Oxaliplatin Hospira 5 Mg/Ml Concentrate For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxaliplatin Hospira 5 mg/ml concentrate for solution for infusion
Oxaliplatin
Read all of this leaflet carefully before you start taking 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, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet (see section 4.).
What is in this leaflet:
1. What Oxaliplatin Hospira is and what it is used for
2. What you need to know before you use Oxaliplatin Hospira
3. How to use Oxaliplatin Hospira
4. Possible side effects
5 How to store Oxaliplatin Hospira
6. Contents of the pack and other information
1. What Oxaliplatin Hospira is and 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 folinic acid (FA).
2. What you need to know before you use Oxaliplatin Hospira Do not use Oxaliplatin Hospira:
> if you are hypersensitive (allergic) to oxaliplatin or any of the other ingredients of Oxaliplatin Hospira
> if you are breast feeding,
> if you already have a reduced number of 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 a severe kidney problem.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Oxaliplatin Hospria:
> if you have moderate kidney problems.
> if you have ever suffered an allergic reaction to other platinum-containing medicines such as carboplatin or cisplatin.
> if you have symptoms of nerve damage such as weakness, numbness, disturbance of feeling 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 regularly carry out neurological examinations, before and regularly during treatment, especially if you are given other drugs which may cause nerve damage.
> if you have any liver problems
> if your blood cell counts are too low after previous infusions of oxaliplatin. Your doctor will regularly take blood to check you have sufficient blood cells.
Before and/or during treatment with oxaliplatin you may be given special medicinal products to prevent and/or treat vomiting.
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.
Children
Oxaliplatin Hospira should not be given to children.
Other medicines and Oxaliplatin Hospira
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
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.
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 for 4 months for women and 6 months for men.
You must not breast-feed while you are treated with oxaliplatin.
Driving and using machines
Oxaliplatin treatment may result in an increased risk of dizziness, nausea and vomiting, and other neurological symptoms that affect gait and balance. If this happens, you should not drive or operate machinery.
3. How to use Oxaliplatin Hospira
For adults only.
Oxaliplatin Hospira should only be used in specialised departments of cancer treatment and should be administered under the supervision of an experienced specialist in cancer treatment.
Dosage
The dose depends on your body surface area (calculated by m2) and your state of health. It also depends on other medicines that are used in your cancer treatment. The usual dose for adults, including the elderly, is 85 mg/m of body surface area once every 2 weeks, before the infusion of the other anti-cancer medicines. The dose you receive will depend on results of blood tests and whether you have previously experienced side effects with oxaliplatin.
Method and route of administration
Oxaliplatin Hospira is diluted before being given by injection into a vein (an intravenous infusion) over a 2-6 hour period. 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.
Frequency of administration
You should usually receive your infusion once every 2 weeks.
Duration of treatment
The duration of treatment will be determined by your doctor. Treatment for 6 months is recommended when oxaliplatin is used after surgery to remove your cancer.
If you are given more Oxaliplatin Hospira than you should:
As this medicine is administered by a healthcare professional, it is highly unlikely that you will be given too little or too much. 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 questions about your treatment, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effect it is important that you inform your doctor before your next treatment.
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 or mouth ulcers)
• Unexplained respiratory symptoms such as a dry cough, difficulty in breathing or crackles
• 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.
• Sensation of pain or discomfort close to or at the injection site during the infusion
• A group of sympotms such as extreme tiredness, little or infrequent urination and abnormal bleeding or bruising (signs of haemolytic uremic syndrome)
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 after the end of the treatment
• 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
• 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 treatment and 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 or coma
• 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 after treatment.
• 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
• Pain or redness close to or at the injection site during the infusion
• Fever which may be accompanied by shaking (rigors)
• 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. Other symptoms of nerve disorders which have been reported include jaw or muscle spasms, twitching, muscle contractions, coordination and balance problems, staggering, double or abnormal/decreased vision, drooping of eyelids, voice problems (hoarseness or loss of voice), speech problems, abnormal tongue sensation, facial or eye pain.
• Neck stiffness, intolerance/dislike of bright light and headache
• Conjunctivitis, visual problems
• Abnormal bleeding, blood in the urine, stools or vomit
• Blood clot, usually in a leg, which causes pain swelling or redness
• Blood clot in the lungs which causes chest pain and breathlessness
• Flushing
• Chest pain
• Hiccups
• Indigestion and heartburn
• Flaking skin, skin rash, increased sweating and nail disorder
• Joint pain and bone pain
• Pain on passing urine or a change in frequency when passing urine
• Abnormal blood tests which show worsening in the way the kidney is working
• 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
• Throat or chest tightness
Uncommon (affects more than 1 in 1,000 but less than 1 in 100 people):
• Hearing problems
• Blockage or swelling of the bowel
• Feeling anxious or nervous
• Blood tests which show an increase in the body’s acidity
• Temporary loss of vision
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/or cough
• 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
• Inflammation of the pancreas
• A group of symptoms such as headache, dizziness, fits, high blood pressure and sight problems (signs of reversible posterior leukoencephalopathy syndrome)
Very rare (affects less than 1 in 10,000 people)
• Liver disease
• Kidney inflammation and kidney failure
Frequency not known (frequency cannot be estimated from available data)
• Allergic vasculitis (inflammation of blood vessels)
• Auto-immune reaction leading to reduction of all blood cell lines (autoimmune pancytopenia).
If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any side effects not mentioned in this leaflet.
5. How to store Oxaliplatin Hospira
Store below 25 °C.
Keep this medicine out of the sight and reach of children. Keep the vial in the outer carton in order to protect from light. Do not freeze.
Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.
Once diluted the infusion preparation should be used immediately. Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C and 6 hours at 25°C. If not used immediately, in-use storage times and conditions are the responsibility of the user and would not normally be longer than 24 hours at 2°C to 8°C.
6. Contents of the pack and other information
What Oxaliplatin Hospira contains
• The active substance is oxaliplatin.
One ml of concentrate for solution for infusion contains 5 mg oxaliplatin.
10 ml of concentrate for solution for infusion contains 50 mg of oxaliplatin.
20 ml of concentrate for solution for infusion contains 100 mg of oxaliplatin.
40 ml of concentrate for solution for infusion contains 200 mg of oxaliplatin.
• The other ingredients are tartaric acid, sodium hydroxide and water for injections
What Oxaliplatin Hospira looks like and contents of the pack
Oxaliplatin Hospira is in the form of a concentrate solution for infusion (a concentrated solution which is diluted to make a solution which can be given as a slow infusion via a drip). Each millilitre (ml) of solution contains 5 milligrams (mg) of oxaliplatin. It is a clear, colourless solution contained in glass containers called vials, containing 50 mg (10 ml), 100 mg (20 ml) and 200 mg (40 ml) of oxaliplatin. The vials are wrapped in a protective plastic to reduce the risk of spillage if the vials break - these are referred to as ONCO-TAIN®. The vials are available in single packs.
The solution is then diluted in glucose 5% solution and can be given as an infusion via a drip.
Marketing Authorisation Holder and Manufacturer
Hospira UK Limited
Horizon
Honey Lane
Hurley
Maidenhead
SL6 6RJ
UK
This leaflet was last revised in 08/2016
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 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 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.
Faeces 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 concentrate or solution for infusion, should come into contact with skin, wash immediately and thoroughly with water.
If oxaliplatin concentrate 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% infusion solution is to be used as a diluent. DO NOT 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 other 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 % 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.
USE ONLY the recommended solvents (see below).
• Any concentrate 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).
Concentrate for solution for infusion
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 concentrate from the vial(s) and then dilute with 250 ml to 500 ml of a glucose 5% solution to give an oxaliplatin concentration between 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 1.3 mg/ml.
Administer by intravenous infusion.
After dilution in glucose 5% solution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C and for 6 hours at 25°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.
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 or chloride containing solutions for dilution.
The compatibility of Oxaliplatin solution for infusion has been tested with representative, PVC-based, administration sets.
Infusion
The administration of oxaliplatin does not require prehydration.
Oxaliplatin diluted in 250 to 500 ml of a glucose 5% 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.
Remnants of the medicinal product as well as all materials that have been used 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.