Online Guide

Information For The User

Oxaliplatin

1. What Oxaliplatin Powder for solution for infusion is and what it is used for

Oxaliplatin is an anti-cancer medicine and is used to treat metastatic (advanced) cancer of the colon (large bowel) or rectum (back passage), or as additional treatment following surgery to remove a tumour (growth) in the colon.

It is used in combination with other anti-cancer medicines called 5-fluorouracil (5-FU) and folinic acid (FA).

2. Before you are given Oxaliplatin for solution for infusion

You should not be given Oxaliplatin powder for solution for infusion

• if you are allergic (hypersensitive) to Oxaliplatin or any of the other ingredients of the Oxaliplatin powder for solution for infusion including lactose monohydrate
• if you already have a reduced number of blood cells
• if you breast feeding
• if you already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes
• if you have severe kidney problems

Take Special care with Oxaliplatin powder for solution for infusion

• 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
• if blood cell counts are too low after previous oxaliplatin treatment. Your doctor will perform tests to check that you have sufficient blood cells before treatment.
• if you have symptoms of nerve damage such as weakness, numbness, disturbances of feeling or taste after previous oxaliplatin treatment. These effects are often triggered by exposure to cold. If you notice such symptoms tell your doctor, especially if they are troublesome and/or last longer than 7 days. Your doctor will carry out neurological examinations, before and regularly during treatment, especially if you are given other medicines which may cause nerve damage. Symptoms of nerve damage can persist after the end of the treatment.
• if you also receive 5-fluorouracil, because the risk of diarrhoea, vomiting, sore mouth and blood abnormalities is increased.

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.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding: Pregnancy

You must not be treated with oxaliplatin unless clearly indicated by your doctor. You must not become pregnant during treatment with oxaliplatin and must use an effective method of contraception. If pregnancy occurs during your treatment, you must immediately inform your doctor. You should take appropriate contraceptive measures during and after cessation of therapy continuing for 4 months for women and 6 months for men.

Breast-feeding

You must not breast-feed while you are treated with oxaliplatin.

Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines:

Oxaliplatin treatment results in an increased risk of dizziness, nausea and vomiting, and other neurologic symptoms that affect gait and balance which may lead to a minor or moderate influence on the ability to drive and use machines. Do not drive or use machines until you are sure of how Oxaliplatin affects you.

3. How Oxaliplatin powder for solution for infusion is given

Oxaliplatin powder for solution for infusion should only be used in specialised departments of cancer treatment and should be administered under the supervision of an experienced specialist in cancer treatment.

Oxaliplatin for powder for solution for infusion is only to be given to adults.

Oxaliplatin is given by injection into a vein (an intravenous infusion) over a 2 to 6 hour period. The injection is first made by mixing the powder with a small amount of water or glucose solution. This is then diluted further in approximately 250 to 500 ml of glucose solution.

The needle must remain in the vein while the medicine is being given. If the needle comes out or becomes loose, or the solution is going into the tissue outside the vein (you may feel discomfort or pain) tell the doctor or nurse immediately.

Oxaliplatin for infusion will be made up in a special area before the doctor or nurse gives it to you.

The dose of oxaliplatin 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 once every 2 weeks before the infusion of the other anticancer medicines.

The dose you receive will also depend on results of blood tests and whether you have previously experienced side effects with Oxaliplatin for powder for solution for infusion.

The duration of treatment will be determined by your doctor. Treatment for 6 months is recommended when oxaliplatin is used after surgery to remove your cancer.

If you are given more Oxaliplatin powder for solution for infusion than you should

Your doctor will ensure that the correct dose for your condition is given. In case of an overdose, you may experience increased side effects. Your doctor will monitor your blood counts carefully and will treat your symptoms.

If you missed a dose of Oxaliplatin powder for solution for infusion

Oxaliplatin needs to be given on a fixed schedule. Be sure to keep all appointments. If you miss a dose, you should discuss this with your doctor. Your doctor will decide when you should be given your next dose of Oxaliplatin.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects of Oxaliplatin

Like all medicines, Oxaliplatin powder for solution for infusion can cause side effects, although not everybody gets them.

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
• Stomatitis/mucositis (sore lips or mouth ulcers)
• Unexplained respiratory symptoms such as a dry cough, difficulty in breathing or crackles
• Swelling of the face, lips, mouth or throat (which may cause difficulty in swallowing or breathing)
• Sensation of pain or discomfort close to or at the injection site during the infusion

Very common (affects more than 1 in 10 people):

• A disorder of the nerves which can cause weakness, tingling or numbness in the fingers, toes, around the mouth or in the throat that may sometimes occur in association with cramps. This is 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 completely there is a possibility of persistent symptoms after the end of the treatment
• Oxaliplatin 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
• Signs of infection such as a sore throat and high temperature
• Reduction in the number of white blood cells, which make infections more likely
• Reduction in blood platelets, which increases risk of bleeding or bruising
• Reduction in red blood cells, which can make the skin pale and cause weakness or breathlessness. Your doctor will take blood to check that you have sufficient blood cells before you start treatment and before each subsequent course
• Allergic reactions skin rash including red itchy skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing) and you may feel you are going to faint
• Loss or lack of appetite
• Too high levels of glucose (sugar) in your blood which may cause a great thirst, dry mouth or a need to urinate more often
• Low blood levels of potassium which can cause abnormal heart rhythm
• Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits or coma
• Taste disorder
• Headache
• Nosebleeds
• Shortness of breath
• Coughing
• Nausea, vomiting medication to prevent sickness is usually given to you by your doctor before treatment and may be continued after treatment
• Diarrhoea, if you suffer from persistent or severe diarrhoea or vomiting contact your doctor immediately for advice
• Sore mouth or lips, mouth ulcers
• Stomach pain, constipation
• Skin disorder
• Hair loss
• Back pain
• Tiredness, loss of strength/weakness, body pain
• Pain or redness close to or at the injection site during the infusion
• Fever
• Blood tests which show changes in the way the liver is working.
• Weight gain (when oxaliplatin is used after surgery to remove the tumour)

Common (affects more than 1 in 100 but less than 1 in 10 people):

• Runny nose
• Nose and throat infection Dehydration Dizziness
• Inflammation of the nerves accompanied by pain, disturbances of feeling, reduced action of the nerve. Other symptoms of nerve disorders which have been reported include jaw or muscle spasms, twitching, muscle contractions, coordination and balance problems, problems with balance, double or abnormal/decreased vision, drooping of eyelids, voice problems (hoarseness or loss of voice), speech problems, abnormal tongue sensation, facial or eye pain.
• Neck stiffness, intolerance/dislike of bright light and headache
• Conjunctivitis, visual problems
• Abnormal bleeding, blood in the urine and stools
• Blood clot, usually in a leg, which causes pain swelling or redness
• Blood clot in the lungs which causes chest pain and breathlessness
• Flushing
• Abnormal blood tests which show worsening in the way the kidney is working
• Chest pain Hiccups
• Indigestion and heartburn
• Flaking skin, skin rash, increased sweating and nail disorder
• Joint pain and bone pain
• Pain on passing urine or a change in frequency when passing urine
• Weight loss (when oxaliplatin is used in the treatment of advanced disease that has spread beyond the bowel to other tissues)
• Depression
• Difficulty sleeping
• Reduction in the number of a special form of white blood cells accompanied by fever and/or generalized infection
• Throat or chest tightness

Uncommon (affects more than 1 in 1,000 but less than 1 in 100 people):

• Hearing problems
• Blockage or swelling of the bowel
• Feeling anxious or nervous
• Blood tests which show an increase in the body’s acidity

• Rare (affects more than 1 in 10,000 but less than 1 in 1,000 people):

• Slurred speech Deafness
• Scarring of the lungs which may cause shortness of breath and/or cough
• Bowel inflammation which causes abdominal pain and/or diarrhoea which may be bloody Inflammation of the optic nerve, visual field disturbances
• Reduction in red blood cells caused by cell destruction, and reduction in blood platelets due to an allergic reaction

Very rare (affects less than 1 in 10,000 people):

• Liver disease
• Kidney inflammation and kidney failure

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 Oxaliplatin powder for solution for infusion

Do not use Oxaliplatin powder for solution for infusion after the expiry date on the vial or carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions when the vial is unopened. The reconstituted solution should be diluted immediately with 5% glucose solution to give an oxaliplatin concentration between not less than 0.2 mg/ml and 0.7 mg/ml. 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Oxaliplatin powder for solution for infusion contains:

Oxaliplatin powder for solution for infusion contains the active ingredient Oxaliplatin 100 mg, with lactose monohydrate as inactive ingredient.

What Oxaliplatin powder for solution for infusion looks like and contents of the pack:

Oxaliplatin powder for solution for infusion is a white to off white lyophilized powder in a clear glass vial. Each glass vial is packed in individual carton.

Marketing Authorisation Holder and manufacturer:

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow HAI 4HF, UK