Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using Mycophenolate Accord?
Mycophenolate Accord contains the active ingredient mycophenolate mofetil. Mycophenolate Accord is used to prevent the rejection of a transplanted organ and work by stopping your immune system from reacting to the transplanted organ. There are many different types of medicines used to prevent rejection of a transplanted organ. Mycophenolate Accord may be used together with other medicines known as ciclosporin and corticosteroids.
For more information, see Section 1. Why am I using Mycophenolate Accord? in the full CMI.
2. What should I know before I use Mycophenolate Accord?
Do not use if you have ever had an allergic reaction to mycophenolate mofetil, polysorbate 80 or any of the other ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Mycophenolate Accord? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Mycophenolate Accord and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use Mycophenolate Accord?
Mycophenolate Accord is an injection for infusion and will be given to you by your doctor or nurse.
More instructions can be found in Section 4. How do I use Mycophenolate Accord? in the full CMI.
5. What should I know while using Mycophenolate Accord?
| Things you should do |
|
| Driving or using machines | Mycophenolate Accord may cause somnolence, confusion, dizziness, tremor or hypotension in some people. This may affect your ability to drive or operate machinery. |
For more information, see Section 5. What should I know while using Mycophenolate Accord? in the full CMI.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
Some of the more common side effects are included in full below in the CMI. Speak to your doctor if you have any of these common side effects and they worry you.
Serious side effects are:
- Signs of other infections e.g. fevers, chills, sore throat, ulcers of the mouth, abdominal pain or bloody stools
- unexpected bruising or bleeding
- signs of anaemia such as excessive tiredness, dizziness or looking pale
- swelling of the hands, ankles or feet, lymph nodes
- hypersensitivity
- breathing difficulties, pain in the chest, chronic cough with blood
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
MYCOPHENOLATE ACCORD
Active ingredient: mycophenolate mofetil
Consumer Medicine Information (CMI)
This leaflet provides important information about using Mycophenolate Accord. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Mycophenolate Accord.
Where to find information in this leaflet:
1. Why am I using Mycophenolate Accord?
2. What should I know before I use Mycophenolate Accord?
3. What if I am taking other medicines?
4. How do I use Mycophenolate Accord?
5. What should I know while using Mycophenolate Accord?
6. Are there any side effects?
7. Product details
1. Why am I using Mycophenolate Accord?
Mycophenolate Accord contains the active ingredient mycophenolate mofetil. Mycophenolate mofetil belongs to a group of medicines called immunosuppressants.
Mycophenolate Accord is used to prevent the rejection of a transplanted organ and work by stopping your immune system from reacting to the transplanted organ.
There are many different types of medicines used to prevent rejection of a transplanted organ.
Mycophenolate Accord may be used together with other medicines known as ciclosporin and corticosteroids.
2. What should I know before I use Mycophenolate Accord?
Warnings
Do not use Mycophenolate Accord if:
- you are allergic to mycophenolate mofetil, polysorbate 80 or any of the other ingredients listed at the end of this leaflet
If you are a woman of childbearing potential, you must have two negative pregnancy tests 8-10 days apart just prior to starting treatment with Mycophenolate Accord.
Repeat pregnancy tests will be performed during routine follow up visits with your doctor.
You should not donate blood while you are being treated with Mycophenolate Accord and for at least 6 weeks after you stop receiving Mycophenolate Accord.
Check with your doctor if you have or have had:
- a history of sunspots or skin cancers
- a history of low blood counts of neutrophils (a type of white blood cell)
- a history of serious stomach or bowel problems (such as ulceration or bleeding)
- rare diseases due to a deficiency of the HGPRT enzyme such as Lesch-Nyhan or Kelley-Seegmiller syndrome
- kidney disease
- allergies to any other medicines, foods, preservatives or dyes
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
As with many medicines, Mycophenolate Accord may harm your developing or breastfeeding baby.
There have been cases of miscarriage and severe birth defects reported when patients have taken Mycophenolate Accord during pregnancy.
You must use two reliable forms of contraception at the same time before beginning Mycophenolate Accord therapy, during therapy and for at least six weeks after stopping Mycophenolate Accord, unless you are not sexually active.
Males: You are recommended to use condoms during treatment and for 90 days after stopping treatment, even if you have had a vasectomy.
Your female partner(s) are recommended to use reliable contraception while you are being treated with Mycophenolate Accord and for 90 days after you have stopped receiving Mycophenolate Accord.
You should not donate semen while you are being treated with Mycophenolate Accord and for 90 days after you have stopped receiving Mycophenolate Accord.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Mycophenolate Accord and affect how it works or Mycophenolate Accord may affect how they work.
- azathioprine, tacrolimus and sirolimus, medicines used to suppress the immune system which can be used to prevent organ rejection after a transplant
- aciclovir, ganciclovir, valaciclovir or valganciclovir, medicines used to treat certain viral infections
- isavuconazole, a medicine used to treat fungal infections
- antacids, medicines used to treat heartburn and indigestion
- cholestyramine, a medicine used to treat high cholesterol
- ciprofloxacin, amoxicillin plus clavulanic acid, norfloxacin plus metronidazole and rifampicin, medicines used to treat infections
- iron supplements, medicines used to treat low iron levels in the blood
- certain vaccines, (especially live vaccines), medicines that work by causing your body to produce its own protection against an infectious disease
- proton-pump inhibitors, medicines used to treat indigestion and stomach ulcers such as lansoprazole and pantoprazole
- calcium-free phosphate binders (such as sevelamer), medicines used to treat high phosphate levels in the blood
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Mycophenolate Accord.
4. How do I use Mycophenolate Accord?
How much to use
Mycophenolate Accord is given to you as an infusion into your vein (intravenously), usually over a period of two or more hours. It is only given in a hospital setting and doses are usually 12 hours apart.
Your doctor will decide what dose of Mycophenolate Accord you will be given. The infusion dose to prevent organ rejection is usually 2 g to 3 g per day depending on which organ has been transplanted.
Your doctor may adjust the dose during treatment depending on your response.
When to use Mycophenolate Accord
If you are receiving Mycophenolate Accord infusion, your doctor will most likely change this medication to mycophenolate mofetil capsules, tablets or suspension once you are able to take these.
If you use too much Mycophenolate Accord
It is unlikely that you will receive an overdose of Mycophenolate Accord because a trained nurse or doctor will give it. If you think that you have been given too much Mycophenolate Accord, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre (by calling 13 11 26), or
- contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Mycophenolate Accord?
Things you should do
- If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Mycophenolate Accord
- Remind any doctor, dentist or pharmacist you visit that you are using Mycophenolate Accord
- If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery
- Tell your doctor if you realise that you are pregnant while taking Mycophenolate Accord
- Be sure to keep all your appointments with your doctor so that your progress can be checked. Your doctor will need to give you regular blood tests
- Wear protective clothing and broad-spectrum sunscreen when outdoors. Medicines that prevent the rejection of transplanted organs can increase the risk of skin cancers
- Tell your doctor if you feel your medicine is not helping your condition
Driving or using machines
Be careful driving or operating machinery until you know how Mycophenolate Accord affects you.
Mycophenolate Accord may cause somnolence, confusion, dizziness, tremor or hypotension in some people.
Make sure you know how you react to Mycophenolate Accord before you drive a car, operate machinery, or do anything else that could be dangerous.
Looking after your medicine
The hospital will store Mycophenolate Accord under the correct conditions.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
Your doctor, nurse or pharmacist will dispose of any Mycophenolate Accord that may be left over.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
To stop you rejecting your organ, transplant medications reduce your body’s own defence mechanisms. This means your body will not be as good at fighting infection. People receiving Mycophenolate Accord therefore develop more infections than usual.
Patients who receive immunosuppressant medicines may also have a small increase in their risk of developing some types of cancer. You should discuss this with your doctor.
If you are over 65 years of age you may have an increase chance of side effects occurring due to immunosuppression.
See the information below and, if you need to, ask your doctor, nurse or pharmacist if you have any further questions about side effects.
Common side effects
| Common side effects | What to do |
|
Speak to your doctor if you have any of these common side effects and they worry you. |
Serious side effects
| Serious side effects (rare) | What to do |
|
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor’s prescription.
What Mycophenolate Accord contains
| Active ingredient (main ingredient) |
mycophenolate mofetil |
| Other ingredients (inactive ingredients) |
citric acid hydrochloric acid polysorbate 80 sodium chloride sodium hydroxide |
Do not take this medicine if you are allergic to any of these ingredients.
What Mycophenolate Accord looks like
Mycophenolate Accord infusion is a sterile white to off-white powder in a clear glass vial. It will be made up into an infusion bag before being given to you. (500 mg Aust R 327728).
Who distributes Mycophenolate Accord
Accord Healthcare Pty Ltd
Level 24, 570 Bourke Street
Melbourne, VIC, 3000
Australia
This leaflet was prepared in January 2022.
Published by MIMS December 2022