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ELOXATIN 5MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): OXALIPLATIN

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Package leaflet: information for the user
ELOXATINE 5 mg/ml concentrate 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 any further questions, ask your doctor, your pharmacist or nurse.
• If you get any side effects, talk to you 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 ELOXATINE is and what it is used for
2.
what you need to know before you use ELOXATINE
3.
How to use ELOXATINE
4.
Possible side effects
5.
How to store ELOXATINE
6.
Contents of the pack and other information

1.

What ELOXATINE is and what it is used for

The active ingredient of ELOXATINE is oxaliplatin.
ELOXATINE is used to treat cancer of the large bowel (treatment of stage III colon cancer after complete
resection of primary tumour, metastatic cancer of colon and rectum). ELOXATINE is used in
combination with other anticancer medicines called 5-fluorouracil and folinic acid.
ELOXATINE is an antineoplastic or anticancer drug and contains platinum.

2.

What you need to know before you use ELOXATINE

Do not use ELOXATINE if






You are allergic to oxaliplatin.
You are breast-feeding.
You already have a reduced number of blood cells.
You already have tingling and numbness in the fingers and/or toes, and have difficulty performing
delicate tasks, such as buttoning clothes.
You have severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking ELOXATINE





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 or mild kidney problems.
If you have any liver problems or abnormal liver function test results during your treatment.
If you have or had heart disorders such as an abnormal electrical signal called prolongation of the
QT interval, an irregular heart beat, or a family history of heart problems.

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If any of the following applies to you at any time, tell your doctor immediately. Your doctor may need to
treat you for these events. Your doctor may need to reduce the dose of ELOXATINE, or delay or stop
your treatment with ELOXATINE.



















If you have an unpleasant sensation in the throat, in particular when swallowing, and have a
sensation of shortness of breath, during the treatment, tell your doctor.
If you have nerve problems in your hands or feet, such as numbness or tingling, or decreased
sensations in your hands or feet, tell your doctor.
If you have headache, altered mental functioning, seizures and abnormal vision from blurriness to
vision loss, tell your doctor.
If you feel or are sick (nausea or vomiting), tell your doctor.
If you have severe diarrhoea, tell your doctor.
If you have sore lips or mouth ulcers (mucositis/ stomatitis), tell your doctor.
If you have diarrhoea, or a reduction in white blood cells or platelets, tell your doctor. Your doctor
may reduce the dose of ELOXATINE or postpone your treatment with ELOXATINE.
If you have unexplained respiratory symptoms such as cough, or any difficulties in breathing, tell
your doctor. Your doctor may stop your treatment with ELOXATINE.
If you develop an extreme tiredness, shortness of breath, or kidney disease where you pass little or
no urine (symptoms of acute renal failure), tell your doctor.
If you have fever (temperature greater than or equal to 38°C), or chills, which could be signs of
infection, tell your doctor immediately. You may be at risk of getting an infection of the blood.
If you have fever > 38°C, tell your doctor. Your doctor may determine you also have a reduction in
white blood cells.
If you experience unexpected bleeding or bruising (disseminated intravascular coagulation), tell
your doctor as these could be signs of blood clots throughout the small vessels of your body.
If you faint (lose consciousness) or have an irregular heartbeat while taking ELOXATINE, tell
your doctor immediately as this may be a sign of a serious heart condition.
If you experience muscle pain and swelling, in combination with weakness, fever, or red-brown
urine, tell your doctor. These could be signs of muscle damage (rhabdomyolysis) and could lead to
kidney problems or other complications.
If you have abdominal pain, nausea, bloody vomit or vomit that looks like “coffee-grounds”, or
dark-colored/ tarry stools, which may be signs of an ulcer of the bowel (gastrointestinal ulcer, with
potential bleeding or perforation), tell your doctor.
If you have abdominal (tummy) pain, bloody diarrhea, and nausea and/or vomiting, which may be
caused by a reduction of blood flow to your gut wall (intestinal ischaemia), tell your doctor.

Other medicines and ELOXATINE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
Pregnancy

It is not recommended that you become pregnant during treatment with oxaliplatin and must use an
effective method of contraception. 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.
Breast-feeding

You must not breast-feed while you are treated with oxaliplatin.
Fertility

Oxaliplatin may have an anti-fertility effect, which could be irreversible. Male patients should seek
advice on conservation of sperm prior to treatment.

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Male patients are advised not to father a child during treatment and until 6 months after treatment,
and to take appropriate contraceptive measures during this time.

Ask your doctor or pharmacist for advice before taking any 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 ELOXATINE, do not drive, operate heavy
machines, or engage in dangerous activities.

3.

How to use ELOXATINE

ELOXATINE is intended only for adults.
For single use only.
Dose
The dose of ELOXATINE 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
ELOXATINE.
Method and route of administration





ELOXATINE 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
ELOXATINE.
ELOXATINE is given by slow injection into one of your veins (an intravenous infusion) over a 2
to 6 hour period.
ELOXATINE 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 ELOXATINE 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 questions about your treatment, ask your doctor, nurse or pharmacist.

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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.
You will find described below the side effects that you could experience.
Tell your doctor immediately if you notice any of the following:

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),

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 particles in your vomit,

Stomatitis/mucositis (sore lips or mouth ulcers),

Unexplained respiratory symptoms such as dry cough, difficulties in breathing 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)

Extreme tiredness with decreased number of red blood cells, and shortness of breath (haemolytic
anaemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia) and
kidney disease where you pass little or no urine (symptoms of Haemolytic-uraemic syndrome).

Other known side effects of ELOXATINE are:
Very common (may affect more than 1 in 10 people)

ELOXATINE 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.

ELOXATINE 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.

ELOXATINE may cause diarrhea, 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.

ELOXATINE 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,

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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 (may affect up to 1 in 10 people)

Infection due to a reduction in white blood cells,















Serious infection of the blood in addition to a reduction in white blood cells (neutropenic
sepsis), which may be fatal,
Reduction in white blood cells accompanied by fever > 38.3°C or a prolonged fever > 38°C for
more than one hour (febrile neutropenia),
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,
High blood pressure,
Depression and insomnia,
Conjunctivitis and visual problems.
Decreased levels of calcium in the blood.

Uncommon (may affect up to 1 in 100 people)





Serious infection of the blood (sepsis), which may be fatal,
Blockage or swelling of the bowel,
Nervousness.

Rare (may affect up to 1 in 1,000 people)

Loss of hearing,

Scarring and thickening in the lungs with difficulties in breathing, sometimes fatal (interstitial lung
disease),

Reversible short-term loss of vision,

Unexpected bleeding or bruising due to widespread blood clots throughout the small blood vessels
of the body (disseminated intravascular coagulation), which may be fatal.
Very rare (may affect up to 1 in 10, 000)

Presence of blood or dark brown coffee-coloured particles in your vomit.

Kidney disease where you pass little or no urine (symptoms of acute renal failure)

Vascular disorders of liver.
Frequency not known (frequency cannot be estimated from the available data)






Serious infection of the blood and low blood pressure (septic shock), which may be fatal,
Convulsion (uncontrolled shaking of the body),
Spasm of the throat causing difficulty in breathing,
Extreme tiredness with decreased number of red blood cells, and shortness of breath (haemolytic
anaemia), alone or combined with low platelet count and kidney disease where you pass little or no
urine (symptoms of Haemolytic-uraemic syndrome), which may be fatal, have been reported,

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Abnormal heart rhythm (QT prolongation), that can be seen on electrocardiogram (ECG), which
may be fatal,
Muscle pain and swelling, in combination with weakness, fever, or red-brown urine (symptoms of
muscle damage called rhabdomyolysis), which may be fatal,
Abdominal pain, nausea, bloody vomit or vomit that looks like "coffee grounds”, or dark-colored/
tarry stools (symptoms of gastrointestinal ulcer, with potential bleeding or perforation), which may
be fatal,
Decreased blood flow to the intestine/bowel (intestinal ischaemia), which may be fatal.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

5.

How to store ELOXATINE

Keep this medicine out of the sight and reach of children.
Prior to mixing this medicine must be kept in the outer carton in order to be protected from light and
must not be frozen.
Do not use this medicine after the expiry date which is stated on the outer pack and vial label. The expiry
date refers to the last day of the month.
ELOXATINE 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, ELOXATINE will be disposed of carefully by the doctor or nurse.

6.

Contents of the pack and other information

What ELOXATINE contains
The active substance is oxaliplatin. Each vial contains 50 mg, 100 mg or 200 mg of oxaliplatin.
The other ingredient is water for injections.
What ELOXATINE looks like and contents of the pack
ELOXATIN vials contain a concentrate for solution for infusion. Each vial contains 50 mg, 100 mg or
200 mg oxaliplatin in water for injections. The vials are supplied in cartons of one vial.
Marketing Authorisation Holder and Manufacturer
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com

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Manufacturer
Aventis Pharma
Rainham Road South
Dagenham
Essex - RM10 7XS
U.K.
or
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
65926 Frankfurt am Main
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium: ELOXATIN 5 mg/ml solution à diluer pour perfusion
France: ELOXATINE 5 mg/ml solution à diluer pour perfusion
Germany: ELOXATIN 5 MG/ML konzentrat zur herstellung einer infusionslösung
Italy: ELOXATIN 5 mg/ml concentrato per soluzione per infusione
Luxembourg: ELOXATIN 5 mg/ml solution à diluer pour perfusion
Netherlands: Eloxatin 5 mg/ml concentraat, concentraat voor oplossing voor infusie
Spain: Eloxatin 5 mg/ml concentrado para solución para perfusión
Sweden: Eloxatin 5 mg/ml, koncentrat till infusionsvätska, lösning
The United Kingdom: Eloxatin 5 mg/ml concentrate for solution for infusion

This leaflet was last revised in June 2015

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The following information is intended for medical or healthcare professionals only
PREPARATION GUIDE FOR USE WITH ELOXATINE 5 mg/ml CONCENTRATE FOR
SOLUTION FOR INFUSION

It is important that you read the entire contents of this procedure prior to the preparation of the
ELOXATINE solution for infusion

1.

FORMULATION

ELOXATINE 5 mg/ml concentrate for solution for infusion is a clear, colourless liquid containing
5 mg/ml oxaliplatin in water for injections.

2.

PRESENTATION

ELOXATINE is supplied as single-dose vials. Each box contains one ELOXATIN vial (50 mg, 100 mg
or 200 mg).
The ELOXATINE 10 ml vial is a Type I clear glass of 50 mg oxaliplatin concentrate for solution for
infusion with bromobutyl elastomer stopper.
The ELOXATINE 20 ml vial is a Type I clear glass of 100 mg oxaliplatin concentrate for solution for
infusion with bromobutyl elastomer stopper.
The ELOXATINE 40 ml vial is a Type I clear glass of 200 mg oxaliplatin concentrate for solution for
infusion with bromobutyl elastomer stopper.
ELOXATINE as packaged for sale:
This medicine must be kept in the outer carton in order to be protected from light and must not be
frozen.
Solution for infusion:
After dilution of the concentrate for solution for infusion in glucose 5% (50 mg/ml) solution, chemical
and physical in-use stability has been demonstrated for 48 hours at 2°C to 8°C and for 24 hours at +25°C.
From a microbiological point of view, the 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 (not to exceed 48 hours).
Inspect visually prior to use. Only clear solutions without particles should be used.
The medicine is for single use only. Any unused solution should be discarded.

3.

RECOMMENDATIONS FOR THE SAFE 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
product, the protection of the environment and in particular the protection of the personnel handling the

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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 concentrate for solution for infusion or solution for infusion, should come into contact
with skin, wash immediately and thoroughly with water.
If oxaliplatin concentrate for solution for infusion or solution for infusion, should come into contact with
mucous membranes, wash immediately and thoroughly with water.

4.

PREPARATION FOR THE INTRAVENOUS ADMINISTRATION

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 dilute for
infusion with sodium chloride or chloride containing solutions.
DO NOT mix with any other medicines in the same infusion bag or administer simultaneously by
the same infusion line.
DO NOT mix with alkaline medicines or solutions, in particular 5-fluorouracil, folinic acid
preparations containing trometamol as an excipient and trometamol salts of others active
substances. Alkaline medicines or solutions will adversely affect the stability of oxaliplatin.

Instruction for use with folinic acid (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 intravenous infusion in glucose 5% (50 mg/ml) solution, over 2 to
6 hours, using a Y-line placed immediately before the site of infusion. These two medicines should not
be combined in the same infusion bag. Folinic acid 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 5-fluorouracil
Oxaliplatin should always be administered before fluoropyrimidines – i.e. 5-fluorouracil. After
oxaliplatin administration, flush the line and then administer 5-fluorouracil.
For additional information on medicines combined with oxaliplatin, see the corresponding
manufacturer’s summary of product characteristics.


USE ONLY the recommended solvents (see below).



Only clear solutions without particles should be used.

4.1

Preparation of the infusion solution

Withdraw the required amount of concentrate from the vial(s) and then dilute with 250 ml to 500 ml of
a glucose 5% (50 mg/ml) solution to give an oxaliplatin concentration between not less than 0.2 mg/ml

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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 2.0 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 48 hours at 2°C to 8°C and for 24 hour 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 (not to exceed 48 hours).
Inspect visually prior to use. Only clear solutions without particles should be used.
The medicine is for single use only. Any unused infusion solution should be discarded (see chapter
“disposal” below).
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.
4.2

Infusion of the solution

The administration of oxaliplatin does not require prehydration.
Oxaliplatin diluted in 250 to 500 ml of a glucose 5% (50 mg/ml) 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.
4.3

Disposal

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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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