Etoposide 20 Mg/Ml Concentrate For Solution For Infusion
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PACKAGE LEAFLET: INFORMATION FOR THE USER Etoposide 20 mg/ml Concentrate for solution for infusion
(Etoposide)
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.
- 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 Etoposide is and what it is used for
2. Before Etoposide is given to you
3. How Etoposide is given to you
4. Possible side effects
5. How to store Etoposide
6. Further information
1. WHAT ETOPOSIDE IS AND WHAT IT IS USED FOR
The name of this medicine is Etoposide 20 mg/ml Concentrate for solution for infusion. It contains the active ingredient Etoposide. Etoposide belongs to a type of drugs known and podophyllotoxin derivatives and it slows or stops the growth of cancer cells.
Etoposide is one of the medicines used to treat a variety of cancers. It can be used alone or in combination with other chemotherapeutic agents.
This medicine is used for the treatment of testicular cancer, lung cancer and certain cases of leukemia (blood cancer).
2. BEFORE ETOPOSIDE IS GIVEN TO YOU
When Etoposide SHOULD NOT be given to you
If the answer is YES to any of these questions, you should probably not receive Etoposide. Please discuss the matter with your doctor immediately. However, your doctor may decide that your treatment with Etoposide is essential.
- are you allergic to etoposide or to one of the other ingredients of this concentrate?
- do you have problems with your liver?
- do you have severe kidney problems?
- do you have problems with the functioning of the bone marrow?
- is the treatment used for a new born baby?
- are you pregnant or planning to become pregnant (see also "Pregnancy and breastfeeding" below)?
- are you breast feeding?
When special care should be taken
If the answer is YES to any of these questions, it is important that you discuss the matter with your doctor BEFORE receiving your first injection.
- are you using other drugs to treat cancer?
- are you receiving, or did you receive in the past, radiation therapy?
- are you suffering from infections?
Tell your doctor about any other treatment you receive for your illness.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular you should tell your doctor if you are taking any of the following:
- anti-coagulants such as warfarin which are used to thin the blood
- the analgesic (pain killing) and fever lowering medicines phenylbutazone, aspirin and aspirin related medicines (sodium salicylate or salicylic acid)
- the immunosuppressant ciclosporine (often given after an organ transplant)
- other drugs used to treat other forms of cancers such as vinblastine, doxorubicin and cisplatin
Etoposide can also have effects on other medicines used to treat cancer. Your doctor will take these effects into account when deciding on your treatment.
Using Etoposide with food and drink Etoposide is not affected by food or drink.
Pregnancy and breast-feeding
You should not use Etoposide if you are pregnant. If you are pregnant you should inform your doctor immediately. Women of child bearing age should take effective contraceptive measures.
You should not breastfeed during treatment with Etoposide.
Fathering children whilst taking Etoposide
Men should not father a child whilst being treated with Etoposide and until 6 months after treatment has finished.
It is advised for men to consider sperm collection (for cryo-conservation) before treatment with etoposide, because infertility after treatment can occur.
Driving and using machines
This medication can cause nausea and vomiting. Precaution is advised in undertaking actions which require extra alertness, such as the use of machines and driving.
Important information about some of the ingredients of Etoposide
This medicinal product contains approximately 30% ethanol (alcohol), i.e. up to 1.5 g per dose. This is equivalent to 30 ml of beer or 12.5 ml of wine per dose. This may be dangerous for patients suffering from alcoholism and for patients in high-risk groups such as those with liver problems or epilepsy (fits). The amount of alcohol in this product may alter the effects of other medicines.
Etoposide contains 30 mg/ml of benzyl alcohol and must not be given to premature babies or new born babies. It may cause toxic and allergic reactions in infants and children up to 3 years old.
3. HOW ETOPOSIDE IS GIVEN TO YOU
Etoposide concentrate for solution for infusion will always be given to you by a healthcare professional. This medicine will be diluted with 0.9 % sodium chloride or 5 % dextrose and will be given to you as an infusion (a "drip") into a vein. How much of the injection will you receive and how often?
- The dose of Etoposide will be individually determined by your doctor. The dose you are given depends on your size: it varies with your surface area. Technically, this is measured in square metres, and is worked out from your height and weight..
- You will receive a treatment cycle consisting of one dose a day during 3 - 5 days, followed by a 10 - 20 days rest.
- The administration will take at least 30 minutes.
- Usually three or four treatment cycles are given, but the duration of the treatment and the number of treatments is determined by the doctor and may vary for each patient.
- Etoposide may be given alone or in combination with other medicines.
- Your condition will be closely monitored during treatment. This routinely involves blood tests and controls of your liver function
- Your dose may be changed depending on your kidney function.
If you have any questions about your treatment schedule ask your doctor, pharmacist or nurse.
If you are given too much Etoposide
If you think you have received too much medicine consult your doctor or a nurse.
If you missed a dose of Etoposide
If you have missed a dose of your treatment, consult your doctor or a nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Etoposide can cause side effects, although not everybody gets them.
You should discuss them with your doctor who will explain the risks and benefits of your treatment.
Some of the side effects can be lessened or treated by other medicines or therapy.
Tell your doctor immediately if you notice any of the following:
- unexplained bruising, reddish or purplish patches on the skin, nosebleeds and bleeding (these may be signs of a decrease in the number of blood platelets, those cells in the blood that help the blood to clot)
- infections
- severe allergic reactions such as fever, reddening of the face and neck, often with a sudden, subjective feeling of heat (flushing), rapid heartbeat, abnormal contraction of your lungs which can cause a cough and wheezing, abnormally low blood pressure and stopping of breathing.
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The following information is intended for medical or healthcare professionals only:
Cytotoxic
Instructions on how to dilute, administer, store and dispose of Etoposide Dilution
Etoposide 20 mg/ml concentrate for solution for infusion must be diluted immediately prior to use with either 5% dextrose in water, or 0.9% sodium chloride solution to give a final concentration of 0.2 to 0.4 mg/ml. At higher concentrations precipitation of etoposide may occur.
Administration
The usual dose of etoposide, in combination with other approved chemotherapeutic agents, ranges from 100-120 mg/m2/day via continuous infusion over 30 minutes for 3-5 days, followed by a resting period of 10-20 days. Generally 3 to 4 chemotherapy cycles are administered. Dose and amount of cycles should be adjusted to the level of bone marrow suppression and the reaction of the tumour.
In patients with renal function impairment the dose should be adjusted.
Etoposide is intended for intravenous administration only.
It may be necessary to stop your treatment with Etoposide.
Although not all of these side effects may occur, tell your doctor if they do occur, as they may need medical attention. The following headings are used to organise the side effects in order of frequency:
- Very common: (may affect more than 1 in 10 users)
- Common: (may affect 1 to 10 users in 100)
- Uncommon: (may affect 1 to 10 users in 1,000)
- Rare: (may affect 1 to 10 users in 10,000)
- Very rare: (may affect 1 user in 10,000)
The side effects could include:
Very Common side effects
- you may produce less red blood cells (anaemia) and platelets than normal. This will be monitored by your doctor during your treatment with regular blood tests.
- infections
- nausea
- vomiting
- loss of appetite
- reversible loss of hair (alopecia), sometimes progressing to total baldness
- feeling of tiredness due to anaemia
Common side effects
- leukaemia (cancer of the blood) in addition to the cancer that you are being treated for
- bleeding
- allergic (hypersensitive) reactions such as fever, reddening of the face and neck, often with a sudden, subjective feeling of heat (flushing), rapid heartbeat, abnormal contraction of your lungs which can cause a cough and wheezing, abnormally low blood pressure and stopping of breathing
- redness of the skin
- facial and tongue swelling
- coughing
- sweating
- bluish discoloration of the skin and mucous membranes
- convulsions (fits)
- spasmodic closure of the voice box (larynx)
- abnormally high blood pressure
- fatigue and drowsiness
- low blood pressure causing dizziness when Etoposide is adminsitered too quickly
- abominal pain
- diarrhoea
- inflammation of the mucous membrane of the mouth
- problems with your liver including increase in liver blood test values (bilirubin, SGOT and alkaline phosphatases); your doctor will monitor your liver function with blood tests during your treatment
Uncommon side effects
- damage to nerves of the hand and feet
- irregular heartbeat
- heartattack
- abnormal contractions in your lungs which can cause a cough and wheezing
- coughing
- spasmodic closure of your throat which makes it difficult to breath-in.
- inflammation of the mucous membranes
- inflammation of the gullet (oesophagus)
- rash
- hives
- darkening of skin (increase in pigmentation)
- itching
Rare side effects
- allergic (hypersensitive) reactions caused by benzyl alcohol
- stroke, occasionally in association with allergic reactions
- a feeling of weakness
- sensations such as burning, prickling, itching, or tingling
- reversible loss of vision
- temporary blindness
- inflammation of an optic nerve
- unusually high concentration of uric acid in the blood (gout)
- inflammation of a vein
- when you are receiving the infusion, if it leaks into the surrounding tissues then irritation and swelling may occur around the location of the leakage
- stopping breathing
- inflammation of the tissue in the lungs
- formation of scar tissue in the lungs
- constipation
- difficulty in swallowing
- taste impairment
- Etoposide can accumulate in your liver and kidneys, especially if you have liver or kidney problems Very rare side effects
- a potentially life-threatening skin disorder accompanied by severe skin blisters and often sores in the membrains of the mouth, nose, eyes and the anal and gential areas.
- inflammatory, itching skin reddening following radiation therapy and subsequent treatment with a rash at the site of previous radiotherapy
- redness and pain of palms of hands and soles of feet
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE ETOPOSIDE
Keep out of the reach and sight of children.
Do not use Etoposide after the expiry date which is stated on the vial and carton after EXP. The expiry date refers to the last day of that month.
Keep the vial in the outer carton, in order to protect from light. Do not refrigerate or freeze.
After dilution the solution should be used immediately. If this is not possible, the diluted solution may be stored at 15 - 25 ° C for not more than 12 hours.
Left-overs of used solutions should be discarded. Solutions showing any signs of precipitation should not be used. Avoid unnecessary contact with the fluid. Rinse skin immediately after contact with the solution. Be sure your doctor or nurse removes any syringes or vials for disposal.
6. FURTHER INFORMATION
What Etoposide contains
- The active substanceis Etoposide. Each vial (5ml) contains 100 mg Etoposide
- The other ingredients are benzyl alcohol, citric acid, ethanol, polysorbate 80 and macrogol 300.
What Etoposide looks like and contents of the pack
Etoposide Concentrate for solution for infusion is a clear to pale yellow solution packaged in clear glass vials containing 5 ml of solution. The vials are packed in carton boxes containing 1 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
APTIL Pharma Limited,
9th Floor, CP House, 97-107 Uxbridge Road, Ealing,
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Ltd.,
9th Floor, CP House, 97-107 Uxbridge Road, Ealing,
This leaflet was last amended 05/2012
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To prevent the occurrence of hypotension, the infusion should be given over at least 30 minutes.
Storage of the prepared solution
Chemical and physical in-use stability has been demonstrated for 24 hours 15-25 °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 12 hours at 15 - 25 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Handling and disposal
The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted:
• Staff should be trained to reconstitute the medicinal product.
• Pregnant staff should be excluded from working with this medicinal product.
• Staff handling this medicinal product during reconstitution should wear protective clothing including mask, goggles and gloves.
• All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
• Liquid waste may be flushed with large amounts of water.
• Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.