Paclitaxel 6 Mg/Ml Concentrate For Solution For Infusion
Package leaflet: Information for the user
Paclitaxel 6 mg/ml Concentrate for solution for infusion
paclitaxel
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 or nurse.
- If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Paclitaxel 6 mg/ml is and what it is used for
2. What you need to know before Paclitaxel 6 mg/ml is given
3. How Paclitaxel 6 mg/ml is given
4. Possible side effects
5. How to store Paclitaxel 6 mg/ml
6. Contents of the pack and other information
1. What Paclitaxel 6mg/ml is and what it is used for
Paclitaxel 6mg/ml contains the active substance Paclitaxel.
Paclitaxel is a cytostatic (medicine against cancer). Paclitaxel inhibits the growth of cancer cells, finally leading to their extirpation. It may stop cancer cells from dividing and growing.
Paclitaxel 6 mg/ml is used to treat different types of cancer, i.e.:
- Ovarian cancer (advanced, with disease site transfer (metastatic), or residual tumour greater that 1 cm after surgical incision into the abdominal wall);
- Breast cancer (treatment of early breast cancer after surgical removal of the primary tumour, advanced and with disease site transfer (metastatic));
- Non-small cell lung cancer (advanced);
- Skin cancer (Kaposi’s sarcoma) in association with AIDS.
Paclitaxel 6 mg/ml may be given alone or in combination with cisplatin or with a medicine belonging to the group anthracyclines (e.g. doxorubicin) or with trastuzumab.
2. What you need to know before you are given Paclitaxel 6mg/ml
Do not use Paclitaxel 6 mg/ml:
- if you are allergic to paclitaxel or any of the other ingredients of this medicine (listed in section 6), and in particular macrogolglycerol ricinoleate;
- if you are breast-feeding;
- if you are pregnant, unless if treatment is clearly necessary;
- if the number of white blood cells or blood platelets is too low;
- if you have serious uncontrolled infections (only in case Paclitaxel 6 mg/ml is used to treat Kaposi’s sarcoma).
Warning and precautions
Talk to your doctor or nurse before taking Paclitaxel 6mg/ml if:
- You have blood disorders. Your doctor will check your blood before each treatment with Paclitaxel 6 mg/ml;
- You get heart problems during treatment with Paclitaxel 6 mg/ml. Your doctor should check the
functioning of your heart before starting the next treatment with Paclitaxel 6 mg/ml;
- You notice marked allergic reactions (e.g. shortness of breath, low blood pressure, facial swelling or rash);
- You during the administration of the medicine are injected into the surrounding tissue. Your doctor should be aware of this risk;
- You are treated with both Paclitaxel 6 mg/ml and doxorubicin or trastuzumab; the functioning of your heart should be checked before and during treatment;
- You experience or have experienced persistent numbness or tingling or pain in hands or feet (peripheral neuropathy); a dose reduction of Paclitaxel 6 mg/ml may be necessary;
- Your liver function is severely impaired; in that case the use of Paclitaxel 6 mg/ml is not recommended;
- You get diarrhoea during or shortly after treatment with Paclitaxel 6 mg/ml; your colon could be inflamed (pseudomembranous colitis). Your doctor should be aware of this risk;
- Your lungs are irradiated concomitantly. You may develop pneumonia (interstitial pneumonitis);
- You suffer from inflammation of the mucosa (mucositis); a dose reduction of Paclitaxel 6 mg/ml may be necessary.
Other medicines and Paclitaxel 6mg/ml
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interaction means that different medicines may influence each other. Interactions may occur when using Paclitaxel 6 mg/ml together withone of the following medicines:
- Erythromycine (against bacterial infection), fluoxetine (against depression) or gemfibrozil (lowering cholesterol). A dose reduction of Paclitaxel 6 mg/ml may be necessary;
- Rifampicin (against bacterial infection), carbamazepin and phenytoin against epilepsy), efavirenz or nevirapine (against infection). A dose increase of Paclitaxel 6 mg/ml may be necessary;
- Some medicines against HIV and AIDS, the so called protease-inhibitors. If you are treated concomitantly with Paclitaxel 6 mg/ml and these medicines, a dose adjustment of Paclitaxel 6 mg/ml may be necessary;
- Cisplatin (to treat cancer); Paclitaxel 6 mg/ml should be given before cisplatin. Your renal function may need to be checked more frequently;
- Doxorubicin (to treat cancer); Paclitaxel 6 mg/ml should only be administered 24 hours following administration of doxorubicin, to avoid high level of doxorubicin in your body;
Pregnancy, breast-feeding and fertility
Pregnancy during or directly following chemotherapy is strongly discouraged and you should take precautions to avoid pregnancy.
Female and male patients of fertile age, and/or their partners, should use contraceptives for at least 6 months after treatment with Paclitaxel 6 mg/ml.
You must not breast-feed your baby when you are treated with Paclitaxel 6 mg/ml.
Paclitaxel can have an anti-fertility effect. Therefore, male patients treated with paclitaxel are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
There is no reason why you should not be able to drive a car or use machines between courses of Paclitaxel 6 mg/ml.This medicine contains alcohol (see section 6). It is recommended not to drive or use machines immediately after a course of treatment. As in all cases, you should not drive a car or use machines if you feel dizzy or light-headed.
Paclitaxel 6 mg/ml contains 396 mg/ml alcohol. This medicine may be harmful to patients with liver
disorders, epilepsy, brain damage or disease, and to children, alcoholics and pregnant women. Alcohol may also influence or enhance the effect of other medicines.
Paclitaxel 6mg/ml contains macrogolglycerol ricinoleate, which may cause hypersensitivity reactions, with low blood pressure, shock, dyspnoea and flushes.
3. How Paclitaxel 6mg/ml is given Dose
Your doctor will decide about the Paclitaxel 6mg/ml dose, which will depend upon your height and body weight.
You will receive medicines to counteract possible hypersensitivity reactions before Paclitaxel 6 mg/ml is administered. That medicine can be given as either tablets or infusion into a vein or both.
The Paclitaxel 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 6 mg/ml either alone or in combination with another anticancer agent.
Your doctor will inform you about the number of courses of Paclitaxel 6 mg/ml you need to receive.
Mode of administration
Paclitaxel 6 mg/ml is given as an infusion into a vein over a period of 3 or 24 hours. Paclitaxel 6 mg/ml is usually given every 2 or 3 weeks, unless your doctor decides otherwise.
If you use more Paclitaxel 6 mg/ml than you should
Not relevant as Paclitaxel 6 mg/ml administered by a doctor or a nurse.
If you forget to use Paclitaxel 6mg/ml
Not relevant as Paclitaxel 6 mg/ml administered by a doctor or a nurse.
If you stop using Paclitaxel 6mg/ml
Not relevant as Paclitaxel 6 mg/ml administered by a doctor or a nurse.
If you have any further questions on the use of this medicine, ask your doctor or nurse
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are hair loss and a reduced number of blood cells. After the end of
treatment your hair should grow again and your blood count should return to normal.
Very common: may affect in more than 1 in 10 people:
- Infections (mainly urinary tract and upper respiratory tract infections), with reported cases of fatal outcome. If you have fever or other sign of infection, tell your doctor immediately. Sometimes serious infections develop that require treatment in the hospital with antibiotics.
- Blood disorders due to suppression of bone marrow; shortage of blood platelets which makes you bruise and bleed more readily (thrombopenia), shortage of white blood cells making you more susceptible to infections (leucopenia, neutropenia), anaemia, bleeding;
- Minor hypersensitivity reactions (mainly as flushing and rash);
- Persistent numbness, tingling or pain in hands or feet (peripheral neuropathy);
- Sleeplessness;
- Low blood pressure;
- Loss of hair;
- Pain in joints and muscles;
Nausea, vomiting, diarrhoea, mucosal inflammation.
Common: may affect up to 1 in 10 people
- Lowered heart beat rate (bradycardia);
- Mild nail and skin changes;
- Administration site reactions (including swelling, pain, redness, induration, thickening of the skin (skin fibrosis), death of skin tissue (skin necrosis));
- Raised liver enzyme levels indicating hepatic function impairment.
Uncommon: may affect up to 1 in 100 people
- Shock state as a result of blood poisoning, severe lowering of blood pressure due to bacteria in the blood, with paleness, restlessness, rapid pulse, moist skin (septic shock);
- Pronounced hypersensitivity reactions (angio-oedema) requiring therapy (e.g., low blood pressure, swelling of tongue or lips, respiratory distress, generalised rash);
- Cold and back pain;
- Myocardial infarction; affection of the heart muscle (cardiomyopathy); change in heart rhythm (rapid heart rhythm: asymptomatic ventricular tachycardia, tachycardia with bigeminy); disturbed signal conduction of the heart (AV block), sometimes loss of consciousness; changes in electrocardiogram;
- High blood pressure;
- Thrombosis; vein inflammation and blood clotting, with painful, tense and red skin;
- Raised level of bilirubin, a yellow breakdown substance of bile, in the blood;
- Hypersensitivity reaction incl. chest pain, rapid pulse, abdominal pain, pain in extremities, excessive sweating and high blood pressure.
Rare: may affect up to 1 in 1,000 people
- Serious and potentially fatal hypersensitivity reactions (anaphylactic reactions);
- Shortage of white blood cells with fever and increased risk of infection (febrile neutropenia);
- Blood poisoning;
- Inflammation of the tissue layer of cells lining the inner wall of the abdomen and pelvis (peritonitis);
- Affection of nerves with feeling of weakness in muscles of arms and legs;
- Pneumonia, shortness of breath, pleural effusion, lung fibrosis, pulmonary embolism, difficulties in breathing;
- Abdominal pain, e.g. as a result of bowel obstruction, bowel perforation; inflammation of colon (ischaemic colitis);
- Inflammation of the pancreas (pancreatitis);
- Itchy, redness, rash, weakness, dehydration, oedema, malaise;
- Raised level of creatinine in the blood indicating renal function impairment;
- Heart failure.
Very rare: may affect up to 1 in 10,000 people
- Serious and potentially fatal hypersensitivity reactions with shock;
- Sudden disorder in blood forming cells (acute myeloid leukaemia, myelodysplastic syndrome);
- Anorexia (loss of appetite);
- Confusion;
- Affection of nerves (autonomic neuropathy) resulting in constipation (paralytic ileus);
- Abrupt lowering of blood pressure sometimes with dizziness, when rising quickly from sitting or supine position (orthostatic hypotension);
- Grand mal seizures, affection of the brains with convulsions and lowered consciousness, brain disease (encephalopathy);
- Dizziness; headache; problems with coordination (ataxia), e.g. unsteady walk;
- Optic nerve and/or visual disturbances such as attacks of swimming eyes (scintillating scotomata);
- Reduction of hearing (ototoxicity); loss of hearing, ringing in the ears (tinnitus);
- Irregular rapid heart rhythm (atrial fibrillation, supraventricular tachycardia);
- Shock;
- Cough;
- Blood clot in a blood vessel of abdomen and bowel (mesenteric thrombosis); inflammation of colon sometimes with persistent severe diarrhoea (pseudomembranous colitis; neutropenic colitis); gullet inflammation; constipation; dropsy (ascites);
- Disturbed liver function (hepatic necrosis, hepatic encephalopathy, which may be life-threatening);
- Serious hypersensitivity reactions, incl. fever, skin redness, pain in joints and/or inflammation of the eye (Stevens-Johnson syndrome); local peeling of the skin (epidermal necrolysis); redness with irregular red (exudative) spots (erythema multiforme); inflammation of the skin with blisters and peeling (exfoliative dermatitis); nettle rash;
- Loose nails (patients on therapy should wear sun protection on hands and feet).
Not known: frequency cannot be estimated from the available data
- Metabolic complications (tumor lysis syndrome);
- Fluid collection in the macula of the eye (macular oedema), presence of perceived flashes of light in the eye (photpsia), deposits within the eye’s vitreous humour (vitreous floaters);
- Inflammation of a vein (phlebitis);
- Chronic skin disease (scleroderma);
- “Butterfly rash” (systemic lupus erythematosus).
If you get any side effects talk to your doctor or nurse. This includes any side effects not listed in this leaflet.
5. How to store Paclitaxel 6mg/ml
Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from light.
Do not use Paclitaxel 6 mg/ml after the expiry date which is stated on the carton after ‘Exp.’. The expiry date refers to the last day of that month.
Do not throw away any medicine via wastewater 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 6 mg/ml contains
- The active substance is paclitaxel. 1 ml of concentrate contains 6 mg paclitaxel.
- The other ingredients are ethanol anhydrous, macrogolglycerol ricinoleate.
What Paclitaxel 6 mg/ml looks like and contents of the pack
Clear, colourless or slightly yellow viscous solution.
The concentrate is packed in vials: 5 ml contains 30 mg paclitaxel; 16.7 ml contains 100 mg paclitaxel; 25 ml contains 150 mg paclitaxel and 50 ml contains 300 mg paclitaxel.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Stragen UK Limited
Castle Court, 41 London Road, Reigate, Surrey RH2 9RJ England
Tel.: +44 (0) 870 351 8744 Fax.: +44 (0) 870 351 8745 E-mail: info@stragenuk.com
Manufacturer:
Haupt Pharma Wolfratshausen GmbH Pfaffenrieder Strasse 5 D-82515 Wolfratshausen Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark, Finland, Netherlands, Norway, Sweden, Paclitaxel Stragen Luxembourg,:
Belgium Paclitaxel Stragen Nordic
United Kingdom: Paclitaxel
Czech Republic, : Pacline
Estonia, Latvia, Lithuania: Paclitaxel SanoSwiss
Poland: Egilitax
This leaflet was last approved in 17.11.2011
For any information about this medicine, please contact:
Stragen UK Limited
Castle Court, 41 London Road, Reigate, Surrey RH2 9RJ England
Tel.: +44 (0) 870 351 8744 Fax.: +44 (0) 870 351 8745 E-mail: info@stragenuk.com
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The following information is intended for medical or healthcare professionals only:
After opening before dilution
Chemical and physical in-use stability has been demonstrated for 28 days at 25 °C following multiple needle entries and product withdrawal.
From a microbiological point of view, once opened the product may be stored for a maximum of 28 days below 25 °C. Other in-use storage times and conditions are the responsibility of the user.
After dilution of the concentrate, physical-chemical stability has been demonstrated for 96 hours below 25 °C.
Diluted solutions should not be refrigerated.
Instructions for use:
Cytostatic agent.
Handling
As with all antineoplastic agents, caution should be exercised when handling Paclitaxel. 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. Pregnant women should not handle paclitaxel.
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.
Preparation for intravenous administration
Prior to infusion, Paclitaxel must be diluted using aseptic techniques in 0.9% sodium chloride solution for infusion, or 5% glucose solution for infusion, or a mixture of 0.9% sodium chloride solution for infusion and 5% glucose solution for infusion, or Ringer’s solution for infusion containing 5% glucose, to a final concentration of 0.3 to 1.2 mg/ml.
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 pm. 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.
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