Etoposide Fresenius 20 mg

ETOPOSIDE FRESENIUS 20 mg/mL contains the active ingredient etoposide. Etoposide belongs to the group of medicines called cytostatics which are used in the treatment of cancer. ETOPOSIDE FRESENIUS 20 mg/mL is used in combination with other anti-cancer medicines in the treatment of certain types of cancers, including tumours of the testicles, the lungs or lymphatic system (non-Hodgkin’s lymphoma). Your doctor will tell you why you have been prescribed ETOPOSIDE FRESENIUS 20 mg/mL.

ETOPOSIDE FRESENIUS 20 mg/mL should not be administered to you:

• if you are hypersensitive (allergic) to etoposide or any of the other ingredients of ETOPOSIDE FRESENIUS 20 mg/mL (listed in section 6);
• if you have recently been given a live vaccine, including yellow fever vaccine;
• if you have severe liver problems;
• if you have severely impaired formation of blood cellular components;
• if you have impaired renal function;
• if you have, or have recently had chickenpox (or recent exposure to it);
• if you have herpes zoster;
• if you have bone marrow depression;
• if you are pregnant or breastfeeding or planning to breastfeed.

If any of the above affects you, or if you are unsure if they do, tell your doctor who will be able to advise you.

Warnings and precautions

ETOPOSIDE FRESENIUS 20 mg/mL should only be administered under the supervision of a medical practitioner with experience in cancer treatment. Some side effects may require immediate attention by the medical practitioner. Talk to your doctor, pharmacist or nurse before you receive ETOPOSIDE FRESENIUS 20 mg/mL:

• if you have a bacterial infection, as it should be treated before you start treatment with ETOPOSIDE FRESENIUS 20 mg/mL;
• if you have a bone marrow disorder. Your doctor will check your blood regularly (see blood tests below);
• if you have low levels of a protein called albumin in your blood;
• if you have recently had radiotherapy or chemotherapy;
• if you have liver or kidney problems.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself ETOPOSIDE FRESENIUS 20 mg/mL injection. It will be given to you by a person who is qualified to do so. ETOPOSIDE FRESENIUS 20 mg/mL is prescribed for adults only as safety in children has not been established. The dose you receive will be individually calculated and prepared for you, depending on your type of cancer and general condition. ETOPOSIDE FRESENIUS 20 mg/mL will be given as a slow infusion into a vein. This may take between 30 to 60 minutes. The duration of the treatment and the number of treatments is determined by the doctor and may vary for each patient.

If you are given more ETOPOSIDE FRESENIUS 20 mg/mL than you should

Since a healthcare provider will administer ETOPOSIDE FRESENIUS 20 mg/mL, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use ETOPOSIDE FRESENIUS 20 mg/mL

Since a healthcare provider will administer ETOPOSIDE FRESENIUS 20 mg/mL, it is unlikely that the dose will be missed.

ETOPOSIDE FRESENIUS 20 mg/mL can have side effects. Not all side effects reported for ETOPOSIDE FRESENIUS 20 mg/mL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving ETOPOSIDE FRESENIUS 20 mg/mL, please consult your healthcare provider for advice. If any of the following happens, stop using ETOPOSIDE FRESENIUS 20 mg/mL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Severe allergic reactions (chills, fever, swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing).
• A potentially life-threatening skin disorder accompanied by severe skin blisters and often sores in the membranes of the mouth, nose, eyes and the anal and genital areas (Stevens-Johnson syndrome, toxic epidermal necrolysis). These are all very serious side effects. If you have them, you may have had a serious reaction to ETOPOSIDE FRESENIUS 20 mg/mL. You may need urgent medical attention or further hospitalisation.

Tell your doctor immediately if you notice any of the following:

• 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 when ETOPOSIDE FRESENIUS 20 mg/mL is taken along with other medicines used to treat cancer. Some symptoms may be nausea, vomiting, cramps, weakness, decreased urination and numbness or tingling. Your doctor will monitor your clinical condition and blood tests for signs of tumour lysis syndrome.

These are all serious side effects. You may need urgent medical attention.

Frequent side effects:

• opportunistic infections
• acute leukaemia
• bone marrow suppression (decreased production of blood cells and platelets)
• leukopenia or neutropenia (decreased production in number of white blood cells)
• thrombocytopenia (decrease in blood platelets)
• anaemia (low haemoglobin content in red cells, causing tiredness, pale skin)
• dizziness
• irregular heartbeat (dysrhythmia), or a heart attack (myocardial infarction)
• high blood pressure
• low blood pressure
• inflammation of a vein (phlebitis)
• loss of appetite
• abdominal pain
• diarrhoea
• constipation
• temporary hair loss
• darkening of skin (pigmentation)
• skin problems such as hives, itching or rash
• sore lips, mouth or throat ulcers
• nausea and vomiting
• damage to the liver (hepatotoxicity)
• increased liver enzymes
• jaundice (increased bilirubin)
• reactions at the site of infusion (pain, irritation and swelling)
• feeling weak (asthenia)
• generally feeling unwell (malaise)

Less frequent:

• tingling or numbness in hands and feet (peripheral neuropathy)
• bleeding
• a sunburn-like rash that may occur on skin that has previously been exposed to radiotherapy and can be severe (radiation recall dermatitis)
• flushing
• difficulty swallowing
• a change in the way things taste
• convulsions (seizures)
• sleepiness or tiredness
• breathing problems
• pulmonary fibrosis (scarring throughout the lungs)
• interstitial pneumonitis (lung inflammation)
• bronchospasm (breathing distress caused by narrowing of the airways)
• temporary blindness
• inflammation of optic nerve
• infertility
• fever

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of ETOPOSIDE FRESENIUS 20 mg/mL. Patients are asked to report any suspected adverse drug reactions to their healthcare provider or Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed.

Store all medicine out of reach of children. Store at or below 25 °C. Do not freeze. Store in the original package, in order to protect from light. ETOPOSIDE FRESENIUS 20 mg/mL when diluted as recommended to a concentration of 0,2 to 0,4 mg/mL in a glass container, is stable for 24 hours at room temperature and exposed to ambient daylight. Do not store the diluted product in a refrigerator (2 °C to 8 °C) as this might cause precipitation. Solutions showing any sign of precipitation should not be used. Do not use ETOPOSIDE FRESENIUS 20 mg/mL 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. Return all unused medicine to your pharmacist. Do dispose of unused medicines in drains or sewerage systems (e.g. toilets). These measures will help protect the environment.