Paclitaxel 6mg/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.
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.
In this leaflet:
- 1. What Paclitaxel is and what it is used for
- 2. Before you use Paclitaxel
- 3. How to use Paclitaxel
- 4. Possible side effects
- 5. How to store Paclitaxel
- 6. Further information
Paclitaxel concentrate for solution for infusion is given only by a doctor or nurse. They can answer any questions you may have after reading this package leaflet.
What Paclitaxel Is And What It Is Used For
This medicinal product is used for treatment of cancer. It can be cancer in the ovaries or breast cancer (advanced or spreading ovarian cancer, advanced or spreading breast cancer). This medicinal product may also be used for a special cancer in the lungs (advanced non-small-cell lung cancer, NSCLC) in patients who cannot be treated with surgery and/or radiotherapy. Paclitaxel may also be used for a special cancer, called Kaposi's sarcoma, which may be associated with AIDS (Acquired Immuno-Deficiency Syndrome) caused by an HIV disease) where other treatments i.e. liposomal anthracyclines have not worked. Paclitaxel works by stopping cell division and is used to prevent the growth of cancer cells.
Before You Use Paclitaxel
Do not use Paclitaxel
- if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients. One of the ingredients, macrogolglycerol ricinoleate, can cause severe allergic reactions.
- if you are pregnant or breast-feeding.
- if the number of white blood cells (neutrophils) is too low. This is measured by a doctor or nurse.
- In patients with Kaposi’s sarcoma, this product should not be used if you have a serious uncontrolled infection.
If you are unsure about anything, ask your doctor or pharmacist.
Take special care with Paclitaxel
- if you have heart disease or liver problems
- when diarrhoea occurs during or shortly after treatment with paclitaxel (pseudomembranous colitis)
- 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 (peripheral neuropathy)
- 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
Pregnancy and breast-feeding
Pregnancy
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 months after treatment.
Tell your doctor immediately if you do become pregnant.
Breast-feeding
- 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 do so.
Ask your doctor or pharmacist for advice before taking any medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have 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.
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 some of the ingredients of Paclitaxel
Paclitaxel contains:
- Alcohol (ethanol) approximately 50% by volume, that is up to about 20 g per dose. This is equivalent to half a litre of beer per dose or a large glass (210ml) of wine per dose. This amount may be dangerous for patients suffering from alcoholism and for high risk patients including those with liver problems or epilepsy (fits). The amount of alcohol in
this product may alter the effects of other medicines. - Macrogolglycerol ricinoleate, which can cause severe allergic (hypersensitivity) reactions.
How To Use Paclitaxel
- Your doctor will decide how much Paclitaxel you will be given. It is given under the supervision of a doctor, who can give you more information. The dose will depend on the type and the extent of the cancer, and your body surface in square metres (m2) which is calculated from your height and weight. The dose you receive will also depend on results of
your blood tests. - Paclitaxel solution has to be diluted before being given to you.
- Paclitaxel is given by infusion (a drip) into a vein for 3 hours. Treatment is usually repeated every three weeks. Treatment of AIDS-related Kaposi’s sarcoma is repeated every other week.
- Depending on the type and severity of the cancer you will receive Paclitaxel either alone or in combination with another anticancer agent.
- Each time before you are given Paclitaxel , you will be given other medicines (premedication) such as dexamethasone, diphenhydramine and cimetidine, or ranitidine.
This is necessary to decrease the risk of severe allergic (hypersensitive) reactions (see section 4. Possible side effects, uncommon).
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 and diarrhoea.
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 infusion.
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 happens, tell your doctor immediately:
- Any abnormal bruising, bleeding, or signs of infections such as a sore throat and high temperature.
- 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.
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.
- 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.
- Hair loss.
- Muscle or joint pain.
- Inflammation of areas such as the lining of the mouth.
Common (affects more than 1 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 1 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):
- Pneumonia
- 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 failure).
- Itching, rash and reddened skin.
- Weakness, high temperature (fever), dehydration, oedema, feeling ill.
- Blood poisoning.
- 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 1 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 cases of fatal outcome).
- Hives (urticaria), scaling and shedding of the skin usually accompanied by redness.
- Severe inflammatory eruption of the skin and mucous membranes (severity ranging from erythema multiforme to Stevens-Johnson syndrome to the most serious toxic epidermal necrolysis (TEN)).
- Disintegration of nails. Hands and feet should be protected against sunshine during the treatment time).
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.
How To Store Paclitaxel
Keep out of the reach and sight of children.
Keep the vial in the outer carton in order to protect from light.
Do not use this medicinal product after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
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.
Further Information
What Paclitaxel contains
- The active substance is paclitaxel.
- 1ml of concentrate for solution for infusion contains 6mg paclitaxel.
- The other ingredients are citric acid, anhydrous, macrogolglycerol ricinoleate and ethanol, anhydrous.
What Paclitaxel looks like and contents of the pack
Paclitaxel 6mg/ml concentrate for solution for infusion is a clear, colourless to pale yellow, slightly viscous solution and is packed into glass vials.
Pack sizes:
1 x 5ml vial (30mg/5ml)
1 x 16.7ml vial (100mg/16.7ml)
1 x 25ml vial (150mg/25ml)
1 x 50ml vial (300mg/50ml)
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
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This leaflet was last revised in
August 2008
If you would like a leaflet with larger text, please contact 01271 311257
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