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ETOPOPHOS 100MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): ETOPOSIDE PHOSPHATE

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Bristol-Myers Squibb Pharmaceuticals Limited

Package Leaflet: Information for the patient

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Powder for Solution for Injection
Read all of this leaflet carefully before you start taking 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, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this Leaflet:
1. What Etopophos is and what it is used for
2. What you need to know before you are given Etopophos
3. How you will be given Etopophos
4. Possible Side Effects
5. How to store Etopophos
6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ETOPOPHOS
Do not receive Etopophos:
- if you are allergic to etoposide, etoposide phosphate or any of the other ingredients of this medicine
(listed in section 6).
- if you have severe liver problems
- If you have recently been given a live vaccine, including Yellow fever vaccine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before receiving Etopophos:
- if you have any infections
- if you have had radiotherapy or chemotherapy recently
- if you have low levels of a protein called albumin in your blood
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.
This medicine can cause a reduction in the level of some blood cells, which could cause you to suffer from
infections, or may mean that your blood doesn’t clot as well as it should if you cut yourself. Blood tests will
be taken at the start of your treatment, and before each dose you take, to make sure that this isn’t happening.
If you have reduced liver or kidney function, your doctor may also want you to take regular blood tests to
monitor these levels.
Children and Adolescents
Use of Etopophos in children under the age of 12 years old is not currently recommended
Other medicines and Etopophos
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is especially important:
• If you are taking a medicine called ciclosporin (a drug used to reduce the activity of the immune system).
• If you are taking cisplatin (a medicine used to treat cancer)
• If you are taking phenytoin (a medicine used to treat epilepsy)
• If you are taking warfarin (a medicine used to prevent blood clots from forming)
• If you have recently been given any live vaccines
• If you are taking phenylbutazone, sodium salicylate, or aspirin
• If you are taking any anthracyclines (a group of medicines used to treat cancer)
• If you are taking any drugs with a similar mechanism of action as Etopophos
Caution should be exercised when administering Etopophos Injection with drugs that are known to inhibit
phosphatase activities.
Pregnancy, breast-feeding and fertility
Do not receive Etopophos if you are pregnant, think you may be pregnant, or if you are breast-feeding.
Both male patients and female patients of child-bearing age should use an effective contraceptive method
(e.g., the barrier method or condoms) during treatment and for at least 6 months after the end of treatment
with Etopophos.
Male patients treated with Etopophos are advised not to father a child during treatment and for up to 6
months after treatment. In addition, men are advised to seek counselling on sperm preservation before
starting treatment.
Both male and female patients who are considering having a child after having treatment with Etopophos
should discuss this with their doctor or nurse.
Driving and using machines
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 ETOPOPHOS
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 3½ hours.

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:
1. Trained personnel should reconstitute the drug.
2. This should be performed in a designated area.
3. Adequate protective gloves should be worn.
4. 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.
5. The cytotoxic preparation should not be handled by pregnant staff.
6. 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.
7. The work surface should be covered with disposable plastic backed absorbent paper.
8. 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.
Administration and Dosage
Etopophos is administered by slow intravenous infusion. ETOPOPHOS SHOULD NOT BE GIVEN BY RAPID
INTRAVENOUS INJECTION.

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100 mg etoposide (as phosphate)

The dose you receive will be based on your body surface area.
If your kidney function is lower than normal, a change to the level of the dose you receive may be needed.
The dosage you receive will be 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.
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
Severe liver, kidney or heart damage from a condition called Tumour Lysis Syndrome, caused by harmful
amounts of substances from the cancer cells getting into the blood stream, has been seen sometimes
when Etopophos is taken along with other drugs used to treat cancer.
Possible side effects experienced with Etopophos are:
- 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
- constipation
- abdominal pain
- damage to the liver (hepatotoxicity)
- Changes in skin colour (pigmentation)
- feeling weak (asthenia)
- generally feeling unwell (malaise)
- temporary hair loss
- soreness, swelling, or ulcers of the mouth, lips, tongue or throat
- chills and/or fever
- diarrhoea
- acute leukaemia
- irregular heart beat (arrhythmia), or a heart attack (myocardial infarction)
- dizziness
- pain or swelling at the injection site
- local soft tissue damage at the injection site in case of leakage into tissue
- skin problems, such as itching or rash
- high or low blood pressure
- flushing
- tingling or numbness in hands and feet
- breathing problems
- tiredness or sleepiness
- difficulty in swallowing
- a change in the way things taste
- convulsions (seizure)
- temporary blindness
- serious reactions of the skin and/or mucous membranes which may include painful blisters and fever,
including extensive detachment of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
- a sunburn-like rash that may occur on skin that has previously been exposed to radiotherapy and can
be severe (radiation recall dermatitis)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects
you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. HOW TO STORE ETOPOPHOS
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Etopophos contains
Each vial of Etopophos contains 100 mg 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
Manufacturer:
Corden Pharma Latina S.p.A.
Via del Murillo Km 2.800
04013 Sermoneta
Latina, Italy
This leaflet was last revised in July 2014
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The recommended course of Etopophos Injection is 60-120 mg/m², (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.
Renal impairment
In patients with impaired renal function, the following initial dose modification should be considered based
on measured creatinine clearance.
Measured Creatinine Clearance
>50 mL/min
15-50 mL/min

Dose of Etoposide Phosphate
100% of dose
75% of dose

Subsequent dosing should be based on patient tolerance and clinical effect. Data are not available in
patients with creatinine clearance <15 mL/min and further dose reductions should be considered in these
patients.
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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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