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 taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have further questions, please askyour doctor.
• This medicine has been prescribed for you. Do not pass it on toothers. 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.
In this leaflet:
1. What Oxaliplatin Powder for Solution for Infusion is and what it is used for
2. Before you are given Oxaliplatin Powder for Solution for Infusion
3. How Oxaliplatin Powder for Solution for Infusion is given
4. Possible side effects
5. How to store Oxaliplatin Powder for Solution for Infusion
6. Further information
rl. What Oxaliplatin Powder for Solution for Infusion is and what it is'1 L 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 folinic acid (FA).
2. Before you are given Oxaliplatin Powderfor Solution for Infusion
Do not use Oxaliplatin Powderfor Solution for Infusion
If you are allergic (hypersensitive) to Oxaliplatin or any of the other ingredients of the Oxaliplatin Powder for Solution for Infusion.
If you have impaired bone marrow function.
If you have severe kidney disease.
If you are breastfeeding.
If you already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes.
Even if you are male, please ensure that you read the section of this leaflet that concerns pregnancy and breast-feeding.
If you already have reduced number of blood cells (white blood cells and/or platelets).
Take Special care with Oxaliplatin Powderfor Solution for Infusion
• If you have had a reaction to any other platinum containing drugs such as carboplatin, cisplatin etc.
• If you have severe kidney disease.
• if you have nerve damage (neuropathy).
• if you have any liver problems.
The following information is intended for medical or healthcare professionals only
Instructions for use
ANTINEOPLASTICAGENT
Incompatibilities:
This medicinal product should not be mixed with other medicinal products except for those mentioned below in section: “Reconstitution of the solution”. Oxaliplatin can be co-administered with folinic acid (FA) via a Y-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 other active substances. Alkaline medicinal products or solutions will adversely affect the stability of Oxaliplatin. (see section “Reconstitution of the solution”)
• DO NOT reconstitute or dilute for infusion with saline or other solutions containing chloride ions (including calcium, potassium or sodium chloride).
• 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.
• 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.
• 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 carry out 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.
If any of the above statements are applicable to you, please tell your doctor before having the injection.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained withouta prescription.
Pregnancy and breast-feeding:
Oxaliplatin should not be used during pregnancy. It is therefore important to tell your doctor if you are pregnant. If you 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 treatmentfor 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. Breast-feeding should be discontinued before starting treatmentwith Oxaliplatin. Askyour doctor or pharmacist for advice before taking 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.
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.
Important information about some of the ingredients of Oxaliplatin Powderfor Solution for Infusion
Oxaliplatin Powder for Solution for Infusion contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How Oxaliplatin Powder for Solution for Infusion is given
Oxaliplatin will be prescribed for you by a specialist in cancer treatment.
Oxaliplatin Powder for Solution for Infusion is given to you as an injection into one of your veins (this is called an intravenous infusion). The infusion is given over 2 - 6 hours period.
The dose of Oxaliplatin is calculated according to your body surface area, which is calculated from your weight and height. The dose will also depend on results of blood tests whether you have previosly experienced side effects with Oxalipaltin. The usual dose for adults including the elderly is 85 mg/m2 of body surface area once every 2
Infusion preparation: Chemical and physical in-use stability has been demonstrated for 24 hours 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.
Instruction for handling, use and disposal
As with other potentially toxic compounds, caution should be exercised when handling and preparing Oxaliplatin solutions.
Instruction 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 preparations 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 personal handling the medicines, in accordance with the hospital policy. It requires a preparation area reserved for this purpose. Smoking, eating and drinking should be forbidden in this area.
Personnel must be provided with appropriate handling materials, notably long sleeved gowns, protection masks, caps, protective covers for work area, container and collection bagsforwaste.
Excreta and vomit must be handled with care.
Pregnant women must be warned to avoid handling cytotoxic agents.
weeks at same time as folinic acid and before the infusion of 5-flurouracil. The duration of treatment will be determined by your doctor. Your doctor may change the dose in some circumstances.
Each course of treatment is called a cycle; your doctor will tell you how many cycles you will receive. Your treatment will last a maximum of 6 months when used after complete resection of your tumour.
Oxaliplatin Powderfor Solution for Infusion will be used with 5-fluorouracil (5-FU)and folinic acid.
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.
Patients with impaired kidney function
In patients with moderate kidney impairment the treatment may be initiated with the normally recommended dose. There is no need for dosage adjustment in patients with mild renal dysfunction.
If you use more Oxaliplatin Powderfor Solution for Infusion
Your doctor will decide what dose of Oxaliplatin you need, and this will be given under close supervision, usually in a hospital setting. The risk of an overdosage in these circumstances is low. In the event of an overdose occurring, your doctor will decide on the treatment necessary.
If you forget to use Oxaliplatin Powderfor Solution for Infusion
Oxaliplatin infusion 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 infusion.
If you stop treatmentwith Oxaliplatin Powderfor Solution for Infusion
Stopping your treatment with Oxaliplatin may stop the effect on tumour growth. Do not stop the treatment with Oxaliplatin unless you have discussed this with your doctor.
If you have any further question on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Immediately inform you doctor 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 orvomiting.
• 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.
Any broken container must be treated with the same precautions and considered as contaminated waste. Contaminated waste should be incinerated in a suitable labelled rigid container. See section headed: Disposal below.
If Oxaliplatin powder, reconstituted solution or solution for infusion, should come into contact with skin, wash immediately and thoroughly with water.
If Oxaliplatin powder, reconstituted solution or solution for infusion, should come into contact with mucous membrane, wash immediately and thoroughly with water.
Special Precaution foradministration
• DO NOT use injection equipment containing aluminium
• DO NOT administer Oxaliplatin 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 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 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).
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• 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.
• Lossorlackofappetite.
• 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).
• Upperrespiratorytractinfection.
• Dehydration.
• Depression, sleeplessness.
• Dizziness.
• Swelling of the nerves to the muscles.
• Rigidity, intolerance of bright light and headache (meningism).
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 %, 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 % (50 mg/ml) solution, never in alkaline solutions or sodium chloride or chloride containing solutions.
Instruction for use with 5fluorouracil (5FUt
Oxaliplatin for Injection should always be administered before fluoropyrimidines i.e. 5fluorouracil (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.
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 mgOxaliplatin/ml.
• 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 but in less than 1 of every 100 patients):
• Hearing problems.
• Blockage orswelling of the bowel.
• Nervousness.
• Blood testwhich 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.
• Lossorimpairmentofthe voice, roughness of the voice (hoarseness).
• Abnormal tongue sensation, difficulty speaking.
• Facial painand/oreye pain.
Rare side effects (seen in more than 1 of every 10,000 but in less than 1 of every 1,000 patients):
• Slurred speech.
• Deafness.
• Unexplained symptoms from the respiratory system such as non-productive 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 (immunoallergic thrombocytopenia).
• 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):
• Liverdisease.
• Kidney inflammation and kidney failure.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reconstituted solution should be diluted immediately with 5% glucose solution. Inspect visually prior to use. Only clear solutions without particles should be used.
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.
The medicinal product is for single use only. Any unused infusion solution should be discarded.
Dilution for intravenous infusion
Only to be used with recommended diluents.
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 2 mg/ml.
Administer by intravenous infusion.
Chemical and physical in-use stability has been demonstrated for 24 hours 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.
5. Howto store Oxaliplatin Powder for Solution for Infusion
Keep out of reach and sight of children. This medicinal product does not require any special storage condition when the vial is unopened.
Do not use after the expiry date stated on the on the vial or carton.
The expiry date refers to the last day of that month.
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.
Oxaliplatin should not come in contact with the eyes or skin. If there is any accidental spillage, tell the doctor or nurse immediately.
When the infusion has finished, doctor or nurse should dispose of any remaining Oxaliplatin carefully.
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 50 mg, with lactose monohydrate as inactive ingredient.
One ml of the reconstituted concentrate solution contains 5 mg Oxaliplatin.
50 mg vial: Each vial contain 50 mg of Oxaliplatin for reconstitution in 10 ml of solvent.
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 clear glass vial.
Pack sizes:
Each glass vial is packed in individual carton.
1 X50 mg vial
Marketing Authorisation Holderand manufacturer:
Accord Healthcare Limited,
Sage House, 319 PinnerRoad,
North Harrow, Middlesex, HA1 4HF, United Kingdom
The leaflet was last approved in 04/2009
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.
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 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 accordance with local requirements related to the disposal of hazardous waste.
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