Oxaliplatin Pch Solution

Oxaliplatin belongs to the group of medicines called antineoplastics, which interferes with the growth of cancer cells to eventually destroy the cancer cells.

OXALIPLATIN PCH is used to treat cancer of the rectum and colon. OXALIPLATIN PCH is given along with other medicines to treat cancer.

OXALIPLATIN PCH should not be administered to you:

• if you are hypersensitive (allergic) to oxaliplatin or any of the other ingredients of OXALIPLATIN PCH (listed in section 6).
• if you are pregnant or breastfeeding your baby (see section Pregnancy, breastfeeding and fertility).
• if your kidney function is severely weakened or you have a kidney disease.
• if you have a condition where the bone marrow does not make enough blood cells, or none at all.
• if you already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes.
• damage to the lungs.

Even if you are male, please ensure that you read the section of this leaflet that concerns pregnancy and breastfeeding.

Warnings and precautions:

Tell your doctor or healthcare provider before being given the injection:

• if you have had a reaction to any other platinum-containing medicine. Allergic reactions can occur during any cycle.
• if you have a kidney disease or kidney problems. You may need additional monitoring and a different dose.
• if you have or had heart disorders such as an abnormal electrical signal called prolongation of the QT interval, an irregular heartbeat, or a family history of heart problems.
• if you have any liver problems.
• don’t have immunisations with live vaccines while you’re having treatment. Ask your doctor or pharmacist how long you should avoid live vaccinations. You can have other vaccines, but they might not give you as much protection as usual.

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. Alternatively, your doctor may need to reduce the dose of OXALIPLATIN PCH or delay or stop your treatment with OXALIPLATIN PCH:

• if you notice the following symptoms: rash or itching, swelling of the face, lips, mouth, throat or other parts of your body, which may cause difficulty in swallowing or breathing (see section 4). You may have a serious allergic reaction to OXALIPLATIN PCH that may need immediate medical attention.
• if you notice a sensation of discomfort or pain close to or at the injection site during the infusion (possible leakage into the surrounding tissue). Your healthcare professional must stop treatment immediately and initiate treatment of local symptoms (see section 3).
• if you have symptoms of nerve damage such as weakness, numbness, disturbances of feeling or taste after previous OXALIPLATIN PCH 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.
• if you experience numbness or tingling in your fingers or toes. These symptoms can persist in some patients after the end of the treatment and may not be reversible. Your doctor will perform a neurological examination regularly, especially if other medicines are co-administered which affect the nerves.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself OXALIPLATIN PCH. It will be given to you by a person who is qualified to do so. OXALIPLATIN PCH may only be given to adults. For single use only.

The dose of OXALIPLATIN PCH is based on your body surface area (calculated from your height and weight). The dose will also depend on results of blood tests and whether you have previously experienced side effects with OXALIPLATIN PCH. The recommended dose for adults including the elderly is 85 mg/m² of body surface.

Method and route of administration :

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

OXALIPLATIN PCH will be given to you at the same time as folinic acid and before the infusion of 5-fluorouracil.

The needle must remain in the vein while the drug 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 nurse or doctor immediately.

Frequency of administration :

You should usually receive your infusion once every two 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 OXALIPLATIN PCH solution comes into contact with your skin, wash immediately and thoroughly with soap and water.

If you receive more OXALIPLATIN PCH than you should: Since a healthcare provider will administer OXALIPLATIN PCH, he/she will control the dosage. However, in the event of overdose your doctor will manage the overdose.

If you forget to use OXALIPLATIN PCH: Since a healthcare provider will administer OXALIPLATIN PCH, it is unlikely that the dose will be missed.

OXALIPLATIN PCH can have side effects. Not all side effects reported for OXALIPLATIN PCH are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving OXALIPLATIN PCH, please consult your healthcare provider for advice. Be sure that you discussed with your doctor the possible side effects of OXALIPLATIN PCH. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequent side effects:

• allergies/allergic reactions, occurring mainly during infusion, sometimes fatal
• stomatitis / mucositis (sore lips or mouth ulcers)
• low platelet count, abnormal bruising (thrombocytopenia). Your doctor will take blood to check that you have sufficient blood cells before you start treatment and before each subsequent course
• 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)
• symptoms of an allergic or anaphylactic reaction with sudden signs such as rash, itching or hives on the skin, difficulties in swallowing, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing, extreme tiredness (you may feel you are going to faint). In the majority of cases, these symptoms occurred during the infusion or immediately after but delayed allergic reactions have also been observed hours or even days after the infusion
• pain in the chest or upper back, difficulty breathing and coughing up blood (symptoms of clots in the lungs).

Less frequent side effects :

• serious infection of the blood (sepsis), which may be fatal
• blockage or swelling of the bowel
• reversible short-term loss of vision
• difficulty in hearing, vertigo, ringing in ears
• unexpected bleeding or bruising due to widespread blood clots throughout the small blood vessels of the body (disseminated intravascular coagulation), which may be fatal
• abnormal bruising, bleeding or signs of infection such as a sore throat and high temperature
• persistent or severe diarrhoea or vomiting
• headache, altered mental functioning, seizures (fits) and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder)
• extreme tiredness with decreased number of red blood cells, and shortness of breath (haemolytic anaemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia)
• scarring and thickening in the lungs with difficulties in breathing, sometimes fatal (interstitial lung disease)
• pain in upper abdomen and pain associated with nausea and vomiting
• kidney disease where you pass little or no urine (symptoms of acute renal failure)
• vascular disorders of the liver (symptoms include abdominal pain and swelling, weight gain and tissue swelling of the feet, ankles or other parts of the body).

Side effects with unknown frequency :

• serious infection of the blood and low blood pressure (septic shock), which may be fatal
• kidney disease where you pass little or no urine (symptoms of Haemolytic-uraemic syndrome)
• auto-immune reaction leading to reduction of all blood cell lines (autoimmune pancytopenia) (symptoms include easy bleeding, easy bruising, shortness of breath, extreme lethargy and weakness, and an increased risk of infection due to the immune compromised state)

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light. Do not freeze the vial or solution for infusion. Infusion preparation: From a microbiological point of view the solution for infusion should be used immediately after preparation. If not used immediately, it should be stored at 2 °C to 8 °C for not longer than 24 hours. Do not use OXALIPLATIN PCH after the expiry date printed on the carton or vial. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).