Mitomicin Accord

Leaflet accompanying the packaging: information for the user

Mitomycin Accord, 40 mg, powder for solution for injection/infusion

Mitomycin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Mitomycin Accord and what is it used for
• 2. Important information before taking Mitomycin Accord
• 3. How to take Mitomycin Accord
• 4. Possible side effects
• 5. How to store Mitomycin Accord
• 6. Contents of the pack and other information

1. What is Mitomycin Accord and what is it used for

Mitomycin is a medicine used to treat cancer, i.e., a medicine that prevents or significantly delays the division of cancer cells, affecting their metabolism in various ways. The action of cancer medicines is based on one of the differences between cancer cells and normal cells, namely the increased rate of cell division due to the lack of growth restrictions.

Indications for use

Mitomycin is used to treat malignant tumors in order to alleviate symptoms (so-called palliative treatment).

Intravenous administration

Mitomycin is administered intravenously, as single-agent chemotherapy (i.e., chemotherapy using one active substance), or as combination chemotherapy (i.e., chemotherapy using several active substances). Mitomycin has shown activity in the following malignant tumors:

• advanced metastatic stomach cancer,
• advanced and/or metastatic breast cancer,
• respiratory tract cancer (non-small cell lung cancer),
• advanced pancreatic cancer.

2. Important information before taking Mitomycin Accord

When not to use Mitomycin Accord

• during breastfeeding;
• in the case of intravenous administration - if you have significantly reduced blood cell counts (pancytopenia) or isolated reduced white blood cell count (leukopenia) or platelet count (thrombocytopenia), bleeding tendency (hemorrhagic diathesis) or acute infection.

Warnings and precautions

Before starting treatment with Mitomycin Accord, tell your doctor or pharmacist:

Children and adolescents

Mitomycin is not recommended for use in children and adolescents.

Mitomycin Accord and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

If you are taking other treatments (especially other anticancer medicines or radiotherapy) that can also harm your body, it is possible to increase the side effects of mitomycin.

There are reports from animal experiments on the loss of mitomycin activity when administered with vitamin B.

During treatment with mitomycin, you should not be vaccinated with live vaccines.

This also applies to medicines used recently.

Pregnancy, breastfeeding, and fertility

Mitomycin should not be used during pregnancy. If treatment with mitomycin during pregnancy is necessary, your doctor will assess the benefits and risks to the fetus.

Women of childbearing age should avoid becoming pregnant. During treatment with mitomycin and for six months after its completion, both men and women must use contraceptive measures. If you become pregnant during treatment, you must inform your doctor.

Before starting treatment with mitomycin, you must stop breastfeeding.

Driving and using machines

Even when mitomycin is used as directed, it can cause nausea and vomiting, reducing reaction time to the point of impairing your ability to drive vehicles and operate machinery. This is especially true when consuming alcohol.

3. How to take Mitomycin Accord

Mitomycin should only be administered by doctors with experience in this type of treatment.

Mitomycin is intended for intravenous injection or infusion after prior dissolution.

Your doctor will determine the dose and dosing schedule suitable for you.

Before administering mitomycin to you in the form of an injection or infusion into a vein, it is recommended to perform lung, kidney, and liver function tests to rule out the presence of diseases that may worsen during mitomycin treatment.

During the administration of mitomycin, the needle should remain in the vein at all times. If the needle comes out of the vein or loosens, or if the medicine leaks into the tissues around the vein (which may be accompanied by a feeling of discomfort or pain), you should immediately inform your doctor or nurse.

Using a higher dose of Mitomycin Accord than recommended

If you accidentally receive a higher dose, you may experience symptoms such as fever, nausea, vomiting, and blood disorders. Your doctor may then recommend symptomatic treatment for these side effects.

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

4. Possible side effects

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

Possible side effects after intravenous administration

Severe allergic reactions (symptoms may include fainting, skin rash or hives, itching, swelling of the lips, face, and respiratory tract, causing breathing difficulties, loss of consciousness - occur very rarely (may affect up to 1 in 10,000 people)).

A severe lung disease characterized by shortness of breath, dry cough, and wheezing (interstitial lung disease) and severe kidney function disorders (nephrotoxicity) may develop. If you notice any of the above reactions, you should immediately inform your doctor, as treatment with mitomycin will need to be discontinued.

Very common(occurring in more than 1 in 10 patients)

• Blood disorders: inhibition of blood cell production in the bone marrow; decreased white blood cell count (leukopenia), which increases the risk of infection; decreased platelet count (thrombocytopenia) causing bruising and bleeding
• Nausea, vomiting Common(occurring in less than 1 in 10 patients)
• Lung disease characterized by shortness of breath, dry cough, and wheezing (interstitial lung disease)
• Shortness of breath, cough, difficulty breathing
• Skin rash and skin irritation
• Feeling of numbness, swelling, and painful redness of the skin of the hands and soles of the feet (palmar-plantar erythrodysesthesia)
• Kidney disorders (kidney failure, nephrotoxicity, glomerulopathy, elevated creatinine levels in the blood) - kidney failure
• Inflammation of connective tissue and tissue necrosis after accidental extravasation (injection into tissues surrounding the vein) Uncommon(occurring in less than 1 in 100 patients)
• Inflammation of mucous membranes
• Inflammation of the mucous membrane of the mouth
• Diarrhea
• Hair loss
• Fever
• Loss of appetite (anorexia) Rare(occurring in less than 1 in 1,000 patients)
• Life-threatening infections
• Blood poisoning (sepsis)
• Decreased red blood cell count, which may be accompanied by acute kidney failure [hemolytic anemia, microangiopathic hemolytic anemia (MAHA), hemolytic-uremic syndrome (HUS)]
• Heart failure after previous treatment with other anticancer medicines (anthracycline antibiotics)
• Increased blood pressure in the pulmonary vessels, which can cause shortness of breath, dizziness, and fainting (pulmonary hypertension)
• Disease of the pulmonary veins causing their blockage (pulmonary veno-occlusive disease)
• Liver failure
• Increased activity of liver enzymes - transaminases
• Yellowing of the skin and whites of the eyes (jaundice),
• Blockage of small veins in the liver (hepatic veno-occlusive disease) leading to fluid retention in the body, liver enlargement, and increased bilirubin levels in the blood
• Generalized skin rash Very rare(occurring in less than 1 in 10,000 people)
• severe allergic reactions (symptoms may include fainting, skin rash or hives, itching, swelling of the lips, face, and respiratory tract, causing breathing difficulties, loss of consciousness)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

tel.: +48 22 49 21 301

fax: +48 22 49 21 309

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mitomycin Accord

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

There are no special precautions for storage.

The medicine should be used immediately after dissolution.

Do not use this medicine after the expiry date stated on the label of the vial and on the carton after EXP. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mitomycin Accord contains

The active substance is mitomycin.

Other ingredients: mannitol

What Mitomycin Accord looks like and contents of the pack

Mitomycin Accord is a blue-violet disc or powder to be dissolved before administration.

It is packed in glass vials made of orange glass with a bromobutyl rubber stopper and a blue aluminum seal.

Mitomycin Accord, 40 mg, is available in packs of 1 or 5 vials, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.

ul. Taśmowa 7

02-677 Warsaw

Tel: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.

ul. Lutomierska 50

95-200 Pabianice

Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: September 2022

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Information intended for healthcare professionals only:

General information

Accidental extravasation of mitomycin should be avoided. In the event of accidental extravasation of the medicinal product, extensive tissue necrosis occurs. To avoid necrosis, the following guidelines should be followed:

• injections should only be made into large veins in the upper limbs;
• injections should not be made directly into a vein, but into an intravenous line through which an infusion is being administered in a safe and proper manner;
• before removing the cannula after administering the product into a central vein, it should be flushed with an infusion for a few minutes to remove any remaining mitomycin. In the event of extravasation, it is recommended to immediately inject 8.4% sodium bicarbonate solution into the extravasation site, followed by injection of 4 mg of dexamethasone. Vitamin B may be helpful in stimulating the regeneration of damaged tissues. The medicinal product Mitomycin Accord should not come into contact with the skin and mucous membranes.

Dosage and administration

The recommended dosage for intravenous administration is 10 to 20 mg/m² body surface area (BSA) every 6 to 8 weeks, 8 to 12 mg/m² every 3 to 4 weeks, or 5 to 10 mg/m² every 1 to 6 weeks. Doses greater than 20 mg/m² increase toxic effects without additional therapeutic benefits.

The maximum cumulative dose of mitomycin is 60 mg/m².

Mitomycin Accord powder is intended for administration as injections or infusions after prior dissolution.

Mitomycin Accord 40 mg, powder for solution for injection/infusion, should not be dissolved in water.

The contents of the 40 mg vial cannot be reconstituted to a concentration of 1 mg/ml.

To achieve this concentration, a product with a different strength should be used.

The prepared solution has a blue-violet color, is clear, and free of visible particles.

Female healthcare workers who are pregnant should not prepare or administer this medicinal product. The medicinal product Mitomycin Accord should not come into contact with the skin. If it does, the skin should be rinsed several times with 8.4% sodium bicarbonate solution, then washed with soap and water. The exposed skin should not be treated with hand cream or emollient, as this may increase the absorption of the medicine into the skin.

In case of contact with the eyes, they should be rinsed several times with 0.9% sodium chloride solution. The person exposed should then be observed for several days to detect any possible corneal damage. If necessary, appropriate treatment should be initiated.

After dilution, the solution should be used immediately.

The contents of the vial are intended for single use only. Any unused solution should be discarded.

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

Notes

• Mitomycin Accord should not be used in mixed injections.
• Other solutions for injection or infusion should be administered separately.
• Accidental extravasation of mitomycin should be avoided.