20 mg / mL concentrate for infusion solution 
Etoposide

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 also applies to any side effects not mentioned in this information.

In this leaflet you will find information about: 
1. What Etoposide Fresenius Kabi is and what it is used for 
2. What you need to know before you are given Etoposide Fresenius Kabi 
3. How Etoposide Fresenius Kabi is given 
4. Possible side effects 
5. How Etoposide Fresenius Kabi should be stored 
6. Contents of the packaging and other information 

What Etoposide Fresenius Kabi is and what it is used for

This medicine is called “Etoposide Fresenius Kabi” but will be called “etoposide” in this leaflet. It contains the active substance etoposide. Etoposide belongs to a group of medicines called chemotherapy drugs that are used to treat cancer.

Etoposide 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)

Etoposide is used to treat 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 etoposide is best discussed with your doctor.

Etoposide contained in Etoposide Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you are given Etoposide Fresenius Kabi

Do not take etoposide:

  • if you are allergic to etoposide or any of the other ingredients of this medicine (listed in section 6)
  • if you are breast-feeding or planning to breast-feed
  • if you have recently been vaccinated with a live vaccine, including the yellow fever vaccine.

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 or nurse before giving etoposide:

  • if you have low levels of a protein called albumin in your blood
  • if you have recently received radiation therapy or chemotherapy.
  • if you have any infection you.
  • if you 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.

Other drugs and etoposide

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

This is especially important

  • if you are taking warfarin (a medicine that prevents blood clots from forming).
  • if you are taking ciclosporin (a medicine used to reduce the activity of the immune system).
  • if you are being treated with cisplatin (a medicine used to treat cancer).
  • if you are taking phenytoin or other medicines used to treat epilepsy.
  • if you are taking phenylbutazone, sodium salicylate, or acetylsalicylic acid
  • if you have recently been vaccinated with any live vaccines.
  • if you are taking any anthracyclines (a group of medicines used to treat cancer).
  • if you are taking any medicines that work in a similar way to etoposide.

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 or pharmacist for advice before taking this medicine.

Pregnancy

Etoposide should not be used during pregnancy unless your doctor considers it necessary.

Breast-feeding

You must not breast-feed while you are being treated with etoposide.

Fertility

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 etoposide.

Men treated with etoposide are advised not to make a woman pregnant during treatment and for up to 6 months after treatment. Men are also advised to seek advice on the possibility of preserving semen before treatment.

Both male and female patients who are considering having children after treatment with etoposide 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 increased 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 or pharmacist.

Etoposide Fresenius Kabi contains ethanol, benzyl alcohol, and polysorbate 80

Ethanol

This medicine contains 30.5% by volume of ethanol (alcohol), which corresponds to 241.4 mg per ml of concentrate, equivalent to 6.1 ml of beer, or 2.5 ml of wine. For a dose of 120 mg / m 2 for a patient with a body surface area of ​​1.73 m 2, this corresponds to 63.32 ml of beer, or 25.95 ml of wine per dose.

Harmful to those suffering from alcoholism.

Attention should be paid to pregnant or lactating women, children, and high-risk groups, such as patients with liver disease or epilepsy.

Benzyl alcohol

This medicine contains 30 mg of benzyl alcohol per ml.

Benzyl alcohol can cause allergic reactions.

If you have liver or kidney problems, talk to your doctor or pharmacist before using this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).

Do not use this medicine for more than 1 week in small children (younger than 3 years) unless your doctor or pharmacist has recommended it.

Benzyl alcohol is associated with the risk of serious side effects such as difficulty breathing in young children. Do not give this medicine to newborns (up to 4 weeks of age) unless your doctor tells you to.

Polysorbate 80

Etoposide Fresenius Kabi contains polysorbate 80. A life-threatening syndrome, with liver and kidney failure, decreased respiratory function, decreased platelet count and abdominal swelling has been reported in premature infants when they received vitamin E injection containing polysorbate 80.

3. How Etoposid Fresenius Kabi is given

Etoposide 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 one, based on etoposide, is 50 to 100 mg / m 2 body surface area, daily for 5 consecutive days or 100-120 mg / m 2 body surface area on days 1, 3, and 5. This treatment regimen can then be repeated depending on the results from the blood samples, but this will not happen 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 / m 2 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 are given too much etoposide

Because a doctor or nurse will give you the medicine, 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 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 may be signs of a severe allergic reaction.

Severe liver, kidney, or heart damage from a condition called tumor lysis syndrome, which is caused by harmful substances from the cancer cells entering the bloodstream, has sometimes been seen when etoposide is taken with other drugs to treat cancer.

Possible side effects are that can be experienced in the treatment with etoposide is;

Very common (may affect more than 1 user in 10)

blood effects (this is why you 
will take blood samples between treatments)temporary hair loss nausea and vomiting abdominal pain loss of appetite
changes in skin color ( pigmentation )constipationpowerlessness ( asthenia )general malaiseliver damage (hepatotoxicity)elevated liver enzymesjaundice (elevated bilirubin )

Common (may affect up to 1 in 10 people)

acute leukemiairregular heartbeat ( arrhythmia ), 
or heart attack (heart attack)dizziness-diarrhea reactions at the infusion site
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 refluxrednessdifficulty swallowing change in how things taste severe allergic reactionsseizuresfeverdrowsiness or fatigue breathing problems temporary blindnesssevere skin 
and/or mucous membrane reactions that may 
include painful blisters 
and fever, including widespread 
skin rash (Stevens-Johnson 
syndrome and toxic epidermal necrolysis )a rash that is reminiscent of a tan 
and that can occur on the skin 
where you have previously received radiation treatment 
(“radiation recall” dermatitis ), this can be serious

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 face and tongueinfertilitybreathing difficulties

5. How to store Etoposid Fresenius Kabi

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 vial and carton after EXP.

The expiration date is the last day of the specified month.

No special temperature instructions. Do not freeze. Store in the original package. Sensitive to light.

Do not store the diluted product in a refrigerator (2 ° C – 8 ° C) as this may cause precipitation. Solutions that show signs of precipitation should not be used.

After dilution

Chemical and physical in-use stability of the solution diluted to a concentration of 0.2 mg/ml or 0.4 mg/ml has been demonstrated for up to 24 hours at 15 ° C – 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 before use are the responsibility of the user and would normally not be longer than 12 hours at 15 ° C -25 ° C, unless dilution has taken place under controlled and validated aseptic conditions.

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 etoposide. 1 ml concentrate for solution for infusion contains 20 mg etoposide. Each 5 ml vial contains 100 mg of etoposide. Each 10 ml vial contains 200 mg of etoposide. Each 25 ml vial contains 500 mg of etoposide. Each 50 ml vial contains 1000 mg of etoposide.
  • The other ingredients are macrogol 300, polysorbate 80 (E433), benzyl alcohol (E1519), ethanol, and anhydrous citric acid (E 330)

What the medicine looks like and the contents of the pack

Etoposide is a clear, pale yellow to pale yellow solution packaged in 5 ml, 10 ml, 30 ml, and 50 ml clear vials of clear type I glass, sealed with a 20 mm bromobutyl rubber stopper and sealed with 20 mm flip-off aluminum caps. (green, blue, red, and yellow).

Pack sizes: Etoposide Fresenius Kabi is available in packs containing 1 vial of 5 ml, 10 ml, 25 ml, and 50 ml.

Not all pack sizes may be marketed.

Manufacturer

Fresenius Kabi Deutschland GmbH

Pfingstweide 53

61169 Friedberg

Germany

Muhammad Nadeem

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