Paxene
paclitaxel
Paclitaxel
Keep this leaflet safe as you may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should 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.
What Paxene is and what it is used for
Before you use Paxene
How to use Paxene
Possible side effects
5 How to store Paxene
6. Further information
Medicinal product no longer authorised
Paxene belongs to a group of medicines known as antineoplastic agents. These agents are used to treat cancer.
Paxene concentrate for solution for infusion is used to treat:
Advanced AIDS-related Kaposi’s sarcoma when certain other treatments (liposomal anthracyclines) have been tried but have not worked. This is a tumour that arises from blood vessels in the skin or internal organs and typically appears as flat or raised, purple to dark brown patches on the skin.
Advanced breast cancer when certain other treatments (standard anthracycline-containing therapy) have been tried but have not worked or when the patient is unsuitable for these treatments.
Advanced ovarian cancer or remaining tumour (> 1 cm) after initial surgery, in combination with cisplatin as first-line treatment.
Advanced ovarian cancer when certain other treatments (platinum-containing combination therapy without taxanes) have been tried but have not worked (as second-line treatment).
Advanced non-small cell lung cancer if potentially curative surgery and/or radiation therapy are not possible, in combination with cisplatin. There is limited information to support treatment of this condition.
if you are hypersensitive (allergic) to paclitaxel or any of the other ingredients of Paxene,
if you have ever had any problems with your liver,
if you have been told that your white blood cell count is very low,
if you have a serious, uncontrolled infection,
if you are pregnant, may become pregnant or are breast-feeding.
Before you start treatment with Paxene and during treatment, you will have regular blood tests to check that it is safe for you to continue with your treatment.
Paxene is not recommended for use in children and adolescents under 18 years.
Tell your doctor immediately if you develop severe or prolonged or bloody diarrhoea during or after treatment with Paxene. This may be a sign of a serious bowel inflammation (pseudomembranous colitis).
If you experience an irregular heart beat, dizziness or faintness during treatment.
If you previously had radiation treatment (radiotherapy) to your chest (see section 4: Possible side effects).
If you are taking other medicines which could interact with paclitaxel (see Using other medicines).
Please tell your doctor before you are given Paxene if you:
are taking ritonavir, nelfinavir, efavirenz, nevirapine (for the treatment of AIDS) or any other prescribed medicines for your condition;
are taking any other medicines prescribed by a physician for any condition (e.g. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals, rifampicin, carbamazepine, phenytoin, phenobarbital);
are taking other medicines that you have bought for yourself without a prescription.
Medicinal product no longer authorised
If you are already being treated with doxorubicin for your condition, then your first dose of paclitaxel should be given 24 hours after doxorubicin.
Paxene may alter the effect of other medicines because of its high alcohol content. If you see another doctor or visit a hospital, remember to tell them what medicines you are taking.
Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding before you receive treatment with Paxene. Paxene cannot be used in pregnancy, and women receiving Paxene must not breast-feed. Adequate contraceptive precautions should be used when receiving Paxene.
Male patients treated with Paxene are advised not to father a child during and up to six months after the treatment.
Paxene contains alcohol. Thus it may not be safe for you to drive or to use machines for up to several hours after you have had your treatment. Check with your doctor. You should be able to drive and use machines between your treatments with Paxene, unless you feel tired or dizzy
This medicine contains approximately 50 % by volume of alcohol. Each infusion contains up to 21 g of alcohol. The amount of alcohol in this medicine may alter the effects of other medicines and should be taken into account in patients with liver disease or epilepsy. Following an infusion of Paxene, the amount of alcohol may impair your ability to drive or use machines.
Paxene contains polyoxyl castor oil, which can cause an allergic reaction.
Your concentrate for solution for infusion will be diluted and given slowly into a vein over about
3 hours unless otherwise stated. The amounts (dose) of Paxene you will be given will be worked out depending on your body surface area in square meters (m2) and will also take into account the results of your blood tests and your medical condition. If necessary, your doctor will adjust the dosage during the treatment.
The usual dose of Paxene is 100 mg/m2 of body surface area. You will be given Paxene every two weeks, as long as the results of your blood tests show that it is safe to carry on with your treatment.
The usual dose of Paxene is 175 mg/m2 of body surface area. You will be given Paxene every three weeks, as long as the results of your blood tests show that it is safe to carry on with your treatment.
Two doses of Paxene may be given: Paxene 175 mg/m2 of body surface area administrated as a 3 hour infusion into a vein, followed by another medicine, cisplatin, every three weeks; alternatively Paxene 135 mg/m2 given as a 24 hour infusion, followed by cisplatin, every three weeks. Your continued treatment will depend on the results of your blood tests showing that it is safe to carry on with your treatment.
Medicinal product no longer authorised
The usual dose of Paxene is 175 mg/m2 of body surface area, followed by cisplatin every three weeks. You will be given this therapy as long as the results of your blood tests show that it is safe to carry on with your treatment.
To help prevent allergic reactions occurring while you are receiving your infusion you will be given medication before your treatment starts. Twelve and then six hours before your infusion you will be given dexamethasone (a steroid), either as a tablet to swallow or as an injection. Half to one hour before your infusion you will be given two different types of injection (an antihistamine and an
H2 antagonist).
You will only be given your infusion under medical supervision, and you will be checked regularly while you are having your infusion to see how you are reacting to it. If you have a history of heart problems, your heart rate may be monitored. If any problems occur while you are having your infusion, the medical staff will be on hand to take any necessary action.
Like all medicines, Paxene can cause side effects, although not everybody gets them.
Side-effects may occur while you are receiving Paxene or following treatment. During treatment, you should tell the medical staff if you feel unwell. If you feel unwell between courses or after your treatment has finished, tell your doctor or pharmacist as soon as you can.
The frequency of possible side-effects listed below is defined using the following convention: very common (affects more than 1 person in 10)
common (affects 1 to 10 persons in 100)
uncommon (affects 1 to 10 persons in 1,000)
rare (affects 1 to 10 persons in 10,000)
very rare (affects less than 1 person in 10,000)
not known (frequency cannot be estimated from the available data Very common side-effects are listed below:
Infections – this may be associated with feeling hot (fever) or cold (chills), sore throat and fungal infection in the mouth (oral candidiasis)
Mild allergic reactions including flushing and skin rash
Low blood pressure, which may make you feel light-headed upon standing
Eating disorders including anorexia
Nerve disorders including tingling sensation or pins and needles of the hands and feet
Feeling or being sick
Mild diarrhoea, constipation and stomach pain
Hair loss
Joint or muscle weakness, pain or loss of sensation in your legs
Pain and swelling might occur around the injection site Common side-effects are listed below:
Flu-like symptoms
Temporary low white blood cell count, which may make you develop an infection
Low blood platelet counts that can cause unusual bleeding (e.g. nose bleeds) and unexplained bruising
Painful sensation in the body
Feeling dizzy
Medicinal product no longer authorised
Feeling agitated
Lack of sleep
Bad taste in your mouth
Loss of balance or staggering
Headache
Ringing in your ears
Abnormal heart rhythm
Feeling faint
Reddening or flushing of your skin
Shortness of breath
Nose bleeds
Dry mouth and mouth ulcers
Indigestion
Discolouration of stool
Changes in your skin and nails
Mild flaking of skin associated with dryness, rash and acne
Pain in the bones and back, as well as leg cramps
Experiencing pain while passing urine
Injection site reactions leading to pain, swelling and hardness of the skin around the injection site. Paxene might also leak from the vein and cause an infection or ulceration of the surrounding skin.
The levels of some enzymes in your blood might rise Uncommon side-effects are listed below:
Severe infections such as pneumonia
Severe anaemia
Feeling tired
Pale skin
Dehydration, weight loss or weight gain
Severe chest pains, irregular heart beat, feeling faint and heart attack
High blood pressure, blood clots and inflammation in the veins
Yellowing of the skin and nails Rare side-effect are listed below:
Infections such as pneumonia
Localised swelling of the skin
Severe allergic reactions (anaphylactic reaction) – you may experience localised itching and swelling of the hands, feet, ankles, face. lips, mouth, tongue or throat
Effects on the nerves controlling your muscles resulting in weakness in the arms and legs
Itching, red skin rash
Problems with your lungs including swelling and fluid accumulation, which may cause breathing problems
Very rare side- effects are listed below:
Acute leukaemia (blood cancer)
Life-threatening allergic reaction (anaphylactic shock)
Appearing and acting confused
Brain disease
Persistent diarrhoea
Fits (convulsions, seizures)
Vision disturbances
Loss of hearing
Medicinal product no longer authorised
Balance problems
Increase in heart beat
Shock
Constipation
Abdominal pain caused by a build up of fluid in the abdomen (ascites), inflammation of the bowel, bowel obstruction, blood clots in the blood vessels to your bowel and perforation of your bowel wall
Disease of the pancreas
Disease in the oesophagus (the tube that carries food into your stomach)
Loss of appetite
Severe skin irritation, lesions and rash
Loosening of finger and toe nails – you should wear protection on your feet and hands when exposed to the sun
Liver damage – yellowing of the skin and abnormal levels of some liver enzymes
f you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. 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.
Keep out of the reach and sight of children.
Do not use Paxene after the expiry date, which is stated on the vial label and outer carton after “use by”. The expiry date refers to the last day of that month.
Do not store above 25 oC.
Keep the vial in the outer carton in order to protect from light.
Your concentrate for solution for infusion will be kept in the pharmacy and they will prepare it, ready to be given by the doctor or nurse. Following dilution, chemical and physical in use stability has been demonstrated for at least 24 hours below 25 oC. From a microbiological point of view, once opened the product should be used immediately. Other in use storage times and conditions are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8 oC.
Do not use Paxene if you notice any visible particles of discolouration of the solution. The prepared solution may appear hazy.
For single use only. Dispose of any remaining contents after first use.
Medicinal product no longer authorised
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.
The active substance is paclitaxel 6 mg/ml (30 mg/5 ml, 100 mg/16.7 ml, 150 mg/25 ml or 300 mg/50 ml).
The other ingredients are polyoxyl castor oil, citric acid (anhydrous) and ethanol.
Paxene is a clear, colourless to slightly yellow, thickish solution that comes in vials containing 5 ml,
16.7 ml, 25 ml and 50 ml of concentrate. Not all pack sizes may be marketed. Marketing Authorisation Holder
Norton Healthcare Limited Albert Basin
Royal Docks London E16 2QJ United Kingdom.
IVAX Pharmaceuticals s.r.o. Ostravská 29/305
Medicinal product no longer authorised
747 70 Opava Komárov Czech Republic
IVAX Pharmaceuticals UK Runcorn
Cheshire
United Kingdom
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
S.A. Mayne Pharma (Benelux) N.V. Tel: + 32 2 332 0315
S.A. Mayne Pharma (Benelux) N.V. Tel: + 32 2 332 0315
IVAX Pharmaceuticals s.r.o Tel: +420 553 641 111
IVAX Drug Research Institute Ltd Tel.: +36 1399 3343
IVAX Pharmaceuticals s.r.o Tel: +420 553 641 111
Norton Healthcare Ltd t/a IVAX Pharmaceuticals UK
Tel.: +44 8705 02 03 04
IVAX Scandinavia AB Tlf.: +46 850 666 300
S.A. Mayne Pharma (Benelux) N.V. Tel: + 32 2 332 0315
Mayne Pharma (Deutschland) GmbH D-85540 Haar
Tel: +49 89 43 77 770
Mayne Pharma (Nordic) AB, Sverige Tel: + 46 8 672 85 00
IVAX Pharmaceuticals s.r.o Tel: +420 553 641 111
Norton Healthcare Ltd t/a IVAX Pharmaceuticals UK
Tel.: +44 8705 02 03 04
Norton Healthcare Ltd t/a IVAX Pharmaceuticals UK
Тηλ.: +44 8705 02 03 04
IVAX Pharma Poland Sp. z.o.o. Tel: +48 22 742 04 25
Combino Pharm, S.L. Tel.: +34 93 480 88 33
Mayne Pharma (Portugal) Lda Tel: + 351 21 485 7430
Mayne Pharma (France) SAS. Tel: + 33 1 41 11 28 50
IVAX Pharmaceuticals s.r.o Tel: +420 553 641 111
Mayne Pharma Plc Tel: + 44 1926 821 010
Medis, d.o.o
Tel: + 386 1 589 69 00
Medicinal product no longer authorised
Norton Healthcare Ltd t/a IVAX Pharmaceuticals UK
Tel.: +44 8705 02 03 04
Mayne Pharma (Italia) s.r.l. Tel: +39 0 81 24 05 911
Mayne Pharma (Nordic) AB, Ruotsi/Sverige Tel: + 46 8 672 85 00
Norton Healthcare Ltd t/a IVAX Pharmaceuticals UK
Тηλ.: +44 8705 02 03 04
Mayne Pharma (Nordic) AB, Sverige Tel: + 46 8 672 85 00
IVAX Pharmaceuticals s.r.o Tel: +420 553 641 111
IVAX Pharmaceuticals s.r.o Tel: +370 525 26490
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The following information is intended for medical or healthcare professionals only:
Further instructions for preparation for infusion
Paxene is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised in handling Paxene. The use of gloves, goggles and protective clothing is recommended. If Paxene solution comes into contact with the skin, wash the skin immediately and thoroughly with soap and water. If Paxene contacts mucous membranes, the membranes should be flushed thoroughly with water. Paxene should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents. Pregnant staff should not handle Paxene.
Paxene must be diluted under aseptic conditions prior to infusion. Paxene should be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection, glucose 50 mg/ml (5%) solution for infusion, or glucose 50 mg/ml (5%) in Ringer’s solution for injection to a final concentration of 0.3 to 1.2 mg/ml.
Following dilution, chemical and physical in-use stability in polypropylene infusion bags has been demonstrated for at least 24 hours when stored below 25 °C.
From a microbiological point of view, the diluted 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.
Medicinal product no longer authorised
Chemical and physical and microbial stability of unused, undiluted product remaining in the vial has been demonstrated for up to 28 days when stored below 25 ºC. Other in-use storage times and conditions are the responsibility of the user.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle.
Levels of the extractable plasticiser DEHP [di-(2-ethylhexyl)phthalate] increase with time and concentration when dilutions are prepared in PVC containers. Consequently, the use of plasticised PVC containers and administration sets is not recommended.
Paxene solutions should be prepared and stored in glass, polypropylene, or polyolefin containers. Non- PVC containing administration sets, such as those which are polyethylene-lined, should be used.
Paxene should be administered through an in-line filter with a microporous membrane not greater than
0.22 µm. Use of filter devices which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DEHP.
Procedures for proper handling and disposal of cytotoxic medicinal products should be followed.