Patient leaflet - Mycophenolate Mofetil 500 mg powder for concentrate for solution for infusion
1. What Mycophenolate mofetil for infusion is and what it is used for
The full name of your medicine is Mycophenolate mofetil 500 mg Powder for concentrate for solution for infusion.
- In this leaflet the shorter name Mycophenolate mofetil for infusion is used.
Mycophenolate mofetil for infusion contains mycophenolate mofetil.
- This belongs to a group of medicines called “immunosuppressants”.
Mycophenolate mofetil for infusion is used to prevent the body rejecting a transplanted organ.
- A kidney or liver.
Mycophenolate mofetil for infusion should be used together with other medicines:
- Ciclosporin
- Corticosteroids.
2. What you need to know before you use Mycophenolate mofetil for infusion
WARNING
Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.
Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.
If you do not fully understand these instructions, please ask your doctor to explain them again before you use mycophenolate. See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Do not use Mycophenolate mofetil for infusion:
- If you are allergic to mycophenolate mofetil, mycophenolic acid, polysorbate 80 or any of the other ingredients of this medicine (listed in section 6)
- If you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.
- If you are pregnant or planning to become pregnant or think you may be pregnant.
- If you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
- If you are breast-feeding.
Do not have this medicine if any of the above applies to you. If you are not sure, talk to your doctor or nurse before having Mycophenolate mofetil for infusion.
Warnings and precautions
Talk to your doctor or nurse straight away before starting treatment with Mycophenolate mofetil for infusion:
- If you are older than 65 years as you may have an increased risk of developing adverse events such as certain viral infections, gastrointestinal bleeding and pulmonary oedema when compared to younger patients
- If you have a sign of infection such as a fever or sore throat
- If you have any unexpected bruising or bleeding
- If you have ever had a problem with your digestive system such as a stomach ulcer
- If you are planning to become pregnant or if you get pregnant while you or your partner are using Mycophenolate mofetil for infusion
- If you have a hereditary enzyme deficiency such as Lesch-Nyhan and Kelley-Seegmiller syndrome
If any of the above apply to you (or you are not sure), talk to your doctor or nurse straight away before starting treatment with Mycophenolate mofetil for infusion.
The effect of sunlight
Mycophenolate mofetil for infusion reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:
- wearing protective clothing that also covers your head, neck, arms and legs
- using a sunscreen with a high protection factor.
Children
Do not administer this medicine to children because safety and efficacy of infusions to paediatric patients have not been established.
Other medicines and Mycophenolate mofetil for infusion
Tell your doctor or nurse if you are taking or have recently taken, any other medicines. This includes medicines obtained without a prescription, such as herbal medicines. This is because Mycophenolate mofetil for infusion can affect the way some other medicines work. Also other medicines can affect the way Mycophenolate mofetil for infusion works.
In particular, tell your doctor or nurse if you are taking any of the following medicines before you start Mycophenolate mofetil for infusion:
- azathioprine or other medicines that suppress your immune system – given after a transplant operation
- cholestyramine – used to treat high cholesterol
- rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)
- phosphate binders – used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood.
- antibiotics – used to treat bacterial infections
- isavuconazole – used to treat fungal infections
- telmisartan – used to treat high blood pressure
- aciclovir, ganciclovir and valganciclovir- used for the treatment and prevention of viral infections
Vaccines
If you need to have a vaccination (a live vaccine) while having Mycophenolate mofetil for infusion, talk to your doctor or pharmacist first. Your doctor will have to advise you on what vaccines you can have.
You must not donate blood during treatment with Mycophenolate mofetil for infusion and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with Mycophenolate mofetil for infusion and for at least 90 days after stopping treatment.
Pregnancy, contraception and breast-feeding
Contraception in women using Mycophenolate mofetil for infusion
If you are a woman who could become pregnant, you must use an effective method of contraception with Mycophenolate mofetil for infusion. This includes:
- Before you start using Mycophenolate mofetil for infusion
- During your entire treatment with Mycophenolate mofetil for infusion
- For 6 weeks after you stop using Mycophenolate mofetil for infusion.
Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation. Two forms of contraception are preferable as this will reduce the risk of unintended pregnancy. Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill.
You cannot become pregnant if any of the following conditions applies to you:
- You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have had treatment for cancer, then there is still a chance you could become pregnant)
- Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)
- Your womb (uterus) has been removed by surgery (hysterectomy)
- Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist)
- You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner’s syndrome or uterine agenesis
- You are a child or teenager who has not started having periods.
Contraception in men using Mycophenolate mofetil for infusion
The available evidence does not indicate an increased risk of malformations or miscarriage if the father uses mycophenolate. However, a risk cannot be completely excluded. As a precaution you or your female partner are recommended to use reliable contraception during treatment and for 90 days after you stop using Mycophenolate mofetil for infusion.
If you are planning to have a child, talk to your doctor about the potential risks and alternative therapies.
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 pharmacist for advice before using this medicine. Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if:
- You plan to become pregnant.
- You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
- You have sex without using effective method of contraception.
If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately. However, keep using Mycophenolate mofetil for infusion until you see him or her.
Pregnancy
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23-27 %) in the unborn baby. Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed)).Your baby may be affected by one or more of these.
If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor. Your doctor may request more than one test to ensure you are not pregnant before starting treatment.
Breast-feeding
Do not use Mycophenolate mofetil for infusion if you are breast-feeding. This is because small amounts of the medicine can pass into the mother’s milk.
Driving and using machines
Mycophenolate mofetil for infusion has a moderate influence on your ability to drive or use any tools or machines. If you feel drowsy, numb or confused, talk to your doctor or nurse and do not drive or use any tools or machines until you feel better.
Mycophenolate mofetil contains polysorbate 80
This medicine contains 25 mg of polysorbate 80 in each vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
Mycophenolate mofetil contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. How to use Mycophenolate mofetil for infusion
Mycophenolate mofetil for infusion is usually given by a doctor or nurse in hospital. It is given as a slow drip (infusion) into a vein.
How much to use
The amount you use depends on the type of transplant you have had. The usual doses are shown below. Treatment will continue for as long as you need to prevent rejection of your transplant organ.
Kidney transplant
Adults
- The first dose is given within 24 hours of the transplant operation.
- The daily dose is 2 g of the medicine given as 2 separate doses.
- This will be given as 1 g in the morning and then 1 g in the evening.
Liver transplant
Adults
- The first dose is given to you as soon as possible after the transplant operation.
- You will have the medicine for at least 4 days.
- The daily dose is 2 g of the medicine given as 2 separate doses.
- This will be given as 1 g in the morning and then 1 g in the evening.
- When you are able to swallow, you will be given this medicine by mouth.
Making up the medicine
The medicine comes as a powder. This needs mixing with glucose before using. Your doctor or nurse will make up the medicine and give it to you. They will follow the instructions under Section 7 “Making up the medicine”.
If you use more Mycophenolate mofetil for infusion than you should
If you think that you have had too much medicine, talk to your doctor or nurse straight away.
If you forget to use Mycophenolate mofetil for infusion
If a dose of Mycophenolate mofetil for infusion is missed, this will be given to you as soon as possible. Your treatment will then continue at the normal times.
If you stop using Mycophenolate mofetil for infusion
Do not stop having Mycophenolate mofetil for infusion unless your doctor tells you to. If you stop your treatment you may increase the chance of rejection of your transplant organ.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, Mycophenolate mofetil for infusion can cause side effects, although not everybody gets them.
Talk to a doctor or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
- you have a sign of infection such as a fever or sore throat
- you have any unexpected bruising or bleeding rash, itching, hives, breathlessness or difficult breathing, wheezing or coughing, lightheadedness, dizziness, changes in levels of consciousness, hypotension, with or without mild generalized itching, skin reddening and facial/throat swelling (symptoms of severe allergic reaction)
Usual problems
Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to check for any changes in:
- the number of your blood cells or signs of infections.
Fighting infections
Mycophenolate mofetil for infusion reduces your body’s defences. This is to stop you rejecting your transplant. As a result, your body will not be as good as normal at fighting infections. This means you may catch more infections than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.
Lymph and skin cancer
As can happen in patients having this type of medicine (immune-suppressants), a very small number of patients on Mycophenolate mofetil for infusion have developed cancer of the lymphoid tissues and skin.
General unwanted effects
You may get general side effects affecting your body as a whole. These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle), headache, flu symptoms and swelling.
Other unwanted effects may include:
Skin problems such as:
- acne, skin growth, cold sores, shingles, hair loss, rash, itching.
Urinary problems such as:
- blood in the urine.
Digestive system and mouth problems such as:
- swelling of the gums and mouth ulcers,
- inflammation of the pancreas, colon or stomach,
- gastrointestinal disorders including bleeding,
- liver disorders,
- diarrhoea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.
Nervous system problems such as:
- feeling drowsy or numb
- tremor, muscle spasms, convulsions
- feeling anxious or depressed, changes in your mood or thoughts.
Heart and blood vessel problems such as:
- change in blood pressure, blood clots, accelerated heartbeat
- pain, redness and swelling of the blood vessels where you had the infusion.
Lung problems such as:
- pneumonia, bronchitis
- shortness of breath, cough which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor if you develop a persistent cough or breathlessness
- fluid on the lungs or inside the chest
- sinus problems.
Other problems such as:
- weight loss, gout, high blood sugar, bleeding, bruising.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Mycophenolate mofetil for infusion
- 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 carton and vial label after EXP.
- Powder for concentrate for solution for infusion: do not store above 30°C.
- Reconstitution and dilution: After reconstitution and dilution, chemical and physical in-use stability of solution for infusion has been demonstrated for 24 hours at 20 to 30 °C. 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.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Mycophenolate mofetil for infusion contains
- The active substance is mycophenolate mofetil.
- The other ingredients are: polysorbate 80, citric acid, hydrochloric acid, sodium chloride and sodium hydroxide (for pH-adjustment).
What Mycophenolate mofetil for infusion looks like and contents of the pack
- Mycophenolate mofetil for infusion is provided in a 20 ml type I clear glass vial with a grey butyl rubber stopper and aluminium flip off seal.
- It is available in packs of either 4 vials or 1 vial.
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Method and route of administration
Mycophenolate mofetil for infusion does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.
The content of Mycophenolate mofetil for infusion vials must be reconstituted with 14 ml of glucose intravenous infusion 5 % each. A further dilution with glucose intravenous infusion 5 % is required to a final concentration of 6 mg/ml. This means that to prepare a 1 g dose of mycophenolate mofetil the content of 2 reconstituted vials (approx. 2 x 15 ml) must be further diluted into 140 ml glucose intravenous infusion 5 % solution. If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 24 hours from reconstitution and dilution of the medicinal product.
Take care not to let the made-up medicine get into your eyes.
- If this happens, rinse your eyes with plain water.
Take care not to let the made-up medicine get on your skin.
- If this happens, wash the area thoroughly with soap and water.
Mycophenolate mofetil for infusion must be given as an intravenous (IV) infusion. The infusion flow rate should be controlled to equate to a 2 hour period of administration.
Mycophenolate mofetil for infusion IV solution should never be administered by rapid or bolus intravenous injection.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare single member S.A.
64th Km National Road Athens, Lamia, Schimatari, 32009, Greece