Oxaliplatin 5mg/Ml Powder For Solution For Infusion
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PACKAGE LEAFLET: INFORMATION FOR THE USER Oxaliplatin 5mg/ml powder for solution for infusion Oxaliplatin
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or your pharmacist
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Oxaliplatin 5mg/ml is and what it is used for
2. What you need to know before you use Oxaliplatin 5mg/ml
3. How to use Oxaliplatin 5mg/ml
4. Possible side effects
5. How to store Oxaliplatin 5mg/ml
6. Contents of the pack and other information
1. What Oxaliplatin 5mg/ml is and what it is used for
The active ingredient of Oxaliplatin 5mg/mlis oxaliplatin.
Oxaliplatin 5mg/ml is used to treat cancer of the large bowel (treatment of stage III coloncancer after complete resection of primary tumour, metastatic cancer of colonand rectum). Oxaliplatin is used in combination with other anticancer medicines called 5 fluorouracil (5-FU) and leucovorin (folinic acid).
Oxaliplatin 5mg/ml is an antineoplastic or anticancer drug and contains platinum.
2. What you need to know before you use Oxaliplatin 5mg/ml
Do not use Oxaliplatin 5mg/ml
• if you are allergic to oaxaliplatin or any of the other ingredients of this medicine (listed in section 6).
• if you are breast-feeding.
• if you already have a reduced number of red or white 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.
• if you have severe kidney problems.
Warnings and precaution
Talk to your doctor or pharmacist before using Oxaliplatin 5mg/ml:
• 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 kidney problems.
• If you have any liver problems.
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. Male patients should take appropriate contraceptive measures during and after cessation of therapy continuing for 6 months.
Consult your doctor if one of the above warnings applies to you or has done in the past.
Other medicines and Oxaliplatin 5mg/ml
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
It is not recommended that you become pregnant during treatment with oxaliplatin and an effective method of contraception must be used. 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.
You must not breast-feed while you are treated with oxaliplatin.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
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 5mg/ml, do not drive, operate heavy machines, or engage in dangerous activities.
3. How to use Oxaliplatin 5mg/ml
Oxaliplatin 5mg/ml is intended for adults only.
For single use only.
Dosage
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. The dose you receive will also depend on results of blood tests and whether you have previously experienced side effects with oxaliplatin.
Method and route of administration
• 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
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 resection of your tumour.
If you use more Oxaliplatin 5mg/ml 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 further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may be_
very common: affects more than 1 user in 10_
common: affects 1 to 10 users in 100_
uncommon: affects 1 to 10 users in 1,000_
rare: affects 1 to 10 users in 10,000_
very rare: affects less than 1 user in 10,000_
not known: frequency cannot be estimated from the available data_
If you experience any side effect it is important that you inform your doctor before your next treatment. You will find described below the side effects that you could experience.
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
• Presence of blood or dark brown coffee-coloured granules in your vomit
• Stomatitis/mucositis (sore lips or mouth ulcers)
• Unexplained respiratory symptoms such as dry cough, difficulties inbreathing or crackles,
• A group of symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder).
Other known side effects of oxaliplatin are:
Very common (affects more than 1 user in 10)
• 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 (affects 1 to 10 users in 100)
• Infection due to a reduction in white blood cells
• 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
• Depression and insomnia
• Conjunctivitis and visual problems.
Uncommon (affects 1 to 10 users in 1000)
• Blockage or swelling of the bowel
• Nervousness.
Rare (affects 1 to 10 users in 10 000)
• Loss of hearing
• Scarring and thickening in the lungs with difficulties in breathing, sometimes fatal (interstitial lung disease)
• Reversible short-term loss of vision.
Very rare (affects less than 1 person in 10 000)
• Presence of blood or dark brown coffee-coloured granules in your vomit.
Frequency unknown (cannot be assessed)
• Convulsion.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store Oxaliplatin 5mg/ml
Keep this medicine out of the sight and reach of children.
Expiry date:
Do not use this medicine after the expiry date, which is stated on the carton and vial after EXP (abbreviation used for expiry date). The expiry date refers to the last day of that month.
Storing your medicine
Unopened vial : This medicinal product does not require any special storage conditions.
Storage conditions for the reconstituted and diluted solutions are given in the information intended for medical and healthcare professionals.
When the infusion has finished, any unused solution will be disposed of carefully by the doctor or nurse. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Oxaliplatin 5mg/ml contains
The active substance is oxaliplatin. One ml of the reconstituted concentrate solution contains 5mg oxaliplatin.
50mg vial: Each vial contains 50mg oxaliplatin for reconstitution in 10ml of solvent.
The other ingredient is lactose monohydrate.
What Oxaliplatin 5mg/ml looks like and contents of the pack
Oxaliplatin 5mg/ml is a white or almost white powder, which is provided in a glass vial with bromobutyl rubber closures and aluminium-plastic combination cap. The vials are supplied in cartons of one vial. Pack size: 1 x 50mg vial
Oxaliplatin 5mg/ml has to be diluted before it can be injected into a vein. This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cadiasun Pharma GmbH Lendersweg 27,
47877 Willich,
Germany
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000 Malta
This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands: Oxaliplatine Hengrui 5 mg/ml poeder voor oplossing voor infusie
Spain: Oxaliplatino Hengrui 5mg/ml polvo para solution para perfusion
United Kingdom: Oxaliplatin 5mg/ml powder for solution for infusion
This leaflet was last approved in: 08/2012
The following information is intended for medical or healthcare professionals only:
SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
As with other potentially toxic compounds, caution should be exercised when handling and preparing oxaliplatin solutions.
Instructions for Handling
The handling of this cytotoxic agent by healthcare personnel requires every precaution to guarantee the protection of the handler and his surroundings.
The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicines used, in conditions that guarantee the integrity of the medicinal product, the protection of the environment and in particular the protection of the personnel handling the medicines, in accordance with the hospital policy. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in this area.
Personnel must be provided with appropriate handling materials, notably long sleeved gowns, protection masks, caps, protective goggles, sterile single-use gloves, protective covers for the work area, containers and collection bags for waste.
Excreta and vomit must be handled with care.
Pregnant women must be warned to avoid handling cytotoxic agents.
Any broken container must be treated with the same precautions and considered as contaminated waste. Contaminated waste should be incinerated in suitably labelled rigid containers. See below chapter “Disposal”.
If Oxaliplatin powder, reconstituted solution or solution for infusion, should come into contact with mucous membranes, wash immediately and thoroughly with water.
Special precautions for administration
• DO NOT use injection equipment containing aluminium.
• DO NOT administer undiluted.
• Only glucose 5 % (50 mg/ml) infusion solution is to be used as a diluent. DO NOT reconstitute or dilute for infusion with sodium chloride or chloride containing solutions.
• DO NOT mix with any other medicinal products in the same infusion bag or administer simultaneously by the same infusion line.
• DO NOT mix with alkaline medicinal products or solutions, in particular 5 fluorouracil, folinic acid preparations containing trometamol as an excipient and trometamol salts of others active substances. Alkaline medicinal products or solutions will adversely affect the stability of oxaliplatin.
Instruction for use with folinic acid (FA) (as calcium folinate or disodium folinate)
Oxaliplatin 85 mg/m2 intravenous infusion in 250 to 500 ml of glucose 5 % (50 mg/ml) solution is given at the same time as folinic acid (FA) intravenous infusion in glucose 5 % solution, over 2 to 6 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 % solution, never in alkaline solutions or sodium chloride or chloride containing solutions.
Instruction for use with 5 fluorouracil (5 FU)
Oxaliplatin should always be administered before fluoropyrimidines - i.e. 5 fluorouracil (5 FU). After oxaliplatin administration, flush the line and then administer 5 fluorouracil (5 FU).
For additional information on medicinal products combined with oxaliplatin, see the corresponding manufacturer's summary of product characteristics.
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.
Reconstitution of the solution
Water for injections or 5% glucose solution should be used to reconstitute the solution:
• For a vial of 50 mg: add 10 ml of solvent to obtain a concentration of 5 mg oxaliplatin/ml.
Only to be used with recommended diluents.
Reconstituted solutions should be diluted with 5% glucose solution.
Reconstituted solution is a clear, colorless to light straw-colored 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 which the physico-chemical stability of oxaliplatin has been demonstrated is 0.2 mg/ml to 1.0 mg/ml.
Administer by intravenous infusion.
After dilution in glucose 5% (50 mg/ml) solution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
From a microbiological point of view, the solution for infusion 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
Inspect the solution 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.
NEVER use sodium chloride solution or chloride containing solutions for either reconstitution or dilution.
The compatibility of Oxaliplatin solution for infusion has been tested with representative, PVC-based, administrative sets.
Infusion
The administration of oxaliplatin does not require prehydration.
Oxaliplatin 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 standard procedures applicable to cytotoxic agents in accordance with local requirements related to the disposal of hazardous waste.
Module 1.3