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PACLITAXEL 6MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): PACLITAXEL

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TEVA UK Ref:

231-30-10074-A LEA PACLITAXEL A/S SOL TEVAH
Version:

9

19 February 2015

Pharma code 1696

93.130.701-H
treatment with Paclitaxel®. Premedication is necessary to
decrease the risk of severe hypersensitive reactions (see
section 4, Possible side effects, uncommon).

The following information is intended for medical or
healthcare professionals only:
Below is a summary of information to assist in the administration of
Paclitaxel. You should be experienced in the handling and use of cytotoxic
agents and be familiar with the SPC of Paclitaxel. Reference should be made
to guidelines on the safe handling of antineoplastic agents.
Handling: as with all antineoplastic agents, caution should be exercised
when handling Paclitaxel. Pregnant women should not handle cytotoxic
agents. Dilution should be carried out under aseptic conditions by trained
personnel in a designated area. Adequate protective gloves should be worn.
Precautions should be taken to avoid contact with the skin or mucous
membranes. In the event of contact with the skin, the area should be
washed with soap and water. Following topical exposure, tingling, burns and
redness have been observed. In the event of contact with the mucous
membranes, these should be flushed thoroughly with water. Upon
inhalation, dyspnoea, chest pain, burning throat and nausea have been
reported.
If unopened vials are refrigerated or frozen, a precipitation may form, that
redissolves with little or no agitation upon reaching room temperature.
Product quality is not affected. If the solution remains cloudy or if an
insoluble precipitate is noted, the vial should be discarded.
Following multiple needle entries and product withdrawals, the vials
maintain microbial, chemical and physical stability for up to 28 days at 25°C.
Other in-use storage times and conditions are the responsibility of the user.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Paclitaxel®, 6 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 any further questions, ask your doctor
• This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor.
What is in this leaflet:

1. What Paclitaxel® is and what it is used for
2. What you need to know before you use Paclitaxel®
3. How to use Paclitaxel®
4. Possible side effects.
5. How to store Paclitaxel®
6. Contents of the pack and other information
Paclitaxel® concentrate for solution for infusion is given only
by healthcare personnel, who can reply to any questions
which you may have after reading this package leaflet.

1

What Paclitaxel® is and what it is used for

The ‘Chemo-Dispensing Pin’ device or similar devices with spikes should not
be used since they can cause the vial stopper to collapse, resulting in loss of
sterile integrity.

Paclitaxel® is an antineoplastic or anticancer agent. It may
stop cancer cells from dividing and growing.

Preparation for intravenous administration: prior to infusion, Paclitaxel
must be diluted using aseptic techniques in 9 mg/ml (0.9%) sodium
chloride solution for infusion, or 50 mg/ml (5%) glucose solution for
infusion, or a mixture of 9 mg/ml (0.9%) sodium chloride solution for
infusion and 50 mg/ml (5%) glucose solution for infusion, or Ringer’s
solution for infusion containing 50 mg/ml (5%) glucose, to a final
concentration of 0.3 to 1.2 mg/ml.

Ovarian cancer (advanced or spreading ovarian cancer,
residual tumour >1 cm after laparotomy)
Either as initial therapy in combination with
platinum-containing medicine, cisplatin, or as a second-line
treatment when other platinum-containing treatments have
not worked.

Chemical and physical in-use stability of the solution prepared for infusion
has been demonstrated for 27 hours at 25°C when diluted in a mixture of
9 mg/ml (0.9%) sodium chloride solution for infusion and 50 mg/ml (5%)
glucose solution for infusion, or Ringer’s solution for infusion containing
50 mg/ml (5%) glucose.
Chemical and physical in-use stability of the solution prepared for infusion
has been demonstrated at 5°C and at 25°C for 14 days when diluted in
50 mg/ml (5%) glucose solution for infusion or in 9 mg/ml (0.9%) sodium
chloride solution for infusion.
Microbiological in-use stability of the solution prepared for infusion has been
demonstrated for 27 hours at 25°C. Other in-use storage times and
conditions are the responsibility of the user.
Upon preparation, solutions may show some haziness, which is attributed
to the formulation vehicle, and is not removed by filtration. Paclitaxel
should be administered through an in-line filter with a microporous
membrane ≤ 0.22 µm. No significant losses in potency have been noted
following simulated delivery of the solution through IV tubing containing an
in-line filter.
There have been rare reports of precipitation during paclitaxel infusions,
usually towards the end of a 24-hour infusion period. Although the cause of
this precipitation has not been elucidated, it is probably linked to the
supersaturation of the diluted solution. To reduce the precipitation risk,
Paclitaxel should be used as soon as possible after dilution, and excessive
agitation, vibration or shaking should be avoided. The infusion sets should
be flushed thoroughly before use. During infusion, the appearance of the
solution should be regularly inspected and the infusion should be stopped if
precipitation is present.
To minimise patient exposure to DEHP [di-(2-ethylhexyl)phthalate] which
may be leached from plasticised PVC infusion materials, diluted paclitaxel
solutions should be stored in non-PVC bottles (glass, polypropylene) or
plastic bags (polypropylene, polyolefin) and administered through
polyethylene-lined administration sets. Use of filter devices which
incorporate short inlet and/or outlet plasticised PVC tubing has not resulted
in significant leaching of DEHP.
Disposal: all items used for the preparation, administration or otherwise
coming into contact with Paclitaxel should undergo disposal according to
local guidelines for the handling of cytotoxic compounds.
Administration and dosage
All patients should be premedicated with corticosteroids, antihistamines and
H2 antagonists prior to administration. The diluted Paclitaxel infusion should
be administrated using non-PVC containing equipment through an in-line
filter with a microporous membrane ≤ 0.22 µm.
The recommended doses for the intravenous infusion of Paclitaxel are as
follows:
First-line ovarian cancer:
135 mg/m2 over 24 hours, followed
by cisplatin 75 mg/m2; or
175 mg/m2 over 3 hours, followed
by cisplatin 75 mg/m2;
Second-line ovarian or breast cancer: 175 mg/m2 over 3 hours;
Adjuvant breast cancer:
175 mg/m2 over 3 hours; following
anthracycline and
cyclophosphamide (AC) therapy;
First-line breast cancer:
220 mg/m2 over 24 hours, 24 hours
after doxorubicin (50 mg/m2),
175 mg/m2 over 3 hours, after
trastuzumab (see trastuzumab SPC);
Non-small cell lung cancer:
175 mg/m2 over 3 hours, followed
by cisplatin 80 mg/m2:
AIDs related Kaposi’s sarcoma:
100 mg/m2 over 3 hours.

Paclitaxel® is used to treat different types of cancer, i.e.:

Breast cancer (treatment of early breast cancer after surgical
removal of the primary tumour, advanced or spreading breast
cancer)
As adjuvant therapy following treatment with anthracycline
and cyclophosphamide (AC).
As initial therapy either in combination with a medicine
belonging to the group known as anthracyclines in patients
for whom anthracyclines therapy is suitable, or with a
medicine called trastuzumab.
On its own, in patients who have not responded to standard
treatments using anthracyclines, or for whom such treatment
should not be used.
A certain type of lung cancer (Non-small cell lung cancer)
In combination with cisplatin, in patients who are not
candidates for potentially curative surgery and/or radiotherapy.
It is also used to treat a special AIDS-related form of cancer
that develops in the connective tissue (Kaposi’s sarcoma)
Where other treatments, i.e. liposomal anthracyclines, have
not worked.

2

What you need to know before you use
Paclitaxel®

Do not use Paclitaxel®
• if you are allergic (hypersensitive) to paclitaxel or any of the
other ingredients of this medicine (listed in section 6),
especially macrogolglycerol ricinoleate in Paclitaxel®
• if you are breast-feeding
• if your liver function is severely reduced
• if your white blood cell count is too low (neutrophils). This
will be measured by a healthcare personnel.
• if you have concurrent, serious, uncontrolled infections.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Paclitaxel®
• if you notice marked allergic (hypersensitivity) reactions
(e.g. shortness of breath, low blood pressure, facial swelling
or rash)
• because this medicinal product contains alcohol and
macrogolglycerol ricinoleate (see section “Paclitaxel®
contains alcohol and macrogolglycerol ricinoleate”)
• if you have a serious disorder in the composition of your
blood; your physician will check your blood every time
before treatment with Paclitaxel®
• if you experience heart problems during Paclitaxel®
treatment; your physician should check the functioning of
your heart before the next treatment with Paclitaxel®
• if you experience continuing numbness, tingling or pain in
hand and feet (peripheral neuropathy); it could be that the
dose of Paclitaxel® has to be reduced
• if you experience diarrhoea during or shortly after treatment
with Paclitaxel®; it could be that your intestine is inflamed
(pseudomembranous colitis). Your physician should consider
this option
• when Paclitaxel® is given to you in combination with
radiotherapy of the lung or with gemcitabine; it could be
that you’ll develop pneumonia (interstitial pneumonitis)
• if you have severe inflammation of the mucous membrane
(mucositis) occurs; it could be that the dose of Paclitaxel®
has to be reduced.
• male patients treated with Paclitaxel® should not father a
child during and up to six months after treatment because
this may cause birth defects
• male patients should seek advice regarding sperm freezing
prior to Paclitaxel® treatment because of the possibility of
infertility.
You will be premedicated with several different medicinal
products (dexamethasone and diphenhydramine or
chlorphenamine and cimetidine or ranitidine) before every

Other medicines and Paclitaxel®
Please tell your doctor or healthcare personnel if you are
taking or have recently taken or might take any other
medicines.
Paclitaxel® should be given:
• before cisplatin when used in combination; your renal
function may need to be checked more frequently.
• 24 hours following administration of doxorubicin, to avoid
high levels of doxorubicin in your body.
If you are treated with a combination of paclitaxel and
doxorubicin or trastuzumab: your heart function will be
checked both before and during treatment.
Caution should be exercised if you are receiving any of the
following medicines:
• A dose reduction of Paclitaxel® may be necessary if you are
using for example: erythromycin (against bacterial
infection), fluoxetine (against depression), some antifungals
(imidazole antifungals) or gemfibrozil (lowing cholesterol).
• A dose increase of Paclitaxel® may be necessary if you are
using for example: rifampicin (against bacterial infection),
carbamazepine, phenytoin or phenobarbital (against
epilepsy), efavirenz or nevirapine (against infection).
• Some medicines against HIV and AIDS, the so-called
protease-inhibitors (e.g. nelfinavir, ritonavir). If you are
treated concomitantly with Paclitaxel® and these medicines,
a dose adjustment of Paclitaxel® may be necessary.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may ne
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking any medicine. Avoid
becoming pregnant while you are given Paclitaxel®. If
pregnancy occurs inform your doctor immediately.
Paclitaxel® must not be used when you are pregnant, unless
clearly necessary.
Paclitaxel® must not be used when you are breast-feeding.
You have to interrupt breast feeding while you are being
treated with Paclitaxel®.
Driving and using machines
There is no reason why you cannot continue driving between
courses of Paclitaxel® but you should remember that this
medicine contains some alcohol and it may be unwise to drive
immediately after a course of treatment. As in all cases, you
should not drive if you feel dizzy or light headed.
Discuss with your doctor, nurse or pharmacist if you are
unsure about anything.
Paclitaxel® contains alcohol and macrogolglycerol ricinoleate
Since this medicinal product contains 49.7% (volume) ethanol
(alcohol), that is up to 20 g per dose, corresponding to 520 ml
of beer per dose or 210 ml of wine per dose. This amount
may be hazardous to patients suffering from alcoholism. This
should also be taken into consideration with high risk patients
as well as those with liver disorder or epilepsy.
The amount of ethanol in this medicinal product may change
the effects of other medicinal products.
This medicinal product also contains macrogolglycerol
ricinoleate, which can cause severe hypersensitivity (allergic)
reactions.

3

How to use Paclitaxel®

Your doctor has decided which dose and how many doses you
will be given. Paclitaxel® will be given under supervision of a
doctor, who can give you more information.
The amount (dose) of Paclitaxel® you will be given is based on
your body surface in square meters (m2). This is calculated
from your height and weight. The dose you receive will also
depend on results of your blood tests. Depending on the type
and severity of the cancer you will receive Paclitaxel® either
alone or in combination with another anticancer agent (e.g.
cisplatin, doxorubicin, trastuzumab). Paclitaxel® is given into a
vein (intravenous use) from an intravenous drip over 3 or 24
hours. Paclitaxel® is usually given every 3 weeks (2 weeks in
patients with Kaposi's sarcoma). The needle must remain in
the vein while the drug is being given. If the needle comes
out or becomes loose, or the solution is going into the tissue
outside the vein (you may feel discomfort or pain) – tell the
doctor or nurse immediately.
Use in children
Paclitaxel® is not recommended for use in children below
18 years due to lack of data on safety and effectiveness.
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, Paclitaxel® can cause side effects, although
not everybody gets them.
Tell your doctor immediately:
• if you get serious hypersensitivity reaction with fever, red
spots on the skin, joint pain and/or inflammation of the eye
(Stevens-Johnson syndrome)
• if you get serious, general and possibly life threatening
hypersensitivity reactions with shock.
• if you get local necrosis of the skin (epidermal necrolysis),
rash with red (moist) irregular spots (erythema multiforme),
nettle rash and formation of bumps (urticaria)
• if you suffer from inflammation of the skin with blisters or
peeling (exfoliative dermatitis),
• if you suffer from allergic condition which causes joint pain,
skin rashes and fever (systemic lupus erythematosis).
• if you get serious hypersensitivity reactions (angioedema)
which make treatment necessary (for low blood pressure,
swelling of tongue or lips, breathing problems or general
rash, chills, back pain, chest pain, fast heart rhythm,

TEVA UK Ref:














































231-30-10074-A LEA PACLITAXEL A/S SOL TEVAH
stomach pain, pain in the hands and feet, sweating, and
high blood pressure)
if you notice any abnormal bruising, bleeding or signs of
infection such as sore throat or high temperature
if you get infection (mainly urinary tract and upper airways:
inflammation of the nose mucous membrane characterized
by a stuffed-up nose, sneezing and secretion (rhinitis) and
inflammation of the throat (pharyngitis) and including
herpes simplex, fungal infection of the mouth) with
reported cases of fatal outcome
if you get mild hypersensitivity reactions (mainly flushing of
the face and skin rash)
if you get severe infection
if you get (delayed) hypersensitivity
if you get abnormal accumulation of fluid in hands, feet and
face (oedema)
if you have decreased heart rate (bradycardia), increased
heart rate (tachycardia), palpitation
if you get irregular fast heart beat (atrial fibrillation)
if you have faster heart beat originating from a specific part
of the heart (supraventricular tachycardia)
if you have disturbance in the heart conductance (AV block)
sometimes with loss of consciousness
if you have sudden disorders of blood forming bone
marrow cells (acute myeloid leukaemia, myelodysplastic
syndrome)
if you suffer from blood disorder (shortage of white blood
cells) accompanied with fever and increased sensitivity for
infections (neutropenic fever)
if you suffer from bleeding nose
if you suffer from severe anaemia
if you get thrombosis, inflammation of the veins with the
formation of a blood clot, which can often be felt as a
painful, harsh strand with a red skin
if you get redness of the skin
if you suffer from skin rash, heavily itching rash (pruritus)
if you suffer from ringing in the ears (tinnitus)
if you suffer from shortage of blood platelets causing
bruises and tendency to bleed (thrombocytopenia)
if you suffer from shortage of white blood cells attended
with an increased sensitivity for infections and associated
fever (severe leucopenia, severe neutropenia, febrile
neutopenia), severe anaemia, bleeding
if you notice black and blood containing stools (melaena)
if you get mild reaction at the place of injection (swelling of
skin due to water retention (oedema), pain, redness
(erythema), hardening of skin (induration), tenderness, skin
discolouration or swelling, extravasation (leaking of drug
outside the vein) which can result in cellulitis (painful
swelling and redness), scar formation (skin fibrosis) and
death of skin tissue (skin necrosis)). The onset of injection
site reactions can be delayed by a week to 10 days.
if you have serious lowering of the blood pressure by
bacteria in the blood accompanied with paleness and
restlessness, high heart rate and moist skin (septic shock)
if you suffer from myocardial infarction
if you suffer from insufficient pump function of the heart
(congestive heart failure)
if you suffer from disorders of the heart muscle
(cardiomyopathy)
if you suffer from disorders in the heart rhythm (fast heart
beat: asymptomatic ventricular tachycardia, tachycardia
with bigeminia)
if you get fever
if you suffer from loss of body fluids (dehydration)
if you suffer from (epileptic) fits, affection of the brain
characterised by, for instance, convulsions and lowering of
the consciousness (encephalopathy), coordination
disturbances (ataxia)
if you have disturbed functioning of the liver (hepatic
necrosis, hepatic encephalopathy) with reported cases of
fatal outcome
if you lose nails (patients in therapy should wear sun
protection on hands and feet)
if you suffer from inflammation of hair follicles (folliculitis)
if you suffer from inflammation of a vein (phlebitis)
if you have discoloration of the nails or nail beds
if you have severe blood poisoning (sepsis)
if you have inflammation of the lungs (pneumonia)
if you have affection of movement nerves causing muscle
weakness of arms and feet (motor neuropathy)
if you have heart failure
if you have shortness of breath.

Very common (may affect more than 1 in 10 people):
• deviations in blood content because of suppression of the
bone marrow (myelosuppression)
• anorexia
• sleepiness
• paraesthesia
• lowered blood pressure
• nausea, vomiting, diarrhoea
• inflammation of the mucous membrane (mucositis)
• inflammation of the mucous membranes in the mouth
(stomatitis), abdominal pain
• hairloss/ baldness
• muscle pain and joint pain
• weakness
• pain.
Common (may affect up to 1 in 10 people):
• flu syndrome
• depression,
• loss of consciousness
• dilated blood vessel resulting in flushing
• dry mouth, mouth ulceration
• indigestion
• dry skin, itch, acne, transient and mild nail and skin changes
• bone pain
• leg cramps, muscle weakness, back pain
• uncomfortable urination
• chest pain
• chills
• increase of certain enzymes in the blood (AST, SGOT).
Uncommon (may affect up to 1 in 100 people):








Version:

weight loss, weight gain
dry eyes, lazy eye (amblyopia)
vision field disorder
disorders of the electrocardiogram
high blood pressure
increase in bilirubin (a waste product that results from the
breakdown of red blood cells).

Rare (may affect up to 1 in 1,000 people):
• inflammation of the abdominal membrane (peritonitis)
• pleural effusion, pneumonia (interstitial pneumonia)
• lung fibrosis, airway occlusion (pulmonary embolism),
breathing difficulties
• pain in the stomach for instance caused by constipation or a
hole in the intestine (intestinal obstruction/perforation)
• inflammation of the pancreas, which causes severe pain in
the abdomen and back (pancreatitis)
• inflammation of the large intestine with possible serious
continuous diarrhoea (ischaemic colitis)
• general discomfort
• increase in blood creatinine.

9

19 February 2015

Storage
There are no special storage conditions. If refrigerated, a precipitate may
form which redissolves with little or no agitation upon reaching room
temperature. Product quality is not affected. If the solution remains cloudy,
or should insoluble precipitate is noted, the vial should be discarded.
Freezing does not adversely affect the product.
An expiry date is given on the outer carton and vial label of the product. It
should not be used after this date.

Very rare (may affect up to 1 in 10,000 people) including
isolated reports:
• confusion, defect of certain nerves (autonomous
neuropathy) which could result in paralysis of the intestine
muscles (paralytic ileus) and a
• sudden drop in blood pressure sometimes with dizziness
caused by, for instance, fast rising from a seated or lying
position (orthostatic hypotension)
• headache
• dizziness
• disorders of the eye nerve and/or disorder of the vision
(scotoma scintillans)
• damage to the ears (ototoxicity), hearing loss, dizziness
(vertigo)
• shock
• cough
• high blood pressure in the lungs
• inflammation of the large intestine with possible serious
continuous diarrhoea (neutropenic colitis,
pseudomembranous colitis, necrotising colitis)
• blood clot in the abdominal membrane (mesenteric
thrombosis)
• inflammation of the gullet (oesophagitis)
• accumulation of fluid in the abdominal cavity (ascites)
• constipation.
Not known (frequency cannot be estimated from the
available data):
• complications caused by the break-down products of dying
cancer cells (tumor lysis syndrome)
• fluid accumulation in the eye (macular oedema), light
flashes in the eye (photopsia), little dots or dust floating in
your field of vision (vitrious floaters)
• excessive deposits of collagen in the skin (scleroderma).
Reporting of side effects
If you get any side effects, talk to your doctor or 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 Paclitaxel®

Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date which
is stated on the vial and the outer carton after “do not use
after” or “exp.”. The first 2 numbers indicate the month, the
last numbers indicate the year. The expiry date refers to the
last day of the month.
No special storage temperature, store in the original carton.
Freezing does not have harmful effects on the product.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect
the environment.

6

Further information

What Paclitaxel® contains
The active substance is paclitaxel.
Paclitaxel®, concentrate for solution for infusion contains 6 mg
paclitaxel per ml.
The other ingredients are macrogolglycerol ricinoleate,
anhydrous ethanol and citric acid.
What Paclitaxel® looks like and the contents of the pack
Paclitaxel® is a clear, colourless or slightly yellow, viscous
solution. It is available in vials with 5 ml, 16.7 ml, 25 ml and
50 ml.
A 5 ml vial contains 30 mg paclitaxel.
A 16.7 ml vial contains 100 mg paclitaxel.
A 25 ml vial contains 150 mg paclitaxel.
A 50 ml vial contains 300 mg paclitaxel.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Manufacturer
Pharmachemie B.V.
Swensweg 5
P.O. Box 552,
2003 RN Haarlem, The Netherlands
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last approved in February 2015
PL 00289/0859

10074-A
93.130.701-H

10074-A
93.130.701-H

The following information is
intended for medical or healthcare
professionals only:
Below is a summary of information to assist
in the administration of Paclitaxel. You
should be experienced in the handling and
use of cytotoxic agents and be familiar with
the SPC of Paclitaxel. Reference should be
made to guidelines on the safe handling of
antineoplastic agents.
Handling: as with all antineoplastic agents,
caution should be exercised when handling
Paclitaxel. Pregnant women should not
handle cytotoxic agents. Dilution should be
carried out under aseptic conditions by
trained personnel in a designated area.
Adequate protective gloves should be
worn. Precautions should be taken to avoid
contact with the skin or mucous
membranes. In the event of contact with
the skin, the area should be washed with
soap and water. Following topical exposure,
tingling, burns and redness have been
observed. In the event of contact with the
mucous membranes, these should be
flushed thoroughly with water. Upon
inhalation, dyspnoea, chest pain, burning
throat and nausea have been reported.
If unopened vials are refrigerated or frozen,
a precipitation may form, that redissolves
with little or no agitation upon reaching
room temperature. Product quality is not
affected. If the solution remains cloudy or if
an insoluble precipitate is noted, the vial
should be discarded.
Following multiple needle entries and
product withdrawals, the vials maintain
microbial, chemical and physical stability for
up to 28 days at 25°C. Other in-use
storage times and conditions are the
responsibility of the user.

Pharma code: 370

The ‘Chemo-Dispensing Pin’ device or
similar devices with spikes should not be
used since they can cause the vial stopper
to collapse, resulting in loss of sterile
integrity.
Preparation for intravenous administration:
prior to infusion, Paclitaxel must be diluted
using aseptic techniques in 9 mg/ml (0.9%)
sodium chloride solution for infusion, or
50 mg/ml (5%) glucose solution for
infusion, or a mixture of 9 mg/ml (0.9%)
sodium chloride solution for infusion and
50 mg/ml (5%) glucose solution for
infusion, or Ringer’s solution for infusion
containing 50 mg/ml (5%) glucose, to a
final concentration of 0.3 to 1.2 mg/ml.
Chemical and physical in-use stability of the
solution prepared for infusion has been
demonstrated for 27 hours at 25°C when
diluted in a mixture of 9 mg/ml (0.9%)
sodium chloride solution for infusion and
50 mg/ml (5%) glucose solution for
infusion, or Ringer’s solution for infusion
containing 50 mg/ml (5%) glucose.
Chemical and physical in-use stability of the
solution prepared for infusion has been
demonstrated at 5°C and at 25°C for 14
days when diluted in 50 mg/ml (5%)
glucose solution for infusion or in 9 mg/ml
(0.9%) sodium chloride solution for
infusion.
Microbiological in-use stability of the
solution prepared for infusion has been
demonstrated for 27 hours at 25°C. Other
in-use storage times and conditions are the
responsibility of the user.
Upon preparation, solutions may show
some haziness, which is attributed to the
formulation vehicle, and is not removed by
filtration. Paclitaxel should be administered
through an in-line filter with a microporous
membrane ≤ 0.22 µm. No significant losses
in potency have been noted following
simulated delivery of the solution through
IV tubing containing an in-line filter.
There have been rare reports of
precipitation during paclitaxel infusions,
usually towards the end of a 24-hour
infusion period. Although the cause of this
precipitation has not been elucidated, it is
probably linked to the supersaturation of
the diluted solution. To reduce the
precipitation risk, Paclitaxel should be used
as soon as possible after dilution, and
excessive agitation, vibration or shaking
should be avoided. The infusion sets should
be flushed thoroughly before use.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Paclitaxel®, 6 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 any further questions, ask your doctor
• This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor.
What is in this leaflet:

1. What Paclitaxel® is and what it is used for
2. What you need to know before you use Paclitaxel®
3. How to use Paclitaxel®
4. Possible side effects.
5. How to store Paclitaxel®
6. Contents of the pack and other information
Paclitaxel® concentrate for solution for infusion is given only
by healthcare personnel, who can reply to any questions
which you may have after reading this package leaflet.

1

What Paclitaxel® is and what it is used for

Paclitaxel® is an antineoplastic or anticancer agent. It may stop
cancer cells from dividing and growing.
Paclitaxel® is used to treat different types of cancer, i.e.:
Ovarian cancer (advanced or spreading ovarian cancer,
residual tumour >1 cm after laparotomy)
Either as initial therapy in combination with
platinum-containing medicine, cisplatin, or as a second-line
treatment when other platinum-containing treatments have
not worked.
Breast cancer (treatment of early breast cancer after surgical
removal of the primary tumour, advanced or spreading breast
cancer)
As adjuvant therapy following treatment with anthracycline
and cyclophosphamide (AC).
As initial therapy either in combination with a medicine
belonging to the group known as anthracyclines in patients for
whom anthracyclines therapy is suitable, or with a medicine
called trastuzumab.
On its own, in patients who have not responded to standard
treatments using anthracyclines, or for whom such treatment
should not be used.
A certain type of lung cancer (Non-small cell lung cancer)
In combination with cisplatin, in patients who are not
candidates for potentially curative surgery and/or radiotherapy.
It is also used to treat a special AIDS-related form of cancer
that develops in the connective tissue (Kaposi’s sarcoma)
Where other treatments, i.e. liposomal anthracyclines, have
not worked.

2

What you need to know before you use
Paclitaxel®

Do not use Paclitaxel®
• if you are allergic (hypersensitive) to paclitaxel or any of the
other ingredients of this medicine (listed in section 6),
especially macrogolglycerol ricinoleate in Paclitaxel®
• if you are breast-feeding
• if your liver function is severely reduced
• if your white blood cell count is too low (neutrophils). This
will be measured by a healthcare personnel.
• if you have concurrent, serious, uncontrolled infections.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Paclitaxel®
• if you notice marked allergic (hypersensitivity) reactions (e.g.
shortness of breath, low blood pressure, facial swelling or
rash)
• because this medicinal product contains alcohol and
macrogolglycerol ricinoleate (see section “Paclitaxel® contains
alcohol and macrogolglycerol ricinoleate”)
• if you have a serious disorder in the composition of your
blood; your physician will check your blood every time
before treatment with Paclitaxel®
• if you experience heart problems during Paclitaxel®
treatment; your physician should check the functioning of
your heart before the next treatment with Paclitaxel®
• if you experience continuing numbness, tingling or pain in
hand and feet (peripheral neuropathy); it could be that the
dose of Paclitaxel® has to be reduced
• if you experience diarrhoea during or shortly after treatment
with Paclitaxel®; it could be that your intestine is inflamed
(pseudomembranous colitis). Your physician should consider
this option
• when Paclitaxel® is given to you in combination with
radiotherapy of the lung or with gemcitabine; it could be
that you’ll develop pneumonia (interstitial pneumonitis)
• if you have severe inflammation of the mucous membrane
(mucositis) occurs; it could be that the dose of Paclitaxel®
has to be reduced.
• male patients treated with Paclitaxel® should not father a
child during and up to six months after treatment because
this may cause birth defects
• male patients should seek advice regarding sperm freezing
prior to Paclitaxel® treatment because of the possibility of
infertility.
You will be premedicated with several different medicinal
products (dexamethasone and diphenhydramine or

Version:

8

18 February 2015

chlorphenamine and cimetidine or ranitidine) before every
treatment with Paclitaxel®. Premedication is necessary to
decrease the risk of severe hypersensitive reactions (see section
4, Possible side effects, uncommon).
Other medicines and Paclitaxel®
Please tell your doctor or healthcare personnel if you are taking
or have recently taken, or might take any other medicines.
Paclitaxel® should be given:
• before cisplatin when used in combination; your renal
function may need to be checked more frequently.
• 24 hours following administration of doxorubicin, to avoid
high levels of doxorubicin in your body.
If you are treated with a combination of paclitaxel and
doxorubicin or trastuzumab: your heart function will be
checked both before and during treatment.
Caution should be exercised if you are receiving any of the
following medicines:
• A dose reduction of Paclitaxel® may be necessary if you are
using for example: erythromycin (against bacterial infection),
fluoxetine (against depression), some antifungals (imidazole
antifungals) or gemfibrozil (lowing cholesterol).
• A dose increase of Paclitaxel® may be necessary if you are
using for example: rifampicin (against bacterial infection),
carbamazepine, phenytoin or phenobarbital (against
epilepsy), efavirenz or nevirapine (against infection).
• Some medicines against HIV and AIDS, the so-called
protease-inhibitors (e.g. nelfinavir, ritonavir). If you are
treated concomitantly with Paclitaxel® and these medicines,
a dose adjustment of Paclitaxel® may be necessary.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking any medicine. Avoid
becoming pregnant while you are given Paclitaxel®. If
pregnancy occurs inform your doctor immediately.
Paclitaxel® must not be used when you are pregnant, unless
clearly necessary.
Paclitaxel® must not be used when you are breast-feeding. You
have to interrupt breast feeding while you are being treated
with Paclitaxel®.
Driving and using machines
There is no reason why you cannot continue driving between
courses of Paclitaxel® but you should remember that this
medicine contains some alcohol and it may be unwise to drive
immediately after a course of treatment. As in all cases, you
should not drive if you feel dizzy or light headed.
Discuss with your doctor, nurse or pharmacist if you are unsure
about anything.
Paclitaxel® contains alcohol and macrogolglycerol ricinoleate
Since this medicinal product contains 49.7% (volume) ethanol
(alcohol), that is up to 20 g per dose, corresponding to 520 ml
of beer per dose or 210 ml of wine per dose. This amount may
be hazardous to patients suffering from alcoholism. This should
also be taken into consideration with high risk patients as well
as those with liver disorder or epilepsy.
The amount of ethanol in this medicinal product may change
the effects of other medicinal products.
This medicinal product also contains macrogolglycerol
ricinoleate, which can cause severe hypersensitivity (allergic)
reactions.

3

How to use Paclitaxel®

Your doctor has decided which dose and how many doses you
will be given. Paclitaxel® will be given under supervision of a
doctor, who can give you more information.
The amount (dose) of Paclitaxel® you will be given is based on
your body surface in square meters (m2). This is calculated
from your height and weight. The dose you receive will also
depend on results of your blood tests. Depending on the type
and severity of the cancer you will receive Paclitaxel® either
alone or in combination with another anticancer agent (e.g.
cisplatin, doxorubicin, trastuzumab). Paclitaxel® is given into a
vein (intravenous use) from an intravenous drip over 3 or 24
hours. Paclitaxel® is usually given every 3 weeks (2 weeks in
patients with Kaposi's sarcoma). The needle must remain in
the vein while the drug is being given. If the needle comes out
or becomes loose, or the solution is going into the tissue
outside the vein (you may feel discomfort or pain) – tell the
doctor or nurse immediately.
Use in children
Paclitaxel® is not recommended for use in children below
18 years due to lack of data on safety and effectiveness.
If you have any further questions on the use of this medicine,
ask your doctor, or pharmacist or nurse.

4

Possible side effects

Like all medicines, Paclitaxel® can cause side effects, although
not everybody gets them.
Tell your doctor immediately:
• if you get serious hypersensitivity reaction with fever, red spots
on the skin, joint pain and/or inflammation of the eye
(Stevens-Johnson syndrome)
• if you get serious, general and possibly life threatening
hypersensitivity reactions with shock.
• if you get local necrosis of the skin (epidermal necrolysis), rash
with red (moist) irregular spots (erythema multiforme), nettle
rash and formation of bumps (urticaria)
• if you suffer from inflammation of the skin with blisters or
peeling (exfoliative dermatitis),
• if you suffer from allergic condition which causes joint pain,
skin rashes and fever (systemic lupus erythematosis).
• if you get serious hypersensitivity reactions (angioedema)
which make treatment necessary (for low blood pressure,
swelling of tongue or lips, breathing problems or general rash,
chills, back pain, chest pain, fast heart rhythm, stomach pain,

Pharma code: 370

TEVA UK Ref: 231-30-10077-B LEA PACLITAXEL 6mg/ml INF TEVAH
Pharma code: 370

pain in the hands and feet, sweating, and high blood pressure)
• if you notice any abnormal bruising, bleeding or signs of
infection such as sore throat or high temperature
• if you get infection (mainly urinary tract and upper airways:
inflammation of the nose mucous membrane characterized by
a stuffed-up nose, sneezing and secretion (rhinitis) and
inflammation of the throat (pharyngitis) and including herpes
simplex, fungal infection of the mouth) with reported cases of
fatal outcome
• if you get mild hypersensitivity reactions (mainly flushing of
the face and skin rash)
• if you get severe infection
• if you get (delayed) hypersensitivity
• if you get abnormal accumulation of fluid in hands, feet and
face (oedema)
• if you have decreased heart rate (bradycardia), increased heart
rate (tachycardia), palpitation
• if you get irregular fast heart beat (atrial fibrillation)
• if you have faster heart beat originating from a specific part of
the heart (supraventricular tachycardia)
• if you have disturbance in the heart conductance (AV block)
sometimes with loss of consciousness
• if you have sudden disorders of blood forming bone marrow
cells (acute myeloid leukaemia, myelodysplastic syndrome)
• if you suffer from blood disorder (shortage of white blood
cells) accompanied with fever and increased sensitivity for
infections (neutropenic fever)
• if you suffer from bleeding nose
• if you suffer from severe anaemia
• if you get thrombosis, inflammation of the veins with the
formation of a blood clot, which can often be felt as a painful,
harsh strand with a red skin
• if you get redness of the skin
• if you suffer from skin rash, heavily itching rash (pruritus)
• if you suffer from ringing in the ears (tinnitus)
• if you suffer from shortage of blood platelets causing bruises
and tendency to bleed (thrombocytopenia)
• if you suffer from shortage of white blood cells attended with
an increased sensitivity for infections and associated fever
(severe leucopenia, severe neutropenia, febrile neutopenia),
severe anaemia, bleeding
• if you notice black and blood containing stools (melaena)
• if you get mild reaction at the place of injection (swelling of
skin due to water retention (oedema), pain, redness
(erythema), hardening of skin (induration), tenderness, skin
discolouration or swelling, extravasation (leaking of drug
outside the vein) which can result in cellulitis (painful swelling
and redness), scar formation (skin fibrosis) and death of skin
tissue (skin necrosis)). The onset of injection site reactions can
be delayed by a week to 10 days.
• if you have serious lowering of the blood pressure by bacteria
in the blood accompanied with paleness and restlessness, high
heart rate and moist skin (septic shock)
• if you suffer from myocardial infarction
• if you suffer from insufficient pump function of the heart
(congestive heart failure)
• if you suffer from disorders of the heart muscle
(cardiomyopathy)
• if you suffer from disorders in the heart rhythm (fast heart beat:
asymptomatic ventricular tachycardia, tachycardia with
bigeminia)
• if you get fever
• if you suffer from loss of body fluids (dehydration)
• if you suffer from (epileptic) fits, affection of the brain
characterised by, for instance, convulsions and lowering of the
consciousness (encephalopathy), coordination disturbances
(ataxia)
• if you have disturbed functioning of the liver (hepatic necrosis,
hepatic encephalopathy) with reported cases of fatal outcome
• if you lose nails (patients in therapy should wear sun
protection on hands and feet)
• if you suffer from inflammation of hair follicles (folliculitis)
• if you suffer from inflammation of a vein (phlebitis)
• if you have discoloration of the nails or nail beds
• if you have severe blood poisoning (sepsis)
• if you have inflammation of the lungs (pneumonia)
• if you have affection of movement nerves causing muscle
weakness of arms and feet (motor neuropathy)
• if you have heart failure
• if you have shortness of breath.
Very common (may affect more than 1 in 10 people):
• deviations in blood content because of suppression of the
bone marrow (myelosuppression)
• anorexia
• sleepiness
• paraesthesia
• lowered blood pressure
• nausea, vomiting, diarrhoea
• inflammation of the mucous membrane (mucositis)
• inflammation of the mucous membranes in the mouth
(stomatitis), abdominal pain
• hairloss/ baldness
• muscle pain and joint pain
• weakness
• pain.
Common (may affect up to 1 in 10 people):
• flu syndrome
• depression,
• loss of consciousness
• dilated blood vessel resulting in flushing
• dry mouth, mouth ulceration
• indigestion
• dry skin, itch, acne, transient and mild nail and skin changes
• bone pain
• leg cramps, muscle weakness, back pain
• uncomfortable urination
• chest pain
• chills
• increase of certain enzymes in the blood (AST, SGOT).

Uncommon (may affect up to 1 in 100 people):
• weight loss, weight gain
• dry eyes, lazy eye (amblyopia)
• vision field disorder
• disorders of the electrocardiogram
• high blood pressure
• increase in bilirubin (a waste product that results from the
breakdown of red blood cells).
Rare (may affect up to 1 in 1,000 people):
• inflammation of the abdominal membrane (peritonitis)
• pleural effusion, pneumonia (interstitial pneumonia)
• lung fibrosis, airway occlusion (pulmonary embolism),
breathing difficulties
• pain in the stomach for instance caused by constipation or a
hole in the intestine (intestinal obstruction/perforation)
• inflammation of the pancreas, which causes severe pain in the
abdomen and back (pancreatitis)
• inflammation of the large intestine with possible serious
continuous diarrhoea (ischaemic colitis)
• general discomfort
• increase in blood creatinine.
Very rare (may affect up to 1 in 10,000 people) including
isolated reports:
• confusion, defect of certain nerves (autonomous neuropathy)
which could result in paralysis of the intestine muscles
(paralytic ileus) and a
• sudden drop in blood pressure sometimes with dizziness
caused by, for instance, fast rising from a seated or lying
position (orthostatic hypotension)
• headache
• dizziness
• disorders of the eye nerve and/or disorder of the vision
(scotoma scintillans)
• damage to the ears (ototoxicity), hearing loss, dizziness
(vertigo)
• shock
• cough
• high blood pressure in the lungs
• inflammation of the large intestine with possible serious
continuous diarrhoea (neutropenic colitis,
pseudomembranous colitis, necrotising colitis)
• blood clot in the abdominal membrane (mesenteric
thrombosis)
• inflammation of the gullet (oesophagitis)
• accumulation of fluid in the abdominal cavity (ascites)
• constipation.
Not known (frequency cannot be estimated from the
available data):
• complications caused by the break-down products of dying
cancer cells (tumor lysis syndrome)
• fluid accumulation in the eye (macular oedema), light flashes
in the eye (photopsia), little dots or dust floating in your field of
vision (vitrious floaters)
• excessive deposits of collagen in the skin (scleroderma).
Reporting of side effects
If you get any side effects, talk to your doctor or 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 Paclitaxel®

Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date which
is stated on the vial and the outer carton after “do not use
after” or “exp.”. The first 2 numbers indicate the month, the
last numbers indicate the year. The expiry date refers to the
last day of the month.
No special storage temperature, store in the original carton.
Freezing does not have harmful effects on the product.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect
the environment

6

Contents of the pack and other information

8

18 February 2015

During infusion, the appearance of the
solution should be regularly inspected and
the infusion should be stopped if
precipitation is present.
To minimise patient exposure to DEHP
[di-(2-ethylhexyl)phthalate] which may be
leached from plasticised PVC infusion
materials, diluted paclitaxel solutions should
be stored in non-PVC bottles (glass,
polypropylene) or plastic bags
(polypropylene, polyolefin) and
administered through polyethylene-lined
administration sets. Use of filter devices
which incorporate short inlet and/or outlet
plasticised PVC tubing has not resulted in
significant leaching of DEHP.
Disposal: all items used for the preparation,
administration or otherwise coming into
contact with Paclitaxel should undergo
disposal according to local guidelines for
the handling of cytotoxic compounds.
Administration and dosage
All patients should be premedicated with
corticosteroids, antihistamines and H2
antagonists prior to administration. The
diluted Paclitaxel infusion should be
administrated using non-PVC containing
equipment through an in-line filter with a
microporous membrane ≤ 0.22 µm.
The recommended doses for the
intravenous infusion of Paclitaxel are as
follows:
First-line
ovarian
cancer:

135 mg/m2 over 24 hours,
followed by cisplatin
75 mg/m2; or
175 mg/m2 over 3 hours,
followed by
cisplatin 75 mg/m2;

Second-line
ovarian or
breast cancer:

175 mg/m2
over 3 hours;

Adjuvant
breast cancer:

175 mg/m2 over 3 hours;
following anthracycline
and cyclophosphamide
(AC) therapy;

First-line
breast cancer:

220 mg/m2 over 24 hours,
24 hours after doxorubicin
(50 mg/m2),
175 mg/m2 over 3 hours,
after trastuzumab (see
trastuzumab SPC);

Non-small cell
lung cancer:

175 mg/m2 over 3 hours,
followed by cisplatin
80 mg/m2:

AIDs related
Kaposi’s
sarcoma:

100 mg/m2
over 3 hours.

Storage
There are no special storage conditions. If
refrigerated, a precipitate may form which
redissolves with little or no agitation upon
reaching room temperature. Product quality
is not affected. If the solution remains
cloudy, or should insoluble precipitate is
noted, the vial should be discarded.
Freezing does not adversely affect the
product.
An expiry date is given on the outer carton
and vial label of the product. It should not
be used after this date.

What Paclitaxel® contains
The active substance is paclitaxel.
Paclitaxel®, concentrate for solution for infusion contains 6 mg
paclitaxel per ml.
The other ingredients are macrogolglycerol ricinoleate,
anhydrous ethanol and citric acid.
What Paclitaxel® looks like and the contents of the pack
Paclitaxel® is a clear, colourless or slightly yellow, viscous
solution. It is available in vials with 5 ml, 16.7 ml, 25 ml and
50 ml.
A 5 ml vial contains 30 mg paclitaxel.
A 16.7 ml vial contains 100 mg paclitaxel.
A 25 ml vial contains 150 mg paclitaxel.
A 50 ml vial contains 300 mg paclitaxel.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Manufacturer
Teva Pharmaceutical Works Private Limited Company
Táncsics Mihály út 82
2100 Gödöllö
Hungary
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last approved in February 2015
PL 00289/0859
10077-B
3-29135030/B

10077-B
3-29135030/B

Pharma code: 370

Version:

TEVA UK Ref: 231-30-10077-B LEA PACLITAXEL 6mg/ml INF TEVAH

Expand view ⇕

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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