4 mg powder for concentrate for solution for infusion, dispersion
mifamurtide

What MEPACT is and what it is used for

MEPACT contains the active substance mifamurtide, which is similar to a component in the cell wall of certain bacteria. It stimulates your immune system, so your body gets help to kill the tumor cells.

MEPACT is used to treat osteosarcoma (skeletal cancer) in children, adolescents, and young adults (between 2 and 30 years old). It is used after you have had a tumor removed through surgery and in conjunction with chemotherapy to kill the remaining cancer cells to reduce the risk of cancer coming back.

What you need to know before you receive MEPACT

Do not use MEPACT

  • if you are allergic to mifamurtid or to any of the other ingredients of this medicine (listed in section 6).
  • if you are taking medicines containing ciclosporin or other calcineurin inhibitors or high doses of non-steroidal anti-inflammatory drugs ( NSAIDs ) (see section “Using other medicines” below).

Warnings and cautions

Talk to your doctor before using MEPACT:

  • if you have or have had problems with your heart or blood vessels, such as blood clots ( thrombosis ), bleeding or inflammation of the veins ( vasculitis ). You should be monitored more closely while receiving MEPACT treatment. If you have long-term or worsening symptoms, consult your doctor, as MEPACT treatment may need to be postponed or stopped.
  • if you have had asthma or other respiratory disorders. Before using MEPACT, you should discuss with your doctor whether you should take medicines for your asthma when using MEPACT.
  • if you have had an inflammation or autoimmune disease or if you have been treated with corticosteroids or other medicines that may affect your immune system.
  • if you have had allergic reactions (rash, shortness of breath, high blood pressure ) to other medicines. If you experience any worsening of symptoms, contact your doctor as they may have been caused by MEPACT.
  • if you have stomach problems such as nausea, vomiting and loss of appetite. If the problems worsen, contact your doctor as they may have been caused by MEPACT while using chemotherapy at the same time .
  • if you experience chills or tremors or feel hot. Measure your body temperature (take the temperature) as you may have a fever. A low white blood cell count ( neutropenia ) can be a sign of a serious infection .

In section 4, you can read more detailed information about warnings and precautions associated with side effects that may be experienced when you receive this medicine.

Other medicines and MEPACT

Tell your doctor if you are taking or have recently taken or plan to take any other medicines. This also applies to over-the-counter medicines. You must tell your doctor if you are taking medicines that contain any of the following active substances:

  • ciclosporin, tacrolimus, used after transplantation to prevent rejection of transplanted organs or other immunosuppressive drugs used e.g. to treat psoriasis (a skin disease).
  • non-steroidal anti-inflammatory drugs ( NSAIDs ), such as acetylsalicylic acid , ibuprofen or diclofenac used to treat headaches, fever or pain. Do not use MEPACT if you are taking high doses of non-steroidal anti-inflammatory drugs ( NSAIDs ).
  • corticosteroids used to treat inflammation, allergies or asthma . Regular use of corticosteroids should be avoided when using MEPACT as it may affect the way the medicine works.

It is recommended that the timing of administration of MEPACT and doxorubicin or other medicinal products be separated if used in the same chemotherapeutic regimen.

Children

Do not give this medicine to children under 2 years of age as there is no information on how safe the medicine is and how well it works for this age group.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

MEPACT has not been studied in pregnant women. MEPACT should therefore not be used during pregnancy or by women of childbearing potential not using effective contraception.

You should use an effective method of contraception if you are being treated with MEPACT.

It is not known if MEPACT passes into breast milk. If you are breastfeeding, talk to your doctor.

Driving and using machines

Some very common or common side effects of MEPACT treatment (such as dizziness, dizziness, tiredness, and blurred vision) may affect your ability to drive and use machines.

MEPACT contains sodium

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

How to use MEPACT

Dose and treatment schedule

MEPACT should only be administered under the supervision of a specialist. Always use this medicine exactly as your doctor has told you. Ask your doctor if you are unsure.

The recommended dose of MEPACT is 2 mg mifamurtide / m 2 body surface area. It is given twice a week (at least three days apart) for the first 12 weeks, then once a week for another 24 weeks.

The treatment schedule for MEPACT can be adapted to suit your chemotherapy schedule. It is not necessary to discontinue the MEPACT treatment schedule if your chemotherapy is delayed. You must complete 36 weeks (9 months) of treatment with MEPACT without interruption.

How MEPACT is given

The lyophilized powder must be prepared into a liquid suspension, filtered using the supplied filter, and further diluted before use. MEPACT is then given as an infusion (drip) directly into a vein ( intravenously ) for about 1 hour. This is done by your doctor or a nurse, who will also monitor you during this time. You do not have to be hospitalized to get MEPACT. It can also be administered to an outpatient.

If you use more MEPACT than you should

You may experience more serious side effects, including fever, chills, fatigue, nausea, vomiting, headache, and low or high blood pressure. In the event of such an overdose, consult your doctor or nearest hospital.

If you stop using MEPACT

You should not stop MEPACT treatment until the end of the treatment schedule without first discussing it with your doctor. If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, MEPACT can cause side effects, although not everybody gets them.

Most patients suffer from chills, fever, and fatigue, especially during the first administration of MEPACT. These side effects are usually mild to moderate and transient and can usually be treated by your doctor, for example with paracetamol for fever.

The use of MEPACT at the same time as chemotherapy can often cause stomach problems such as nausea, vomiting, and loss of appetite.

Contact your doctor immediately

  • if you develop persistent fever or chills for more than 8 hours after your dose of MEPACT, as this may be a sign of an infection or
  • if you get a rash or have difficulty breathing (wheezing).
  • if you have stomach problems.

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

  • fever, tremors / tremors, weakness, fatigue or general discomfort
  • nausea and / or vomiting, diarrhea or constipation
  • headache or dizziness
  • fast heartbeat
  • high blood pressure or low blood pressure
  • no appetite
  • sweating
  • pain, including general pain, pain in muscles and / or joints and pain in the back, chest, abdomen, arms or legs
  • cough, difficulty breathing or rapid breathing
  • low body temperature
  • low number of red blood cells .

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

  • blue staining of tissue such as skin or gums due to too little oxygen
  • noticeable increase in the frequency or force of the heartbeat
  • swelling in the arms or legs or other swelling
  • discomfort in the chest
  • stomach upset, decreased appetite or weight loss
  • redness , swelling, infection or other local reaction at the injection site.
  • skin rash or redness , dermatitis, itching , dry skin, pallor or transient redness
  • inflammation of the skin, tendons, muscles or similar tissues that provide support to the body
  • inflammation in a friend
  • pain in the upper abdomen or chest wall, swollen or aching abdomen, indigestion or pain in the liver
  • other pain, including neck pain, shoulders, groin, skeleton or throat, postoperative pain
  • cramps or stiffness in muscles
  • freezing unit
  • feeling tired, drowsy or drowsy
  • burning, stinging / burning sensation, decreased sensitivity to sensations, or feeling sensations without stimuli
  • involuntary shaking
  • dehydration
  • low potassium concentration in the blood
  • mucositis
  • stuffy or inflamed nose, throat or sinuses
  • infection of the upper respiratory tract (such as colds) or urinary tract (such as cystitis )
  • general infection
  • Herpes simplex ( virus ) – infection
  • productive cough (mucus cough), wheezing or labored breathing or impaired shortness of breath
  • spotting or nosebleeds
  • fluid in the chest cavity
  • blood in the urine, difficulty or pain when urinating or frequent urination.
  • difficulty sleeping, depression, anxiety or confusion
  • dizziness
  • earring
  • dimsyn
  • hair loss
  • difficult, painful menstruation
  • hearing loss
  • low white blood cell count with or without fever, low platelet count .

How to store MEPACT

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

Unopened vial

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.

Keep the vial in the outer carton. Sensitive to light.

Ready-made suspension

Once reconstituted in sodium chloride 9 mg/ml (0.9%) solution, it is stored at room temperature (approximately 20ºC – 25ºC) and used within 6 hours.

Do not use this medicine if there are visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is mifamurtide. Each vial contains 4 mg mifamurtide. After reconstitution , each ml of suspension contains 0.08 mg of mifamurtide.
  • The other ingredients are 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) and 1,2-dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS). See section 2 “MEPACT contains sodium”.

What the medicine looks like and contents of the pack

MEPACT is a white to off-white homogeneous cake or powder for concentrate for solution for infusion.

MEPACT is delivered in a carton that contains

  • a 50 ml vial with gray butyl stopper, aluminum seal and plastic cap,
  • a sterile filter for MEPACT that is delivered in blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Takeda France SAS

112 avenue Kléber

75116 Paris

France

Manufacturer

Takeda Austria GmbH

St. Peter ‑ Straβe 25

A ‑ 4020 Linz

Austria

Delpharm Novara Srl

Via Crosa, 86

28065 Cerano (NO)

Italy

Other sources of information

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

Muhammad Nadeem

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