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OXALIPLATIN 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): OXALIPLATIN

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TEVA UK Ref:

Version:

231-30-86247-D LEA OXALIPLATIN A/S SOLN TEVAH FrPCH

1

9 September 2015

93.130.870-E

The following information is intended for
medicinal and healthcare professionals only

4. PREPARATION FOR THE INTRAVENOUS
ADMINISTRATION

PREPARATION GUIDE FOR USE WITH
OXALIPLATIN 5 MG/ML CONCENTRATION
FOR SOLUTION FOR INFUSION

Special precautions for administration

(Please note this is a Prescriber Information
Leaflet NOT the SPC. For full details regarding
this product please refer to the SPC.)
It is important that you read the entire contents of
this procedure prior to the preparation of Oxaliplatin
5 mg/ml, concentrate for solution for infusion.
1. FORMULATION
Oxaliplatin 5mg/ml concentrate for solution
for infusion is a clear, colourless or almost
colourless liquid, containing 5mg/ml
oxaliplatin and 45mg/ml lactose monohydrate
in water for injections.
2. PRESENTATION
Oxaliplatin 5mg/ml is supplied as single-dose
vials. Oxaliplatin 5mg/ml is a clear, colourless
to almost colourless solution in a colourless
glass vial with bromobutyl rubber stopper,
aluminium seal and snap-cap.
4 ml of concentrate for solution for infusion
contain 20 mg of oxaliplatin.
10 ml of concentrate for solution for infusion
contain 50 mg of oxaliplatin.
20 ml of concentrate for solution for infusion
contain 100 mg of oxaliplatin.
40 ml of concentrate for solution for infusion
contains 200 mg of oxaliplatin
Each box contains one Oxaliplatin 5mg/ml
vial. Not all pack sizes may be marketed.
Oxaliplatin 5mg/ml as packaged for sale:
Store below 25°C. Keep the vial in the outer
carton in order to protect from light.
Solution for infusion:
After dilution in 5% glucose, chemical and
physical in-use stability has been
demonstrated for 24 hours at 2-8°C and for 6
hours at 25°C.
From a microbiological point of view, the
infusion preparation should be used
immediately.
If not used immediately, the 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 2-8°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 solution should be discarded.
3. RECOMMENDATIONS FOR SAFE HANDLING
As with other potentially toxic compounds,
caution should be exercised when handling
and preparing oxaliplatin solution.
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
medicines used, in conditions that guarantee
the protection of the environment and in
particular the protection of the personnel
handling the medicines. 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 section “Disposal”.
If oxaliplatin concentrate for solution for
infusion or infusion solution should come into
contact with skin, wash immediately and
thoroughly with water.
If oxaliplatin concentrate for solution for
infusion or infusion solution, should come into
contact with mucous membranes, wash
immediately and thoroughly with water.

• DO NOT use injection material containing
aluminium.
• DO NOT administer undiluted.
• ONLY dilute with 5% glucose solution. DO
NOT dilute for infusion with saline or
chloride containing solutions.
• DO NOT mix with any other medicinal
product 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 (5-FU), folinic acid (FA)
preparations containing trometamol as an
excipient and trometamol salts of other
active substances. The alkaline medicinal
products or solutions will adversely affect
the stability of oxaliplatin.
Instruction for use with folinic acid (FA)
(calcium folinate or sodium folinate)
Oxaliplatin 85 mg/m2 IV in 250 to 500 ml of
5% glucose solution can be co-administered
with folinic acid (FA) IV infusion in 5% glucose
solution during 2 to 6 hours, using a Y-line,
which is placed immediately before the site of
injection. The drugs should not be combined in
the same infusion bag. Folinic acid (FA) must
be diluted using isotonic infusion solutions
such as 5% glucose solution but NOT sodium
chloride solutions, chloride containing
solutions or alkaline solutions.
Instruction for use with 5-fluorouracil (5-FU)
Oxaliplatin should always be administered
before fluoropyrimidines (e.g. 5-fluorouracil
(5-FU)).
Always flush the line following oxaliplatin
administration and only after that can
5-fluorouracil (5-FU) be administered.
4.1 Preparation of the infusion solution
Withdraw the required amount of solution
from the vial(s) and then dilute with 250 ml to
500 ml of a 5% glucose solution to give an
oxaliplatin concentration between 0.2 mg/ml
and 0.7mg/ml. The concentration range over
which the physico-chemical stability of
oxaliplatin has been demonstrated is 0.2mg/ml
to 2.0 mg/ml.
Administer by intravenous infusion.
After dilution in 5% glucose, chemical and
physical in-use stability has been
demonstrated for 24 hours at 2-8°C and for 6
hours at 25°C.
From a microbiological point of view, this
infusion prepared 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 2-8°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 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.
4.2 Infusion of the solution
The administration of oxaliplatin does not
require prehydration.
Oxaliplatin diluted in 250 to 500 ml of 5%
glucose solution to give a concentration not
less than 0.2 mg/ml must be infused either by
peripheral vein or central venous line over 2 to
6 hours. When oxaliplatin is administered with
5-fluorouracil (5-FU), the oxaliplatin infusion
should precede that of 5-fluorouracil (5-FU).
4.3 Disposal
Remnants of the medicinal products 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 in
accordance with local requirements related to
the disposal of hazardous waste.

93.130.870-E
86247-D

Package leaflet: Information for the user

Oxaliplatin 5 mg/ml, concentrate for
solution for infusion
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it
again.
• If you have 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 5 mg/ml is and what it is
used for
2. What you need to know before Oxaliplatin
5 mg/ml is administered to you
3. How Oxaliplatin 5 mg/ml is administered
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 a cytostatic (anticancer
medicine) which is used to treat metastatic
(advanced) cancer of the large bowel (colon and
rectum) or as an additional treatment following
surgery to remove a tumour (growth) in the
colon. Oxaliplatin is used in combination with
other anticancer medicines, called 5-fluorouracil
(5-FU) and leucovorin (folinic acid).

2

What you need to know before
Oxaliplatin 5 mg/ml is administered to
you

Do not use Oxaliplatin 5 mg/ml:
(see also section “Warnings and precautions ”)
• if you are allergic to oxaliplatin, or any of the
other ingredients of this medicine (listed in
section 6)
• if you are breast-feeding (see also section
‘Pregnancy, breast-feeding and fertility’)
• 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 in
performing delicate tasks, such as buttoning
clothes
• if you have severe kidney problems.
Warnings and precautions
Talk to your doctor,pharmacist or nurse before
you receive Oxaliplatin 5 mg/ml if you:
• experience abnormal feeling of pain or tingling
in the fingers, feet, around the mouth or throat,
during or several hours after treatment. This
can also happen after exposure to cold (for
instance after drinking cold drinks).
• have moderate kidney problems.
• have any liver problems.
• have ever suffered an allergic reaction to
platinum-containing medicines, such as
carboplatin or cisplatin.
• experience inflammation of the mucosa (of the
mouth).
• experience unexplainable breathing problems.
Oxaliplatin 5 mg/ml administration will be
stopped until a lung disorder can be excluded.
You will regularly have neurological examinations
(see also section 4 “Possible side effects”).
This therapy can cause a decrease of blood cells.
Therefore, your doctor will take blood to check
that you have sufficient blood cells before you
start treatment and before each subsequent
course. This is necessary to continue therapy (see
also section 2 “Do not use Oxaliplatin 5 mg/ml”).
Your doctor may prescribe antisickness medicines
to prevent nausea (feeling sick) and vomiting
(being sick).
Other medicines and Oxaliplatin 5 mg/ml
Tell your doctor or pharmacist if you are
taking/using, have recently taken/used or might
take/use any other medicines, including medicines
obtained without prescription.
Pregnancy, breast-feeding and fertility
This medicine should not be used during
pregnancy, because animal studies have shown a
possible risk of abnormalities in the developing
foetus.
Women should use contraceptive measures
during and up to 4 months after therapy. 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.
This medicine must not be used during
breast-feeding.
Oxaliplatin may have an anti-fertility effect,
which could be permanent. Male patients are
therefore advised not to father a child and to use
contraceptive measures during and up to 6
months after treatment and to seek advice on
preservation of sperm prior to treatment.
Driving and using machines:
No studies on the effect on the ability to drive and

using machines have been performed. Oxaliplatin
5 mg/ml however, can cause side effects such as
dizziness, nausea (feeling sick) and vomiting
(being sick) and other neurological symptoms that
effect gait and balance. If this happens you should
not drive or operate machinery. If you have vision
problems while receiving Oxaliplatin 5 mg/ml, do
not drive, operate heavy machines, or engage in
dangerous activities.

3

How Oxaliplatin 5 mg/ml is administered

Oxaliplatin 5 mg/ml is only used in adults.
Oxaliplatin 5 mg/ml will be prescribed for you by a
specialist in cancer treatment.
Carefully follow the advice of your doctor when
Oxaliplatin 5 mg/ml is administered to you.
The administered amount (the dose) is dependent
on the body surface and will be established by
your doctor.
Technically, this is measured in square metres (m2),
but is actually calculated from your height and
weight.
General guidance
The usual dose for adults, including elderly, is
85 mg/m2 body surface area once every 2 weeks
before the infusion of other anticancer medicines.
Oxaliplatin 5 mg/ml is given by intravenous
infusion (injection into a vein) over a 2 to 6 hour
period.
The duration of the treatment will be determined
by your doctor.
If oxaliplatin accidentally leaks out of the vein into
the surrounding tissues while administered, the
administration will be stopped immediately and
appropriate measures will be taken.
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.
There is no specific antidote for oxaliplatin
overdose. 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 the treatment, ask
your doctor, pharmacist or nurse.
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 further questions on the use of
this medicine, ask your doctor, pharmacist or
nurse.

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 (being
sick)
• 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).
You should stop taking Oxaliplatin 5 mg/ ml and
see your doctor immediately if you experience
symptoms of angioedema such as:
• Swollen face, tongue or pharynx
• Difficulty to swallow
• Hives and difficulties to breathe.
The following side effects can occur:
Very common (may affect more than 1 in 10
people)
• Bacterial or viral infection.
• Reduction in the number of red blood cells
(anaemia: this may cause tiredness), reduction in
the number of platelets associated with bruises
and abnormal bleeding (thrombocytopenia),
reduction in the number of white blood cells
associated with increased infection risk
(neutropenia, leukopenia or lymphopenia).
• Hypersensitivity to certain chemicals associated
with symptoms such as watery eyes, runny
nose, rash or tightness of the chest
(allergy/allergic reactions).
• Lack of appetite (anorexia), changes in blood
glucose level (this can be recognized by great
thirst, dry mouth or a need to urinate more
often), low potassium in blood (this can be
recognized by muscle cramps, muscle
weakness or fatigue), abnormal sodium blood
level (this can be recognized by tiredness and
confusion).
• A disorder of 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

TEVA UK Ref:

231-30-86247-D LEA OXALIPLATIN A/S SOLN TEVAH FrPCH

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 (Lhermitte’s sign).
Oxaliplatin can sometimes cause an unpleasant
sensation in the throat, in particular when
swallowing, and give the sensation of
shortness of breath (pharyngolaryngeal
dysaestesia). This sensation, if it happens,
usually occurs during or within hours of the
infusion and may be triggered by exposure to
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.
Abnormal sensation, change in taste, headache.
Shortness of breath (dyspnoea), coughing, nose
bleeds.
Diarrhoea, nausea (feeling sick), vomiting
(being sick) (medication to prevent the sickness
is usually given to you by your doctor before
treatment and may be continued after
treatment), abdominal pain, constipation, sore
mouth/lips or mouth ulcers (stomatitis/mucositis).
Skin disorder, hair loss.
Back pain.
Increase in liver enzymes, increase in alkaline
phosphatase in the blood, increase in bilirubin
in the blood, increase in lactate dehydrogenase
in the blood, weight gain (when oxaliplatin is
given after primary therapy (adjuvant
therapy)).
Fever, rigors (tremors), fatigue, body weakness
(asthenia), pain, , reactions close to or at the
injection site (e.g. local pain, redness, swelling
during the infusion, blood clot formation,
sometimes death of skin cells (skin necrosis).

• Speech disorder, neurologic disorder with
symptoms such as headache, altered mental
functioning, seizures and abnormal vision from
blurriness to vision loss (reversible posterior
leukoencephalopathy syndrome)
• Transient decrease of visual acuity, abnormal
visual field, decrease in eyesight caused by
inflammation of the optical nerve (optical
neuritis), reversible transient loss of vision
• Deafness
• Scarring of the lungs which causes shortness of
breath (pulmonary fibrosis) difficulties in
breathing and/or scarring of the lungs,
sometimes fatal (interstitial lung disease).
• Inflammation of the bowel (colitis), sometimes
with diarrhoea, inflammation of the pancreas
(pancreatitis).

Common (may affect up to 1 in 10 people)
• Inflammation of the mucous membranes of
the nose with symptoms of a stuffed nose,
sneezing and nasal discharge (rhinitis),
infection of the respiratory tract, infection due
to a reduction in white blood cells (neutropenic
sepsis).
• A serious condition (with fever) caused by a
decrease of white blood cells associated with
an increased susceptibility for infections (febrile
neutropenia).
• Rash, conjunctivitis, inflammation of the
mucous membranes of the nose with
symptoms of a stuffed nose, sneezing and
nasal discharge (rhinitis), shock (strong blood
pressure drop, paleness, restlessness, rapid
heart rate, moist skin, decreased
consciousness) caused by a sudden vascular
dilation as a result of a severe hypersensitivity
reaction to certain substances (anaphylactic
shock), tightness of the chest caused by
cramping of the respiratory tract muscles
(bronchospasm), chest pain, sudden swelling
of the skin and mucosa (eg throat or tongue)
(angio-oedema) and low blood pressure.
• A deficiency of body fluid (dehydration).
• Depression, sleeplessness.
• Dizziness, inflammation of the nerves
associated with muscle weakness, difficulty
with specific movements and sometimes
muscle cramps (motor neuritis), neck stiffness
(meningism).
• Conjunctivitis, visual problems.
• Bleeding (haemorrhage), flushing,
inflammation of veins associated with blood
clot formation (deep vein thrombosis), high
blood pressure (hypertension).
• Hiccups, chest pain, blood clots in the lungs
which cause chest pain end breathlessness
(pulmonary embolism).
• Disturbed digestion with symptoms such as a
feeling of fullness in your stomach, stomach
pain, burping, nausea (feeling sick), vomiting
(being sick) and heartburn (dyspepsia),
regurgitation of acid and/or heartburn
(gastroesophageal reflux), bleeding in the
gastrointestinal tract or bleeding of the rectum
(end of the bowel) (gastrointestinal
haemorrhage, rectal haemorrhage).
• Flaking skin (Hand & foot syndrome), redness
of the skin (erythematous rash), rash, increased
perspiration (hyperhidrosis), nail disorder.
• Joint pain (arthralgia), bone pain.
• Blood in urine (haematuria), difficult or pain on
passing urine, abnormal frequency on passing
urine.
• Increased blood creatinine level, weight loss
(when oxaliplatin is given as therapy when the
cancer has spread elsewhere in the body
(metastasis)).

Keep this medicine out of the sight and reach of
children.
Store below 25°C. Keep the vial in the outer
carton in order to protect from light.
Do not use this medicine after the expiry date
which is stated on the carton and the vial after
EXP. The expiry date refers to the last day of that
month.
When the infusion has finished, any remaining
Oxaliplatin 5 mg/ml will be disposed of carefully
by the doctor or nurse.
Medicines should not be disposed in wastewater or
household waste. Ask your pharmacist how to
dispose of medicines when no longer required.
These measures will help protect the environment.














Very rare (may affect up to 1 in 10,000 people)
• Liver disease that your doctor will monitor for
you.
• Changes in kidney function.
Unknown (frequency cannot be estimated from
the available data)
• An abnormal, involuntary contraction of the
muscles (convulsion)
• Occasionally other symptoms have been
observed, like jaw and muscle spasms,
coordination and balance problems, throat or
chest tightness.
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

6

How to store Oxaliplatin 5 mg/ml

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 ingredients are lactose monohydrate
and water for injections.
What Oxaliplatin 5 mg/ml looks like and contents
of the pack
Oxaliplatin 5 mg/ml is a clear, colourless to almost
colourless solution in a colourless glass vial with
bromobutyl rubber stopper, aluminium seal and
polypropylene snap-cap.
4 ml of concentrate for solution for infusion
contains
20 mg of 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 vials are supplied in cartons each containing
one vial. Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder is TEVA UK
Limited, Eastbourne, BN22 9AG and the company
responsible for manufacture is:
Pharmachemie B.V., Swensweg 5, PO Box 552,
2003 RN Haarlem, The Netherlands.
Product Licence number:
PL 00289/0310
This leaflet was last revised in August 2015.

Uncommon (may affect up to 1 in 100 people)
• Blood tests which show an increase in acidity
(metabolic acidosis).
• Nervousness
• Hearing problems
• Blockage (ileus) or swelling of the bowel
(intestinal obstruction)
Rare (may affect up to 1 in 1,000 people)
• Blood abnormality (reduction in the number of
platelets) caused by an allergic reaction
associated with bruises and abnormal bleeding
(immunoallergic thrombocytopenia), reduction
in the number of red blood cells (anaemia)
caused by degradation of blood (haemolytic
anaemia)

93.130.870-E
86247-D

Version:

1

9 September 2015

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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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