Recotaxin 50 mg/10 ml/100 mg/20 ml/200 mg/40 ml Solution

The active ingredient of RECOTAXIN is oxaliplatin. RECOTAXIN is an antineoplastic or anticancer medicine that contains oxaliplatin, which is a medicine which has platinum in its chemical structure. It is used to treat cancer of the large bowel (colon and rectum). RECOTAXIN is used in combination with other anticancer medicines called 5-fluorouracil (5- FU) and folinic acid. RECOTAXIN has to be dissolved and made into a solution before it can be injected into a vein.

RECOTAXIN should not be administered to you:

• if you are allergic to oxaliplatin or any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.
• if you already have a reduced number of blood cells.
• if you already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes (a sign of peripheral nerve damage).
• if you have severe kidney problems.

Warnings and precautions

RECOTAXIN may only be administered to you under the supervision of a doctor, who specialised in oncology and has the facilities for regular monitoring, during and after therapy.

You will not be expected to give yourself RECOTAXIN. RECOTAXIN will be administered to you under the direction of a doctor specialised in oncology (cancer treatment) RECOTAXIN is intended only for adults and is for single use only.

How much to receive:

• Your doctor will work out your dose of RECOTAXIN. This depends on your height and weight (body surface area).
• The usual dose is 85 mg/m2 of body surface area. You will receive RECOTAXIN by intravenous infusion (infusion into a vein) over a 2 to 6-hour period.
• The dose you receive will also depend on results of blood tests and whether you have previously experienced side effects with RECOTAXIN.

Method and route of administration

• RECOTAXIN 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 RECOTAXIN.
• RECOTAXIN is given by slow injection into one of your veins (an intravenous infusion) over a 2 to 6-hour period.

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 removal of your tumour.

While you are being given RECOTAXIN and between each treatment cycle. Things you must do:

• 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.
• Avoid cold foods and drinks and cover skin prior to exposure to cold during or within 48 hours following being given RECOTAXIN, 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 RECOTAXIN. Contact your doctor if this happens to you, and do not drive and use machinery until your vision is clear.

Your doctor will tell you how long your treatment with RECOTAXIN will last. Do not stop any treatment unless your doctor tells you to do so.

If you have the impression that the effect of RECOTAXIN is too strong or too weak, tell your doctor or pharmacist.

If you receive more RECOTAXIN 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.

If you forget to use RECOTAXIN: Since a health care provider will administer RECOTAXIN, it is unlikely that the dose will be missed.

RECOTAXIN can have side effects. Not all side effects reported for RECOTAXIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking RECOTAXIN, please consult your healthcare provider for advice.

If any of the following happens, stop taking RECOTAXIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Skin rash or itching.
• Fainting.
• Yellowing of your skin and eyes (also called jaundice).

These are all very serious side effects. If you have them, you may have had a serious reaction to RECOTAXIN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately if you notice any of the following:

Frequent side effects:

• RECOTAXIN 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 (movement of lowering your chin down to your chest).
• RECOTAXIN 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.
• RECOTAXIN 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 maybe continued after treatment.
• RECOTAXIN 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.
• 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 (inability to fall asleep),
• Conjunctivitis (eye infection) and visual problems,
• Decreased levels of calcium in the blood.
• Fall

These are all serious side effects. You may need urgent medical attention.

The below side effects occur less frequently:

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

The below side effects’ frequency is unknown:

• 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 dark-coloured/tarry stools (symptoms of gastrointestinal ulcer, with potential bleeding or perforation), which may be fatal,
• Oesophageal inflammation (inflammation of the lining of the oesophagus-the tube that connects your mouth with your stomach-resulting in pain and swallowing difficulty).
• Decreased blood flow to the intestine/bowel (intestinal ischaemia), which may be fatal.
• Risk of new cancers. Leukaemia, a form of blood cancer, has been reported in patients after taking RECOTAXIN in combination with certain other medicines. Talk to your doctor about the potential for increased risk of this type of cancer when taking RECOTAXIN and certain other medicines.

If you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of RECOTAXIN.

Your doctor, nurse or pharmacist is responsible for storing RECOTAXIN. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 25 °C. Do not freeze. Keep the vial in the outer carton in order to protect from light. Protect from moisture. Do not store in a bathroom. Do not use after the expiry date stated on the label.

Infusion preparation: If not used immediately, RECOTAXIN should be stored at or between 2 °C to 8 °C for not longer than 24 hours. For single use only, any unused solution should be discarded. When the infusion has finished, RECOTAXIN will be disposed of carefully by the doctor or nurse. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).