20 mg / mL concentrate for infusion solution
etoposide
1. What Eposin is and what it is used for
The name of this medicine is Eposin. Each vial contains 100 or
500 mg of the active substance etoposide. Etoposide belongs to a group of medicines called chemotherapy drugs that are used to treat cancer.
Eposin is used to treat certain types of cancer in adults:
- testicular cancer
- small cell lung cancer
- cancer of the blood ( acute myeloid leukemia )
- the tumor is in the lymphatic system ( Hodgkin’s lymphoma, non-Hodgkin’s lymphoma )
- genital cancer (gestational trophoblast neoplasia and ovarian cancer)
Eposin is used in the treatment of certain types of cancer in children:
- cancer of the blood ( acute myeloid leukemia )
- the tumor is in the lymphatic system ( Hodgkin’s lymphoma, non-Hodgkin’s lymphoma )
The exact reason why you were prescribed Eposin is best discussed with your doctor.
The etoposide contained in Eposin may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Eposin
You should not receive Eposin
- if you are allergic to etoposide or any of the other ingredients of this medicine (listed in section 6).
- if you have recently been vaccinated with a live vaccine, including the yellow fever vaccine.
- if you are breast-feeding or planning to breast-feed.
If any of the above applies to you, or you are not sure if it applies to you, consult your doctor.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Eposin if you:
- have any infection you
- have received radiation therapy or chemotherapy recently
- have low levels of a protein called albumin in your blood
- have liver or kidney problems
Effective cancer treatment can quickly destroy cancer cells on a large scale. In very rare cases, this can cause harmful amounts of substances from these cancer cells to be released into the bloodstream. If this happens, it can cause problems with the liver, kidneys, heart, or blood and lead to death if left untreated. To prevent this, your doctor will need to take regular blood tests to monitor the level of these substances during treatment with this medicine.
This medicine can cause a decrease in certain blood cells which can lead to you getting an infection or it can mean that your blood does not coagulate as well if you cut yourself. Blood samples will be taken at the beginning of your treatment and before each dose you receive to check that this is not happening.
If you have impaired liver or kidney function, your doctor may also want to take regular blood tests to monitor your liver and kidney function. See also section “Eposin contains ethanol, benzyl alcohol and polysorbate 80”.
Other medicines and Eposin
Tell your doctor or healthcare professional if you are taking, have recently taken, or might take any other medicines.
This is especially important if you:
- takes ciclosporin (used to reduce the activity of the immune system)
- treated with cisplatin (used to treat cancer)
- taking phenytoin or other medicines used in epilepsy
- takes warfarin (prevents blood clots from forming)
- recently vaccinated with any live vaccine
- take phenylbutazone, sodium salicylate, or acetylsalicylic acid (painkillers)
- take some anthracyclines (a group of medicines used to treat cancer)
- take some medicines that work in a similar way to Eposin (eg cyclophosphamide, carmustine, lomustine, 5-fluorouracil, vinblastine, doxorubicin, bleomycin, ifosfamide, methotrexate)
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Eposin must not be used during pregnancy unless clearly necessary by your doctor.
You must not breast-feed while you are being treated with Eposin.
Both male and female patients who may become pregnant must use an effective contraceptive (eg a barrier method or condom) during treatment and up to 6 months after stopping treatment with Eposin.
Men treated with Eposin are advised not to make a woman pregnant during treatment and for up to 6 months after treatment. Men are also advised to obtain information about the possibility of preserving semen before treatment.
Both male and female patients who are considering having children after treatment with Eposin should discuss this with a doctor or nurse.
Driving and using machines
The effect on the ability to drive and use machines has not been studied. If you feel tired, unwell, dizzy, or faint, do not drive or use machines until you have discussed this with your doctor.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor, pharmacist, or nurse.
Eposin contains ethanol, benzyl alcohol, and polysorbate 80
Eposin contains ethanol
Eposin contains ethanol (alcohol). Vial 5 ml contains a maximum of 1.2 g ethanol and vial 25 ml contains autumn 6 g ethanol. This can be harmful to people suffering from alcoholism. Attention should be paid to pregnant women, children, and high-risk groups such as patients with liver disease or epilepsy.
Eposin contains benzyl alcohol
This medicine contains 30 mg of benzyl alcohol per ml. Benzyl alcohol can cause allergic reactions. Benzyl alcohol is associated with the risk of serious side effects such as difficulty breathing in young children. Eposin should therefore not be given to newborns (up to 4 weeks of age) and should not be used for more than 1 week in young children (younger than 3 years) unless prescribed by a doctor.
If you are pregnant or breast-feeding or have impaired liver or kidney function, consult your doctor, pharmacist, or nurse before receiving this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects(metabolic acidosis ).
Eposin contains polysorbate 80
Eposin contains polysorbate 80. In premature infants, a life-threatening syndrome with liver and kidney failure, impaired lung capacity, decreased platelet count and ascites (fluid in the abdomen) has been associated with a vitamin-E injection containing polysorbate 80.
3. How to get Eposin
Eposin will be given to you by a doctor or nurse. It will be given as a slow infusion into a vein. This can take between 30 to 60 minutes.
The dose you receive will be tailored to you and calculated by your doctor. The usual dose is 50 to 100 mg / m2 body surface area, daily for 5 consecutive days or 100-120 mg / m2 body surface area on days 1, 3, and 5. This course of treatment can then be repeated depending on the results of the blood tests, but this will not occur until at least 21 days after the first course of treatment.
For children treated for cancer of the blood or lymphatic system, a dose of 75 to 150 mg / m2 of body surface area is used daily for 2 to 5 days.
Your doctor may sometimes prescribe a different dose, especially if you are, or have been, receiving other treatment for your cancer or if you have kidney problems.
If you take more Eposin then you should
Because this medicine is given to you while you are in hospital, an overdose is unlikely. Should this still occur, your doctor will treat any subsequent symptoms.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or nurse immediately if you get any of the following symptoms: swollen tongue or throat, difficulty breathing, rapid heartbeat, reddening of the skin, or rash. These symptoms may be a sign of a severe allergic reaction.
Serious liver-, kidney or heart damage from a condition called tumor lysis syndrome, which is caused by harmful levels of substances from the cancer cells that get into the bloodstream, have sometimes been seen as Eposin taken with other drugs for the treatment of cancer.
Possible side effect s that can be experienced with Eposin are:
Very common (may affect more than 1 user in 10):
- blood effects (this is why you will have to take blood samples between treatment courses)
- temporary hair loss
- nausea, vomiting
- abdominal pain
- loss of appetite
- change in skin color ( pigmentation )
- constipation
- powerlessness ( asthenia )
- general malaise
- liver damage (hepatotoxicity), hepatic impairment, jaundice (elevated bilirubin )
Common (may affect up to 1 in 10 people):
- acute leukemia (blood cancer)
- irregular heart rhythm ( arrhythmia ) or heart attack
- dizziness
- diarrhea
- injection site reactions
- severe allergic reactions
- high blood pressure
- low blood pressure
- sore lips, sores in the mouth or throat
- skin problems such as itching or rash
- inflammation in a friend
- infection
Uncommon (may affect up to 1 in 100 people):
- tingling or loss of sensation in the hands and feet
- bleeding
Rare (may affect up to 1 in 1,000 people):
- acid reflux
- redness
- difficulty swallowing
- change in how things taste
- seizures
- fever
- drowsiness or fatigue
- breathing problems
- temporary blindness
- severe skin and/or mucosal reactions that may include painful blisters and fever, including widespread skin rash (Steven-Johnson syndrome and toxic epidermal necrolysis )
- rash reminiscent of sunburn and which may occur on radiation-treated skin (” dermatitis” ), this may be
- allergic reactions caused by benzyl alcohol
Has been reported (occurs in an unknown number of users):
- tumor lysis syndrome (complications of substances released by the cancer cells entering the bloodstream)
- swelling of the face and tongue
- infertility
- breathing difficulties
Reporting of side effects
5. How to store Eposin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Keep the vial in the outer carton. Sensitive to light. Do not freeze.
A reconstituted infusion solution should be used immediately. Infusion fluid with a concentration of 0.2 mg etoposide/ml and 0.4 mg etoposide/ml is stable for 12 hours when stored at a maximum of 25 ° C for protection against cold in both glass and plastic containers.
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.
6. Contents of the packaging and other information
Content declaration
- The active substance is 20 mg etoposide per ml.
- The other ingredients are anhydrous citric acid, benzyl alcohol (30 mg/ml), polysorbate 80, macrogol, anhydrous ethanol.
What the medicine looks like and the contents of the pack
Pack size: 5 ml, 10×5 ml, 1×25 ml, 10×25 ml in vial .
Not all pack sizes may be marketed.
Manufacturer:
Pharmachemie BV, Box 552, 2003 RN Haarlem, The Netherlands