PACLITAXEL 6 MG/ ML CONCENTRATE FOR SOLUTION FOR INFUSION.
Active substance(s): PACLITAXEL
PACLITAXEL 6 mg/ ml
CONCENTRATE FOR SOLUTION FOR INFUSION
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms 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 or pharmacist.
In this leaflet:
What Paclitaxel is and what it is used for
Before you use Paclitaxel
How to use Paclitaxel
Possible side effects
How to store Paclitaxel
WHAT PACLITAXEL IS AND WHAT IT IS USED FOR
The name of your medicine is Paclitaxel 6 mg/ ml concentrate for solution for infusion. Paclitaxel is
available as vials containing 30 mg, 100 mg, or 300 mg paclitaxel in a 6 mg/ml solution which has to
be diluted before being given to you.
Paclitaxel is used to treat:
Ovarian cancer: either as initial therapy in combination with the platinum-containing medicine,
cisplatin, or as a second-line treatment when other platinum-containing treatments have not worked.
Breast cancer: As initial therapy either in combination with a medicine belonging to the group known
as anthracyclines (i.e. doxorubicin, epirubicin, daunorubicin) for patients that are suitable, or with a
medicine called trastuzumab. As adjuvant therapy following treatment with anthracycline and
cyclophosphamide (AC). On its own in patients who have not responded to standard treatments using
anthracyclines, or for whom such treatment should not be used.
Non-small cell lung cancer: in combination with cisplatin, in patients who are not candidates for
potentially curative surgery and/or radiotherapy.
AIDs-related Kaposi's sarcoma: where other treatments i.e. liposomal anthracyclines have not
BEFORE YOU USE PACLITAXEL
Do not use PACLITAXEL
if you have shown signs of hypersensitivity (severe) allergy to paclitaxel or any other
ingredients on previous occasions
if you are pregnant or breastfeeding
if the number of white blood cells (neutrophils) is too low. This is measured by a doctor or
in patients with Kaposi's sarcoma, this product should not be used if you have a serious
if you are unsure about anything, ask your doctor or pharmacist.
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Take special care with PACLITAXEL
if you have heart disease or liver problems
when diarrhoea occurs during or shortly after the treatment with paclitaxel (pseudomenbranous
if you have Kaposi's sarcoma and severe inflammation of the mucous membrane (membranes
lining the passages of the body that open to the outside) occurs
if you have had nerve problems in your hands or in feet, such as numbness, tingling or burning
if you have blood problems, such as changes in the number of some cells
if paclitaxel is given to you in combination with radiotherapy of the lung.
It is important to tell the doctor about any of your medical conditions, whether they are included in the
above lists or not. Please tell your doctor if you are taking, or have recently taken, any other
medicines, including ones that are not prescribed for you.
Using other medicines
please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription
when used in combination, paclitaxel should be given before cisplatin
paclitaxel should be given 24 hours after doxorubicin
special care should be observed if you are taking medicines which influence the metabolism of
paclitaxel such as: erythromycin, fluoxetine, gemfibrozil, rifampicin, carbamazepine, phenytoin,
phenobarbital, efavirenz, and nevirapine and for HIV patients receiving protease inhibitors
(ritonavir, nelfinavir) as concomitant therapy
if you go into hospital, let the medical staff know you are taking paclitaxel.
Pregnancy and breast-feeding
Do not use paclitaxel if you think you are pregnant or you are trying to become pregnant. Paclitaxel
can damage the unborn baby.
Pregnancy must be avoided and both partners should use reliable contraception during treatment with
paclitaxel and for at least 6 month after treatment. Tell your doctor immediately if you do become
Paclitaxel should not be used when you are breast-feeding. You should stop breast feeding while you
are being treated with paclitaxel. Do not restart breast feeding until your doctor tells you it is safe to
Ask your doctor or pharmacist for advice before taking any medicine
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 or use machines
immediately after a course of treatment. As in all cases, you should not drive or use machines if you
feel dizzy or light-headed.
Important Information about PACLITAXEL
This medicinal product contains polyoxyl castor oil which may cause severe allergic reactions.
It also contains 49.7% vol ethanol (alcohol), i.e. up to 21 g (19.5 g ) per average dose, equivalent to
740 ml (687 ml) of a 3.5% vol beer, 190 ml (176.4) of a 14% vol wine per dose. This may be harmful
to patients suffering from alcoholism.
It should also be taken into account when considering using this medicine in children and high risk
groups such as those with liver disease or epilepsy. The alcohol in this medicine may also affect the
way other medicines work.
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HOW TO USE PACLITAXEL
If you are prescribed Paclitaxel, it will be given to you by doctors or nurses experienced in giving
Paclitaxel will normally be given to you by a doctor or a nurse through a drip (infusion) into a vein.
Your doctor will decide what dose to give and the number of days treatment you will receive
depending upon your condition. The dose you receive will be based on your body surface area and the
result of blood tests carried out before treatment. The usual dose is 175mg/m2, body surface area,
given over 3 hours followed by the cisplatin for ovarian and lung cancer. You will also receive
cisplatin after paclitaxel if you are being treated for lung cancer. For breast cancer recommended dose
is 175mg/m² administered over 3 hours following therapy with anthracycline and cyclophosphamide.
When used in combination with doxorubicin paclitaxel will be administered 24 hours after
doxorubicin at a dose of 220 mg/m2. The timing of paclitaxel administration after trastuzumab will
depend on how you react to this medicine.
If you are given too much PACLITAXEL
Your dose will be carefully calculated by the doctors, so overdose is unlikely. However, if
too much is given this is likely to make the usual side effects worse, particularly blood disorders,
numbness/tingling especially of the arms, hands, legs or feet and stomach upsets including vomiting
POSSIBLE SIDE EFFECTS
Like all medicines, paclitaxel can cause side effects, although not everybody gets them.
The following side effects may occur after treatment with Paclitaxel concentrate for solution for
The most frequent side effects are hair loss and decreased blood cell count. Your hair grows back and
your blood cell count returns to normal after you have finished your paclitaxel treatment.
If any of the following happen, tell the doctor immediately
any abnormal bruising, bleeding, or signs of infections such as a sore throat and high
severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands,
feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing),
and you may feel you are going to faint
breathlessness and dry cough due to damage to the lung
reaction at the injection site, e.g. local swelling, pain, redness.
Other known side effects are
Very common (affects more than 1 out of 10 people):
an effect on the bone marrow, which can cause decreased numbers of some blood cells. This
may cause anaemia. It can also lead to infections, mainly urinary tract and upper respiratory
tract infections with reported cases of fatal outcome pain, redness or swelling at the injection
decreased number of blood platelets and bleeding
milder allergic (hypersensitivity) reactions, such as flushing and rash
nerve problems affecting the hands and or feet (peripheral neuropathy), which can cause
tingling feelings in the skin, numbness and/or pain
low blood pressure
feeling sick (nausea), being sick (vomiting) and diarrhoea
muscle or joint pain
inflammation of areas such as the lining of the mouth.
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Common (affects more than l out of 100 people):
slow heart beat (pulse)
mild changes in nail and skin which soon disappear
painful swelling and inflammation where the injection is given which may cause tissue
hardening (occasionally cellulitis, thickening and scarring of the skin (skin fibrosis), death of
skin cells(skin necrosis))
changes in blood tests that check how the liver is working.
Uncommon (affects less than l out of 100 people):
a state of shock resulting from blood poisoning
serious allergic (hypersensitivity) reactions with e.g. decreased or increased blood
pressure, swelling of the face, difficulty in breathing, skin rash, chills back pain, chest
pain, fast heart beat, abdominal pain, pain in arms and legs, sweating
serious heart problems like heart muscle degeneration (cardiomyopathy), serious
changes in your heart's rhythm even with fainting heart attack
increased blood pressure
blood clot (thrombosis), inflammation of a vein in connection with blood clots.
yellowing of the skin (jaundice).
Rare (affects less than 1 out of 1,000 people):
reduced number of a type of white blood cell with fever (febrile neutropenia)
serious allergic (anaphylactic) reaction. Effects on the nerves, which can cause muscle weakness
in the arms and legs
difficulty in breathing, fluid on the lungs, inflammation of the lungs and other lung problems
(lung fibrosis, pulmonary embolism), markedly impaired pulmonary function (respiratory
itching, rash and reddened skin
weakness, high temperature (fever), dehydration, oedema, feeling ill
blockage of the intestines, penetration of the wall of the small intestine or large bowel,
inflammation of the lining of the belly (peritoneum), inflammation of the intestine caused by
inadequate blood supply, inflammation of the pancreas
increased level of the substance creatinine in the blood.
Very rare (occurs with less than l out of 10,000 of the users):
acute leukaemia (a type of blood cancer), myelodysplastic syndrome (a diverse collection of
blood cell disorders)
life threatening allergic reaction (anaphylactic shock)
loss of appetite, shock due to decreased blood pressure, cough
effects on the nervous system which can cause paralysis of the intestines (gut) and a
decrease in blood pressure when standing up or sitting up from a lying down position
fits (epileptic seizures), cramps, confusion, dizziness, alteration in brain function or structure,
headache, loss of the ability to coordinate muscular movement
problems with eyesight and visual disturbances, usually in patients given larger doses
reduction or loss of hearing, ringing in the ears (tinnitus), vertigo
abnormal heart rhythm (atrial fibrillation, supraventricular tachycardia).
a blood clot in the mesenteric artery, pseudomembranous colitis (an infection
of the colon caused by specific bacteria), inflammation of the oesophagus constipation,
collection of fluid in the abdomen (belly).
severe inflammation of the large bowel presenting with fever, watery or bloody diarrhoea, and
crampy abdominal pain (neutropenic colitis)
death of liver cells (necrosis of the liver), confusion and other effects (hepatic encephalopathy)
caused by changes in the way the liver works (both with reported causes of fatal outcome)
hives (urticaria) scaling and shedding of the skin usually accompanied by redness
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severe inflammatory eruption of the skin and mucous membranes (severity ranging
from erythema multiform to Stevens-Johnson syndrome to the most serious toxic epidermal
disintegration of nails. Hands and feet should be protected against sunshine during the treatment
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet,
please tell your doctor or pharmacist.
HOW TO STORE PACLITAXEL
Keep out of the reach and sight of children.
This medicine should not be used after the expiry date which is stated on the vial label and carton after
“EXP”. The expiry date refers to the last day of that month.
Your medication should not be stored above 25°C. The vials should be kept in the original package in
order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
What PACLITAXEL Concentrate for solution for infusion contains
The active substance is paclitaxel.
The other ingredients are citric acid anhydrous, ethanol and polyoxyl castor oil.
Each ml contains 6 mg of the active ingredient paclitaxel.
Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone
else. It may harm them even if their symptoms are the same as yours.
What PACLITAXEL Concentrate for solution for infusion looks like and contents of the pack
Paclitaxel 6 mg/ ml concentrate for solution for infusion is a clear colourless viscous solution and is
packed into type 1 flint glass vials.
1 x 5 ml vial (30mg/5ml)
1 x 20 ml vial (l00mg/16.7ml)
1 x 50 ml vial (300mg/50ml)
The vials are packaged individually in a carton. Boxes containing 10 cartons are also available.
Not all presentations may be marketed.
Marketing Authorisation Holder:
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW
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APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th floor, C.P. House, 97-107 Uxbridge Road,
Ealing, London W5 5TL
APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th floor, C.P. House, 97-107 Uxbridge Road,
Ealing, London W5 5TL
This leaflet was last revised in October 2012
-----------------------------------------------------------------------INFORMATION FOR HEALTH PROFESSIONALS
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 for
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
Concentrate for solution for infusion. 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 and mucous membranes. In the event of contact with the skin,
the area should be washed with soap and water. Following topical exposure, tingling, burning 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
If unopened vials are refrigerated, a precipitate 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, storage and administration should be carried out in non-PVC containing equipment.
Preparation for IV administration: prior to infusion, Paclitaxel must be diluted using aseptic
techniques in 0.9% Sodium Chloride Injection, or 5% Dextrose Injection, or 5% Dextrose and 0.9%
Sodium Chloride Injection, or 5% Dextrose in Ringer's Injection, to a final concentration of 0.3 to 1.2
Chemical and physical in-use stability of the solution prepared for infusion has been demonstrated at
2°C to 8°C and at 25°C for 7 days when diluted in 5% Dextrose Injection, 5% Dextrose and 0.9%
Sodium chloride Injection, 5% Dextrose in Ringer's Injection and for 14 days when diluted in 0.9%
Sodium chloride Injection.
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From a microbiological point of view, the product 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 to 8°C, unless dilution has taken place in controlled
and validated aseptic conditions. After dilution the solution is for single use only.
Upon preparation, solutions may show 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
24hr 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
Disposal: all items used for 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 administered 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 should be a 3-week interval between courses, dependent upon patient tolerance.
PACLITAXEL should not be readministered until the neutrophil count is ≥1.5x10 /L and the platelet
count is ≥100x10 /L. Patients experiencing severe neutropenia or severe peripheral neuropathy should
be subject to a dose reduction of 20% for subsequent courses.
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After opening before dilution the vials should not be stored above 25°C and should be stored in the
original package to protect from light. 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 an insoluble precipitate is noted, the vial should be discarded. Freezing does not
adversely affect the product.
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