Oxaliplatin
Oxaliplatin 5mg/ml Powder for Solution for Infusion
1. WHAT OXALIPLATIN POWDER IS AND WHAT IT IS USED FOR
Oxaliplatin powder 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 anticancer agents, 5-fluorouracil (5-FU) and folinicacid(FS).
2. BEFORE YOU USE
Do not use Oxaliplatin powder
• if you are allergic (hypersensitive) to oxaliplatin or the other ingredient of Oxaliplatin powder, lactose monohydrate.
• if you are breast-feeding
• if you already have a reduced number of blood cells (white blood cells and/or platelets).
• 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
Breast-feeding should be discontinued before starting treatment with Oxaliplatin powder.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unknown whether treatment with Oxaliplatin powder affects the ability to drive and use machines. If you feel sleepy and/or dizzy following oxaliplatin infusion do not drive, operate potentially dangerous machinery, or engage in other activities that may be hazardous because of decreased alertness.
3. HOW TO USE
For adults only.
Oxaliplatin powder will be prescribed for you by a specialist in cancer treatment. Oxaliplatin powder is given by injection into a vein (an intravenous infusion) over a 2 to 6 hour period.
The dose of Oxaliplatin powder 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 powder. The usual dose for adults including the elderly is 85 mg/m2 of body surface area once every 2 weeks at the same time as folinic acid and before the infusion of 5-fluorouracil. 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.
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 doctor or nurse immediately.
If you use more Oxaliplatin powder than you should
As this medicine is given in a hospital, it is unlikely that you will be given too little or too much. However tell your doctor if you have any concerns.
Even if you are male, please ensure that you read the section of this leaflet that concerns pregnancy and breast-feeding.
Take special care with Oxaliplatin powder
• if you have ever suffered an allergic reaction to platinum-containing medicines such as carboplatin or cisplatin
• if you have moderate kidney problems
• if you have any liver problems
• 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 your 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.
• ifyou 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. Ifyou 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 ifyou are given other drugs which may cause nerve damage. Symptoms of nerve damage can persist after the end of the treatment.
• ifyou also receive 5-fluorouracil, because the risk of diarrhoea, vomiting, sore mouth and blood abnormalities is increased.
Using other medicines
Please tell your doctor ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Oxaliplatin powder should not be used during pregnancy. It is therefore important to tell your doctor ifyou are pregnant. Ifyou become pregnant during your treatment, you must inform your doctor immediately.
Effective birth control to prevent pregnancy is advised during treatment and after the end of treatment for the following 4 months for women and for 6 months for men.
Oxaliplatin may have an anti-fertility effect which could be irreversible. Men treated with oxaliplatin 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.
If you forget to use Oxaliplatin powder
Oxaliplatin powder needs to be given on a fixed schedule. Be sure to keep all appointments. Ifyou miss a dose, you should discuss this with your doctor. Your doctor will decide when you should be given your next dose of Oxaliplatin powder.
If you stop treatment with Oxaliplatin powder
Stopping your treatment with Oxaliplatin powder may stop the effect on tumour growth. Do not stop treatment with Oxaliplatin powder unless you have discussed this with your doctor. Ifyou have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Oxaliplatin powder can cause side effects, although not everybody gets them. Ifyou experience any side effect it is important that you inform your doctor before your next treatment.
Immediately inform your doctor ifyou 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.
• Sore lips or mouth ulcers (stomatitis/ mucositis).
• Unexplained symptoms from the respiratory system such as nonproductive cough, breathing difficulties or voice alterations.
• Symptoms of an allergic reaction such as swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulties in swallowing or breathing).
Very common side effects (seen in more than 1 of every 10 patients):
• Effects on the nerves (peripheral sensory 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.This side effect 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 disappear completely there
is a possibility of continued symptoms of peripheral sensory neuropathy (weakness or numbness because of nerve damage) 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.
• Signs of infection such as a sore throat and high temperature.
• Decreased number of white blood cells, which increase the risk of infection.
• Decreased number of blood platelets, which increase the risk of bleedings and bruising.
• Decreased number of red blood cells, which may 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 reaction – skin rash including red itchy skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulties in swallowing or breathing) and can make you feel like fainting.
• Loss or lack of appetite.
• High levels of glucose (blood sugar) in your blood, which may cause thirst, dry mouth and frequent urination.
• Low levels of potassium in your blood, which may cause abnormal heart beat.
• Low levels of sodium in your blood, which may cause fatigue and confusion, muscular jerking, cramps or coma.
• Taste alterations.
• Headache.
• Nose bleeds.
• Breathlessness.
• Cough.
• Nausea (feeling sick) and vomiting (being sick) – medication to prevent the sickness is usually given 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 lips or mouth ulcers.
• Abdominal pain, constipation.
• Skin disorder.
• Hair loss.
• Back pain.
• Fatigue, weakness and pain.
• Reaction close to or at the injection site during the infusion (local pain, redness, swelling of skin, hardening of skin, death of skin tissue).
• Fever.
• Alteration in blood tests including those relating to abnormalities in liver function.
• Weight increase.
• Rigors (tremors).
Common side effects (seen in more than 1 of every 100 but in less than 1 of every 10 patients):
• Runny nose (rhinitis).
• Upper respiratory tract infection.
• Dehydration.
• Depression, sleeplessness.
• Dizziness.
• Swelling of the nerves to the muscles.
• Rigidity, intolerance of bright light and headache (meningism).
• Inflammation of the conjunctiva, abnormal vision.
• Abnormal bleeding, blood in the urine/ stools.
• Blood clots, usually in the leg, which can cause pain, swelling or redness.
• Blood clots in the lungs, which can cause chest pain and breathing difficulties.
• Flushing.
• Hiccups, chest pain.
• Indigestion and heart burn.
• Flaking skin, skin rash, increased sweating and nail disorders.
• Joint pain and bone pain.
• Pain on passing urine and changes in the frequency of urination.
• Alteration in blood test which measures the kidney function.
• Weight decrease.
• Tightness of the chest caused by cramp of the respiratory tract muscles (bronchospasm).
• Decrease in blood pressure.
• Shock (strong blood pressure drop, paleness, restlessness, rapid heart rate, moist skin, decreased consciousness) caused by a sudden vascular dilatation as a result of a severe hypersensitivity reaction to certain substances (anaphylactic shock).
• Swelling of hands, feet, ankles, face, lips, mouth or throat which may cause difficulties in swallowing or breathing (angioedema).
• Blood abnormality (deficiency of certain white blood cells) accompanied by increased susceptibility to infections (febrile neutropenia/neutropenic sepsis).
Uncommon side effects (seen in more than 1 of every 1,000 butin less than 1 of every 100 patients):
• Hearing problems.
• Blockage or swelling of the bowel.
• Nervousness.
• Blood test which indicates increased acidity in the blood.
• Jaw spasms, muscle spasms, involuntary muscle contractions, muscle twitching.
• Difficulties with co-ordination, balance, and walking.
• Throat or chest tightness.
• Eye disorders such as drooping of the upper eye lid, and double vision.
• Loss or impairment of the voice, roughness of the voice (hoarseness).
• Abnormal tongue sensation, difficulty speaking.
• Facial pain and/or eye pain.
Rare side effects (seen in more than 1 of every 10,000 butin less than 1 of every 1,000 patients):
• Slurred speech.
• Deafness.
• Unexplained symptoms from the respiratory system such as nonproductive cough, breathing difficulties or crackles (interstitial lung disease, pulmonary fibrosis).
• Inflammation of the large bowel which may cause abdominal pain or diarrhoea (colitis).
• Blood abnormality (lack of platelets) caused by an allergic reaction associated with bruises and abnormal bleeding (immunoallergicthrombocytopenia).
• Lack of red blood cells caused by too much degradation of blood (haemolytic anaemia).
• Transient reduction in visual acuity, disturbance of the visual field, inflammation of the optic nerve (optic neuritis).
Very rare side effects (seen in less than 1 of every 10,000 patients):
• Liver disease
• Kidney inflammation and kidney failure
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. HOW TO STORE
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions when the vial is unbroken.
Do not use Oxaliplatin powder after the expiry date which is stated on the carton and label.
The expiry date refers to the last day of that month.
The reconstituted solution should immediately be diluted with 5% glucose solution to give a concentration between 0.2mg/ml and 0.7mg/ml. Once diluted the infusion solution should be used immediately. Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C
Oxaliplatin 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, any remaining Oxaliplatin powder will be disposed of carefully by the doctor or nurse.
Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Oxaliplatin powder contains
• The active substance is oxaliplatin.
• The other ingredient is lactose monohydrate.
One ml of the reconstituted concentrate solution contains 5mg oxaliplatin. 50mg vial: Each vial contains 50mg oxaliplatin for reconstitution in 10ml of solvent.
100mg vial: Each vial contains lOOmg oxaliplatin for reconstitution in 20ml of solvent.
What Oxaliplatin powder looks like and contents of the pack
Powder for solution for infusion: A white or almost white powder, which is provided in a colourless glass vial that has a rubber closure and has a metallic cap containing a plastic disk.
Vial will be packed with or without a protective plastic overwrap.
Pack sizes: 1 x 50mg vial 1 x 100 mg vial
Not all pack sizes may be marketed.
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