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OXALIPLATIN 5MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): OXALIPLATIN

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Sandoz Ltd
Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

PL 04416/1450

PIL
27/04/2016

Package leaflet: Information for the patient
Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion
Oxaliplatin

Read all of this leaflet carefully before you are given 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 nurse.
 If you get any side effects, talk to your doctor or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet:
1.
What Oxaliplatin 5 mg/ml is and what it is used for
2.
What you need to know before you are given Oxaliplatin 5 mg/ml
3.
How Oxaliplatin 5 mg/ml is used
4.
Possible side effects
5
How to store Oxaliplatin 5 mg/ml
6.
Contents of the pack and other information

1.

What Oxaliplatin 5 mg/ml is and what it is used for

Oxaliplatin 5 mg/ml is an anticancer medicine and contains the active substance oxaliplatin.
Oxaliplatin 5 mg/ml is used for treating bowel cancer after it has been removed by surgery or
when it has already spread.
Oxaliplatin 5 mg/ml is used in combination with other anticancer medicines called 5fluorouracil (5-FU) and folinic acid (FA).

2.What you need to know before you are given Oxaliplatin 5 mg/ml
Talk to your doctor or nurse before you are given Oxaliplatin 5 mg/ml:

1.
2.
3.
4.

if you are allergic to oxaliplatin
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
5. if you have severe kidney problems
Warnings and precautions:

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Sandoz Ltd
Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

PL 04416/1450

PIL
27/04/2016

Talk to your doctor before you are given Oxaliplatin 5 mg/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 mild or moderate kidney problems
 if you have any liver problems or abnormal liver function test results during your treatment
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 Oxaliplatin 5 mg/ml
, or delay or stop your treatment with Oxaliplatin 5 mg/ml











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 Oxaliplatin 5 mg/ml or postpone your treatment with

Oxaliplatin 5 mg/ml
If you have unexplained respiratory symptoms such as cough, or any difficulties in breathing,
tell your doctor. Your doctor may stop your treatment with Oxaliplatin 5 mg/ml
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.

Other medicines and Oxaliplatin 5 mg/ml
Tell your doctor if you are using, have recently used or might use 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

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Sandoz Ltd
Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion




PL 04416/1450

PIL
27/04/2016

Oxaliplatin may have an anti-fertility effect, which could be irreversible. Male patients should
seek advice on conservation of sperm prior to treatment.
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 increase 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, do not drive,
operate heavy machines, or engage in dangerous activities.
3.

How Oxaliplatin 5 mg/ml is used

This medicine will be administered by medical personnel; do not take it yourself.
Oxaliplatin 5 mg/ml is intended in adults only.
Dosage
The dose of Oxaliplatin 5 mg/ml 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 5 mg/ml.
Method and route of administration



Oxaliplatin 5 mg/ml 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 5 mg/ml.
Oxaliplatin 5 mg/ml is given by slow injection into one of your veins (an intravenous
infusion) over a 2 to 6 hour period.

If feelings of discomfort or pain arise at the injection site inform the healthcare
professionals immediately.
 Oxaliplatin 5 mg/ml 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.

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Sandoz Ltd
Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

PL 04416/1450

PIL
27/04/2016

Your treatment will last a maximum of 6 months when used after complete resection of your
tumour.
If you received more Oxaliplatin 5 mg/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 administration of Oxaliplatin 5 mg/ml is forgotten
Your doctor will decide on what time you will receive this medicine. If you think you missed
a dose, please contact your doctor as soon as possible.
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:


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.
 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 Oxaliplatin 5 mg/ml:
Very common (may affect more than 1 in 10 people):

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Sandoz Ltd
Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

PL 04416/1450

PIL
27/04/2016

 Oxaliplatin 5 mg/ml 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 that 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 completely there is a possibility of persistent
symptoms after the end of the treatment Some people have experienced a tingling, shocklike sensation passing down the arms or trunk when the neck is flexed.



Oxaliplatin 5 mg/ml 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
usually subsides without the need for any treatment. Your doctor may decide to alter your



Oxaliplatin 5 mg/ml may cause diarrhea, mild nausea (feeling sick) and vomiting (being

treatment as a result.














sick). However, medication to prevent sickness is usually given to you by your doctor before
treatment and may be continued after treatment.
Oxaliplatin 5 mg/ml 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), tiredness, loss of strength/weakness, 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 nosebleeds
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,
Indigestion and heartburn, flushing, hiccups and dizziness
Increased sweating and nail disorders, flaking skin
Chest pain
Runny nose and lung disorders
Joint pain and bone pain
Pain on passing urine and changes of kidney function, change in frequency when passing
urine, dehydration
Blood in the urine and stools, swelling of the veins, clots in the lung
High blood pressure
Depression, difficulty sleeping
Conjunctivitis, visual problems

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Sandoz Ltd
Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

PL 04416/1450

PIL
27/04/2016

 Dizziness
 Inflammation of nerves leading to muscle spasms, cramps, loss of certain reflexes
Neck Stiffness, intolerance/dislike of bright light and headache
 Loss of weight
Uncommon (may affect up to 1 in 100 people):


Serious infection of the blood(sepsis), which may be fatal






Nervousness
Hearing problems (ototoxicity)
Impaired or blocked bowel passage
Disturbance in the body's acid-base balance

Rare (may affect up to 1 in 1,000 people):
 Reduction in blood platelets due to an allergic reaction associated with bruises and
abnormal bleeding (immunoallergic thrombocytopenia)
 Reduction in red blood cells caused by cell destruction
 Slurred speech
 Temporary fall in visual acuity; visual field disturbances, reversible short-term vision
loss, inflammation of the optic nerve
 Deafness (loss of hearing)


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

 Bowel inflammation causing abdominal pain or diarrhoea, including severe bacterial
infection (Clostridium difficile)
 Pancreatitis



Very rare (may affect up to 1 in 10,000 people): Vascular disorders of liver.
Changes in kidney function, kidney disease where you pass little or no urine (symptoms of



acute renal failure)
Presence of blood or dark brown coffee-coloured particles in your vomit.

Frequency not known (cannot be estimated from the available data):
 Convulsion (uncontrolled shaking of the body)







Serious infection of the blood and low blood pressure (septic shock), which may be fatal,
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.
Allergic vasculitis (inflammation of blood vessels)
Auto-immune reaction leading to reduction of all blood cell lines (autoimmune
pancytopenia).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme

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Sandoz Ltd
Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

PL 04416/1450

PIL
27/04/2016

(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 Oxaliplatin 5 mg/ml

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton
after EXP. The expiry date refers to the last day of that month.
Do not freeze.
Oxaliplatin 5 mg/ml 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, Oxaliplatin 5 mg/ml will be disposed of carefully by the doctor or
nurse.

Solution for infusion:
After dilution in glucose 50 mg/ml (5 %) solution for infusion, chemical and physical in-use
stability has been demonstrated for 48 hours at 2 - 8°C and for 6 hours at 15 - 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.
Inspect visually prior to use. Do not use this medicine if you notice particles in the diluted
solution.

6. Contents of the pack and other information
What Oxaliplatin 5 mg/ml contains

The active substance is oxaliplatin.
1 ml of concentrate for solution for infusion contains 5 mg of oxaliplatin.

The other ingredient is water for injections.
What Oxaliplatin 5 mg/ml looks like and contents of the pack
Oxaliplatin 5 mg/ml is a clear colourless liquid.
The medicinal product comes in plastic containers called vials.
50 mg vial: each vial contains 10 ml concentrate for solution for infusion.
100 mg vial: each vial contains 20 ml concentrate for solution for infusion.
150 mg vial: each vial contains 30 ml concentrate for solution for infusion.
200 mg vial: each vial contains 40 ml concentrate for solution for infusion

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Sandoz Ltd
Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

PL 04416/1450

PIL
27/04/2016

Pack sizes: 1, 5 and 10 vial(s).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
United Kingdom

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany
Or
Lek Pharmaceuticals d.d.
Verovskova 57, 1526 Ljubljana
Slovenia
This leaflet was last revised in 04/2016.

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Sandoz Ltd
Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

PL 04416/1450

PIL
27/04/2016

----------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
__________________________________________
Instructions for use
CYTOSTATIC
HANDLING OXALIPLATIN 5 MG/ML
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 nursing or medical 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 medicinal products used. The conditions must guarantee the
integrity of the product, the protection of the environment and particularly 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 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.

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Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion





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Only glucose 50 mg/ml (5 %) solution for infusion 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
others medicinal products active substances. Alkaline medicinal products or solutions
will adversely affect the stability of oxaliplatin.

Instruction for use with folinic acid (as calcium folinate or disodium folinate)
Oxaliplatin 85mg/m² intravenous infusion in 250 to 500 ml of glucose 50 mg/ml (5 %)
solution for infusion is given at the same time as folinic acid (FA) intravenous infusion in
glucose 50 mg/ml (5 %) solution for infusion, 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 must not contain trometamol as an excipient
and must only be diluted using isotonic glucose 50 mg/ml (5 %) solution for infusion, never
in alkaline solutions or sodium chloride or chloride containing solutions.
Instruction for use with 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 summary of product characteristics.
USE ONLY the recommended solvents (see below).
Concentrate for solution for infusion
Inspect visually prior to use. Only clear solutions without particles should be used.
Dilution before infusion
Withdraw the required amount of concentrate from the vial(s) and then dilute with 250 ml to
500 ml of a glucose 50 mg/ml (5 %) solution for infusion 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 2 mg/ml.
Administer by intravenous infusion.
After dilution in glucose 50 mg/ml (5 %) solution for infusion, chemical and physical in-use
stability has been demonstrated for 48 hours at 2 - 8°C and for 6 hours at 15 - 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.

PIL.1450.003.0d

V009: PSUSA outcome to update SPC & PIL

IS

Sandoz Ltd
Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

PL 04416/1450

PIL
27/04/2016

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 50 mg/ml (5 %) solution for infusion 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.
Incompatibilities
The medicinal product should not be mixed with other medicinal products in the same
infusion bag or infusion line.
- DO NOT mix the concentrate for solution for infusion and the diluted medicinal product
with any other medication in the same infusion bag or administer simultaneously by the
same infusion line in the absence of compatibility studies. Under instructions for use
described in section “Instruction for use with folinic acid (as calcium folinate or disodium
folinate)” oxaliplatin can be co-administered with folinic acid via a Y-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 other
medicines. Alkaline medicines or solutions will adversely affect the stability of oxaliplatin
- DO NOT dilute oxaliplatin with saline or other solutions containing chloride ions
(including calcium, potassium or sodium chlorides). Only glucose 50 mg/ml (5 %) solution
for infusion is to be used as a diluent.
- DO NOT use injection equipment containing aluminium.
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 and with due regard to current laws 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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