Oxaliplatin 5mg/Ml Powder For Solution For Infusion
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxaliplatin 5 mg/ml powder for solution for infusion
Oxaliplatin
Read all of this leaflet carefully before you start using this medicine
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Oxaliplatin powder for solution for infusion is and what it is used for
2. Before you are given Oxaliplatin powderfor solution for infusion
3. How Oxaliplatin powderforsolutionforinfusion isgiven
4. Possible side effects
5. How to store Oxaliplatin powderforsolutionforinfusion
6. Furtherinformation
1. What Oxaliplatin Powder for solution for infusion is and l what it is used for ;
Oxaliplatin is an anti-cancer drug 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 folinicacid (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 breastfeeding
• 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
The following information is intended for medical or healthcare professionals only
Instructions for use Posoloqv
FOR ADULTS ONLY
The recommended dose for Oxaliplatin in adjuvant setting is 85 mg/m2 intravenously repeated every 2 weeks for 12 cycles (6 months).
The recommended dose for Oxaliplatin in treatment of metastatic colorectal cancer is 85 mg/m2 intravenously repeated every 2 weeks.
Dosage given should be adjusted according to tolerability. Oxaliplatin should always be administered before fluoropyrimidines i.e. 5fluorouracil (5FU).
Oxaliplatin powderfor solution for infusion is administered as a 2- to 6-hour intravenous infusion in 250 to 500 ml of glucose 5% solution (50 mg/ml) to give a concentration between 0.2 mg/ml and 0.70 mg/ml; 0.70 mg/ml is the highest concentration in clinical practice foran oxaliplatin dose of 85 mg/m2.
Oxaliplatin powder for solution for infusion was mainly used in combination with continuous infusion 5-fluorouracil based
Take Special care with Oxaliplatin powderfor 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 carryout neurological examinations, before and regularly during treatment, especially if you are given other drugs 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 for4 months for women and 6 months for men.
Breast-feeding
You must not breast-feed while you are treated with oxaliplatin. Askyourdoctoror 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 powderforsolutionforinfusion isgiven
Oxaliplatin powderfor 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 powderfor solution for infusion is only to be given to adults.
regimens. For the two-weekly treatment schedule 5-fluorouracil regimens combining bolus and continuous infusion were used.
Special Populations
Renal impairment:
• Oxaliplatin has not been studied in patients with severe renal impairment.
• In patients with moderate renal impairment, treatment may be initiated at the normally recommended dose. There is no need for dose adjustment in patients with mild renal dysfunction.
Hepatic impairment:
• In a phase I study including patients with several levels of hepatic impairment, frequency and severity of hepatobiliary disorders appeared to be related to progressive disease and impaired liver function tests at baseline. No specific dose adjustment for patients with abnormal liver function tests was performed during clinical development.
Elderly patients:
• No increase in severe toxicities was observed when Oxaliplatin for Injection was used as a single agent or in combination with 5-fluorouracil in patients over the age of 65. In consequence no specific dose adaptation is required for elderly patients.
Method of administration
Oxaliplatin powder for solution for infusion is administered by intravenous infusion.
The administration of Oxaliplatin powder for solution for infusion does not require hyperhydration.
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 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 doctorornurse immediately.
Oxaliplatin for infusion will be made up in a special area before the doctorornurse 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 powderfor 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 yourcancer.
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
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 ormouth ulcers)
• Unexplained respiratory symptoms such as a dry cough, difficulty in breathing orcrackles
• Swelling of the face, lips, mouth or throat (which may cause difficulty in swallowing or breathing)
Oxaliplatin powderfor solution for infusion is diluted in 250 to 500 ml of glucose 5% solution (50 mg/ml) to give a concentration not less than 0.2 mg/ml must be infused either via a peripheral vein or central venous line over 2 to 6 hours. Oxaliplatin infusion must always precede the administration of 5-fluorouracil.
In the event of extravasation, administration must be discontinued immediately.
As with other potentially toxic compounds, caution should be exercised when handling and preparing Oxaliplatin solutions.
Instruction for use with folinic acid (FA) (as calcium folinate or disodium folinatet
Oxaliplatin 85 mg/m2 intravenous infusion in 250 to 500 ml of glucose 5 % (50 ml) solution is given at the same time as folinic acid (FA) intravenous infusion in glucose 5 % (50 ml) solution, over 2to6 hours, using a Y-line placed immediately before the site of infusion. These two medicinal products should not be combined in the same infusion bag. Folinic acid (FA) must not contain trometamol as an excipient and must only be diluted using isotonic glucose 5 % (50 ml) solution, never in alkaline solutions orsodium chloride or chloride containing solutions.
Instruction for use with 5fluorouracil (5FU)
Oxaliplatin for Injection should always be administered before fluoropyrimidines i.e. 5fluorouracil (5 FU).
After Oxaliplatin administration, flush the line and then administer5 fluorouracil (5 FU).
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• 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 afterthe end of the treatment
• Oxaliplatin can sometimes cause an unpleasant sensation in the throat, in particularwhen 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 yourtreatment 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 treatmentand 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 orcoma
• 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 aftertreatment.
• 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
For additional information on medicinal products combined with Oxaliplatin, see the corresponding manufacturer's summary of product characteristics.
- USE ONLY the recommended solvents (see below).
-Any reconstituted solution that shows evidence of precipitation should not be used and should be destroyed with due regard to legal requirements for disposal of hazardous waste (see below).
Reconstitution of the solution
Water for injections or 5% glucose solution should be used to reconstitute the solution.
For a vial of 100 mg: add 20 ml of solvent to obtain a concentration of 5 mg Oxaliplatin/ml.
From a microbiological and chemical point of view, the reconstituted solution should be diluted immediately with 5% glucose solution.
Inspect visually prior to use. Only clear solutions without particles should be used.
The medicinal product is for single use only. Any unused infusion solution should be discarded.
Dilution for intravenous infusion
Withdraw the required amount of reconstituted solution from the vial(s) and then dilute with 250 ml to 500 ml of a 5% glucose solution to give an Oxaliplatin concentration between not less than 0.2 mg/ml and 0.7 mg/ml. The concentration range over
• Pain or redness close to orat 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. Othersymptoms 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.
• Neckstiffness, 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 orredness
• 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 ora 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
• Throatorchesttightness
Uncommon (affects more than 1 in 1,000 but less than 1 in 100 people):
• Hearing problems
• Blockage orswelling of the bowel
• Feeling anxious ornervous
• 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/orcough
• 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
which the physico-chemical stability of Oxaliplatin has been demonstrated is 0.2 mg/ml to 2 mg/ml.
Administer by intravenous infusion.
After dilution in glucose 5 % (50 mg/ml) solution, chemical and physical inuse stability has been demonstrated at 2°C to 8°C. 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.
NEVER use sodium chloride solution or chloride containing solutions for either reconstitution or dilution.
Infusion
The administration of Oxaliplatin for Injection does not require prehydration. Oxaliplatin for Injection diluted in 250 to 500 ml of a 5% glucose solution to give a concentration not less than 0.2 mg/ml must be infused either by peripheral vein or central venous line over 2 to 6 hours. When Oxaliplatin is administered with 5-fluorouracil, the Oxaliplatin infusion must precede the administration of 5-fluorouracil.
Disposal
Remnants of the medicinal product as well as all materials that have been used for reconstitution, for dilution and administration must be destroyed according to hospital standard procedures applicable to cytotoxic agents in
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 yourdoctoror pharmacist
5. How to store Oxaliplatin powderforsolutionforinfusion
Do not use Oxaliplatin powderfor solution for infusion afterthe 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 clearglass vial.
Each glass vial is packed in individual carton.
Marketing Authorisation Holder and manufacturer:
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow HA14HF, UK
The leafletwas lastapproved in 07/2008
accordance with local requirements related to the disposal of hazardous waste.
Incompatibilities:
This medicinal product should not be mixed with other medicinal products in the same infusion bag or infusion line, except for those mentioned in this leaflet. Oxaliplatin can be coadministered with folinic acid (FA) via a Y-line.
• DO NOT mix with alkaline medicinal products orsolutions, in particular 5-fluorouracil, folinic acid preparations containing trometamol as an excipient and trometamol salts of other active substances. Alkaline medicinal products or solutions will adversely affect the stability of Oxaliplatin.
• DO NOT reconstitute or dilute oxaliplatin with saline or other solutions containing chloride ions (including calcium, potassium or sodium chloride).
• DO NOT mix with other medicinal products in the same infusion bag or infusion line.
• DO NOT use injection equipment containing aluminium.
Shelf-life
Reconstituted solution in the original vial: From a microbiological and chemical point of view, the reconstituted solution should be diluted immediately.
Infusion preparation: Store at 2°C to 8°C for not longer than 24 hours. From a microbiological pointofview, the infusion preparation should be used immediately.
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