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Myocet liposomal (previously Myocet)
doxorubicin

Package leaflet: Information for the user


Myocet liposomal 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.

carbonate and water for injections (in the buffer vial).


What Myocet liposomal looks like and contents of the pack

Myocet liposomal consists of a powder, dispersion and solvent for concentrate for dispersion for

infusion. It is supplied as a three-vial system: doxorubicin HCl, liposomes and buffer.


Once the content of the vials has been mixed together the resulting liposomal dispersion is orange-red and opaque.


Myocet liposomal 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


This leaflet was last revised in {MM/YYYY}.


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The following information is intended for healthcare professionals only:


PREPARATION GUIDE


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

    (3) 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 liposomal 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 liposomal since no preservative is present.


      1. Preparation of Myocet liposomal

        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 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 vial of 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 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 a water bath, heat the 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 liposomes. Inject into the 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 buffer vial.

        • Remove the reconstituted 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 doxorubicin HCl. Remove venting device.

        • SHAKE VIGOROUSLY.

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        • 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 liposomal. 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 liposomal 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 liposomal 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 liposomal 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 liposomal should be administered by intravenous infusion over a period of 1 hour. Warning: Myocet liposomal 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.