Etopophos 100mg Powder For Solution For Injection
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EtopophOS™ 100mg Powder for Solution for Injection
_ 100 mg etoposide (as phosphate)
—— Please read this leaflet carefully before you are given your medicine.
It provides a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.
In this Leaflet:
“ 1. What Etopophos is and what it is used for _ 2. Before you are given your medicine
3. How you will be given your medicine
4. Possible Side Effects
5. How to store your medicine
6. Further Information
1. WHAT ETOPOPHOS IS AND WHAT IT IS USED FOR
The name of your medicine is Etopophos. Etopophos contains the active ingredient etoposide phosphate. Etoposide phosphate belongs to a group of medicines called anticancer agents which are used in the treatment of cancer.
Etopophos is used to treat certain types of cancer, in particular small cell lung cancer and testicular cancer.
2. BEFORE YOU ARE GIVEN YOUR MEDICINE Do not receive Etopophos if you:
- are allergic (hypersensitive) to etoposide , etoposide phosphate or any other ingredients of Etopophos
- have severe liver problems Tell you doctor if you:
- have any infections Important Information
Effective anti-cancer treatment can destroy cancer cells rapidly in large numbers. On very rare occasions this may cause harmful amounts of substances from these cancer cells to be released into the blood. If this happens it can cause problems with the liver, kidney, heart or blood, which may result in death if not treated.
In order to prevent this, your doctor will need to do regular blood tests to monitor the level of these substances during treatment with this medicine.
Taking with other medicines
Always tell your doctor or pharmacist about other medicines you may be taking or have recently taken including those obtained without a prescription.
This is especially important if you are taking a medicine called:
- ciclosporin used following organ transplant
- cisplatin used to treat certain forms of cancer or if you are taking any medicines to treat:
- cancer
- immune diseases
Pregnancy and breast-feeding
Do not receive Etopophos if you are pregnant, think you may be pregnant, or if you are breast-feeding.
Driving or operating machinery
You can drive and operate machinery while receiving Etopophos, but do not do so if you feel dizzy or light-headed.
3. HOW YOU WILL BE GIVEN YOUR MEDICINE
Etopophos will be given to you by a doctor or nurse. It may be given as a slow infusion into a vein from an intravenous drip. This may take up to 3% hours.
The dose you receive will be based on your body surface area and worked out by your doctor. Etopophos is usually given once daily for five consecutive days. This will be repeated every 3 weeks.
This may vary depending on the results of regular blood tests.
If you are given too much Etopophos
As Etopophos is given to you by a doctor or nurse, overdose is unlikely. If this does occur, your doctor will treat any symptoms that follow. 1 2 3 4 5 6 7 8 9
4. POSSIBLE SIDE EFFECTS
Like all medicines, Etopophos can cause side effects, although not everybody gets them.
If you notice any of the following, tell your doctor immediately:
- swelling of the face, lips, or tongue
- skin rash
- difficulty breathing
As these may be signs of an allergic reaction
Very common side effects experienced with Etopophos (affecting more than 10% of patients) include:
- blood disorders including a reduction in the number of white blood cells, a reduction in the number of platelets in the blood and a reduction in red blood cells (anaemia) (your doctor will carry out blood tests between courses of treatment to control these)
- feeling sick and/or being sick
- loss of appetite
- soreness and swelling of the mouth and tongue
- weakness and generally feeling unwell
- temporary hair loss
- chills and/or fever
Common side effects experienced with Etopophos (affecting between 1% and 10% of patients) include:
- constipation
- diarrhoea
- abdominal pain
- a change in the way things taste
- dizziness
- pain or swelling at the injection site;
Other possible side effects include:
- high blood pressure
- flushing
- irregular breathing
- coughing
- liver or kidney problems
- tiredness or sleepiness
- itching, rash or colouration of the skin
- difficulty in swallowing
- temporary blindness
- local soft tissue damage at the injection site in case of leakage into tissue
If you notice any of these, or any other effects, during or after your treatment has finished tell your doctor.
5. HOW TO STORE YOUR MEDICINE
This medicine will be stored in the pharmacy and made up in a special area before the doctor or nurse gives it to you. It should be stored between 2-8°C. The vial should be kept in the outer carton.
Do not use after the expiry date shown on the packaging of Etopophos Injection.
6. FURTHER INFORMATION What Etopophos contains
Each vial of Etopophos contains 100mg of the active ingredient etoposide phosphate. The other ingredients are: dextran 40 and sodium citrate.
What Etopophos looks like and contents of the pack Etopophos is a white to off-white dry powder.
It is supplied in 20ml glass vials with butyl rubber stopper and flip-off aluminium seal. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Bristol-Myers Squibb Pharmaceuticals Limited Uxbridge Business Park,
Sanderson Road,
Uxbridge,
Middlesex UB8 1DH,
England
Tel: 0800 731136 Maunfacturer
Corden Pharma Latina S.p.A.
Via del Murillo Km 2.800 04013 Sermoneta Latina, Italy
DATE OF LAST REVISION September 2010
1244137
PLEASE DETACH BEFORE HANDING ABOVE SECTION TO THE PATIENT
INFORMATION FOR HEALTH PROFESSIONALS
Below is a summary of the information to assist in the administration of Etopophos. You should be experienced in the handling and use of cytotoxic agents and be familiar with the SPC for Etopophos Injection. Reference should be made to the Summary of Product Characteristics for full prescribing information.
Preparation of Intravenous Solution
Immediately prior to administration, the content of each vial must be reconstituted with either 5 ml or 10 ml Water for Injection B.P., 5% Glucose Intravenous Infusion B.P. or 0.9% Sodium Chloride Intravenous Infusion BP to a concentration equivalent to 20 mg/ml or 10 mg/ml etoposide (22.7 mg/ml or 11.4 mg/ml etoposide phosphate), respectively. This produces a clear colourless to pale yellow solution.
Following reconstitution the solution may be administered without further dilution or it can be further diluted to concentrations as low as 0.1 mg/mL etoposide (0.14 mg/ml etoposide phosphate) with either 5% Glucose Intravenous Infusion BP or 0.9% Sodium Chloride Intravenous Infusion BP.
Chemical and physical in-use stability has been demonstrated for 7 days at 2-8°C.
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 7 days at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
When reconstituted as directed, Etopophos solutions can be stored in glass or plastic containers under refrigeration (2-8°C) for 7 days; at controlled room temperature 20-25°C for 24 hours following reconstitution with Sterile Water for Injection, USP, 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP; or at controlled room temperature 20-25°C for 48 hours following reconstitution with Bacteriostatic Water for Injection with Benzyl Alcohol or Bacteriostatic Sodium Chloride for Injection with Benzyl Alcohol. Etopophos solutions further diluted as directed can be stored under refrigeration (2-8°C) or at controlled room temperature 20-25°C for 24 hours.
Etopophos should not be physically mixed with any other drug.
Guidelines for the safe handling of anti-neoplastic agents:
Trained personnel should reconstitute the drug.
This should be performed in a designated area.
Adequate protective gloves should be worn.
Precautions should be taken to avoid the drug accidentally coming into contact with the eyes. In the event of contact with the eyes, irrigate with large amounts of water and/or saline.
The cytotoxic preparation should not be handled by pregnant staff.
Adequate care and precautions should be taken in the disposal of items (syringes, needles etc) used to reconstitute cytotoxic drugs. Excess material and body waste may be disposed of by placing in double sealed polythene bags and incinerating at a temperature of 1,000°C. Liquid waste may be flushed with copious amounts of water.
The work surface should be covered with disposable plastic backed absorbent paper.
Use Luer-Lock fittings on all syringes and sets. Large bore needles are recommended to minimise pressure and the possible formation of aerosols. The latter may also be reduced by the use of a venting needle.
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Administration and Dosage
Etopophos is administered by slow intravenous infusion. ETOPOPHOS SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.
The recommended course of Etopophos Injection is 60-120 mg/m3, (etoposide equivalent) i.v daily for five consecutive days. As Etopophos produces myelosuppression, courses should not be repeated more frequently than at 21 day intervals. In any case, repeat courses of Etopophos should not be given until the blood picture has been checked for evidence of myelosuppression and found to be satisfactory.
Etopophos solutions may be infused over 5 minutes to 3.5 hours.
Care should be taken to avoid extravasation.
Elderly:
No dosage adjustment is necessary.
Paediatric use:
Safety and effectiveness in children have not been established.
Storage
Store between 2-8°C. Keep the vial in the outer carton.
An “expiry date” is given on the packaging of Etopophos Injection. The injection should not be used after this date.