy, mild hair loss (alopecia),
• Alteration in blood tests including those relating to abnormalities in liver function.
Common (affects less than 1 person in 10)
• Infection due to a reduction in white blood cells,
• Indigestion and heart burn, hiccups, flushing, dizziness,
• Increased sweating and nail disorders, flaking skin,
• Chest pain,
• Lung disorders and runny nose,
• Joint pain and bone pain,
• Pain on passing urine and changes in kidney function, changes of frequency of urination, dehydration,
• Blood in the urine/stools, swelling of the veins, clots in the lung,
• Depression and insomnia,
• Conjunctivitis and visual problems.
Uncommon (affects less than 1 person in 100)
• Blockage or swelling of the bowel,
• Nervousness.
Rare (affects less than 1 person in 1000)
• Loss of hearing,
• Scarring and thickening in the lungs with difficulties in breathing, sometimes fatal (interstitial lung disease),
• Reversible short-term loss of vision.
Very rare (affects less than 1 person in 10 000)
• Presence of blood or dark brown coffee-coloured granules in your vomit.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Eloxatin
• Keep out of the reach and sight of children.
• Prior to mixing this medicinal product must be kept in the outer carton in order to be protected from light and must not be frozen.
• Do not use after the expiry date, which is stated on the outer pack and vial. The expiry date refers to the last day of the month.
Eloxatin should not come into contact with the eyes or skin. If there is any accidental spillage, tell the doctor or nurse immediately.
When the infusion has finished, Eloxatin will be disposed of carefully by the doctor or nurse.
6. Further information
- What Eloxatin contains
The active substance is called oxaliplatin. Each vial contains 50 mg, 100 mg or 200 mg of oxaliplatin.
The other ingredient is water for injections.
- What Eloxatin looks like and contents of the pack
Eloxatin vials contain a concentrate for solution for infusion. Each vial contains 50 mg, 100 mg or 200 mg oxaliplatin in water for injections. The vials are supplied in cartons of one vial.
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