Mikofenolan mofetilu Accord

Leaflet accompanying the packaging: information for the user

Mykofenolan mofetylu Accord, 500 mg,

powder for concentrate for solution for infusion
Mycophenolate Mofetil

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a doctor or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet:

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

1. What Mykofenolan mofetylu Accord is and what it is used for

Mykofenolan mofetylu Accord contains mycophenolate mofetil.

• It belongs to a group of medicines called "immunosuppressants".

Mykofenolan mofetylu Accord is used to prevent rejection of a transplanted organ

• Kidney or liver

Mykofenolan mofetylu Accord should be used in combination with other medicines:

• Cyclosporine
• Corticosteroids

2. Important information before taking Mykofenolan mofetylu Accord

WARNING
Mycophenolate causes birth defects and miscarriages. If the patient is a woman of childbearing age who may become pregnant, she must provide a negative pregnancy test result before starting treatment and follow the doctor's recommendations for contraception.
The doctor will discuss the therapy with the patient and provide written information, in particular regarding the effect of mycophenolate on unborn children. The patient should read the information carefully and follow the instructions.
If the patient does not fully understand these instructions, they should consult their doctor to explain them again before taking mycophenolate. The patient should also read the additional information provided in this section under "Warnings and precautions" and "Pregnancy and breastfeeding".

When not to take Mykofenolan mofetylu Accord

• if the patient is allergic to mycophenolic acid, mycophenolate mofetil, polysorbate 80, or any of the other ingredients of Mykofenolan mofetylu Accord (listed in section 6);
• if the patient is a woman of childbearing age and has not provided a pregnancy test result excluding pregnancy before the first prescription of the medicine, as mycophenolate causes birth defects and miscarriages;
• in case of pregnancy, planned pregnancy, or suspected pregnancy.
• in case of not using effective contraception (see Pregnancy, contraception, and breastfeeding).
• if the patient is breastfeeding;

Do not take this medicine if any of the above points apply to the patient.
In case of doubts, please consult a doctor or pharmacist before taking Mykofenolan mofetylu Accord.

Warnings and precautions

Before starting treatment with Mykofenolan mofetylu Accord, the patient should discuss with their doctor or nurse if:

• the patient is over 65 years old, as they may be at increased risk of side effects, such as certain viral infections, gastrointestinal bleeding, and pulmonary edema,
• there are symptoms of infection (such as fever or sore throat),
• there are any unexplained bruises or bleeding,
• the patient has ever had or has gastrointestinal disorders, such as stomach ulcers,
• the patient is planning to become pregnant or has become pregnant while taking Mykofenolan mofetylu Accord,
• the patient has a hereditary deficiency of enzymes, such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

If any of the above cases apply to the patient (or if the patient is unsure), they should consult their doctor before starting treatment with Mykofenolan mofetylu Accord.

Sun exposure

Mykofenolan mofetylu Accord weakens the body's defense mechanisms. This increases the risk of skin cancer. The patient should limit exposure to sunlight and ultraviolet (UV) radiation. This can be achieved by:

• wearing protective clothing that covers the head, neck, arms, and legs,
• using sunscreens with a high protection factor.

Children

This medicine should not be given to children, as there is limited data on safety and efficacy in this age group, and dosage recommendations cannot be established.

Mykofenolan mofetylu Accord and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken. This includes medicines obtained without a prescription, such as herbal medicines. Mykofenolan mofetylu Accord may affect the action of some medicines. Also, some medicines may affect the action of Mykofenolan mofetylu Accord.
In particular, before starting treatment with Mykofenolan mofetylu Accord, the patient should inform their doctor or nurse about taking any of the following medicines:

• azathioprine or other medicines that suppress the immune system, given after a transplant,
• cholestyramine, used to treat high cholesterol,
• rifampicin, an antibiotic used to prevent or treat infections, such as tuberculosis (TB),
• phosphate-binding agents, used in patients with chronic kidney failure to reduce phosphate absorption into the blood,
• antibiotics, used to treat bacterial infections,
• isavuconazole, used to treat fungal infections,
• telmisartan, used to treat high blood pressure,
• acyclovir, ganciclovir, or valganciclovir, used to treat or prevent viral infections.

Vaccines

If the patient needs to be vaccinated (with a live vaccine) while taking Mykofenolan mofetylu Accord, they should consult their doctor or pharmacist first. The doctor will advise which vaccine to administer.
The patient should not donate blood during treatment with Mykofenolan mofetylu Accord and for at least 6 weeks after the end of treatment. Men should not donate semen during treatment with Mykofenolan mofetylu Accord and for at least 90 days after the end of treatment.

Pregnancy, contraception, and breastfeeding

Contraception in women taking Mykofenolan mofetylu Accord

If the patient is a woman of childbearing age who may become pregnant, she must use effective contraception during treatment with Mykofenolan mofetylu Accord. This applies to the period:

• before starting treatment with Mykofenolan mofetylu Accord
• during the entire treatment period with Mykofenolan mofetylu Accord
• for 6 weeks after the end of treatment with Mykofenolan mofetylu Accord

The patient should discuss with their doctor the most suitable method of contraception. The choice will depend on the individual situation of the patient. It is best for the patient to use two methods of contraception, as this will reduce the risk of unintended pregnancy. The patient should contact their doctor as soon as possible if they think that contraception may not be effective or if they have missed a contraceptive pill.
The patient is not capable of becoming pregnant if any of the following criteria apply:

• •She is postmenopausal, i.e., over 50 years old and has not had a menstrual period for over a year (if menstrual periods have stopped due to cancer treatment, there is still a possibility of becoming pregnant).
• •She has had her fallopian tubes and both ovaries removed (bilateral salpingo-oophorectomy).
• •She has had her uterus removed (hysterectomy)
• •Her ovaries have stopped working (premature ovarian failure confirmed by a gynecological specialist)
• •She was born with one of the following rare disorders that result in infertility: XY genotype, Turner syndrome, or uterine agenesis
• •She is a child or adolescent who has not yet started menstruating.

Contraception in men taking Mykofenolan mofetylu Accord

Available data do not indicate an increased risk of miscarriage or birth defects in the child if the father is taking mycophenolate. However, this risk cannot be completely ruled out.
As a precaution, it is recommended that the patient or their partner use effective contraception during treatment and for 90 days after the end of treatment with Mykofenolan mofetylu Accord.
If the patient is planning to have a child, they should discuss the risks and other treatment options with their doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding and suspects that they may be pregnant or are planning to have a child, they should consult their doctor or pharmacist before taking this medicine. The doctor will inform the patient about the risks associated with pregnancy and other treatments that can be taken to prevent rejection of the transplanted organ, if:

• the patient is planning to become pregnant,
• the patient has not had a menstrual period or has had unusual menstrual bleeding or suspects that they are pregnant.
• the patient has had unprotected sex.

The patient should immediately inform their doctor if they become pregnant during treatment with mycophenolate.
However, the patient should continue to take Mykofenolan mofetylu Accord until they have consulted their doctor.

Pregnancy

Mycophenolate causes very frequent miscarriages (50%) and severe birth defects in the unborn child (23-27%). The reported birth defects include ear, eye, facial (cleft lip/palate), finger, heart, esophagus (the tube connecting the throat to the stomach), kidney, and nervous system (e.g., spina bifida) defects. The child of a patient treated with mycophenolate may have one or more of these anomalies.
If the patient is a woman of childbearing age, she must provide a negative pregnancy test result before starting treatment and follow the doctor's recommendations for contraception. The doctor may request more than one pregnancy test before starting treatment to ensure that the patient is not pregnant.

Breastfeeding

Mykofenolan mofetylu Accord should not be taken during breastfeeding, as small amounts of the medicine may pass into breast milk.

Driving and using machines

Mykofenolan mofetylu Accord has a moderate effect on the ability to drive and use tools or machines. If the patient feels drowsy, numb, or confused, they should tell their doctor or nurse and not drive or use machines until they feel better.

Mykofenolan mofetylu Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially "sodium-free".

3. How to take Mykofenolan mofetylu Accord

Mykofenolan mofetylu Accord is administered in a hospital by a doctor or nurse.
The medicine is given as a slow intravenous infusion.

What dose to take

The dose of the medicine depends on the type of organ transplanted in the patient. The usual doses are presented below. Treatment will be continued as long as immunosuppression is necessary to prevent rejection of the transplanted organ in the patient.

Kidney transplant

Adults:

• The first dose of the medicine is given within 24 hours of the transplant operation.
• The daily dose is 2 g of the medicine, taken in two separate doses.
• The patient should take 1 g of the medicine in the morning and 1 g of the medicine in the evening.

Liver transplant

Adults:

• The first dose of the medicine is given as soon as possible after the transplant.
• The patient will receive the medicine for at least 4 days
• The daily dose is 2 g of the medicine, taken in two separate doses.
• The patient should take 1 g of the medicine in the morning and 1 g of the medicine in the evening.
• When the patient is able to swallow, the medicine will be given orally.

Preparing the medicine

The medicine comes in the form of a powder. Before use, it must be mixed with a glucose solution.
The doctor or nurse will prepare the medicine and administer it to the patient. They will follow the instructions in section 7 "Preparing the medicine".

Taking a higher dose of Mykofenolan mofetylu Accord than recommended

If the patient thinks that they have been given too much medicine, they should immediately contact their doctor or nurse.

Missing a dose of Mykofenolan mofetylu Accord

If a dose of Mykofenolan mofetylu Accord is missed, the next dose will be given to the patient as soon as possible. Then, treatment will continue as usual.

Stopping treatment with Mykofenolan mofetylu Accord

Do not stop taking Mykofenolan mofetylu Accord unless the doctor decides to do so.
Stopping treatment with Mykofenolan mofetylu Accord may increase the risk of rejection of the transplanted organ by the body.
In case of any further doubts about taking the medicine, the patient should consult their doctor or nurse.

4. Possible side effects

Like all medicines, Mykofenolan mofetylu Accord can cause side effects, although not everybody gets them.
The patient should immediately inform their doctor or nurse if they experience the following serious side effects – the patient may need urgent treatment:

• symptoms of infection, such as fever or sore throat,
• unexplained bruises or bleeding,
• rash, swelling of the face, lips, tongue, or throat, difficulty breathing - this may indicate a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Common disorders

The most common disorders include: diarrhea, decreased white or red blood cell count, infections, and vomiting. The doctor will regularly order blood tests to check for any changes in:

• blood cell count or signs of infection.

Fighting infections

Mykofenolan mofetylu Accord weakens the body's immune system. This action prevents the rejection of the transplant. As a result, the body will not fight infections as effectively as usual. This means that patients may become ill more often than usual, including infections of the brain, skin, mouth, stomach, intestines, lungs, and urinary system.

Malignant lymphoma and skin cancer

In a very small number of patients treated with Mykofenolan mofetylu Accord, malignant lymphoma and skin cancer have occurred, which can occur in patients taking this type of medicine (immunosuppressant).

Systemic side effects

The patient may experience systemic side effects. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, fatigue, sleep disorders, pain (such as stomach, chest, joint, or muscle pain, headache, flu-like symptoms, swelling).
Other side effects may include:

• Skin disorders, such as:
• acne, herpes, shingles, skin thickening, hair loss, rash, itching.

Urinary system disorders, such as:

• blood in the urine

Gastrointestinal and oral disorders, such as:

• gum hypertrophy and oral ulcers,
• pancreatitis, colitis, or stomach inflammation,
• gastrointestinal disorders, including bleeding,
• liver disorders
• diarrhea, constipation, nausea, indigestion, loss of appetite, bloating.

Nervous system disorders, such as:

• drowsiness or numbness,
• tremors, muscle spasms, seizures,
• anxiety or depression, thinking, or mood disorders.

Heart and blood vessel disorders, such as:

• changes in blood pressure, blood clots, rapid heart rate,
• pain, redness, and swelling of blood vessels, in which an infection has occurred

Lung disorders, such as:

• pneumonia, bronchitis,
• shortness of breath, cough, which may be caused by bronchiectasis (a condition in which the airways are abnormally enlarged) or pulmonary fibrosis (scarring of the lungs). If persistent cough or shortness of breath occurs, the patient should contact their doctor.
• fluid in the lungs or chest,
• sinus disorders.

Other disorders, such as:

• weight loss, gout, high blood sugar, bleeding, bruising.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, with its seat at:
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Mykofenolan mofetylu Accord

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and vial, marked with the symbol EXP. The expiry date refers to the last day of the month.
• Powder for concentrate for solution for infusion: do not store above 30°C.
• Reconstituted and diluted medicine: after reconstitution and dilution, chemical and physical stability has been demonstrated for at least 24 hours at a temperature between 20°C and 30°C. From a microbiological point of view, the solution should be used immediately. If the product is not used immediately, the storage conditions and storage time are the responsibility of the user.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Mykofenolan mofetylu Accord contains

• The active substance of the medicine is mycophenolate mofetil.
• The other ingredients are: polysorbate 80, anhydrous citric acid, hydrochloric acid, sodium chloride, sodium hydroxide (to adjust pH)

What Mykofenolan mofetylu Accord looks like and what the pack contains

Mykofenolan mofetylu Accord is packaged in 20 ml type I glass vials, closed with a bromobutyl rubber stopper and an aluminum flip-off seal.
Mykofenolan mofetylu Accord is available in packs containing 1 or 4 vials.
Not all pack sizes may be marketed.

7. Preparing the medicine

Method and route of administration

Mykofenolan mofetylu Accord does not contain antibacterial preservatives, so the reconstitution and dilution of the product must be carried out under aseptic conditions.
The contents of each vial of Mykofenolan mofetylu Accord should be reconstituted in 14 ml of 5% glucose solution for intravenous infusion. Further dilution in 5% glucose solution is necessary to achieve a final concentration of 6 mg/ml. This means that to prepare a dose of 1 g of mycophenolate mofetil, the reconstituted contents of two vials (containing approximately 2 x 15 ml) should be diluted in 140 ml of 5% glucose solution for intravenous infusion. If the infusion solution is not prepared immediately before use, the infusion should be started no later than 24 hours after reconstitution and preparation of the infusion solution.
Care should be taken to avoid getting the prepared medicine into the eyes.

• If this happens, the eyes should be rinsed with a large amount of plain water.

Care should be taken to avoid contact between the prepared medicine and the skin.

• If this happens, the skin should be washed thoroughly with soap and water.

Mykofenolan mofetylu Accord should be administered by intravenous infusion (IV). The infusion rate should be controlled to ensure that the infusion time is 2 hours.
The solution for intravenous administration of Mykofenolan mofetylu Accord should never be administered rapidly or as a bolus.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Tąśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
85-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Member State

Marketing authorization holder

Medicinal product name

Austria
Mycophenolatmofetil Accord 500 mg Pulver zur Herstellung eines Infusionslösungskonzentrats
Belgium
Mycophenolate mofetil Accord Healthcare 500 mg powder for concentrate for solution for infusion / poudre pour solution à diluer pour perfusion / Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Denmark
Mycophenolatmofetil Accord 500 mg pulver til koncentrat til infusionsvæske, opløsning
France
Mycophénolate mofétil Accord 500 mg poudre pour solution à diluer pour perfusion
Spain
Micofenolato de mofetilo Accord 500 mg polvo para concentrado para solución para perfusión EFG
Netherlands
Mycofenolaatmofetil Accord 500 mg poeder voor concentraat voor oplossing voor infusie
Malta
Mycophenolate mofetil 500 mg Powder for concentrate for solution for infusion

Date of last revision of the leaflet: March 2024