100 mg powder for infusion solution 
etoposide

Read all of this leaflet carefully before you start taking 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 pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Etopofos is and what it is used for 
2. What you need to know before you use Etopofos 
3. How to use Etopofos 
4. Possible side effects 
5. How to store Etopofos 
6. Contents of the packaging and other information 

1. What Etopofos is and what it is used for

The name of this medicine is Etopofos. Each vial contains the active substance etoposide phosphate equivalent to 100 mg etoposide.

Etoposide belongs to a group of medicines called chemotherapy drugs that are used to treat cancer.

Etopophos is used to treat certain types of cancer in adults:

  • testicular cancer
  • small cell lung cancer
  • cancer of the blood ( acute myeloid leukemia )
  • tumor is in the lymphatic system ( Hodgkin’s lymphoma , non-Hodgkin’s lymphoma )
  • genital cancer (gestational trophoblast neoplasia and ovarian cancer)

Etopophos is used to treat certain types of cancer in children:

  • cancer of the blood ( acute myeloid leukemia )
  • tumor is in the lymphatic system ( Hodgkin’s lymphoma , non-Hodgkin’s lymphoma )

The exact reason why you have been prescribed Etopofos is best discussed with your doctor.

Etoposide contained in Etopofos may also be approved for the treatment of other diseases 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.

2. What you need to know before using Etopofos

Do not use Etopofos

  • 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 or pharmacist before receiving Etopofos

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

Effective treatment for cancer 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 medicines and Etopofos

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 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 warfarin (a medicine that prevents blood clots from forming).
  • if you have recently been vaccinated with any live vaccines.
  • if you are taking phenylbutasone, sodium salicylate or acetylsalicylic acid .
  • if you are taking any anthracyclines (a group of medicines used to treat cancer).
  • if you are taking any medicines that have a similar mechanism of action to Etopofos.

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. Etopofos should not be used during pregnancy unless your doctor considers it absolutely necessary. You must not breast-feed while you are being treated with Etopofos. Both male patients 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 Etopofos. Men treated with Etopofos are advised against getting 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 Etopofos 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 or pharmacist.

Etopophos contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose , ie essentially ‘sodium-free’.

3. How to use Etopofos

Etopofos will be given to you by a doctor or nurse. It will be given as a slow infusioninto 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 more Etopofos than you should

Because Etopofos is given to you by a doctor or nurse, an overdose is unlikely. Should this still occur, your doctor will treat all 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 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 Etopofos is taken with other medicines to treat cancer.

Possible side effect s that can be experienced with Etopofos is;

Very common side effect is (affects more than 1 in 10)

blood effects (this is why you will have to take blood samples between treatment courses)temporary hair lossnausea and vomitingabdominal painloss of appetite
change in skin color ( pigmentation )constipationpowerlessness ( asthenia )general malaiseliver damage (hepatotoxicity)elevated liver enzymesjaundice (elevated bilirubin )

Common adverse s (affects up to 1 in 10)

acute leukemiairregular heartbeat ( arrhythmia ) or a heart attack (heart attack)dizzinessdiarrheainjection site reactions
severe allergic reactionshigh blood pressurelow blood pressuresore lips, sores in the mouth or throatskin problems such as itching or rashinflammation in a friendinfection

Less common side effects are (affecting up to 1 in 100)

tingling or loss of sensation in the hands and feet
bleeding

Rare side effects are (affecting up to 1 in 1000 users)

acid refluxrednessdifficulty swallowingchange in how things tasteseizuresfeverdrowsiness or fatiguebreathing problems
temporary blindnesssevere skin and / or mucous membrane reactions that may include painful blisters and fever, including widespread skin rash (Steven-Johnson syndrome and toxic epidermal necrolysis )a rash that is reminiscent of a tan and that can occur on 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 the face and tongue infertilitybreathing difficulties

5. How to store Etopofos

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 and vial after “EXP”. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ºC – 8 ºC). Keep the vial in the outer carton. Sensitive to light.

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

What Etopofos contains

  • The active substance is etoposide phosphate. Each vial contains etoposide phosphate equivalent to 100 mg etoposide.
  • The other ingredients are sodium citrate and Dextran 40.

What the medicine looks like and contents of the pack

Etopophos is a white to off-white powder. It comes in a glass vial with a butyl rubber stopper and an aluminum cap seal.

Etopofos is available in packs of 1, 5 or 10 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Cheplapharm Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

Corden Pharma (Latina) SpA

Via del Murillo Km 2,800

04013 Sermoneta, Latina

Italy

Muhammad Nadeem

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