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OXALIPLATIN HOSPIRA 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): OXALIPLATIN / OXALIPLATIN / OXALIPLATIN

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Date: 03 Feb 2017
Time:
Product Details:

19:31

0905-04
Version No: 01
PAR‑2017‑0000905
United Kingdom
Perigord No: 302253

SVI012-5

Smallest Body Text
8 pt

Packaging Site

Black

Svus

Dimensions:
380 x 240 mm

Pharmacode:
N/A

Barcode:
N/A

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 Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your doctor,
pharmacist or nurse.
• 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
The active ingredient of Oxaliplatin Hospira is oxaliplatin.
Oxaliplatin is an anticancer drug that contains platinum.
Oxaliplatin 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).
Oxaliplatin is used in combination with other anticancer
medicines called 5-fluorouracil and folinic acid.

2. What you need to know before you use Oxaliplatin
Hospira

• If you have or had heart disorders such as an abnormal
electrical signal called prolongation of the QT interval, an
irregular heartbeat, or a family history of heart problems.

Frequency of administration

Other medicines and Oxaliplatin Hospira

Duration of treatment

SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER
HANDLING

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

The duration of treatment will be determined by your doctor.
Your treatment will last a maximum of 6 months when used
after complete resection of your tumour

As with other potentially toxic compounds, caution should be
exercised when handling and preparing oxaliplatin solutions.

Pregnancy, breast-feeding and fertility
Pregnancy
• It is not recommended that you become pregnant during
treatment with oxaliplatin You 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.
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 oxaliplatin, do not drive, use heavy
machines, or engage in dangerous activities.

3. How to use Oxaliplatin Hospira

Do not use Oxaliplatin Hospira if:

For adults only.

• You are allergic to oxaliplatin or any of the other ingredients
of this medicine (listed in section 6)
• 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.

Oxaliplatin is intended only for adults.
The dose of oxaliplatin is based on your body surface area
This is calculated from your height and weight. The usual
dose for adults, including the elderly, is 85 mg/m2 of body
surface area. The dose you receive will also depend on results
of blood tests and whether you have previously experienced
side effects with oxaliplatin.

Warnings and precautions

Method and route of administration

Talk to your doctor, pharmacist or nurse before using
Oxaliplatin Hospria:
• If you have ever suffered an allergic reaction to other
platinum-containing medicines such as carboplatin or
cisplatin. Allergic reactions can occur during oxaliplatin
infusion.
• If you have moderate or mild kidney problems.
• If you have any liver problems

• Oxaliplatin will be prescribed for you by a specialist in
cancer treatment.
• You will be treated by a healthcare professional, who will
have made up the required dose of oxaliplatin.
• Oxaliplatin is given by slow injection into one of your veins
(an intravenous infusion) over a 2 to 6 hour period.
• Oxaliplatin will be given to you at the same time as folinic
acid and before the infusion of 5-fluorouracil.

Dosage

You should usually receive your infusion once every 2 weeks.

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, nurse, 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.
You will find described below the side effects that you could
experience.

Tell your doctor immediately if you notice any of the
following:
• Abnormal bruising, bleeding or signs of infection such as a
sore throat and high temperature
• Persistent or severe diarrhoea or vomiting
• Presence of blood or dark brown coffee-coloured particles
in your vomit
• 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.
• A group of symptoms such as headache, altered
mental functions, 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 are:
Very common (may affect more than 1 in 10 people):
Oxaliplatin can affect the nerves (peripheral neuropathy).
You may feel a tingling and/or numbness in the fingers, toes,
around the mouth or in the throat, which may sometimes
occur in association with cramps.

The following information is intended for medical or healthcare
professionals only:

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.
0905-4

Date: 03 Feb 2017
Time:
Product Details:

19:31

0905-04
Version No: 01
PAR‑2017‑0000905
United Kingdom
Perigord No: 302253

SVI012-5

Smallest Body Text
8 pt

Packaging Site

Black

Svus

Dimensions:
380 x 240 mm

Pharmacode:
N/A

Barcode:
N/A

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.

These effects are often triggered by exposure to cold e.g.
opening a refrigerator or holding a cold drink. You may also
have difficulty in performing delicate tasks, such as buttoning
clothes. Although in the majority of cases these symptoms
resolve themselves completely, there is a possibility of
persistent symptoms of peripheral sensory neuropathy after
the end of the treatment.
Some people have experienced a tingling, shock-like
sensation passing down the arms or trunk when the neck is
flexed.
• Oxaliplatin can sometimes cause an unpleasant sensation
in the throat, in particular when swallowing, and give
the sensation of shortness of breath. This sensation, if
it happens, usually occurs during or within hours of the
infusion and may be triggered by exposure to the cold.
Although unpleasant, it will not last long and goes away
without the need for any treatment. Your doctor may decide to
alter your treatment as a result.
• Oxaliplatin may cause diarrhoea, mild nausea (feeling sick)
and vomiting (being sick); however medication to prevent
the sickness is usually given to you by your doctor before
treatment and may be continued after treatment.
• Oxaliplatin causes temporary reduction in the number of
blood cells. The reduction of red cells may cause anaemia
(a reduction of red cells), abnormal bleeding or bruising
(due to a reduction in platelets).
The reduction in white blood cells may make you prone to
infections.

The compatibility of Oxaliplatin solution for infusion has been
tested with representative, PVC-based, administration sets.

Your doctor will take blood to check that you have sufficient
blood cells before you start treatment and before each
subsequent course.
• Sensation of discomfort close to or at the injection site
during the infusion,
• Fever, rigors (tremors), mild or severe tiredness, body pain,
• Weight changes, loss or lack of appetite, taste disorders,
constipation,
• Headache, back pain,
• Swelling of the nerves to your muscles, neck stiffness,
abnormal tongue sensation possibly altering speech,
stomatitis/mucositis (sore lips or mouth ulcers),
• Stomach pain,
• Abnormal bleeding including nose bleeds,
• Coughing, difficulty in breathing,
• Allergic reactions, skin rash which may be red and itchy,
mild hair loss (alopecia),
• Alteration in blood tests including those relating to
abnormalities in liver function.

Infusion

Common (may affect up to 1 in 10 people):

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 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.

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.

• Infection due to a reduction in white blood cells,
• Reduction in white blood cells accompanied by fever
> 38.3°C or a prolonged fever > 38°C for more than one
hour (febrile neutropenia),
• Serious infection of the blood in addition to a reduction in
white blood cells (neutropenic sepsis), which may be fatal,
• Indigestion and heartburn, 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 people)
• 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 available data)
• Allergic vasculitis (inflammation of blood vessels)
• Auto-immune reaction leading to reduction of all blood cell
lines (autoimmune pancytopenia).
• 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.
• 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 coloured/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
Website: 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 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.
Oxaliplatin 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 will be disposed of
carefully by the doctor or nurse.

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 12/2016.
Ref gxOA 1_0

0905-4

Expand Transcript

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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