Myfortic
Immunosuppressant for Kidney Transplant Rejection Prevention
Quick Facts About Myfortic
Key Takeaways About Myfortic
- Prevents kidney transplant rejection: Myfortic is always used with ciclosporin and corticosteroids as part of a triple immunosuppressive regimen following kidney transplantation
- Critical pregnancy warning: Mycophenolate causes a 50% miscarriage rate and 23–27% birth defect rate – effective contraception is mandatory for women of childbearing potential
- Increased infection risk: As an immunosuppressant, Myfortic reduces the body’s ability to fight infections; report any signs of infection (fever, sore throat) to your doctor immediately
- Do not crush or split tablets: Myfortic tablets are enteric-coated to protect the stomach lining – they must be swallowed whole
- Never stop without medical advice: Stopping Myfortic on your own significantly increases the risk of transplant rejection and potential organ loss
What Is Myfortic and What Is It Used For?
Myfortic (mycophenolic acid) is an immunosuppressant medicine used to prevent the body’s immune system from rejecting a transplanted kidney. It is always used in combination with other immunosuppressive medicines, including ciclosporin and corticosteroids.
Myfortic contains mycophenolic acid in the form of sodium mycophenolate. It belongs to a group of medicines called immunosuppressants, which work by dampening the activity of the immune system. After kidney transplantation, the body naturally recognises the new organ as foreign tissue and mounts an immune response to destroy it. This process, known as acute rejection, can lead to the loss of the transplanted kidney if not prevented with medication.
The active substance in Myfortic, mycophenolic acid (MPA), works by selectively inhibiting an enzyme called inosine monophosphate dehydrogenase (IMPDH). This enzyme plays a critical role in the de novo synthesis of guanosine nucleotides, which are essential building blocks for DNA replication in rapidly dividing cells. T-lymphocytes and B-lymphocytes – the immune cells primarily responsible for transplant rejection – are uniquely dependent on this pathway for their proliferation. By blocking IMPDH, mycophenolic acid selectively suppresses the growth and activity of these lymphocytes without significantly affecting other cell types that can use alternative (salvage) pathways for nucleotide production.
Myfortic is specifically formulated as an enteric-coated tablet. The enteric coating prevents the tablet from dissolving in the acidic environment of the stomach, instead releasing the active ingredient in the more alkaline environment of the small intestine. This design was developed to reduce upper gastrointestinal side effects such as stomach pain and nausea, which are commonly associated with mycophenolate therapy. Clinical studies, including the pivotal ERL B301 and ERL B302 trials, demonstrated that the enteric-coated formulation provides equivalent immunosuppressive efficacy to mycophenolate mofetil (CellCept) while potentially offering improved gastrointestinal tolerability in some patients.
Myfortic is typically initiated within 72 hours of the transplant procedure, as part of an induction immunosuppressive regimen. It is intended for long-term use and treatment continues for as long as immunosuppression is needed to maintain the function of the transplanted kidney. The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines and the American Society of Transplantation (AST) both recommend mycophenolate-based regimens as standard of care in kidney transplantation due to their well-established efficacy in reducing acute rejection episodes.
Mycophenolic acid is not the same as mycophenolate mofetil, although both deliver MPA as the active compound. Myfortic (sodium mycophenolate, enteric-coated) and CellCept (mycophenolate mofetil) are not interchangeable on a milligram-for-milligram basis. Never switch between these formulations unless specifically instructed to do so by your transplant physician.
What Should You Know Before Taking Myfortic?
Before starting Myfortic, you must inform your doctor about all medical conditions and medications. Women of childbearing potential must have a negative pregnancy test and use effective contraception. Myfortic is contraindicated in pregnancy and during breastfeeding.
Contraindications
You should not take Myfortic if any of the following apply to you:
- Allergy to mycophenolic acid, sodium mycophenolate, mycophenolate mofetil or any of the other ingredients in this medicine
- Pregnancy or planning to become pregnant – mycophenolate causes severe birth defects and a high rate of miscarriage
- Women of childbearing potential who have not completed a negative pregnancy test before starting treatment
- Women of childbearing potential not using effective contraception – two forms of contraception are recommended
- Breastfeeding – small amounts of the medicine can pass into breast milk
Mycophenolate causes a very high rate of miscarriage (50%) and severe birth defects (23–27%) in exposed pregnancies. Reported birth defects include malformations of the ears, eyes, face (cleft lip/palate), fingers, heart, oesophagus, kidneys, and nervous system (such as spina bifida). Women of childbearing potential must use two forms of effective contraception before, during, and for 6 weeks after stopping treatment. Men taking Myfortic should use reliable contraception during treatment and for at least 90 days after the last dose.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Myfortic if you have or have had any of the following:
- Serious digestive problems such as gastric ulcers – Myfortic can worsen gastrointestinal conditions
- Rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan or Kelley-Seegmiller syndrome – patients with these conditions should not take mycophenolate
- History of hepatitis B or C – Myfortic may increase the risk of viral reactivation; your doctor may monitor you with blood tests
You should also be aware of the following important safety information:
- Increased skin cancer risk: Myfortic reduces the skin’s natural protection against UV radiation. Limit sun exposure, wear protective clothing, and use high-SPF sunscreen regularly. Your transplant team may recommend annual dermatological screening
- Infection susceptibility: Because Myfortic suppresses the immune system, you are more vulnerable to bacterial, viral, and fungal infections. Contact your doctor immediately if you develop signs of infection such as fever, sore throat, persistent cough, or breathlessness
- Blood monitoring: Your doctor will perform regular blood tests to monitor white blood cell counts, liver function, and kidney function during treatment. Dose adjustments may be necessary based on these results
- Antibody levels: Your doctor may monitor immunoglobulin levels, particularly if you experience recurrent infections. Low antibody levels may require modification of your immunosuppressive regimen
- Persistent cough or breathlessness: Report these symptoms immediately, as they may indicate pulmonary complications such as interstitial lung disease, particularly when combined with other immunosuppressive agents
Pregnancy and Breastfeeding
Mycophenolate poses one of the most significant teratogenic risks of any commonly used immunosuppressive medicine. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have both issued strong warnings about the reproductive risks associated with mycophenolate products.
Women of childbearing potential must meet all of the following requirements before starting Myfortic:
- A negative pregnancy test must be confirmed before the first prescription is issued
- Two effective forms of contraception must be used continuously – before starting, during the entire course of treatment, and for 6 weeks after stopping Myfortic
- Your doctor will provide both verbal and written information about the risks to the foetus
If you become pregnant while taking mycophenolate, you must inform your doctor immediately. However, do not stop taking the medication on your own, as this could lead to transplant rejection. Your transplant team will assess the situation and help you make an informed decision about how to proceed.
Breastfeeding is not recommended during Myfortic treatment, as small amounts of the medicine can pass into breast milk and potentially harm the nursing infant.
Contraception for men: Although current evidence does not conclusively demonstrate an increased risk of birth defects or miscarriage when the father is taking mycophenolate, the risk cannot be entirely excluded. As a precautionary measure, male patients or their female partners should use reliable contraception during treatment and for at least 90 days after the last dose.
Children and Elderly Patients
Myfortic is not recommended for children and adolescents because safety and efficacy have not been established in this age group. Paediatric transplant recipients may be prescribed alternative mycophenolate formulations under specialist supervision.
For elderly patients (65 years and older), no dose adjustment is necessary. However, elderly patients may be at increased risk for certain side effects due to age-related decline in immune function, and closer monitoring is advisable.
Driving and Operating Machinery
Myfortic has a minor effect on the ability to drive or use machines. Side effects such as dizziness, tremor, or drowsiness may occasionally impair your reaction time. You should assess your own fitness to drive based on how you feel while taking this medication. If you experience any symptoms that could affect your driving ability, do not drive until the symptoms resolve.
Important Information About Ingredients
Myfortic tablets contain sodium (13 mg per 180 mg tablet, 26 mg per 360 mg tablet, corresponding to 0.65% and 1.3% respectively of the WHO recommended maximum daily sodium intake for adults) and lactose. If you have been told by your doctor that you have an intolerance to certain sugars (including lactose, galactose, or glucose), consult your doctor before taking this medicine.
How Does Myfortic Interact with Other Drugs?
Myfortic can interact with several other medications, including other immunosuppressants, antiviral agents, cholesterol-lowering medicines, and antacids. Always inform your doctor about all medicines you are taking, including over-the-counter products.
Drug interactions with mycophenolic acid can either reduce its effectiveness – potentially increasing the risk of transplant rejection – or increase its side effects. Because transplant patients typically take multiple medications simultaneously, careful coordination between your transplant team and pharmacist is essential.
Major Interactions
| Drug | Effect | Clinical Advice |
|---|---|---|
| Azathioprine | Both suppress bone marrow; combined use greatly increases risk of severe myelosuppression | Do not use together – contraindicated combination |
| Tacrolimus | May increase mycophenolic acid exposure; combined immunosuppression increases infection and malignancy risk | Can be used together under specialist supervision with dose adjustments and monitoring |
| Cholestyramine | Binds mycophenolic acid in the gut, significantly reducing its absorption and blood levels | Avoid combination; if needed, separate doses by at least 2 hours |
| Aciclovir / Ganciclovir | Both drugs compete for renal tubular secretion, leading to increased blood levels of both MPA metabolite (MPAG) and the antiviral | Monitor for increased side effects of both medicines, especially in patients with impaired kidney function |
Other Interactions
| Drug | Effect | Clinical Advice |
|---|---|---|
| Antacids (Mg/Al) | Magnesium and aluminium-containing antacids reduce absorption of mycophenolic acid | Separate doses by at least 2 hours |
| Activated charcoal | Adsorbs mycophenolic acid, reducing its bioavailability | Avoid concurrent use |
| Ciclosporin | Ciclosporin inhibits enterohepatic recirculation of MPA, potentially reducing MPA levels | Standard combination; dose adjustments may be needed if ciclosporin is reduced or discontinued |
| Live vaccines | Immunosuppression may reduce vaccine efficacy and increase risk of infection from live vaccines | Avoid live vaccines during treatment; inactivated vaccines may be less effective |
You must not donate blood during treatment with Myfortic and for at least 6 weeks after stopping treatment. Men must not donate sperm during treatment and for at least 90 days after the last dose.
Food Interactions
Myfortic can be taken with or without food. However, you should choose one approach and remain consistent – always take your dose either with meals or between meals – to ensure a consistent amount of medication is absorbed each day. The enteric coating means that food does not significantly affect the overall absorption of mycophenolic acid, but consistency helps maintain stable drug levels in the blood.
What Is the Correct Dosage of Myfortic?
The recommended daily dose of Myfortic is 1,440 mg (720 mg twice daily). Myfortic is only prescribed by transplant physicians experienced in managing transplant recipients. The first dose is given within 72 hours of transplantation.
Adults
Standard Adult Dose
1,440 mg daily, taken as 720 mg twice daily (morning and evening).
Each 720 mg dose equals 4 tablets of 180 mg or 2 tablets of 360 mg.
Treatment Initiation
The first 720 mg dose should be given within 72 hours of kidney transplantation. Treatment is used in combination with ciclosporin and corticosteroids as part of a standard triple immunosuppressive regimen.
Patients with Severe Kidney Problems
Renal Impairment
The daily dose should not exceed 1,440 mg (720 mg twice daily). No specific dose reduction is mandated for renal impairment, but patients should be carefully monitored, as drug exposure may be altered in severe renal dysfunction.
Children and Adolescents
Paediatric Use
Myfortic is not recommended for use in children and adolescents, as safety and efficacy have not been established in this age group.
Elderly Patients
Patients 65 Years and Older
No dose adjustment is required. The recommended dose of 1,440 mg daily (720 mg twice daily) applies to elderly patients. However, elderly patients may have an increased susceptibility to infections and other side effects, and should be monitored closely.
How to Take Myfortic
Following the correct administration instructions is essential for Myfortic to work effectively:
- Swallow the tablets whole with a glass of water – do not crush, chew, or split the tablets, as this destroys the enteric coating
- Do not take broken tablets – if a tablet is cracked or damaged, discard it and use an intact tablet
- Take consistently with or without food – choose one approach and maintain it for the duration of treatment
- Take at regular intervals – morning and evening doses should be approximately 12 hours apart to maintain stable blood levels
- Continue treatment for as long as directed by your transplant team – immunosuppression is typically required for life after transplantation
Missed Dose
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a missed one. If you are unsure about what to do, contact your doctor or pharmacist for advice.
Overdose
If you take too many Myfortic tablets, or if a child accidentally ingests the medicine, contact your doctor, hospital, or poison control centre immediately. Overdose with mycophenolate may lead to excessive immunosuppression and increased susceptibility to infections. It may also increase the likelihood of haematological side effects such as low white blood cell counts. There is no specific antidote; treatment is supportive and may include measures to reduce drug absorption, such as activated charcoal (most effective within the first hour). Take the medicine packaging with you so that healthcare professionals can identify what was taken.
What Are the Side Effects of Myfortic?
Like all medicines, Myfortic can cause side effects, although not everyone experiences them. As an immunosuppressant, Myfortic increases the risk of infections and, with long-term use, certain types of cancer. Contact your doctor immediately if you notice signs of infection, unusual bleeding, or new skin growths.
Immunosuppressive medicines, including Myfortic, reduce the body’s natural defence mechanisms. This is necessary to prevent rejection of the transplanted kidney, but it also means that the body becomes less able to fight off infections. Patients taking Myfortic may experience more frequent infections of the urinary tract, respiratory tract, skin, mouth, and gastrointestinal system than they would otherwise.
Your doctor will perform regular blood tests to monitor for changes in blood cell counts, blood sugar, lipids, and cholesterol levels throughout your treatment. Elderly patients may experience more side effects due to age-related immune decline.
Serious Side Effects – Contact Your Doctor Immediately
- Signs of infection: fever, chills, sweating, persistent fatigue, drowsiness, or lack of energy
- Gastrointestinal bleeding: bloody vomit, black or bloody stools, or stomach/intestinal ulcers
- Swollen lymph nodes, new skin growths, or changes in existing moles – may indicate cancer, which can occur in patients on long-term immunosuppression
- Severe allergic reaction: rash, hives, difficulty breathing, wheezing, dizziness, facial/throat swelling
Very Common
May affect more than 1 in 10 people
- Low white blood cell count (leucopenia)
- Low blood calcium (hypocalcaemia)
- Low blood potassium (hypokalaemia)
- High uric acid levels (hyperuricaemia)
- High blood pressure (hypertension)
- Anxiety
- Diarrhoea
- Joint pain (arthralgia)
Common
May affect up to 1 in 10 people
- Anaemia (tiredness, breathlessness, pallor)
- Low platelet count (thrombocytopenia) – unexpected bleeding or bruising
- High potassium (hyperkalaemia), low magnesium (hypomagnesaemia)
- Dizziness, headache, cough
- Low blood pressure (hypotension), breathlessness (dyspnoea)
- Abdominal pain, gastritis, bloating, constipation, indigestion, flatulence, nausea, vomiting
- Fatigue, fever
- Abnormal liver or kidney function tests
- Respiratory tract infections
- Acne, weakness (asthenia), muscle pain (myalgia)
- Swollen hands, ankles, or feet (peripheral oedema)
- Itching (pruritus)
Uncommon
May affect up to 1 in 100 people
- Rapid heartbeat (tachycardia), extra heartbeats, fluid in the lungs (pulmonary oedema)
- Lymphocele (fluid-filled swelling under the skin)
- Tremor, insomnia
- Red, swollen eyes (conjunctivitis), blurred vision
- Wheezing, belching, bad breath, bowel obstruction (ileus), mouth ulcers, heartburn, tongue discolouration, dry mouth, gum overgrowth, pancreatitis, peritonitis
- Bone infection, blood and skin infections
- Blood in urine, kidney damage, painful or difficult urination
- Hair loss, bruising
- Joint inflammation (arthritis), back pain, muscle cramps
- Loss of appetite, high blood sugar (diabetes), high cholesterol, low phosphate
- Flu-like symptoms, pain, stiffness, thirst, weakness
- Abnormal dreams, delusions, impotence
- Interstitial lung disease (cough, difficulty breathing, painful breathing)
Not Known
Frequency cannot be estimated from available data
- Agranulocytosis (severe white blood cell deficiency) – fever, sore throat, frequent infections
- Severe allergic reactions – rash, hives, wheezing, dizziness, facial/throat swelling, low blood pressure
Side Effects Reported with Similar Medicines
The following additional side effects have been reported with the mycophenolate class of immunosuppressants:
- Inflammation of the colon, cytomegalovirus (CMV) gastritis
- Intestinal perforation (development of a hole through the intestinal wall), potentially causing severe abdominal pain with bleeding
- Stomach or duodenal ulcers
- Deficiency of specific white blood cell types or all blood cells (pancytopenia)
- Serious infections including endocarditis (heart valve infection), meningitis, and tuberculosis
- Bronchiectasis (permanent widening of the airways in the lungs)
- Atypical mycobacterial infections, which can present as persistent cough or breathlessness
If you experience any side effects, including those not listed here, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to your national medicines regulatory authority. By reporting side effects, you can help provide more information on the safety of this medicine.
How Should You Store Myfortic?
Store Myfortic in the original packaging to protect it from moisture. Keep it out of the sight and reach of children. No special temperature conditions are required.
Proper storage of Myfortic is essential to maintain the medication’s effectiveness and safety. Follow these storage guidelines:
- Keep out of sight and reach of children – mycophenolate is particularly dangerous if accidentally ingested by a child
- No special temperature requirements – store at room temperature
- Store in the original blister packaging – the tablets are sensitive to moisture; do not remove them from the blister until ready to take
- Do not use damaged packaging – if the blister pack appears damaged or shows signs of having been opened, do not use the tablets
- Check the expiry date – do not use after the expiry date printed on the carton (the last day of the stated month)
- Dispose of properly – do not dispose of medicines via household waste or wastewater. Return unused medicines to your pharmacy for safe disposal to protect the environment
What Does Myfortic Contain?
The active substance is mycophenolic acid (as sodium mycophenolate), available in 180 mg and 360 mg enteric-coated tablets. Each tablet strength has a distinct colour and shape for easy identification.
Active Ingredient
Each tablet contains either 180 mg or 360 mg of mycophenolic acid (as sodium mycophenolate). Mycophenolic acid is the pharmacologically active form; sodium mycophenolate is the salt form used in the formulation to improve stability and absorption.
Inactive Ingredients (Excipients)
Tablet core (both strengths): maize starch, povidone, crospovidone, lactose, colloidal anhydrous silica, magnesium stearate.
180 mg tablet coating: hypromellose phthalate, titanium dioxide (E171), yellow iron oxide (E172), indigotine (E132).
360 mg tablet coating: hypromellose phthalate, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Appearance
Myfortic 180 mg: Light green, round, film-coated enteric tablets, imprinted with “C” on one side. Available in blister packs of 20, 50, 100, 120, or 250 tablets.
Myfortic 360 mg: Light orange-red, oval, film-coated enteric tablets, imprinted with “CT” on one side. Available in blister packs of 50, 100, 120, or 250 tablets.
Not all pack sizes may be marketed in your country.
Frequently Asked Questions About Myfortic
Both Myfortic (sodium mycophenolate) and CellCept (mycophenolate mofetil) deliver mycophenolic acid (MPA) as the active immunosuppressive compound. The key difference is the formulation: Myfortic uses an enteric coating that releases MPA in the small intestine rather than the stomach, which was designed to reduce upper gastrointestinal side effects. The two products are not milligram-for-milligram equivalent – Myfortic 720 mg provides a comparable MPA exposure to CellCept 1,000 mg. Never switch between these formulations without your transplant doctor’s guidance.
No. Myfortic must not be taken during pregnancy. Mycophenolate causes a 50% miscarriage rate and 23–27% risk of severe birth defects, including malformations of the ears, eyes, face, heart, kidneys, and nervous system. Women of childbearing potential must use two forms of effective contraception and have a confirmed negative pregnancy test before starting treatment. If you become pregnant while on Myfortic, contact your doctor immediately but do not stop the medication on your own.
Yes. As an immunosuppressant, Myfortic reduces the immune system’s ability to fight infections. Patients may experience more frequent bacterial, viral, and fungal infections, commonly affecting the urinary tract, respiratory system, skin, and mouth. You should contact your doctor immediately if you develop a fever, sore throat, persistent cough, or any other signs of infection. Your doctor will perform regular blood tests to monitor your immune function throughout treatment.
No. You should never stop taking Myfortic without your doctor’s approval, even if you feel well. Immunosuppressive therapy is essential to prevent your body from rejecting the transplanted kidney. Stopping treatment – even temporarily – significantly increases the risk of acute rejection, which can lead to permanent damage to the transplant or complete graft loss. If you are experiencing side effects, discuss them with your transplant team to explore dose adjustments or alternative strategies.
Live vaccines (such as MMR, varicella, or yellow fever vaccine) must be avoided while taking Myfortic, as immunosuppression may allow the weakened virus in the vaccine to cause an actual infection. Inactivated vaccines (such as influenza and COVID-19 vaccines) are generally considered safe but may be less effective because your immune system is suppressed. Your transplant team will advise you on which vaccinations are safe and appropriate. Ideally, vaccinations should be completed before starting immunosuppressive therapy.
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the one you missed. Consistent dosing is important for maintaining stable immunosuppression, so try to take your tablets at the same times each day. If you frequently forget doses, consider setting reminders or using a pill organiser.
References
- KDIGO Clinical Practice Guideline for the Care of Kidney Transplant Recipients. American Journal of Transplantation. 2009;9 Suppl 3:S1-155. Updated 2024.
- European Medicines Agency (EMA). Myfortic Summary of Product Characteristics. Available at: EMA – Myfortic EPAR
- Salvadori M, et al. Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. American Journal of Transplantation. 2004;4(2):231-236.
- Budde K, et al. Enteric-coated mycophenolate sodium provides higher mycophenolic acid predose levels compared with mycophenolate mofetil: implications for therapeutic drug monitoring. Therapeutic Drug Monitoring. 2007;29(3):381-384.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. 2023.
- U.S. Food and Drug Administration (FDA). Myfortic (mycophenolic acid) Prescribing Information. Updated 2023.
- Halloran PF. Immunosuppressive drugs for kidney transplantation. New England Journal of Medicine. 2004;351(26):2715-2729.
- European Medicines Agency. Updated measures for mycophenolate-containing medicines. EMA/732280/2015.
- American Society of Transplantation (AST). Guidelines for Immunosuppression in Solid Organ Transplantation. Updated 2024.
- British National Formulary (BNF). Mycophenolic acid. Available at: BNF – NICE
Editorial Team
This article was written by the iMedic Medical Editorial Team, comprising licensed specialist physicians in transplant medicine, nephrology, and clinical pharmacology. All content is reviewed according to international guidelines from KDIGO, AST, EMA, and the WHO.
Our editorial process follows the GRADE evidence framework to ensure the highest quality of medical information. This article is based on peer-reviewed research, official prescribing information, and current clinical practice guidelines.