MYOCET 50mg
powder and pre-admixtures for concentrate for liposomal dispersion for infusion
Doxorubicin HCI
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 or your hospital pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- 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 MYOCET is and what is it used for.
- 2. Before you use MYOCET.
- 3. How to use MYOCET.
- 4. Possible side effects.
- 5. How to store MYOCET.
- 6. Further information
What Myocet Is And What Is It Used For
MYOCET consists of a powder and pre-admixtures for concentrate for liposomal dispersion for infusion and is supplied as a three-vial system: MYOCET doxorubicin HCI, MYOCET liposomes and MYOCET buffer. The active substance is presented as a lyophilised powder for single-use.
Once the content of the vials has been mixed together the resulting liposomal dispersion is orange-red and opaque.
MYOCET is available in cartons containing 2 sets of the three constituents.
MYOCET is a preparation of the anti-tumour agent doxorubicin, which is encased in microscopic fat particles known as liposomes. Doxorubicin belongs to a group of anti-tumour medicines called anthracyclines. It damages the tumour cells.
MYOCET, in combination with cyclophosphamide, is used for the first-line treatment of metastatic breast cancer in women.
Before You Use Myocet
You should tell your doctor if:
- you are allergic to doxorubicin or any of the ingredients contained in MYOCET.
- you are pregnant, or think you may be pregnant, or are breast-feeding.
- you have a history of cardiovascular disease (for example heart attacks, heart failure or long-standing high blood pressure).
- you have problems with your liver.
Do not use MYOCET if:
- you are allergic to doxorubicin or any of the ingredients contained in MYOCET.
Take special care with MYOCET.
Doxorubicin may cause blood disorders and heart problems; therefore careful monitoring will be performed.
Doxorubicin is an irritant and special care should be taken when administering the infusion of MYOCET. If MYOCET leaks from the infusion site into the skin and surrounding tissues, the infusion must be stopped immediately and ice applied to the affected area for 30 minutes. Subsequently, the MYOCET infusion will be started in another vein.
MYOCET may cause infusion-related side effects, such as flushing, fever, chills, headaches and back pain. These can be avoided by increasing the length of time the infusion is given over.
Using MYOCET with food and drink.
There are no known interactions with food and drink.
Pregnancy and breast-feeding
Tell your doctor or pharmacist if you are pregnant, think you may be pregnant or are breast-feeding, before you receive treatment with this medicine. MYOCET can not be used in pregnancy and women receiving MYOCET should not breast-feed. Women of childbearing potential should use an effective contraceptive during and up to 6 months after treatment with MYOCET.
Driving and using machines:
MYOCET has been reported to cause dizziness. If you feel dizzy or are unsure of yourself do not drive or operate machinery.
Taking other medicines:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. MYOCET may interact with substances that are known to interact with doxorubicin. Such substances include cyclosporin, phenobarbital, streptozocin, phenytoin, warfarin.
How To Use Myocet
The dose of MYOCET will be calculated according to the surface area of your body. When MYOCET is administered in combination with cyclophosphamide the generally recommended dose is 60-75mg/m2. Your doctor will work out exactly how much you need based on your individual circumstances and may choose to lower the dose.
MYOCET is administered by a health care professional as an intravenous infusion, after reconstitution of the individual vials and dilution.
The infusion will be carried out one day every 3 weeks.
The number of infusions will depend on the circumstances of your disease or response to the medicine. Repeated treatment courses with MYOCET are possible. Treatment usually lasts for approximately 3-6 months.
Myocet Side Effects
Like all medicines, MYOCET can have side effects.
The very common side effects are blood disorders, where reduced levels of certain blood cells may cause:
- reduced resistance to infection or fever,
- sore mouth or throat and mouth ulcers,
- increased bruising,
- tiredness, lack of energy, feeling dizzy.
Your doctor will monitor your blood regularly for these effects and will decide if specific treatment is required.
Other very common side effects may include:
- diarrhoea, vomiting and feeling sick,
- hair loss.
Other less common side effects may include:
- shortness of breath and swollen ankles because of heart failure, irregular heart beat, low potassium level in the blood (which may be noticed as weakness and cramps),
- breathing difficulties, cough, chest pains and fainting, coughing blood,
- swelling and reddening and blistering of the skin around the injection site,
- stomach pains from an open sore on the lining of the stomach, also called gastric ulcer and pain and swelling of the food pipe,
- fever and chills (covers pneumonitis, plus breathing difficulties and cough), muscle weakness and aches,
- yellowing of the skin and/or eyes, also called jaundice,
- change in frequency of urination, painful urination and blood in the urine,
- constipation, feeling thirsty and loss of appetite,
- skin problems including itchiness of the skin, tender, swollen areas around hair roots and nail disorder,
- abnormal manner of walking,
- speech difficulties,
- back pain,
- nose bleeds,
- agitation,
- sleepiness or drowsiness but sometimes insomnia.
During the infusion at the hospital, you may have an allergic reaction and notice any of the following:
- breathlessness,
- tightness in the chest and throat,
- fever and chills,
- facial swelling,
- dizziness,
- light-headedness,
- tiredness,
- headache,
- back pain,
- flushing.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
How To Store Myocet
Keep out of the reach and sight of children.
Store in a refrigerator (2°C - 8°C).
From a microbiological point of view, the 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 24 hours at 2°C - 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Do not use after the expiry date stated on the label and carton.
Do not use MYOCET if you notice that it shows evidence of discoloration, precipitation or any other particulate matter.
Further Information
What MYOCET contains:
MYOCET 50mg powder and pre-admixtures for concentrate for liposomal dispersion for infusion
Liposomal doxorubicin
- The active substance is doxorubicin HCI, 50mg.
- The other ingredients are lactose (MYOCET doxorubicin HCI vial), egg phosphatidylcholine, cholesterol, citric acid and sodium hydroxide and water for injections (MYOCET liposomes vial), and sodium carbonate and water for injections (MYOCET buffer vial).
Marketing Authorisation Holder and Manufacturer:
The marketing authorisation holder is:
The Manufacturer is:
This leaflet was last approved on: 11/2008
1686/1
PR - MYOC601 - GB - 02
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