Mycophenolate Mofetil Hexal: Uses, Dosage & Side Effects
An immunosuppressant medication used to prevent organ rejection after kidney, heart, or liver transplantation, taken in combination with ciclosporin and corticosteroids
Mycophenolate Mofetil Hexal is an immunosuppressant medication containing the active substance mycophenolate mofetil. It is prescribed to prevent organ rejection (transplant rejection) after kidney, heart, or liver transplantation. Mycophenolate mofetil works by selectively inhibiting the proliferation of T and B lymphocytes, the immune cells primarily responsible for recognizing and attacking transplanted organs. It is always used in combination with other immunosuppressive agents, typically ciclosporin and corticosteroids. Available as 500 mg film-coated tablets, Mycophenolate Mofetil Hexal is a generic formulation that is bioequivalent to the original branded product CellCept. This medication requires a prescription and must be initiated and supervised by a transplant specialist.
Quick Facts: Mycophenolate Mofetil Hexal
Key Takeaways
- Mycophenolate Mofetil Hexal is used to prevent organ rejection after kidney, heart, or liver transplantation and must always be taken in combination with ciclosporin and corticosteroids as directed by your transplant specialist.
- The medication works by selectively suppressing T and B lymphocyte proliferation through inhibition of the enzyme IMPDH, which is essential for the de novo synthesis of guanosine nucleotides that these immune cells depend on.
- Mycophenolate mofetil must never be taken during pregnancy due to a high risk of birth defects and miscarriage; women of childbearing potential must use two effective forms of contraception and have a confirmed negative pregnancy test before starting treatment.
- Long-term immunosuppression increases the risk of infections and certain cancers (particularly lymphoma and skin cancer); regular blood monitoring, sun protection, and avoidance of unnecessary UV exposure are essential throughout treatment.
- Common side effects include gastrointestinal disturbances (diarrhea, nausea, vomiting), blood disorders (leukopenia, anemia), and increased susceptibility to infections; regular blood tests are required to monitor for these and other potential complications.
What Is Mycophenolate Mofetil Hexal and What Is It Used For?
Mycophenolate Mofetil Hexal contains the active substance mycophenolate mofetil (MMF), which belongs to the class of immunosuppressive agents. After oral administration, mycophenolate mofetil is rapidly absorbed and converted (hydrolyzed) into its active form, mycophenolic acid (MPA). MPA is a potent, selective, non-competitive, and reversible inhibitor of the enzyme inosine monophosphate dehydrogenase (IMPDH), specifically the type II isoform that is predominantly expressed in activated lymphocytes. IMPDH is a critical enzyme in the de novo biosynthesis pathway for guanosine nucleotides, which are essential building blocks of DNA and RNA.
The selectivity of mycophenolate mofetil for lymphocytes is based on a fundamental difference in how various cell types synthesize purines. T and B lymphocytes – the immune cells that drive organ rejection – are almost entirely dependent on the de novo pathway for purine synthesis. In contrast, most other cell types in the body have access to an alternative salvage pathway that can recycle purines independently of IMPDH. By inhibiting IMPDH, MPA therefore has a much more potent cytostatic (growth-inhibiting) effect on lymphocytes than on other cell types. This selective action means that mycophenolate mofetil can effectively suppress the immune response against the transplanted organ while having a relatively limited impact on other rapidly dividing cells in the body.
Beyond its antiproliferative effects on lymphocytes, MPA also inhibits the glycosylation of adhesion molecules on lymphocytes, reducing their ability to bind to vascular endothelial cells and migrate to sites of inflammation and graft rejection. Additionally, MPA has been shown to suppress antibody formation by B lymphocytes, which contributes to the prevention of antibody-mediated rejection. These multiple mechanisms of action work together to provide comprehensive immunosuppressive coverage in the transplant setting.
Mycophenolate Mofetil Hexal is a generic formulation manufactured by Hexal (part of the Sandoz division of Novartis). It has been demonstrated to be bioequivalent to the original branded product CellCept, meaning it delivers the same amount of active substance to the bloodstream at the same rate. The European Medicines Agency (EMA) and other regulatory authorities have approved this generic formulation based on rigorous bioequivalence studies, confirming that it can be used interchangeably with the originator product.
Mycophenolate Mofetil Hexal is indicated for the prophylaxis (prevention) of acute transplant rejection in the following settings:
- Kidney transplantation: Mycophenolate mofetil is used in combination with ciclosporin and corticosteroids to prevent acute rejection of kidney allografts. The landmark pivotal trials demonstrated that MMF significantly reduced the incidence of biopsy-proven acute rejection compared with azathioprine or placebo when added to a ciclosporin-based immunosuppressive regimen. Kidney transplantation is the most common solid organ transplant worldwide, and mycophenolate mofetil has become a cornerstone of standard immunosuppressive protocols.
- Heart transplantation: In cardiac transplant recipients, mycophenolate mofetil is used in combination with ciclosporin and corticosteroids to reduce the risk of acute rejection. Studies have shown improved survival outcomes compared with azathioprine-based regimens, with significantly lower rates of biopsy-proven rejection and fewer patients requiring treatment for rejection episodes.
- Liver transplantation: Mycophenolate mofetil is also approved for the prevention of acute rejection following liver transplantation, used as part of a combination immunosuppressive regimen with ciclosporin and corticosteroids. Liver transplant recipients face unique immunological challenges, and mycophenolate mofetil has shown efficacy in reducing rejection episodes in this population as well.
It is important to understand that mycophenolate mofetil is always used as part of a combination immunosuppressive regimen. No single immunosuppressant can adequately prevent organ rejection on its own. The standard triple-therapy approach combining mycophenolate mofetil with a calcineurin inhibitor (such as ciclosporin or tacrolimus) and corticosteroids targets different aspects of the immune response, providing synergistic immunosuppression while allowing lower doses of each individual drug, thereby reducing the specific side effects associated with each agent.
Mycophenolate Mofetil Hexal is a generic version of CellCept. Generic medicines undergo rigorous testing to demonstrate bioequivalence with the original product. This means that Mycophenolate Mofetil Hexal delivers the same active substance at the same rate and to the same extent as CellCept. However, transplant patients should not switch between different brands or formulations of mycophenolate without guidance from their transplant specialist, as even small changes in drug exposure can potentially affect graft outcomes.
What Should You Know Before Taking Mycophenolate Mofetil Hexal?
Contraindications
There are specific situations in which Mycophenolate Mofetil Hexal must not be used. Understanding these contraindications is critical before starting treatment.
- Hypersensitivity: Do not take Mycophenolate Mofetil Hexal if you are allergic to mycophenolate mofetil, mycophenolic acid, or any of the excipients in the formulation. Hypersensitivity reactions have been reported and can include rash, itching, swelling, and in rare cases, anaphylaxis.
- Pregnancy: Mycophenolate mofetil is contraindicated in pregnancy. It is a known human teratogen that causes birth defects in approximately 22–27% of exposed pregnancies, including cleft lip and palate, microtia and other ear abnormalities, congenital heart defects, and malformations of the fingers and toes. The rate of spontaneous miscarriage in exposed pregnancies is approximately 45%. A negative pregnancy test result is required before starting therapy.
- Women of childbearing potential not using effective contraception: Treatment must not be initiated in women of childbearing potential who are not using at least two reliable forms of contraception simultaneously, one of which should be a highly effective method.
- Breastfeeding: It is not known whether mycophenolate mofetil is excreted in human breast milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during treatment with mycophenolate mofetil.
Warnings and Precautions
Mycophenolate mofetil causes severe birth defects and miscarriage. Women of childbearing potential must have a negative pregnancy test before starting treatment, use two effective methods of contraception simultaneously before, during, and for 6 weeks after stopping treatment, and report any suspected pregnancy to their doctor immediately. Men taking mycophenolate mofetil (or their female partners) should also use reliable contraception during treatment and for at least 90 days after the last dose.
Before and during treatment with Mycophenolate Mofetil Hexal, your doctor should be informed about the following:
- Infections: Mycophenolate mofetil suppresses the immune system, which increases the risk of infections, including opportunistic infections caused by bacteria, viruses, and fungi. Serious infections such as BK virus-associated nephropathy (which can lead to kidney graft loss), cytomegalovirus (CMV) reactivation, and JC virus-associated progressive multifocal leukoencephalopathy (PML) have been reported. Patients should report any signs of infection promptly, including fever, sore throat, unusual bruising, or unexplained fatigue.
- Malignancies: Long-term immunosuppression with any agent, including mycophenolate mofetil, increases the risk of developing certain types of cancer. Post-transplant lymphoproliferative disorder (PTLD), which is often associated with Epstein-Barr virus (EBV), and skin cancer (including melanoma and non-melanoma types) are the most frequently observed. Patients should minimize UV exposure by wearing protective clothing, using broad-spectrum sunscreen, and avoiding tanning beds. Regular skin examinations by a dermatologist are recommended.
- Blood disorders: Mycophenolate mofetil can cause significant bone marrow suppression leading to neutropenia (low neutrophil count), leukopenia (low white blood cell count), anemia, thrombocytopenia (low platelet count), and pancytopenia. Complete blood counts should be performed weekly during the first month of treatment, twice monthly during the second and third months, and then monthly through the first year. If severe neutropenia (absolute neutrophil count <1.3 × 10³/µL) develops, treatment may need to be interrupted or the dose reduced.
- Gastrointestinal disorders: Mycophenolate mofetil has been associated with serious gastrointestinal complications, including gastrointestinal hemorrhage, ulceration, perforation, and rarely, colitis (including CMV colitis). Patients with active serious digestive system disease should be treated with caution. Dose reduction or interruption may be considered if significant GI side effects develop.
- Pure red cell aplasia (PRCA): Cases of PRCA have been reported in transplant patients receiving mycophenolate mofetil, usually in combination with other immunosuppressants. PRCA presents as severe anemia with very low or absent reticulocytes. If PRCA is suspected, dose reduction or discontinuation may be considered.
- Vaccinations: Live attenuated vaccines should be avoided during treatment with mycophenolate mofetil. Inactivated vaccines may be administered, but the immune response may be diminished. Influenza vaccination is recommended annually. Your transplant team will advise you on appropriate vaccination schedules.
- Hereditary enzyme deficiencies: Mycophenolate mofetil is not recommended for use in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT), such as Lesch-Nyhan and Kelley-Seegmiller syndromes, as these patients may have an altered response to the drug.
Pregnancy and Breastfeeding
Mycophenolate mofetil is a teratogen and is classified as pregnancy category D (positive evidence of human fetal risk). Data from clinical experience and published literature demonstrate that exposure to mycophenolate mofetil during pregnancy is associated with an increased risk of congenital malformations, particularly external ear anomalies (including microtia and anotia), cleft lip with or without cleft palate, and congenital heart defects (ventricular and atrial septal defects). Limb anomalies, esophageal atresia, and nervous system malformations have also been reported.
The pregnancy prevention program requires that all women of childbearing potential must have two negative pregnancy tests (serum or urine with a sensitivity of at least 25 mIU/mL) before starting therapy. The first test should be performed at the time of the initial consultation, and the second test 8–10 days later and immediately before starting treatment. Pregnancy tests should be repeated as clinically indicated, for example at every clinic visit. Patients should be counseled about the teratogenic risks and the absolute necessity of effective contraception.
Two complementary forms of contraception must be used simultaneously. At least one of these must be a highly effective method, such as an intrauterine device (IUD), hormonal implant, tubal ligation, or vasectomy of the male partner. It is important to note that mycophenolate mofetil may reduce the effectiveness of hormonal contraceptives through pharmacokinetic interactions, so hormonal contraception alone is not considered sufficient. The second method may be a hormonal contraceptive (combined pill, patch, or ring), a male condom, diaphragm, or cervical cap with spermicide.
Breastfeeding is contraindicated during treatment with mycophenolate mofetil. Studies in rats have shown that mycophenolate mofetil is excreted in milk. It is not known whether this substance is excreted in human breast milk. Given the potential for serious adverse effects in breastfed infants and the immunosuppressive nature of the drug, a decision must be made to either discontinue breastfeeding or to use an alternative immunosuppressive agent where appropriate.
Male patients taking mycophenolate mofetil should be aware that the drug may affect sperm quality. The available evidence suggests that mycophenolate mofetil does not significantly affect male fertility at therapeutic doses, but as a precaution, sexually active male patients or their female partners should use reliable contraception during treatment and for at least 90 days after the last dose.
How Does Mycophenolate Mofetil Hexal Interact with Other Drugs?
Drug interactions with mycophenolate mofetil can affect both its absorption and elimination, potentially altering its effectiveness or increasing the risk of side effects. Understanding these interactions is essential for safe treatment. The active metabolite mycophenolic acid (MPA) undergoes enterohepatic recirculation, meaning it is excreted in bile, reabsorbed from the intestine, and then returned to the liver. Drugs that interfere with this cycle can significantly reduce MPA levels.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Azathioprine | Both drugs inhibit purine synthesis; additive bone marrow suppression | Avoid combination – not recommended due to overlapping mechanisms |
| Cholestyramine | Interrupts enterohepatic recirculation of MPA; reduces MPA AUC by approximately 40% | Avoid combination; significant reduction in drug exposure |
| Live vaccines (e.g., MMR, varicella, BCG, yellow fever) | Risk of vaccine-strain infection due to immunosuppression | Contraindicated during treatment |
| Rifampicin | Induces UDP-glucuronosyltransferase; reduces MPA AUC by approximately 18–70% | Avoid combination if possible; monitor MPA levels closely |
| Telmisartan | Reduces conversion of mycophenolate mofetil to MPA by inhibiting hepatic esterase | Use with caution; potential reduction in MPA levels |
Minor Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Antacids (aluminium/magnesium hydroxide) | Reduces absorption of mycophenolate mofetil | Separate doses by at least 2 hours |
| Proton pump inhibitors (omeprazole, pantoprazole) | May reduce MPA exposure by approximately 20–35% | Use with caution; consider monitoring MPA levels |
| Aciclovir / Ganciclovir | Competitive renal tubular secretion; increased levels of both drugs and MPAG | Monitor for toxicity, especially in patients with renal impairment |
| Ciclosporin A | May reduce MPA levels by inhibiting biliary excretion of MPAG (enterohepatic recirculation) | Expected when used together; doses are adjusted accordingly |
| Hormonal contraceptives | MMF may reduce the efficacy of combined oral contraceptives | Use additional non-hormonal contraception; do not rely solely on hormonal methods |
| Norfloxacin / Metronidazole | Combined use may reduce MPA exposure by approximately 30% | Short-term use acceptable; monitor MPA levels with prolonged courses |
When mycophenolate mofetil is used in combination with tacrolimus (an alternative calcineurin inhibitor to ciclosporin), MPA levels tend to be higher because tacrolimus does not inhibit the enterohepatic recirculation of MPA to the same extent as ciclosporin. Your transplant specialist will account for this pharmacokinetic difference when determining the appropriate dose. Therapeutic drug monitoring of MPA may be performed in some centers to ensure optimal exposure and minimize the risk of rejection or toxicity.
Always inform your transplant team about all prescription medications, over-the-counter drugs, herbal supplements, and dietary products you are taking. Some herbal preparations, such as St. John’s wort (Hypericum perforatum), can induce the enzymes responsible for MPA metabolism and should be avoided during treatment with mycophenolate mofetil.
What Is the Correct Dosage of Mycophenolate Mofetil Hexal?
Mycophenolate Mofetil Hexal should always be prescribed and supervised by a physician experienced in the management of organ transplant patients. The dosage depends on the type of transplant, and the medication is taken orally, twice daily. Tablets should be swallowed whole with a glass of water and should not be broken, crushed, or chewed. The film coating prevents contact with the active substance, which could be harmful if absorbed through the skin or mucous membranes.
Adults
Kidney Transplant Recipients
Dose: 1 g (two 500 mg tablets) twice daily, taken in the morning and evening
Total daily dose: 2 g per day
Timing: Treatment should be started within 72 hours of transplantation
This dose has been established through the pivotal clinical trials and provides the optimal balance between efficacy in preventing rejection and tolerability. Higher doses (3 g/day) did not demonstrate significant additional benefit in kidney transplant recipients but were associated with a higher incidence of side effects.
Heart Transplant Recipients
Dose: 1.5 g (three 500 mg tablets) twice daily, taken in the morning and evening
Total daily dose: 3 g per day
Timing: Treatment should be started within 5 days of transplantation
The higher dose in heart transplant recipients reflects the greater immunological challenge of cardiac allografts and is supported by clinical trial evidence demonstrating improved outcomes at this dose level.
Liver Transplant Recipients
Dose: 1.5 g (three 500 mg tablets) twice daily, taken in the morning and evening
Total daily dose: 3 g per day (oral)
Timing: Oral therapy should be initiated as soon as it can be tolerated
In the immediate post-transplant period, intravenous mycophenolate mofetil may be given initially and then transitioned to oral therapy when clinically appropriate.
Children and Adolescents
For kidney transplant recipients aged 2 to 18 years, the recommended dose of mycophenolate mofetil oral suspension is 600 mg/m² body surface area (BSA) administered twice daily (up to a maximum of 2 g per day). Mycophenolate Mofetil Hexal 500 mg film-coated tablets may be prescribed to pediatric patients with a BSA of at least 1.25 m² who can swallow tablets. For patients with a BSA between 1.25 m² and 1.5 m², the recommended dose is 750 mg twice daily (using a combination of tablet strengths or oral suspension). For patients with a BSA greater than 1.5 m², the dose is 1 g twice daily.
There are currently no data available on the use of mycophenolate mofetil in pediatric heart or liver transplant recipients. Therefore, no dosing recommendations can be made for these populations.
Elderly Patients
The recommended doses of mycophenolate mofetil for elderly patients are the same as those for younger adults. No specific dose adjustment is necessary based on age alone. However, elderly transplant patients may be more susceptible to adverse effects, particularly infections and gastrointestinal complications. Careful clinical monitoring is warranted, and dose reductions may be required on an individual basis if adverse effects occur.
Renal Impairment
In kidney transplant recipients experiencing severe chronic renal graft dysfunction (GFR <25 mL/min/1.73 m²), doses higher than 1 g twice daily should be avoided, and patients should be carefully observed. No dose adjustments are needed for kidney transplant recipients with delayed graft function in the immediate post-operative period. For heart and liver transplant recipients with severe renal impairment, no formal pharmacokinetic data are available, but similar caution is advised.
Missed Dose
If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten one. Maintaining consistent drug levels is important for preventing organ rejection, so try to take your doses at the same times every day (approximately 12 hours apart).
Overdose
Reports of mycophenolate mofetil overdose have been received from clinical trials and post-marketing surveillance. In the majority of these cases, no adverse events were reported. In those overdose cases where adverse events were reported, the events fall within the known safety profile of the drug. An overdose could potentially lead to over-suppression of the immune system and increased susceptibility to infections and bone marrow suppression. If overdose occurs, it may be useful to administer bile acid sequestrants such as cholestyramine to enhance elimination of MPA through interruption of its enterohepatic recirculation. There is no specific antidote for mycophenolate mofetil overdose. MPA is not effectively removed by hemodialysis, although MPAG can be partially removed at high plasma concentrations.
Never change your dose of Mycophenolate Mofetil Hexal without consulting your transplant specialist. Reducing the dose too much or stopping the medication can lead to organ rejection. Taking too much can cause serious infections and bone marrow suppression. Strict adherence to your prescribed dosing schedule is one of the most important factors in long-term transplant success.
What Are the Side Effects of Mycophenolate Mofetil Hexal?
Like all immunosuppressive medications, mycophenolate mofetil can cause side effects. The side effect profile is influenced by the overall immunosuppressive burden of the treatment regimen, as patients typically receive mycophenolate mofetil in combination with ciclosporin (or tacrolimus) and corticosteroids. It can be difficult to attribute individual side effects to a specific drug. The information below reflects the comprehensive safety data from clinical trials and post-marketing surveillance.
The frequency of side effects is classified according to the following convention: very common (affects more than 1 in 10 patients), common (1 in 10 to 1 in 100), uncommon (1 in 100 to 1 in 1,000), rare (1 in 1,000 to 1 in 10,000), and very rare (less than 1 in 10,000).
Very Common
Affects more than 1 in 10 patients
- Diarrhea (often dose-related, may be severe)
- Nausea
- Vomiting
- Abdominal pain
- Leukopenia (low white blood cells)
- Anemia
- Sepsis (blood infection)
- Gastrointestinal candidiasis (thrush)
- Urinary tract infection
- Herpes simplex
- Herpes zoster (shingles)
Common
Affects 1 in 10 to 1 in 100 patients
- Thrombocytopenia (low platelet count)
- Neutropenia (low neutrophil count)
- Pancytopenia (reduced all blood cell types)
- Pneumonia
- Influenza
- Upper respiratory tract infection
- Cytomegalovirus (CMV) infection
- Skin cancer (squamous cell carcinoma, basal cell carcinoma)
- Lymphoproliferative disorder / lymphoma
- Headache
- Insomnia
- Tremor
- Hypertension (high blood pressure)
- Hypotension (low blood pressure)
- Dyspepsia (indigestion)
- Constipation
- Gastritis
- Flatulence
- Elevated liver enzymes
- Hyperglycemia (high blood sugar)
- Hypercholesterolemia (high cholesterol)
- Peripheral edema (swelling)
- Joint pain
- Muscle pain
- Renal impairment
- Rash
- Acne
Uncommon
Affects 1 in 100 to 1 in 1,000 patients
- Gastrointestinal hemorrhage
- Gastrointestinal ulceration
- Gastrointestinal perforation
- Pancreatitis
- Colitis (including CMV colitis)
- Esophagitis
- Intestinal villous atrophy
- BK virus infection
- Prostatitis
- Agranulocytosis (severely low granulocytes)
Rare
Affects 1 in 1,000 to 1 in 10,000 patients
- Pure red cell aplasia (PRCA)
- Progressive multifocal leukoencephalopathy (PML)
- Meningitis
- Endocarditis
- Bone marrow failure
Not Known
Frequency cannot be estimated from available data
- Hypogammaglobulinemia (low antibody levels)
- Bronchiectasis (irreversible lung damage)
- Interstitial lung disease
- Pulmonary fibrosis
The gastrointestinal side effects of mycophenolate mofetil are among the most frequently reported reasons for dose reduction or treatment interruption. Diarrhea occurs in up to 30–45% of patients, depending on the transplant type and concomitant medications. Strategies to manage gastrointestinal symptoms include dose splitting (smaller doses taken more frequently while maintaining the same total daily dose), taking the medication with food (although this may slightly reduce absorption), and in some cases, switching to the enteric-coated formulation of mycophenolate sodium (Myfortic), which may be better tolerated by some patients.
The immunosuppressive nature of mycophenolate mofetil means that patients are at increased risk of developing infections throughout the course of treatment. Prophylactic medications are commonly prescribed to reduce the risk of specific infections, such as valganciclovir or ganciclovir for CMV prevention, and trimethoprim-sulfamethoxazole for Pneumocystis jirovecii pneumonia prophylaxis. Your transplant team will determine the appropriate prophylactic regimen based on your individual risk profile.
If you experience any unusual symptoms, particularly signs of infection (fever, chills, persistent cough, sore throat, painful urination), unusual bruising or bleeding, severe or persistent diarrhea, or any other concerning symptoms, contact your transplant team promptly. Do not reduce or stop your medication without medical advice, as this could lead to organ rejection.
How Should You Store Mycophenolate Mofetil Hexal?
Proper storage of Mycophenolate Mofetil Hexal is essential to maintain the medication’s effectiveness and safety throughout its shelf life. The film-coated tablets should be stored at a temperature not exceeding 30°C (86°F). This means they should be kept in a cool, dry place away from direct sunlight and heat sources. Do not store the medication in a bathroom or near a kitchen sink where humidity levels may be elevated.
The tablets should be kept in their original blister packaging until the time of use. The blister packaging provides protection against moisture and light, which could degrade the active substance. Do not remove tablets from the blister pack in advance to store them in a pill organizer for extended periods, as this may expose them to environmental conditions that could affect their stability.
Always check the expiry date printed on the packaging before taking the medication. Do not use Mycophenolate Mofetil Hexal after the expiry date (EXP) stated on the carton and blister. The expiry date refers to the last day of that month. Expired medication should be returned to a pharmacy for safe disposal.
Keep this and all medications out of the sight and reach of children. Mycophenolate mofetil is a potent immunosuppressant and can be harmful if accidentally ingested by children or adults for whom it is not prescribed. Do not dispose of medications via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use, as proper disposal helps protect the environment.
Do not crush, break, or chew the film-coated tablets. If a tablet is accidentally broken or crushed, avoid inhaling the powder or allowing it to come into direct contact with your skin or mucous membranes. If skin contact occurs, wash the area thoroughly with soap and water. If eye contact occurs, rinse with plain water. These precautions are important because the active substance can be absorbed through the skin and mucous membranes.
What Does Mycophenolate Mofetil Hexal Contain?
Understanding the complete composition of Mycophenolate Mofetil Hexal is important, particularly for patients with known allergies or intolerances to specific pharmaceutical excipients. The formulation consists of the active substance and several inactive ingredients (excipients) that serve specific pharmaceutical purposes.
Active Substance
Each film-coated tablet contains 500 mg of mycophenolate mofetil. Mycophenolate mofetil (chemical name: 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate) is the 2-morpholinoethyl ester of mycophenolic acid (MPA). It functions as a prodrug, meaning it is pharmacologically inactive until it is converted to its active form, MPA, by esterases in the body. The molecular weight is 433.50 g/mol, and the empirical formula is C₂₃H₃₁NO₇.
Excipients (Inactive Ingredients)
Tablet core:
- Microcrystalline cellulose: Serves as a diluent and binder, providing the structural foundation of the tablet
- Povidone K30: Acts as a binder to hold the tablet components together during compression
- Croscarmellose sodium: Functions as a superdisintegrant to ensure the tablet breaks apart properly after swallowing, facilitating drug release and absorption
- Magnesium stearate: Used as a lubricant to prevent the tablet from sticking to the manufacturing equipment during production
Film coating:
- Hypromellose (hydroxypropyl methylcellulose): Forms the main film coating barrier, protecting the tablet core and facilitating swallowing
- Hydroxypropylcellulose: Assists in film formation and acts as a plasticizer in the coating
- Titanium dioxide (E171): Provides the white base color and protects the active substance from degradation by light
- Indigo carmine (E132): Provides the characteristic blue-purple color of the tablets, aiding in product identification
- Iron oxide red (E172): May be included to achieve the final tablet color for identification purposes
The 500 mg film-coated tablets are lavender-colored, capsule-shaped (oblong) tablets. They may bear imprints or breaklines for identification purposes. Although some tablets may have a score line, this is for identification only and the tablets should not be divided. The tablets are packaged in PVC/PVDC/Aluminium blister packs, typically in pack sizes of 50, 100, 150, or 300 tablets, although not all pack sizes may be marketed in every country.
Frequently Asked Questions About Mycophenolate Mofetil Hexal
Mycophenolate Mofetil Hexal and CellCept both contain the same active ingredient (mycophenolate mofetil) in the same dose. Mycophenolate Mofetil Hexal is a generic version manufactured by Hexal (Sandoz/Novartis), while CellCept is the original branded product made by Roche. The generic version has been demonstrated to be bioequivalent through rigorous testing, meaning it delivers the same amount of active substance at the same rate. The inactive ingredients (excipients) may differ slightly between the two products. While they are considered interchangeable from a regulatory standpoint, transplant patients should only switch between formulations under the supervision of their transplant specialist, as consistent drug exposure is critical for preventing rejection.
There is no specific absolute contraindication to alcohol consumption while taking mycophenolate mofetil. However, alcohol can worsen gastrointestinal side effects such as nausea, stomach upset, and diarrhea, which are already common with this medication. Excessive alcohol use can also impair liver function and the immune system, both of which are important considerations for transplant patients. Most transplant specialists recommend limiting alcohol intake significantly or avoiding it altogether. Always discuss alcohol use with your transplant team.
Mycophenolate mofetil can be taken with or without food for kidney transplant patients. However, for consistency and to maximize absorption, it is generally recommended to take it on an empty stomach (at least 1 hour before or 2 hours after a meal). Food does not significantly affect the total amount of drug absorbed (AUC) but may delay the time to peak concentration. If you experience gastrointestinal discomfort, your doctor may advise taking it with food, accepting a modest reduction in peak drug levels. The most important thing is to take it consistently at the same times every day.
Live attenuated vaccines (such as MMR, varicella, yellow fever, oral polio, BCG, and live nasal influenza vaccine) must be avoided during treatment with mycophenolate mofetil, as there is a risk of developing the infection from the vaccine strain in immunosuppressed patients. Inactivated vaccines (such as influenza injection, COVID-19 mRNA/protein-based vaccines, pneumococcal, and hepatitis B) can be given, but the immune response may be reduced, meaning you may not achieve full protection. Annual influenza vaccination and pneumococcal vaccination are generally recommended for transplant patients. Discuss all vaccinations with your transplant team before receiving them.
Regular blood monitoring is essential during treatment with mycophenolate mofetil. Complete blood counts (CBC) should be performed weekly during the first month, twice monthly during the second and third months, and monthly for the remainder of the first year. After the first year, blood tests are typically performed every 1–3 months, depending on clinical stability. These tests monitor for leukopenia, neutropenia, anemia, and thrombocytopenia. Additional tests may include liver function tests, kidney function tests, blood glucose, and therapeutic drug monitoring of MPA levels in some centers. Your transplant team will determine the exact schedule based on your individual needs.
Mycophenolate mofetil can be used in patients with kidney problems, including those who have received a kidney transplant. However, in kidney transplant recipients with severe chronic renal graft dysfunction (GFR less than 25 mL/min/1.73 m²), the dose should not exceed 1 g twice daily. Patients with delayed graft function do not require dose adjustment in the immediate post-operative period, but they should be carefully monitored. For non-kidney transplant recipients with severe renal impairment, no specific dose adjustments have been established, but careful monitoring and possible dose reduction may be advisable. Your transplant specialist will determine the appropriate dose based on your kidney function.
References
- European Medicines Agency (EMA). Mycophenolate mofetil – Summary of Product Characteristics. Available at: www.ema.europa.eu. Accessed December 2025.
- U.S. Food and Drug Administration (FDA). CellCept (mycophenolate mofetil) – Full Prescribing Information. Reference ID: 5118825. Updated 2024.
- Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO Clinical Practice Guideline for the Care of Kidney Transplant Recipients. American Journal of Transplantation. 2024;24(Suppl 2):S1–S197.
- Allison AC, Eugui EM. Mycophenolate mofetil and its mechanisms of action. Immunopharmacology. 2000;47(2–3):85–118. doi:10.1016/S0162-3109(00)00188-0
- Halloran PF. Immunosuppressive drugs for kidney transplantation. New England Journal of Medicine. 2004;351(26):2715–2729. doi:10.1056/NEJMra033540
- British National Formulary (BNF). Mycophenolate Mofetil. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk. Accessed December 2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List (2023). Geneva: WHO; 2023. Mycophenolic acid listed as essential immunosuppressant.
- Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. Transplantation. 1996;61(7):1029–1037.
- European Mycophenolate Mofetil Cooperative Study Group. Placebo-controlled study of mycophenolate mofetil combined with cyclosporine and corticosteroids for prevention of acute rejection. Lancet. 1995;345(8961):1321–1325.
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