Myfortic

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Mycophenolic Acid

Method of action: Immunosuppressive

Treatment option: Kidney Transplant

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Myfortic

Myfortic Quick Facts

Property	Description
Active ingredient	Mycophenolic acid (MPA) as the sodium salt
Form	Delayed-release tablets (Enteric-coated)
Pharmacological class	Immunosuppressive agent, Antimetabolite
Common use	Prevention of organ rejection in kidney transplant patients
Origin	Synthetic derivative

What Type of Medicine is Myfortic?

Myfortic is a prescription-only drug classified as an antimetabolite immunosuppressant. The active compound is mycophenolic acid (MPA), which is administered in the form of the mycophenolate sodium salt. This classification indicates that the medicine works by interfering with the vital metabolic processes of immune cells. Its pharmacological mechanism involves selectively blocking the enzyme IMPDH, which is critical for lymphocyte proliferation. The medicinal substance is a synthetic derivative based on a naturally derived compound.

Composition and Form: The Delayed-Release Formulation

Myfortic is supplied as a delayed-release tablet, often referred to as an enteric-coated tablet, a distinctive design feature that ensures optimal delivery of the active ingredient. The protective coating is engineered to bypass the acidic environment of the stomach, preventing dissolution until the tablet reaches the less acidic small intestine. This controlled release is a crucial differentiating factor, aiming to enhance gastrointestinal tolerability while ensuring effective absorption of the mycophenolic acid moiety.

What is Myfortic's Core Purpose?

The core purpose of Myfortic is the prophylaxis of organ rejection following an allogeneic renal transplant (kidney transplant). It achieves this by selectively limiting the proliferation and mobilization of lymphocytes, the key immune cells primarily responsible for attacking foreign tissue. This targeted action is fundamental to supporting the successful long-term survival of the donated organ.

What side effects are possible with Myfortic?

Possible Side Effects and Safety Information

The safety profile of Myfortic is directly shaped by its function as an antimetabolite immunosuppressant, which increases susceptibility to infections and other adverse events. Regulatory documents classify adverse reactions based on their frequency of occurrence in clinical studies.

Frequency and System Classifications

Adverse reactions are formally grouped by the body system affected (System-Organ Class or SOC). Events are categorized by incidence, with Very Common (ge 1 in 10 patients) and Common (ge 1 in 100 patients) being the most frequently documented categories.

Classification	Key Affected System	Examples of Adverse Reactions
Very Common	Blood and Lymphatic System Disorders	Leukopenia (low white blood cell count), Anemia
Very Common	Gastrointestinal Disorders	Diarrhea, Vomiting, Nausea, Abdominal pain
Common	Infections and Infestations	Urinary Tract Infections, Candidiasis
Common	Vascular Disorders	Hypertension (high blood pressure)

Serious Adverse Reactions and Safety Constraints

The official label highlights the risk of Serious Infections and an increased risk of malignancies, including lymphomas and skin cancers, due to the suppression of the immune system. Rare but severe risks such as Progressive Multifocal Leukoencephalopathy (PML) and Pure Red Cell Aplasia (PRCA) are also documented.

Population-specific constraints are critical: the medicine is contraindicated during pregnancy due to the high documented risk of spontaneous abortion and congenital malformations. Furthermore, adverse events may be more frequent at the beginning of treatment, and its immunosuppressive action may reduce the intended efficacy of vaccines.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose Scope

The most significant and expected manifestations of an acute overdose of mycophenolic acid, the active component in Myfortic, involve the hematological and gastrointestinal systems. Specifically, documented overdose presentations primarily consist of blood-related abnormalities, including leukopenia (low white blood cell count) and neutropenia (low neutrophil count), alongside various gastrointestinal symptoms.

Overdose data is considered sparse, but there is a recognized potential for severe immunosuppression when plasma levels of the drug are excessively high. Management strategies are focused on reducing drug exposure.

Required Emergency Action

Immediate medical attention is necessary if a person has taken more than the prescribed dose of Myfortic or has otherwise used too much mycophenolate. You should seek emergency medical help right away, which may include calling local emergency services or a national Poison Control center.

Standard clinical procedures for managing overdose of this substance may involve measures to limit absorption. Since the drug is extensively bound to plasma proteins, hemodialysis is not expected to effectively remove clinically significant amounts of mycophenolic acid from the body. Instead, agents that interfere with the enterohepatic circulation, such as oral activated charcoal or cholestyramine, may be considered by healthcare providers to help decrease systemic exposure.

Therapeutic Uses of Myfortic

What Myfortic Treats: Main Uses and Benefits

Myfortic is commonly used in clinical settings involving the prevention of organ rejection in patients who have undergone a kidney transplant. It is used for the prophylaxis of organ rejection in adult and certain pediatric patients who have received a kidney transplant.

The core application addresses conditions characterized by periods of heightened symptoms related to the risk of organ rejection. Myfortic is applied in contexts to manage the risk of acute rejection episodes and is a foundational element of maintenance immunosuppressive therapy. The primary conditions and scenarios the medication is relevant for include prophylaxis of organ rejection after allogeneic renal transplant and the management of certain conditions involving chronic immune-mediated damage, such as active lupus nephritis.

“The primary benefit assists with maintaining functional stability of the transplanted organ, supporting patients in managing the risk of acute symptomatic events.”

This supportive management contributes to improved comfort during symptomatic phases, which helps the patient cope more steadily with long-term challenges. The therapeutic benefit supports the patient during difficult episodes by easing distress and helping to manage chronic symptoms associated with autoimmune conditions.

Quick Fact: Relevant for Functional Stress
Myfortic is commonly used to help manage symptoms that create noticeable physiological strain, particularly in transplant recipients, where it helps maintain a sense of stability during symptomatic phases.

Eligibility and Restrictions for Use

Who Can and Cannot Use Myfortic?

This section defines the population eligibility for Myfortic (mycophenolate sodium) strictly based on official regulatory documentation.

Populations for Established Use

Myfortic is officially indicated for adult patients and pediatric patients 5 years of age receiving an allogeneic renal (kidney) transplant. Use is established as part of a combination immunosuppressive regimen alongside cyclosporine and corticosteroids. The safety and efficacy of Myfortic are not established in children younger than five years of age.

Absolute Non-Eligibility (Contraindications)

Myfortic is contraindicated and must not be used in the following populations:

Classification	Population or Condition
Hypersensitivity	Patients with a known allergy to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil (MMF), or any excipients.
Reproductive Status	Pregnant women and women of childbearing potential who are not using highly effective contraception.
Hereditary Condition	Patients with a rare hereditary deficiency of HGPRT (e.g., Lesch-Nyhan syndrome).

Conditions Requiring Caution or Monitoring

Official labeling requires careful monitoring for patients with severe chronic renal impairment (GFR leq 25 mLcdot min^-1cdot 1.73 m^-2). The medicine should be administered with caution in patients with active serious digestive system disease, such as ulceration or hemorrhage.

What should I know about interactions with other medicines?

The official regulatory profile for Myfortic focuses on documented interaction patterns that primarily affect the systemic exposure of mycophenolic acid (MPA). These interactions are classified based on their potential to decrease drug levels or compete for elimination pathways.

Interactions Affecting Drug Exposure

A number of products can significantly reduce MPA exposure and are generally not recommended for co-administration. These include antacids containing magnesium and aluminum, and agents that interfere with MPA's necessary recirculation through the liver and gut, such as Cholestyramine and Sevelamer. Certain antibiotics like norfloxacin and metronidazole, and the anti-tuberculosis agent Rifampin, also fall under this restriction. Co-administration with Cyclosporine is documented to result in reduced MPA concentrations.

Another type of interaction involves competition for renal elimination. Drugs that share the same renal tubular secretion pathway, such as Acyclovir or Ganciclovir, may lead to increased plasma concentrations of both the co-administered drug and the MPA metabolite, MPAG.

Mechanism of Action

Myfortic (mycophenolic acid, MPA) functions as a selective immunosuppressant by interfering with the fundamental metabolic pathways of the immune system's primary cells.

Enzyme Inhibition and Nucleotide Depletion

The drug's action begins at the molecular level, where it serves as an uncompetitive and reversible inhibitor of the enzyme Inosine Monophosphate Dehydrogenase (IMPDH). This specific blockade interrupts the de novo synthesis of Guanosine Triphosphate (GTP) and other vital nucleotides, which are required precursors for DNA and RNA synthesis.

Selective Cytostasis of T- and B-Lymphocytes

The mechanism is highly selective because T- and B-lymphocytes, the key cells driving the immune response, are critically dependent on the IMPDH-mediated pathway for rapid growth and multiplication. This nucleotide deprivation results in a potent cytostatic effect, specifically arresting the proliferation of these immune cells while having a comparatively limited impact on the metabolism of most other body cells, which can use a non-targeted alternative pathway.

Suppression of the Proliferative Immune Response

By preventing the growth of activated T- and B-lymphocytes, Myfortic disrupts the body's ability to mount the coordinated, large-scale immune response. The physiological consequence of this targeted blockade is the suppression of both cellular and humoral immunity, which creates a state of suppressed cellular immune response.

Dosage and Administration Information

How to Use Myfortic: Official Administration Guidelines

The administration of Myfortic (mycophenolate sodium) is structured for use as part of a long-term, multi-drug immunosuppressive regimen following a kidney transplant. The therapy is initiated and maintained under the supervision of qualified transplant specialists.

Administration Scope

Instruction	Detail
Route of Administration	The medication is taken orally (by mouth).
Dosing Schedule (Adults)	The standard maintenance dose is 720 mg administered twice daily (BID), for a total daily intake of 1,440 mg (1.44 g).
Dosing Schedule (Pediatric)	For patients aged 5 years and older who are at least six months post-transplant, the dose is 400 mg/ m^2 body surface area (BSA) twice daily, not exceeding the adult daily maximum of 1,440 mg.
Frequency and Timing	The standard regimen is twice daily. Tablets are taken consistently in relation to meals: this typically requires an empty stomach (1 hour before or 2 hours after food) or strict consistency in taking the dose either with or without food.
Special Procedural Condition	Myfortic is administered as a component of a combination therapy that typically includes cyclosporine and corticosteroids.

Administration Requirements

Myfortic is supplied as a delayed-release tablet which is swallowed whole to ensure the integrity of the protective coating. The tablets are not to be crushed, chewed, or cut. No dose adjustment is generally required for older adults (65 years and above), and modification is not typically required during episodes of acute organ rejection. If a dose is missed, it is generally recommended to be taken as soon as possible, though a double dose should not be taken to compensate for the missed one.

Recent Clinical Evidence

Myfortic: Recent Clinical Evidence

Research has explored the use of Myfortic (mycophenolate mofetil) in preventing acute organ rejection in adult kidney transplant recipients. Studies primarily investigate whether Myfortic, used in combination with other immunosuppressants (such as ciclosporin and corticosteroids), influences the rate of biopsy-proven acute rejection episodes within the first year following transplantation.

Efficacy and Study Context

Pivotal registration trials examined the efficacy of Myfortic compared to other available immunosuppressive agents. These studies typically defined the primary outcome as the percentage of participants who experienced treatment failure, often a composite measure including graft loss, acute rejection, or premature discontinuation due to adverse effects. The research explored the need for rescue therapy and measured the percentage of patients with no acute rejection.

Key studies have been published examining the long-term patterns of use and tolerability. Clinical data often focuses on the enteric-coated formulation to see if it may be associated with differences in gastrointestinal adverse events compared to the immediate-release formulation (mycophenolate mofetil). Evidence from these studies is used to inform current treatment protocols regarding maintenance immunosuppression.

Safety Data in Trials

Safety profiles were evaluated across the clinical trial program. The most frequently observed adverse events included infections (e.g., cytomegalovirus), neutropenia, and gastrointestinal issues. Researchers continue to examine long-term data for any potential influence on infection risk and malignancy rates in transplant recipients.

Key Studies & References

Frequently Asked Questions (FAQ)

Common questions about Myfortic (FAQ)

Q: How is Myfortic different from the drug CellCept or mycophenolate mofetil?

Myfortic contains mycophenolic acid (MPA) as the active ingredient, while CellCept contains mycophenolate mofetil (MMF). Myfortic is formulated as a delayed-release, enteric-coated tablet, which is designed to dissolve in the intestine rather than the stomach. Official labeling indicates that these products are not interchangeable.

Q: What does the term 'immunosuppressant' mean in relation to Myfortic?

Myfortic is classified as an antimetabolite immunosuppressant. This means its mechanism involves selectively interfering with the rapid growth and multiplication of specific immune cells, called lymphocytes, which are the cells primarily responsible for a rejection response against a transplanted organ.

Q: Does Myfortic increase sensitivity to the sun or skin cancer risk?

Official product information states that use is associated with an increased risk of developing certain malignancies, including skin cancer. Regulatory advice is to limit sun and ultraviolet (UV) light exposure by wearing protective clothing and using a sunscreen with a high protection factor.

Q: Can Myfortic affect fertility in men or women?

The medicine is contraindicated (must not be used) during pregnancy due to the high risks of spontaneous abortion and congenital malformations. Official product information emphasizes the need for women of childbearing potential to use highly effective contraception. Labels also include warnings specific to males of reproductive potential.

Q: Is Myfortic a medication that needs to be taken long-term?

According to official documents, Myfortic is indicated for the prophylaxis (prevention) of organ rejection and is prescribed as part of a long-term immunosuppressive regimen following a kidney transplant.

Q: Can Myfortic be safely taken with antacids or proton pump inhibitors?

Official documents describe that antacids containing magnesium and aluminum can reduce the level of Myfortic in the body, and co-administration is generally discouraged. However, studies with a common proton pump inhibitor (PPI) found no change in Myfortic levels.

Q: Why do patients sometimes switch from CellCept to Myfortic?

The delayed-release, enteric-coated formulation of Myfortic was studied to investigate its potential for differences in gastrointestinal adverse events compared to the immediate-release formulation. The difference in design suggests a potential benefit in gastrointestinal tolerability, which is a key area of focus when treatment adjustments are considered.

Q: Does Myfortic affect blood pressure or cholesterol levels?

Hypertension (high blood pressure) is listed as a Very Common adverse reaction in regulatory documents. Information regarding the effect on cholesterol levels is not consistently reported as a Very Common or Common adverse event.

Q: Does Myfortic cause common side effects like headache or fatigue?

Official regulatory documents list both headache and fatigue (asthenia) as Common adverse reactions experienced by patients taking this medication.

Q: Are there any specific foods that are described as interacting with Myfortic?

Studies indicate that taking Myfortic with a high-fat meal has no effect on the overall amount of drug the body absorbs. However, the US label advises taking the medication on an empty stomach to help avoid variability in absorption.

Q: Why is avoiding sun exposure so important when taking this medication?

The official labels advise limiting exposure to sunlight and UV light due to the medication’s immunosuppressive action, which leads to an increased risk of developing skin cancer. Using protective clothing and sunscreen is part of the required safety guidance.

Q: How is the safety of Myfortic assessed over time?

Safety is assessed and monitored primarily through regular laboratory tests. Complete blood counts are typically monitored frequently during the initial months of treatment (weekly, then twice monthly) and then monthly through the first year to check for blood disorders.

Q: What are the risks described regarding the long-term use of Myfortic?

Long-term use is associated with certain risks described in regulatory documents. These include an increased likelihood of serious infections, including opportunistic infections, and an increased risk of developing malignancies, such as lymphoma and skin cancers.

Q: How quickly does Myfortic start to have its effect after starting treatment?

Regulatory documents state that treatment should be initiated within 72 hours of the transplant procedure. Pharmacokinetic data indicates that the active ingredient reaches its highest concentration in the blood approximately 1.5 to 2.5 hours after administration.

Q: Are there any common vitamins or herbal supplements that are known to interact with Myfortic?

General drug interaction resources indicate potential moderate interactions between mycophenolate products and certain multivitamin and mineral preparations. Regulatory interaction resources indicate that assessment by a healthcare provider may be appropriate before co-administering these preparations.

Q: What is the role of regular blood tests for people taking Myfortic?

Regular blood tests, including complete blood counts, are required to monitor for blood disorders such as leukopenia (low white blood cells) or anemia, which are common adverse effects. They are also used to check for viral infections like BK virus and CMV.

Q: Is there a generic version of Myfortic available?

Yes, regulatory authorities, such as the FDA, indicate that there are generic mycophenolic acid products available. Generic products contain the same active ingredient as Myfortic.

Q: What are the signs of a possible infection that people taking Myfortic should be aware of?

Official patient guides describe symptoms that should be reported to a healthcare provider. These may include evidence of infection such as a temperature of 100.5 F or higher, cold or flu symptoms (e.g., sore throat), pain during urination, or white patches in the mouth.

Q: Is Myfortic used for any autoimmune diseases?

While the core indication is kidney transplant rejection prophylaxis, official labels in some regions also indicate its use for the induction and maintenance treatment of specific classes of lupus nephritis, which is an autoimmune disease.

Q: Is it common to experience hair changes, such as thinning, while taking Myfortic?

Alopecia (hair loss or thinning) is noted as an uncommon adverse reaction in some regulatory documents. This indicates it is experienced by less than 1 in 100 patients.

Q: Does Myfortic affect liver function, and how is that monitored?

Abnormal hepatic function tests (tests related to the liver) are listed as a Common adverse reaction. Monitoring is also recommended for patients with existing Hepatitis B or C infection due to the risk of viral reactivation associated with immunosuppression.

Q: What should be done if an adverse reaction occurs while taking Myfortic?

Official guidance emphasizes the need to promptly report specific symptoms, such as any evidence of infection, unexpected bruising, bleeding, or any manifestation of bone marrow depression, to a healthcare provider.

Q: Are there different strengths of Myfortic tablets available?

According to official product information, Myfortic is available in two dosage strengths: 180 mg and 360 mg of mycophenolic acid. Product availability may vary depending on the country.

Q: Why do some people experience tremors or nervousness with Myfortic?

Anxiety (related to nervousness) is listed as a Common or Very Common psychiatric adverse reaction in some regulatory documents. Regulatory documents do not typically list tremors among the most frequent adverse reactions for this specific formulation.

How should Myfortic be stored and disposed of?

Storage Requirements

Myfortic tablets must be stored at controlled room temperature, specifically between 59 to 86 F (15 to 30 C). The container must be kept tightly closed and stored in a dry place to maintain the stability of the medication. The medicine does not need to be refrigerated. To preserve the delayed-release formulation, the tablets must not be crushed, chewed, or cut. Keep Myfortic and all medicines out of the sight and reach of children.

Disposal Instructions

Unused or expired Myfortic should be discarded using an authorized drug take-back program or mail-back envelope when available. If a take-back option is not accessible, the product can be disposed of in household trash by first mixing it with an undesirable substance, such as used coffee grounds or dirt, then sealing the mixture in a container before discarding it. Medicines must not be thrown away via wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.