Oxaliplatin 5mg/ml concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, your pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Oxaliplatin is and what it is used for
2. What you need to know before you use Oxaliplatin
3. How to use Oxaliplatin
4. Possible side effects
5. How to store Oxaliplatin
6. Contents of the pack and other information

• 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 difficultly performing delicate tasks, such as buttoning clothes,
• You have severe kidney problems.

Talk to your doctor or pharmacist before taking oxaliplatin

• If you have ever suffered an allergic reaction to platinum-containing medicines such as carboplatin, cisplatin. Allergic reactions can occur during any oxaliplatin infusion,
• If you have moderate or mild kidney problems,
• If you have any liver problems or abnormal liver function test results during your treatment.
• If you have or had heart disorders such as an abnormal electrical signal called prolongation of the QT interval, an irregular heart beat, or a family history of heart problems.

If any of the following applies to you at any time, tell your doctor immediately. Your doctor may need to treat you for these events, and may need to potentially reduce the dose of oxaliplatin, or delay or stop oxaliplatin treatment.

• If you have an unpleasant sensation in the throat, in particular when swallowing, and have a sensation of shortness of breath, during the treatment, tell your doctor.
• If you have nerve problems in your hands or feet, such as numbness or tingling, or decreased sensations in your hands or feet, tell your doctor.
• If you have headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss, tell your doctor.
• If you feel or are sick (nausea or vomiting), tell your doctor.
• If you have severe diarrhoea, tell your doctor.
• If you have sore lips or mouth ulcers (mucositis/ stomatitis), tell your doctor.
• If you have diarrhoea, or a reduction in white blood cells or platelets, tell your doctor. Your doctor may reduce the dose of oxaliplatin or postpone your treatment with oxaliplatin.
• If you have unexplained respiratory symptoms such as cough, or any difficulties in breathing, tell your doctor. Your doctor may stop your treatment with oxaliplatin.
• If you develop an extreme tiredness, shortness of breath, or kidney disease where you pass little or no urine (symptoms of acute renal failure), tell your doctor.
• If you have fever (temperature greater than or equal to 38°C), or chills, which could be signs of infection, tell your doctor immediately. You may be at risk of getting an infection of the blood.
• If you have fever ≥ 38°C, tell your doctor. Your doctor may determine you also have a reduction in white blood cells.
• If you experience unexpected bleeding or bruising (disseminated intravascular coagulation), tell your doctor as these could be signs of blood clots throughout the small vessels of your body.
• If you faint (lose consciousness) or have an irregular heartbeat while taking Oxaliplatin, tell your doctor immediately as this may be a sign of a serious heart condition.
• If you experience muscle pain and swelling, in combination with weakness, fever, or redbrown urine, tell your doctor. These could be signs of muscle damage (rhabdomyolysis) and could lead to kidney problems or other complications.
• If you have abdominal pain, nausea, bloody vomit or vomit that looks like “coffeegrounds”, or dark-colored/ tarry stools, which may be signs of an ulcer of the bowel (gastrointestinal ulcer, with potential bleeding or perforation), tell your doctor.
• If you have abdominal (tummy) pain, bloody diarrhoea, and nausea and/or vomiting, which may be caused by a reduction of blood flow to your gut wall (intestinal ischeamia), tell your doctor.
• If you have recently received or plan to receive any vaccines. During treatment with oxaliplatin, you should not have a vaccination with "live" or "attenuated" vaccines, such as yellow fever vaccine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy

• 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.

Breast-feeding

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

Fertility

• Oxaliplatin may have an anti-fertility effect, which could be irreversible. Male patients should seek advice on conservation of sperm prior to treatment.
• Male patients are advised not to father a child during treatment and until 6 months after treatment, and to take appropriate contraceptive measures during this time.

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

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 Oxaliplatin, do not drive, operate heavy machines or engage in dangerous activities.

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 85mg/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 Oxaliplatin.

• Oxaliplatin 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 Oxaliplatin.
• Oxaliplatin is given by slow injection into one of your veins (an intravenous infusion) over a 2 to 6 hour period.
• Oxaliplatin will be given to you at the same time as folinic acid and before the infusion of 5-fluorouracil.

You should usually receive your infusion once every 2 weeks.

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.

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.

Very common (may affect more than 1 in 10 people)

• Oxaliplatin 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.
• 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.
• Oxaliplatin 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.
• Oxaliplatin 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 (may affect up to 1 in 10 people)

• Infection due to a reduction in white blood cells,
• Serious infection of the blood in addition to a reduction in white blood cells (neutropenic sepsis), which may be fatal,
• Reduction in white blood cells accompanied by fever > 38.3°C or a prolonged fever > 38°C for more than one hour (febrile neutropenia),
• 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,
• High blood pressure,
• Depression and insomnia,
• Conjunctivitis and visual problems,
• Decreased levels of calcium in the blood,
• Fall.

Uncommon (may affect up to 1 in 100 people)

• Serious infection of the blood (sepsis), which may be fatal,
• Blockage or swelling of the bowel,
• Nervousness.

Rare (may affect up to 1 in 1,000 people)

• Loss of hearing,
• Scarring and thickening in the lungs with difficulties in breathing, sometimes fatal (interstitial lung disease),
• Reversible short-term loss of vision,
• Unexpected bleeding or bruising due to widespread blood clots throughout the small blood vessels of the body (disseminated intravascular coagulation), which may be fatal.

Very rare (may affect up to 1 in 10, 000 people)

• Presence of blood or dark brown coffee coloured particles in your vomit,
• Kidney disease where you pass little or no urine (symptoms of acute renal failure),
• Vascular disorders of liver.

Frequency not known (frequency cannot be estimated from the available data)

• Allergic vasculitis (inflammation of blood vessels),
• Auto-immune reaction leading to reduction of all blood cell lines (autoimmune pancytopenia), pancytopenia,
• Serious infection of the blood and low blood pressure (septic shock), which may be fatal,
• Convulsion (uncontrolled shaking of the body),
• Spasm of the throat causing difficulty in breathing,
• Extreme tiredness with decreased number of red blood cells, and shortness of breath (haemolytic anaemia), alone or combined with low platelet count and kidney disease where you pass little or no urine (symptoms of Haemolytic-uraemic syndrome), which may be fatal, have been reported.
• Abnormal heart rhythm (QT prolongation), that can be seen on electrocardiogram (ECG), which may be fatal,
• Myocardial infarction (Heart attack), angina pectoris (pain or uncomfortable feeling in the chest),
• Muscle pain and swelling, in combination with weakness, fever, or red-brown urine (symptoms of muscle damage called rhabdomyolysis), which may be fatal,
• Abdominal pain, nausea, bloody vomit or vomit that looks like "coffee grounds”, or darkcolored/ tarry stools (symptoms of gastrointestinal ulcer, with potential bleeding or perforation), which may be fatal,
• Oesophageal inflammation (inflammation of the lining of the esophagus - the tube that connects your mouth with your stomach- resulting in pain and swallowing difficulty),
• Decreased blood flow to the intestine/bowel (intestinal ischemia), which may be fatal,
• Risk of new cancers. Leukaemia, a form of blood cancer, has been reported in patients after taking Oxaliplatin in combination with certain other medicines. Talk to your doctor about the potential for increased risk of this type of cancer when taking Oxaliplatin and certain other medicines.
• Non-cancerous abnormal liver nodules (focal nodular hyperplasia)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is oxaliplatin.
• Each vial contains 50 mg, 100 mg or 200 mg of oxaliplatin.
• The other ingredient is water for injections.

Oxaliplatin concentrate for solution for infusion is a clear, colourless liquid, free from visible particles. Oxaliplatin vials contain a concentrate for solution for infusion. Each vial contains 50 mg, 100 mg or 200 mg of oxaliplatin in water for injections. The vials are supplied in cartons of one vial.