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Active substance: PACLITAXEL

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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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
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
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 secondline 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
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 strongly reduced
if your white blood cell count is too low (neutrophils). This will be measured by a healthcare
if you have concurrent, serious, uncontrolled infections.

Warnings and precautions
Talk to your doctor before you take 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
“Important information about some of the ingredients of Paclitaxel”)
- 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, belonging to the classes
corticosteroids (for example dexamethasone), antihistamines (for example diphenhydramine or
chlorphenamine) and H2 antagonists (for example 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, 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
- 24 hours following administration of doxorubicin, to avoid high levels of doxorubicin in your
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 (lowering 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 hepatic 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
If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur amongst others:

Tell your doctor immediately:
• if you notice any abnormal bruising, bleeding or signs of infection such as sore throat or high
Very common (may affect more than 1 in 10 people):
• 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
• deviations in blood content because of suppression of the bone marrow (myelosuppression)
• shortage of blood platelets causing bruises and tendency to bleed (thrombocytopenia)
• shortage of white blood cells attended with an increased sensitivity for infections (severe
leucopenia, severe neutropenia), anaemia, bleeding
• mild hypersensitivity reactions (mainly flushing of the face and skin rash)
• anorexia
• neuropathy, mainly constant numbness, tingling or pain in hands and feet (peripheral
• 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
• abnormal accumulation of fluid in hands, feet and face (oedema)
Common (may affect up to 1 in 10 people):
• flu syndrome
• blood disorder (shortage of white blood cells) accompanied with fever and increased
sensitivity for infections (neutropenic fever)
• depression,
• severe form of neuropathy, mainly resulting in constant numbness, tingling or pain in hands
and feet (peripheral neuropathy), nervousness, sleeplessness, abnormal thinking, taste
perversion, abnormal walking, movement disorder (hypokinesia), decreased sense of touch
• decreased heart rate (bradycardia), increased heart rate (tachycardia), palpitation
• loss of consciousness
• dilated blood vessel resulting in flushing
• bleeding nose
• dry mouth, mouth ulceration
• black and blood containing stools (melaena)
• indigestion
• dry skin, itch, acne, transient and mild nail and skin changes
• bone pain
• leg cramps, muscle weakness, back pain

uncomfortable urination
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.
chest pain
increase of certain enzymes in the blood (AST, SGOT).

Uncommon (may affect up to 1 in 100 people):
• severe infection
• serious lowering of the blood pressure by bacteria in the blood accompanied with paleness and
restlessness, high heart rate and moist skin (septic shock)
• severe anaemia
• (delayed) hypersensitivity
• 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, pain in the hands and feet, sweating, and
high blood pressure)
• weight loss, weight gain
• dry eyes, lazy eye (amblyopia)
• vision field disorder
• myocardial infarction
• insufficient pump function of the heart (congestive heart failure)
• disorders of the heart muscle (cardiomyopathy)
• disorders in the heart rhythm (fast heart beat: asymptomatic ventricular tachycardia,
tachycardia with bigeminia)
• disturbance in the heart conductance (AV block) sometimes with loss of consciousness
• disorders of the electrocardiogram
• high blood pressure
• 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
• discoloration of the nails or nail beds
• 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):
• severe blood poisoning (sepsis)
• inflammation of the lungs (pneumonia)
• inflammation of the abdominal membrane (peritonitis)
• fever associated with a low number of specific white blood cells which are needed to fight an
infection (febrile neutropenia)
• serious general and possibly life threatening hypersensitivity reactions (anaphylactic reactions)
• affection of movement nerves causing muscle weakness of arms and feet (motor neuropathy)
• heart failure
• shortness of breath
• 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
• 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

redness of the skin
skin rash, heavily itching rash (pruritus)
loss of body fluids (dehydration)
water retention (oedema)
general discomfort
increase in blood creatinine.

Very rare(may affect up to 1 in 10,000 people):
• sudden disorders of blood forming bone marrow cells (acute myeloid leukaemia,
myelodysplastic syndrome)
• serious, general and possibly life threatening hypersensitivity reactions with shock
• 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)
• (epileptic) fits, affection of the brain characterised by, for instance, convulsions and lowering
of the consciousness (encephalopathy), coordination disturbances (ataxia)
• headache
• dizziness
• disorders of the eye nerve and/or disorder of the vision (scotoma scintillans)
• damage to the ears (ototoxicity), hearing loss, dizziness (vertigo)
• ringing in the ears (tinnitus)
• irregular fast heart beat (atrial fibrillation)
• faster heart beat originating from a specific part of the heart (supraventricular tachycardia)
• 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
• disturbed functioning of the liver (hepatic necrosis, hepatic encephalopathy) with reported
cases of fatal outcome
• serious hypersensitivity reaction with fever, red spots on the skin, joint pain and/or
inflammation of the eye (Stevens-Johnson syndrome)
• local necrosis of the skin (epidermal necrolysis), rash with red (moist) irregular spots
(erythema multiforme), nettle rash and formation of bumps (urticaria)
• losing nails (patients in therapy should wear sun protection on hands and feet)
• inflammation of hair follicles (folliculitis)
• inflammation of the skin with blisters or peeling (exfoliative dermatitis),
Not known (frequency cannot be determined from the available data):
• complications caused by the break-down products of dying cancer cells (tumor lysis
• 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)
• inflammation of a vein (phlebitis)
• excessive deposits of collagen in the skin (scleroderma)
• allergic condition which causes joint pain, skin rashes and fever (systemic lupus erythematosis).

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: 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 medicine 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
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
Pharmachemie B.V.
Swensweg 5
P.O. Box 552,
2003 RN Haarlem, The Netherlands
Teva Pharmaceutical Works Private Limited Company
Táncsics Mihály út 82
2100 Gödöllö

Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG

This leaflet was last revised in February 2015
PL 00289/0859

Only the paragraph containing the details of the current batch release site will be included in the
printed version of the PIL
----------------------------------------------------------------------------------------------------------------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.
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. During infusion, the appearance
of the solution should be regularly inspected and the infusion should be stopped if precipitation is
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
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 3 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.
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

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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.