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Myocet (doxorubicin hydrochloride) – Package leaflet - L01DB01

Updated on site: 08-Oct-2017

Medication nameMyocet
ATC CodeL01DB01
Substancedoxorubicin hydrochloride
ManufacturerTeva B.V.

Package leaflet: Information for the user

Myocet 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion

Liposomal doxorubicin hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Myocet is and what it is used for

2.What you need to know before you are given Myocet

3.How Myocet is given

4.Possible side effects

5.How to store Myocet

6.Contents of the pack and other information

1.What Myocet is and what is it used for

Myocet contains a medicine called “doxorubicin”, which damages tumour cells. This type of medicine is called “chemo-therapy”. The medicine is contained inside very small droplets of fat called “liposomes”.

Myocet is used in adult women for the first-line treatment of breast cancer that has spread (“metastatic breast cancer”). It is used with another medicine called “cyclophosphamide”. Please also read the patient information leaflet carefully that comes with that medicine.

2. What you need to know before you are given Myocet

Do not have Myocet:

if you are allergic to doxorubicin or any of the other ingredients of this medicine (listed in section 6).

Do not have Myocet if this applies to you. If you are not sure, talk to your doctor or nurse before having Myocet.

Warning and precautions

Talk to your doctor or nurse before having Myocet.

Check with your doctor or nurse before having your medicine if:

you have ever had heart problems such as a heart attack, heart failure or you have had high blood pressure for a long time

you have liver problems.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before having Myocet.

Tests

Your doctor will do tests during your treatment to check that the medicine is working properly. They will also look out for any side effects such as blood problems or heart problems.

Radiation therapy

If you have already had radiation therapy, this may react with Myocet. You may get painful, red or dry skin. This can happen straight away or later on in your treatment.

Other medicines and Myocet

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Myocet can affect the way some other medicines work. Also some other medicines can affect the way Myocet works.

In particular tell your doctor or nurse if you are taking any of the following medicines:

phenobarbital or phenytoin – for epilepsy

warfarin – for thinning the blood

streptozotocin – for cancer of the pancreas

cyclosporine – for changing your immune system.

If any of the above apply to you (or you are not sure), please talk to your doctor or nurse before having Myocet.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before having Myocet.

Myocet should not be used during pregnancy unless clearly necessary.

Women having Myocet should not breast-feed.

Women who could get pregnant should use effective contraception during treatment with Myocet and for 6 months after treatment.

Driving and using machines

You may feel dizzy after having Myocet. If you feel dizzy or are not sure how you feel, do not drive or use any tools or machines.

Myocet contains sodium

Myocet is available in cartons containing 1 set or 2 sets of 3 vials (not all pack-sizes may be marketed). When the 3 vials have been mixed together, your medicine contains about 108 mg sodium. This should be taken into consideration by patients on a controlled sodium diet.

3.How Myocet is given

This medicine is normally given by a doctor or nurse. It is given as a drip (infusion) into a vein.

How much you will be given

Your doctor will work out exactly how much you need. This is based on the size of your body (measured in “square metres” or “m2”).

The recommended dose is between 60 and 75 mg of the medicine for each square meter of your body:

this is given once every 3 weeks

the medicine “cyclophosphamide” is given on the same day. The doctor may give you a lower dose if they think you need it.

The number of times you have the drip depends on:

the stage of your breast cancer

how well your body responds to the medicine. Treatment usually lasts for about 3 to 6 months.

If you get Myocet on your skin

Tell your doctor or nurse straight away if any medicine leaks from the drip (infusion) onto your skin. This is because Myocet can damage your skin. The drip will be stopped straight away. Ice will be put on the affected area for 30 minutes. Then the drip will be started in another vein.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Tell your doctor or nurse straight away if you notice any of the following side effects. These are signs of an allergic reaction and your drip (infusion) may have to be stopped:

feeling breathless or a tight chest or throat

headache or back pain

fever or chills

swollen or flushed face

feeling tired, dizzy or light-headed.

If you notice any of the side effects listed above, tell your doctor or nurse straight away.

Other side effects

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

hair loss

fever, chills, pain

loss of appetite, diarrhoea, feeling or being sick (nausea or vomiting)

reduced levels of certain blood cells – your doctor will regularly check your blood for this and decide if any treatment is required. Signs may include:

-increased bruising

-sore mouth, throat or mouth ulcers

-reduced resistance to infection or fever

-feeling tired or dizzy, having a lack of energy.

Common (may affect up to 1 in 10 people):

muscle aches, back pain, headache

difficulty breathing, chest pains

feeling thirsty, pain or swelling of your food pipe

shortness of breath, swollen ankles, muscle cramps. These may be signs of heart failure, uneven heart beat or a low potassium level in your blood

liver function tests abnormal

difficulty sleeping

nose bleeds, hot flushes

constipation, weight loss

skin rash and nail problems.

Uncommon (may affect up to 1 in 100 people):

coughing up blood

feeling agitated, feeling sleepy

low blood pressure, feeling unwell

a change in how you walk, speech problems

stomach pains which may be a sign of a stomach ulcer forming

muscle weakness

itchy, dry skin or swollen areas around hair roots

swollen, red and blistering skin around where the drip was given

high blood glucose level (your doctor will see this in a blood test)

yellow skin or eyes. These may be signs of a liver problem called jaundice.

change in how often you pass water (urine), pain on passing water or blood in your urine

Not Known: frequency cannot be estimated from the available data:

Redness and pain on the hands and feet

Myocet may cause some side effects that are related to how fast the drip is given. These include flushing, fever, chills, headaches and back pain. These side effects may stop if the drip is given more slowly over a longer period of time.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Myocet

-Keep this medicine out of the sight and reach of children.

-Do not use this medicine after the expiry date stated on the label and carton.

-Store in a refrigerator (2ºC to 8ºC).

-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 2οC – 8οC, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.

-Do not use this medicine if you notice that it shows evidence of discoloration, precipitation or any other particulate matter.

-Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Content of the pack and other information

What Myocet contains

-The active substance is liposome–encapsulated doxorubicin. This corresponds to 50 mg doxorubicin hydrochloride.

-The other ingredients are lactose (in the doxorubicin HCl vial), phosphatidylcholine, cholesterol, citric acid, sodium hydroxide and water for injections (in the liposomes vial), and sodium carbonate and water for injections (in the buffer vial).

What Myocet looks like and contents of the pack

Myocet consists of a powder, dispersion and solvent for concentrate for dispersion for infusion. It is supplied as a three-vial system: Myocet doxorubicin HCl, Myocet liposomes and Myocet buffer.

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 1 set or 2 sets of the three constituents. Not all pack-sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer

GP-Pharm

Polígon Industrial Els Vinyets - Els Fogars, Sector 2, Carretera Comarcal C244, km 22 08777 Sant Quintí de Mediona (Barcelona) Spain

Teva Operations Poland Sp. z o.o. ul. Mogilska 80

31-546 Kraków Poland

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

PREPARATION GUIDE

Myocet 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion Liposomal doxorubicin hydrochloride

It is important you read the entire contents of this guide prior to the preparation of this medicinal product.

1.PRESENTATION

Myocet is supplied as a three-vial system: (1) Myocet doxorubicin HCl, (2) Myocet liposomes, and

(3) Myocet buffer. In addition to these three components, 0.9% (w/v) sodium chloride solution for injection will also be required for the reconstitution of the doxorubicin HCl. Myocet must be reconstituted prior to administration.

2.RECOMMENDATIONS FOR SAFE HANDLING

The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted, namely:

Personnel should be trained to reconstitute the medicinal product.

Pregnant staff should be excluded from handling the medicinal product.

Personnel handling this medicinal product during reconstitution should wear protective clothing including masks, goggles and gloves.

All items for administration or cleaning, including gloves, should be placed in a high-risk, waste disposal bag for high-temperature incineration. Liquid waste may be flushed with large amounts of water.

Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.

3.PREPARATION FOR THE INTRAVENOUS ADMINISTRATION

Aseptic technique must be strictly observed throughout handling of Myocet since no preservative is present.

3.1Preparation of Myocet

Step 1. Set up

Two alternative heating methods can be used : a Techne DB-3 Dri Block heater or a water bath:

Turn on the Techne DB-3 Dri Block heater and set the controller to 75°C-76°C. Verify the temperature set point by checking the thermometer(s) on each heat block insert.

If using a water bath, turn on the water bath and allow it to equilibrate at 58°C (55°C-60°C). Verify the temperature set point by checking the thermometer.

(Please note that whilst the control settings on the water bath and heat block are set to different levels the temperature of the vial contents are in the same range (55°C-60°C)).

• Remove the carton of Myocet constituents from the refrigerator.

Step 2. Reconstitute doxorubicin HCl

Withdraw 20 ml sodium chloride solution for injection (0.9%), (not provided in the package), and inject into each Myocet doxorubicin HCl, intended for preparation.

Shake well in the inverted position to ensure doxorubicin is fully dissolved.

Step 3. Heat in water bath or dry heat block

Heat the reconstituted Myocet doxorubicin HCl vial in the Techne DB-3 Dri Block heater with the thermometer in the block reading (75°C-76°C) for 10 minutes (not to exceed 15 minutes).

If using the water bath heat the Myocet doxorubicin HCl vial with the thermometer temperature reading 55°C-60°C for 10 minutes (not to exceed 15 minutes).

While heating proceed to step 4.

Step 4. Adjust pH of liposomes

Withdraw 1.9 ml of Myocet liposomes. Inject into Myocet buffer vial to adjust the pH of liposomes. Pressure build-up may require venting.

Shake well.

Step 5. Add pH-adjusted liposomes to doxorubicin

Using a syringe, withdraw the entire vial contents of pH-adjusted liposomes from the Myocet buffer vial.

Remove the reconstituted Myocet doxorubicin HCl vial from the water bath or dry heat block. SHAKE VIGOROUSLY. Carefully insert a pressure-venting device equipped with a hydrophobic filter. Then IMMEDIATELY (within 2 minutes) inject the pH-adjusted liposomes into the vial of heated reconstituted Myocet doxorubicin HCl. Remove venting device.

SHAKE VIGOROUSLY.

WAIT FOR A MINIMUM OF 10 MINUTES BEFORE USING, KEEPING THE MEDICINE AT ROOM TEMPERATURE.

The Techne DB-3 Dri Block Heater is fully validated for use in the constitution of Myocet. Three inserts, each with two 43.7mm openings per insert must be used. To ensure correct temperature control the use of a 35mm immersion thermometer is recommended.

The resulting reconstituted preparation of Myocet contains 50 mg of doxorubicin HCl/25 ml of concentrate for liposomal dispersion for infusion (2 mg/ml).

After reconstitution the finished product must be further diluted in 0.9% (w/v) sodium chloride solution for injection, or 5% (w/v) glucose solution for injection to a final volume of 40 ml to 120 ml

per 50 mg reconstituted Myocet so that a final concentration of 0.4 mg/ml to 1.2 mg/ml doxorubicin is obtained.

Once constituted, the liposomal dispersion for infusion containing liposome encapsulated doxorubicin should be a red-orange opaque homogeneous dispersion. All parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the preparation if foreign particulate matter is present.

It has been demonstrated that once reconstituted Myocet has a chemical and physical in-use stability at room temperature for up to 8 hours or in a refrigerator (2οC-8οC) for up to 5 days.

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 2οC-8οC, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.

Myocet should be administered by intravenous infusion over a period of 1 hour.

Warning: Myocet must not be administered by the intramuscular or subcutaneous route or as a bolus injection.

4.DISPOSAL

Any unused product or waste material should be disposed of in accordance with local requirements.

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