Principal Display Panel – 500 Mg

Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) , Use in Special Populations (8.1 , 8.3) ] . Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] . Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3) ] .

Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see Clinical Studies (14.1) ], heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ] , in combination with other immunosuppressants.

ADULTS DOSING Kidney Transplant 1 g twice daily orally ( 2.2 ) Heart Transplant 1.5 g twice daily orally ( 2.3 ) Liver Transplant 1.5 g twice daily orally ( 2.4 ) PEDIATRICS Kidney Transplant 600 mg/m 2 orally twice daily, up to maximum of 2 g daily ( 2.2 ) Reduce or interrupt dosing in the event of neutropenia. ( 2.5 ) See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia. ( 2.5 )

Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product.

Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-Morpholinoethyl ( E )-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate. It has a molecular formula of C 23 H 31 NO 7 , a molecular weight of 433.50, and the following structural formula: Mycophenolate mofetil, USP is a white to almost white crystalline powder. It is practically insoluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of mycophenolate mofetil and tablets containing 500 mg of mycophenolate mofetil. Inactive ingredients in mycophenolate mofetil 250 mg capsules include black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD & C Blue No. 2, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. In addition, the imprinting ink contains the following: ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Inactive ingredients in mycophenolate mofetil 500 mg tablets include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide.

See FPI for drugs that may interfere with systemic exposure and reduce mycophenolate mofetil efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs that interfere with enterohepatic recirculation, telmisartan, calcium-free phosphate binders. ( 7.1 ) Mycophenolate mofetil may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended. ( 7.2 ) See FPI for other important drug interactions. ( 7 )

Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ).

Safety and effectiveness of mycophenolate mofetil have been established in pediatric patients 3 months and older for the prophylaxis of kidney rejection after allogeneic kidney transplant. Use of mycophenolate mofetil in this population is supported by evidence from adequate and well-controlled studies of mycophenolate mofetil in adults with additional data from one open-label, pharmacokinetic and safety study of mycophenolate mofetil in pediatric patients after receiving allogeneic kidney transplant [see Dosage and Administration (2.2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical Studies (14.1) ] . Safety and effectiveness in pediatric patients receiving allogeneic heart or liver transplants have not been established.

Clinical studies of mycophenolate mofetil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between geriatric and younger patients. In general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies [see Adverse Reactions (6.1) , Drug Interactions (7) ] .

In a 104-week oral carcinogenicity study in mice, MMF in daily doses up to 180 mg/kg was not tumorigenic. The highest dose tested was 0.4 times the recommended clinical dose (2 g/day) in renal transplant patients and 0.3 times the recommended clinical dose (3 g/day) in cardiac transplant patients when corrected for differences in body surface area (BSA). In a 104-week oral carcinogenicity study in rats, MMF in daily doses up to 15 mg/kg was not tumorigenic. The highest dose was 0.07 times the recommended clinical dose in kidney transplant patients and 0.05 times the recommended clinical dose in heart transplant patients when corrected for BSA. While these animal doses were lower than those given to patients, they were maximal in those species and were considered adequate to evaluate the potential for human risk [see Warnings and Precautions (5.2) ] . The genotoxic potential of MMF was determined in five assays. MMF was genotoxic in the mouse lymphoma/thymidine kinase assay and the in vivo mouse micronucleus assay. MMF was not genotoxic in the bacterial mutation assay, the yeast mitotic gene conversion assay or the Chinese hamster ovary cell chromosomal aberration assay. MMF had no effect on fertility of male rats at oral doses up to 20 mg/kg/day. This dose represents 0.1 times the recommended clinical dose in renal transplant patients and 0.06 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (principally of the head and eyes) in the first generation offspring in the absence of maternal toxicity. This dose was 0.02 times the recommended clinical dose in renal transplant patients and 0.01 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.

The following adverse reactions are discussed in greater detail in other sections of the label: Embryofetal Toxicity [see Warnings and Precautions (5.1) ] Lymphomas and Other Malignancies [see Warnings and Precautions 5.2) ] Serious Infections [see Warnings and Precautions (5.3) ] Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [see Warnings and Precautions (5.4) ] Gastrointestinal Complications [see Warnings and Precautions (5.5) ] Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions (5.7) ]

Possible signs and symptoms of acute overdose include hematological abnormalities such as leukopenia and neutropenia, and gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, vomiting, and dyspepsia. The experience with overdose of mycophenolate mofetil in humans is limited. The reported effects associated with overdose fall within the known safety profile of the drug. The highest dose administered to kidney transplant patients in clinical trials has been 4 g/day. In limited experience with heart and liver transplant patients in clinical trials, the highest doses used were 4 g/day or 5 g/day. At doses of 4 g/day or 5 g/day, there appears to be a higher rate, compared to the use of 3 g/day or less, of gastrointestinal intolerance (nausea, vomiting, and/or diarrhea), and occasional hematologic abnormalities, particularly neutropenia [see Warnings and Precautions (5.4) ] . Treatment and Management: MPA and the phenolic glucuronide metabolite of MPA (MPAG) are usually not removed by hemodialysis. However, at high MPAG plasma concentrations ( > 100 µg/mL), small amounts of MPAG are removed. By increasing excretion of the drug, MPA can be removed by bile acid sequestrants, such as cholestyramine [see Clinical Pharmacology (12.3) ] .

1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy.

Mycophenolate Mofetil Capsules, USP and Mycophenolate Mofetil Tablets, USP (mye'' koe fen' oh late moe' fe til) Read the Medication Guide that comes with mycophenolate mofetil before you start taking it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. What is the most important information I should know about mycophenolate mofetil? Mycophenolate mofetil can cause serious side effects, including: Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take mycophenolate mofetil during pregnancy have a higher risk of miscarriage during the first 3 months (first trimester), and a higher risk that their baby will be born with birth defects. If you are a female who can become pregnant , your doctor must talk with you about acceptable birth control methods (contraceptive counseling) to use while taking mycophenolate mofetil. You should have 1 pregnancy test immediately before starting mycophenolate mofetil and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests. You must use acceptable birth control during your entire mycophenolate mofetil treatment and for 6 weeks after stopping mycophenolate mofetil, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. Mycophenolate mofetil decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take mycophenolate mofetil, and you could become pregnant. If you take birth control pills while using mycophenolate mofetil you must also use another form of birth control. Talk to your doctor about other birth control methods that you can use while taking mycophenolate mofetil. If you are a sexually active male whose female partner can become pregnant while you are taking mycophenolate mofetil , use effective contraception during treatment and for at least 90 days after stopping mycophenolate mofetil. If you plan to become pregnant, talk with your doctor. Your doctor will decide if other medicines to prevent rejection may be right for you. If you become pregnant while taking mycophenolate mofetil, do not stop taking mycophenolate mofetil. Call your doctor right away. You and your doctor may decide that other medicines to prevent rejection may be right for you. You and your doctor should report your pregnancy to the Mycophenolate Pregnancy Registry either: By phone at 1-800-617-8191 or By visiting the REMS website at: www.mycophenolateREMS.com The purpose of this registry is to gather information about the health of you and your baby. Increased risk of getting certain cancers. People who take mycophenolate mofetil have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have: unexplained fever, prolonged tiredness, weight loss or lymph node swelling a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other a change in the size and color of a mole a new skin lesion or bump any other changes to your health Increased risk of getting serious infections. Mycophenolate mofetil weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with mycophenolate mofetil and can lead to hospitalizations and death. These serious infections can include: Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with mycophenolate mofetil include: Shingles, other herpes infections, and cytomegalovirus (CMV). CMV can cause serious tissue and blood infections. BK virus. BK virus can affect how your kidney works and cause your transplanted kidney to fail. Hepatitis B and C viruses. Hepatitis viruses can affect how your liver works. Talk to your doctor about how hepatitis viruses may affect you. COVID-19 A brain infection called Progressive Multifocal Leukoencephalopathy (PML). In some patients, mycophenolate mofetil may cause an infection of the brain that may cause death. You are at risk for this brain infection because you have a weakened immune system. Call your doctor right away if you have any of the following symptoms: weakness on one side of the body you do not care about things you usually care about (apathy) you are confused or have problems thinking you cannot control your muscles Fungal infections. Yeasts and other types of fungal infections can happen with mycophenolate mofetil and can cause serious tissue and blood infections (See “What are the possible side effects of mycophenolate mofetil?” ). Call your doctor right away if you have any of the following signs and symptoms of infection: temperature of 100.5°F or greater cold symptoms, such as a runny nose or sore throat flu symptoms, such as an upset stomach, stomach pain, vomiting or diarrhea earache or headache pain during urination white patches in the mouth or throat unexpected bruising or bleeding cuts, scrapes or incisions that are red, warm and oozing pus   See “What are the possible side effects of mycophenolate mofetil?” for information about other serious side effects. What is mycophenolate mofetil? Mycophenolate mofetil is a prescription medicine to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant. Rejection is when the body’s immune system perceives the new organ as a “foreign” threat and attacks it. Mycophenolate mofetil is used with other medicines containing cyclosporine and corticosteroids. Who should not take mycophenolate mofetil? Do not take mycophenolate mofetil if you are allergic to mycophenolate mofetil or any of the ingredients in mycophenolate mofetil capsules or tablets. See the end of this Medication Guide for a complete list of ingredients in mycophenolate mofetil capsules and tablets. What should I tell my doctor before taking mycophenolate mofetil? Tell your doctor about all of your medical conditions, including if you: have any digestive problems, such as ulcers. have Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome, or another rare inherited deficiency hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take mycophenolate mofetil if you have one of these disorders. plan to receive any vaccines. People taking mycophenolate mofetil should not receive live vaccines. Some vaccines may not work as well during treatment with mycophenolate mofetil. are pregnant or plan to become pregnant. See “What is the most important information I should know about mycophenolate mofetil?” are breastfeeding or plan to breastfeed. It is not known if mycophenolate mofetil passes into breast milk. You and your doctor will decide if you will take mycophenolate mofetil or breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Some medicines may affect the way mycophenolate mofetil works, and mycophenolate mofetil may affect how some medicines work. Especially tell your doctor if you take: birth control pills (oral contraceptives). See “What is the most important information I should know about mycophenolate mofetil?” sevelamer (Renagel ® , Renvela ™ ). These products should be taken at least 2 hours after taking mycophenolate mofetil. acyclovir (Zovirax ® ), valacyclovir (Valtrex ® ), ganciclovir (CYTOVENE ® -IV, Vitrasert ® ), valganciclovir (VALCYTE ® ). rifampin (Rifater ® , Rifamate ® , Rimactane ® , Rifadin ® ). antacids that contain magnesium and aluminum (mycophenolate mofetil and the antacid should not be taken at the same time). proton pump inhibitors (PPIs) (Prevacid ® , Protonix ® ). sulfamethoxazole/trimethoprim (BACTRIM ™ , BACTRIM DS ™ ). norfloxacin (Noroxin ® ) and metronidazole (Flagyl ® , Flagyl ® ER, Flagyl ® IV, Metro IV, Helidac ® , Pylera ™ ). ciprofloxacin (Cipro ® , Cipro ® XR, Ciloxan ® , Proquin ® XR) and amoxicillin plus clavulanic acid (Augmentin ® , Augmentin XR ™ ). azathioprine (Azasan ® , Imuran ® ). cholestyramine (Questran Light ® , Questran ® , Locholest Light, Locholest, Prevalite ® ). Know the medicines you take. Keep a list of them to show to your doctor or nurse and pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor. How should I take mycophenolate mofetil? Take mycophenolate mofetil exactly as prescribed. Do not stop taking mycophenolate mofetil or change the dose unless your doctor tells you to. If you miss a dose of mycophenolate mofetil, or you are not sure when you took your last dose, take your prescribed dose of mycophenolate mofetil as soon as you remember. If your next dose is less than 2 hours away, skip the missed dose and take your next dose at your normal scheduled time. Do not take 2 doses at the same time. Call your doctor if you are not sure what to do. Take mycophenolate mofetil capsules and tablets on an empty stomach, unless your doctor tells you otherwise. Do not crush mycophenolate mofetil tablets. Do not open or crush mycophenolate mofetil capsules. If you are not able to swallow mycophenolate mofetil tablets or capsules, your doctor may prescribe mycophenolate mofetil oral suspension. This is a liquid form of mycophenolate mofetil. Your pharmacist will mix the medicine before you pick it up from a pharmacy. Do not mix mycophenolate mofetil oral suspension with any other medicine. Mycophenolate mofetil oral suspension should not be mixed with any type of liquids before taking the dose. Do not breathe in (inhale) or let mycophenolate mofetil powder or oral suspension come in contact with your skin or mucous membranes. If you accidentally get the powder or oral suspension on the skin, wash the area well with soap and water. If you accidentally get the powder or oral suspension in your eyes or other mucous membranes, flush with plain water. If you take too much mycophenolate mofetil, call your doctor or the poison control center right away. What should I avoid while taking mycophenolate mofetil capsules and tablets? Avoid becoming pregnant. See “What is the most important information I should know about mycophenolate mofetil?” Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take mycophenolate mofetil have a higher risk of getting skin cancer (See “What is the most important information I should know about mycophenolate mofetil?” ). Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen with a high protection factor. This is especially important if your skin is very fair or if you have a family history of skin cancer. You should not donate blood while taking mycophenolate mofetil and for at least 6 weeks after stopping mycophenolate mofetil. You should not donate sperm while taking mycophenolate mofetil and for 90 days after stopping mycophenolate mofetil. Mycophenolate mofetil may influence your ability to drive and use machines (See “What are the possible side effects of mycophenolate mofetil?” ). If you experience drowsiness, confusion, dizziness, tremor, or low blood pressure during treatment with mycophenolate mofetil, you should be cautious about driving or using heavy machines. What are the possible side effects of mycophenolate mofetil? Mycophenolate mofetil can cause serious side effects, including: See “What is the most important information I should know about mycophenolate mofetil?” Low blood cell counts. People taking high doses of mycophenolate mofetil each day may have a decrease in blood counts, including: white blood cells, especially neutrophils. Neutrophils fight against bacterial infections. You have a higher chance of getting an infection when your white blood cell count is low. This is most common from 1 month to 6 months after your transplant. red blood cells. Red blood cells carry oxygen to your body tissues. You have a higher chance of getting severe anemia when your red blood cell count is low. platelets. Platelets help with blood clotting. Your doctor will do blood tests before you start taking mycophenolate mofetil and during treatment with mycophenolate mofetil to check your blood cell counts. Tell your doctor right away if you have any signs of infection (See “What is the most important information I should know about mycophenolate mofetil?” ), including any unexpected bruising or bleeding. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting. Stomach problems. Stomach problems including intestinal bleeding, a tear in your intestinal wall (perforation) or stomach ulcers can happen in people who take mycophenolate mofetil. Bleeding can be severe and you may have to be hospitalized for treatment. Call your doctor right away if you have sudden or severe stomach-area pain or stomach-area pain that does not go away, or if you have diarrhea. Inflammatory reactions.  Some people taking mycophenolate mofetil may have an inflammatory reaction with fever, joint stiffness, joint pain, and muscle pain. Some of these reactions may require hospitalization. This reaction could happen within weeks to months after your treatment with mycophenolate mofetil starts or if your dose is increased. Call your doctor right away if you experience these symptoms. The most common side effects of mycophenolate mofetil include: diarrhea blood problems including low white and red blood cell counts infections blood pressure problems fast heartbeat swelling of the lower legs, ankles and feet changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) stomach problems including diarrhea, constipation, nausea and vomiting rash nervous system problems such as headache, dizziness and tremor Side effects that can happen more often in children than in adults taking mycophenolate mofetil include: stomach area pain fever infection pain blood infection (sepsis) diarrhea vomiting sore throat colds (respiratory tract infections) high blood pressure low white blood cell count low red blood cell count These are not all of the possible side effects of mycophenolate mofetil. Tell your doctor about any side effect that bothers you or that does not go away.   Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   You may also report side effects to Mylan at 1-877-446-3679 (1-877-4-INFO-RX). How should I store mycophenolate mofetil? Store mycophenolate mofetil capsules and tablets at room temperature between 20° to 25°C (68° to 77°F). Keep mycophenolate mofetil tablets in the light resistant container that they come in. Keep mycophenolate mofetil and all medicines out of the reach of children. General Information about the safe and effective use of mycophenolate mofetil. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate mofetil for a condition for which it was not prescribed. Do not give mycophenolate mofetil to other people, even if they have the same symptoms that you have. It may harm them.   This Medication Guide summarizes the most important information about mycophenolate mofetil. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolate mofetil that is written for health professionals. What are the ingredients in mycophenolate mofetil capsules and tablets? Active Ingredient: mycophenolate mofetil Inactive Ingredients: Mycophenolate mofetil 250 mg capsules: black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD & C Blue No. 2, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. In addition, the imprinting ink contains the following: ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.   Mycophenolate mofetil 500 mg tablets: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide.   Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). The brands listed are trademarks of their respective owners. This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Auro PR Inc. RD 156 Caguas West Industrial Park, Lot 24 Caguas, PR 00725 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-11971 R6 3/23

Mycophenolate Mofetil Capsules, USP are available containing 250 mg of mycophenolate mofetil, USP. The 250 mg capsules are hard-shell gelatin capsules with a caramel opaque cap and a lavender opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 2250 in black ink on both the cap and body. Mycophenolate Mofetil Tablets, USP are available containing 500 mg of mycophenolate mofetil, USP. The 500 mg tablets are light pink, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and 472 on the other side.

Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective, uncompetitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines, whereas other cell types can utilize salvage pathways, MPA has potent cytostatic effects on lymphocytes. MPA inhibits proliferative responses of T- and B-lymphocytes to both mitogenic and allospecific stimulation. Addition of guanosine or deoxyguanosine reverses the cytostatic effects of MPA on lymphocytes. MPA also suppresses antibody formation by B-lymphocytes. MPA prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection. MMF did not inhibit early events in the activation of human peripheral blood mononuclear cells, such as the production of interleukin-1 (IL-1) and interleukin-2 (IL-2), but did block the coupling of these events to DNA synthesis and proliferation.

There is a lack of information regarding the pharmacodynamic effects of MMF.

Warnings and Precautions, Serious Infections ( 5.3 )     10/2021 Warnings and Precautions, Acute Inflammatory Syndrome Associated with Mycophenolate Products ( 5.7 )     10/2021

Blood Dyscrasias (Neutropenia, Red Blood Cell Aplasia): Monitor with blood tests; consider treatment interruption or dose reduction. ( 5.4 ) Gastrointestinal Complications: Monitor for complications such as bleeding, ulceration and perforations, particularly in patients with underlying gastrointestinal disorders. ( 5.5 ) Hypoxanthine-Guanine Phosphoribosyl-Transferase Deficiency: Avoid use of mycophenolate mofetil. ( 5.6 ) Acute Inflammatory Syndrome Associated with Mycophenolate Products: Monitor for this paradoxical inflammatory reaction. ( 5.7 ) Immunizations: Avoid live attenuated vaccines. ( 5.8 ) Blood Donation: Avoid during therapy and for 6 weeks thereafter. ( 5.11 ) Semen Donation: Avoid during therapy and for 90 days thereafter. ( 5.12 ) Potential Impairment on Driving and Use of Machinery: Mycophenolate mofetil may affect ability to drive or operate machinery. ( 5.14 )

NDC 51079-721-20 Mycophenolate Mofetil Capsules, USP 250 mg 100 Capsules (10 x 10) Each capsule contains: Mycophenolate mofetil, USP 250 mg Usual Dosage: See accompanying prescribing information and Medication Guide. CAUTION: Special Handling and Disposal Instructions - see prescribing information. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in Puerto Rico Rx only S-10456 R6 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date.

Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see Human Data ] . Oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.02 to 0.1 times the recommended clinical doses in kidney and heart transplant patients) [see Animal Data ] . Consider alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman. The estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning.

Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) , Use in Special Populations (8.1 , 8.3) ] . Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] . Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3) ] .

Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see Clinical Studies (14.1) ], heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ] , in combination with other immunosuppressants.

ADULTS DOSING Kidney Transplant 1 g twice daily orally ( 2.2 ) Heart Transplant 1.5 g twice daily orally ( 2.3 ) Liver Transplant 1.5 g twice daily orally ( 2.4 ) PEDIATRICS Kidney Transplant 600 mg/m 2 orally twice daily, up to maximum of 2 g daily ( 2.2 ) Reduce or interrupt dosing in the event of neutropenia. ( 2.5 ) See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia. ( 2.5 )

Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product.

See FPI for drugs that may interfere with systemic exposure and reduce mycophenolate mofetil efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs that interfere with enterohepatic recirculation, telmisartan, calcium-free phosphate binders. ( 7.1 ) Mycophenolate mofetil may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended. ( 7.2 ) See FPI for other important drug interactions. ( 7 )

Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ).

Safety and effectiveness of mycophenolate mofetil have been established in pediatric patients 3 months and older for the prophylaxis of kidney rejection after allogeneic kidney transplant. Use of mycophenolate mofetil in this population is supported by evidence from adequate and well-controlled studies of mycophenolate mofetil in adults with additional data from one open-label, pharmacokinetic and safety study of mycophenolate mofetil in pediatric patients after receiving allogeneic kidney transplant [see Dosage and Administration (2.2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical Studies (14.1) ] . Safety and effectiveness in pediatric patients receiving allogeneic heart or liver transplants have not been established.

Clinical studies of mycophenolate mofetil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between geriatric and younger patients. In general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies [see Adverse Reactions (6.1) , Drug Interactions (7) ] .

In a 104-week oral carcinogenicity study in mice, MMF in daily doses up to 180 mg/kg was not tumorigenic. The highest dose tested was 0.4 times the recommended clinical dose (2 g/day) in renal transplant patients and 0.3 times the recommended clinical dose (3 g/day) in cardiac transplant patients when corrected for differences in body surface area (BSA). In a 104-week oral carcinogenicity study in rats, MMF in daily doses up to 15 mg/kg was not tumorigenic. The highest dose was 0.07 times the recommended clinical dose in kidney transplant patients and 0.05 times the recommended clinical dose in heart transplant patients when corrected for BSA. While these animal doses were lower than those given to patients, they were maximal in those species and were considered adequate to evaluate the potential for human risk [see Warnings and Precautions (5.2) ] . The genotoxic potential of MMF was determined in five assays. MMF was genotoxic in the mouse lymphoma/thymidine kinase assay and the in vivo mouse micronucleus assay. MMF was not genotoxic in the bacterial mutation assay, the yeast mitotic gene conversion assay or the Chinese hamster ovary cell chromosomal aberration assay. MMF had no effect on fertility of male rats at oral doses up to 20 mg/kg/day. This dose represents 0.1 times the recommended clinical dose in renal transplant patients and 0.06 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (principally of the head and eyes) in the first generation offspring in the absence of maternal toxicity. This dose was 0.02 times the recommended clinical dose in renal transplant patients and 0.01 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.

The following adverse reactions are discussed in greater detail in other sections of the label: Embryofetal Toxicity [see Warnings and Precautions (5.1) ] Lymphomas and Other Malignancies [see Warnings and Precautions 5.2) ] Serious Infections [see Warnings and Precautions (5.3) ] Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [see Warnings and Precautions (5.4) ] Gastrointestinal Complications [see Warnings and Precautions (5.5) ] Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions (5.7) ]

Possible signs and symptoms of acute overdose include hematological abnormalities such as leukopenia and neutropenia, and gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, vomiting, and dyspepsia. The experience with overdose of mycophenolate mofetil in humans is limited. The reported effects associated with overdose fall within the known safety profile of the drug. The highest dose administered to kidney transplant patients in clinical trials has been 4 g/day. In limited experience with heart and liver transplant patients in clinical trials, the highest doses used were 4 g/day or 5 g/day. At doses of 4 g/day or 5 g/day, there appears to be a higher rate, compared to the use of 3 g/day or less, of gastrointestinal intolerance (nausea, vomiting, and/or diarrhea), and occasional hematologic abnormalities, particularly neutropenia [see Warnings and Precautions (5.4) ] . Treatment and Management: MPA and the phenolic glucuronide metabolite of MPA (MPAG) are usually not removed by hemodialysis. However, at high MPAG plasma concentrations ( > 100 µg/mL), small amounts of MPAG are removed. By increasing excretion of the drug, MPA can be removed by bile acid sequestrants, such as cholestyramine [see Clinical Pharmacology (12.3) ] .

Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-Morpholinoethyl ( E )-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate. It has a molecular formula of C 23 H 31 NO 7 , a molecular weight of 433.50, and the following structural formula: Mycophenolate mofetil, USP is a white to almost white crystalline powder. It is practically insoluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of mycophenolate mofetil and tablets containing 500 mg of mycophenolate mofetil. Inactive ingredients in mycophenolate mofetil 250 mg capsules include black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD & C Blue No. 2, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. In addition, the imprinting ink contains the following: ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Inactive ingredients in mycophenolate mofetil 500 mg tablets include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide.

1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy.

Mycophenolate Mofetil Capsules, USP and Mycophenolate Mofetil Tablets, USP (mye'' koe fen' oh late moe' fe til) Read the Medication Guide that comes with mycophenolate mofetil before you start taking it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. What is the most important information I should know about mycophenolate mofetil? Mycophenolate mofetil can cause serious side effects, including: Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take mycophenolate mofetil during pregnancy have a higher risk of miscarriage during the first 3 months (first trimester), and a higher risk that their baby will be born with birth defects. If you are a female who can become pregnant , your doctor must talk with you about acceptable birth control methods (contraceptive counseling) to use while taking mycophenolate mofetil. You should have 1 pregnancy test immediately before starting mycophenolate mofetil and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests. You must use acceptable birth control during your entire mycophenolate mofetil treatment and for 6 weeks after stopping mycophenolate mofetil, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. Mycophenolate mofetil decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take mycophenolate mofetil, and you could become pregnant. If you take birth control pills while using mycophenolate mofetil you must also use another form of birth control. Talk to your doctor about other birth control methods that you can use while taking mycophenolate mofetil. If you are a sexually active male whose female partner can become pregnant while you are taking mycophenolate mofetil , use effective contraception during treatment and for at least 90 days after stopping mycophenolate mofetil. If you plan to become pregnant, talk with your doctor. Your doctor will decide if other medicines to prevent rejection may be right for you. If you become pregnant while taking mycophenolate mofetil, do not stop taking mycophenolate mofetil. Call your doctor right away. You and your doctor may decide that other medicines to prevent rejection may be right for you. You and your doctor should report your pregnancy to the Mycophenolate Pregnancy Registry either: By phone at 1-800-617-8191 or By visiting the REMS website at: www.mycophenolateREMS.com The purpose of this registry is to gather information about the health of you and your baby. Increased risk of getting certain cancers. People who take mycophenolate mofetil have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have: unexplained fever, prolonged tiredness, weight loss or lymph node swelling a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other a change in the size and color of a mole a new skin lesion or bump any other changes to your health Increased risk of getting serious infections. Mycophenolate mofetil weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with mycophenolate mofetil and can lead to hospitalizations and death. These serious infections can include: Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with mycophenolate mofetil include: Shingles, other herpes infections, and cytomegalovirus (CMV). CMV can cause serious tissue and blood infections. BK virus. BK virus can affect how your kidney works and cause your transplanted kidney to fail. Hepatitis B and C viruses. Hepatitis viruses can affect how your liver works. Talk to your doctor about how hepatitis viruses may affect you. COVID-19 A brain infection called Progressive Multifocal Leukoencephalopathy (PML). In some patients, mycophenolate mofetil may cause an infection of the brain that may cause death. You are at risk for this brain infection because you have a weakened immune system. Call your doctor right away if you have any of the following symptoms: weakness on one side of the body you do not care about things you usually care about (apathy) you are confused or have problems thinking you cannot control your muscles Fungal infections. Yeasts and other types of fungal infections can happen with mycophenolate mofetil and can cause serious tissue and blood infections (See “What are the possible side effects of mycophenolate mofetil?” ). Call your doctor right away if you have any of the following signs and symptoms of infection: temperature of 100.5°F or greater cold symptoms, such as a runny nose or sore throat flu symptoms, such as an upset stomach, stomach pain, vomiting or diarrhea earache or headache pain during urination white patches in the mouth or throat unexpected bruising or bleeding cuts, scrapes or incisions that are red, warm and oozing pus   See “What are the possible side effects of mycophenolate mofetil?” for information about other serious side effects. What is mycophenolate mofetil? Mycophenolate mofetil is a prescription medicine to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant. Rejection is when the body’s immune system perceives the new organ as a “foreign” threat and attacks it. Mycophenolate mofetil is used with other medicines containing cyclosporine and corticosteroids. Who should not take mycophenolate mofetil? Do not take mycophenolate mofetil if you are allergic to mycophenolate mofetil or any of the ingredients in mycophenolate mofetil capsules or tablets. See the end of this Medication Guide for a complete list of ingredients in mycophenolate mofetil capsules and tablets. What should I tell my doctor before taking mycophenolate mofetil? Tell your doctor about all of your medical conditions, including if you: have any digestive problems, such as ulcers. have Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome, or another rare inherited deficiency hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take mycophenolate mofetil if you have one of these disorders. plan to receive any vaccines. People taking mycophenolate mofetil should not receive live vaccines. Some vaccines may not work as well during treatment with mycophenolate mofetil. are pregnant or plan to become pregnant. See “What is the most important information I should know about mycophenolate mofetil?” are breastfeeding or plan to breastfeed. It is not known if mycophenolate mofetil passes into breast milk. You and your doctor will decide if you will take mycophenolate mofetil or breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Some medicines may affect the way mycophenolate mofetil works, and mycophenolate mofetil may affect how some medicines work. Especially tell your doctor if you take: birth control pills (oral contraceptives). See “What is the most important information I should know about mycophenolate mofetil?” sevelamer (Renagel ® , Renvela ™ ). These products should be taken at least 2 hours after taking mycophenolate mofetil. acyclovir (Zovirax ® ), valacyclovir (Valtrex ® ), ganciclovir (CYTOVENE ® -IV, Vitrasert ® ), valganciclovir (VALCYTE ® ). rifampin (Rifater ® , Rifamate ® , Rimactane ® , Rifadin ® ). antacids that contain magnesium and aluminum (mycophenolate mofetil and the antacid should not be taken at the same time). proton pump inhibitors (PPIs) (Prevacid ® , Protonix ® ). sulfamethoxazole/trimethoprim (BACTRIM ™ , BACTRIM DS ™ ). norfloxacin (Noroxin ® ) and metronidazole (Flagyl ® , Flagyl ® ER, Flagyl ® IV, Metro IV, Helidac ® , Pylera ™ ). ciprofloxacin (Cipro ® , Cipro ® XR, Ciloxan ® , Proquin ® XR) and amoxicillin plus clavulanic acid (Augmentin ® , Augmentin XR ™ ). azathioprine (Azasan ® , Imuran ® ). cholestyramine (Questran Light ® , Questran ® , Locholest Light, Locholest, Prevalite ® ). Know the medicines you take. Keep a list of them to show to your doctor or nurse and pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor. How should I take mycophenolate mofetil? Take mycophenolate mofetil exactly as prescribed. Do not stop taking mycophenolate mofetil or change the dose unless your doctor tells you to. If you miss a dose of mycophenolate mofetil, or you are not sure when you took your last dose, take your prescribed dose of mycophenolate mofetil as soon as you remember. If your next dose is less than 2 hours away, skip the missed dose and take your next dose at your normal scheduled time. Do not take 2 doses at the same time. Call your doctor if you are not sure what to do. Take mycophenolate mofetil capsules and tablets on an empty stomach, unless your doctor tells you otherwise. Do not crush mycophenolate mofetil tablets. Do not open or crush mycophenolate mofetil capsules. If you are not able to swallow mycophenolate mofetil tablets or capsules, your doctor may prescribe mycophenolate mofetil oral suspension. This is a liquid form of mycophenolate mofetil. Your pharmacist will mix the medicine before you pick it up from a pharmacy. Do not mix mycophenolate mofetil oral suspension with any other medicine. Mycophenolate mofetil oral suspension should not be mixed with any type of liquids before taking the dose. Do not breathe in (inhale) or let mycophenolate mofetil powder or oral suspension come in contact with your skin or mucous membranes. If you accidentally get the powder or oral suspension on the skin, wash the area well with soap and water. If you accidentally get the powder or oral suspension in your eyes or other mucous membranes, flush with plain water. If you take too much mycophenolate mofetil, call your doctor or the poison control center right away. What should I avoid while taking mycophenolate mofetil capsules and tablets? Avoid becoming pregnant. See “What is the most important information I should know about mycophenolate mofetil?” Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take mycophenolate mofetil have a higher risk of getting skin cancer (See “What is the most important information I should know about mycophenolate mofetil?” ). Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen with a high protection factor. This is especially important if your skin is very fair or if you have a family history of skin cancer. You should not donate blood while taking mycophenolate mofetil and for at least 6 weeks after stopping mycophenolate mofetil. You should not donate sperm while taking mycophenolate mofetil and for 90 days after stopping mycophenolate mofetil. Mycophenolate mofetil may influence your ability to drive and use machines (See “What are the possible side effects of mycophenolate mofetil?” ). If you experience drowsiness, confusion, dizziness, tremor, or low blood pressure during treatment with mycophenolate mofetil, you should be cautious about driving or using heavy machines. What are the possible side effects of mycophenolate mofetil? Mycophenolate mofetil can cause serious side effects, including: See “What is the most important information I should know about mycophenolate mofetil?” Low blood cell counts. People taking high doses of mycophenolate mofetil each day may have a decrease in blood counts, including: white blood cells, especially neutrophils. Neutrophils fight against bacterial infections. You have a higher chance of getting an infection when your white blood cell count is low. This is most common from 1 month to 6 months after your transplant. red blood cells. Red blood cells carry oxygen to your body tissues. You have a higher chance of getting severe anemia when your red blood cell count is low. platelets. Platelets help with blood clotting. Your doctor will do blood tests before you start taking mycophenolate mofetil and during treatment with mycophenolate mofetil to check your blood cell counts. Tell your doctor right away if you have any signs of infection (See “What is the most important information I should know about mycophenolate mofetil?” ), including any unexpected bruising or bleeding. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting. Stomach problems. Stomach problems including intestinal bleeding, a tear in your intestinal wall (perforation) or stomach ulcers can happen in people who take mycophenolate mofetil. Bleeding can be severe and you may have to be hospitalized for treatment. Call your doctor right away if you have sudden or severe stomach-area pain or stomach-area pain that does not go away, or if you have diarrhea. Inflammatory reactions.  Some people taking mycophenolate mofetil may have an inflammatory reaction with fever, joint stiffness, joint pain, and muscle pain. Some of these reactions may require hospitalization. This reaction could happen within weeks to months after your treatment with mycophenolate mofetil starts or if your dose is increased. Call your doctor right away if you experience these symptoms. The most common side effects of mycophenolate mofetil include: diarrhea blood problems including low white and red blood cell counts infections blood pressure problems fast heartbeat swelling of the lower legs, ankles and feet changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) stomach problems including diarrhea, constipation, nausea and vomiting rash nervous system problems such as headache, dizziness and tremor Side effects that can happen more often in children than in adults taking mycophenolate mofetil include: stomach area pain fever infection pain blood infection (sepsis) diarrhea vomiting sore throat colds (respiratory tract infections) high blood pressure low white blood cell count low red blood cell count These are not all of the possible side effects of mycophenolate mofetil. Tell your doctor about any side effect that bothers you or that does not go away.   Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   You may also report side effects to Mylan at 1-877-446-3679 (1-877-4-INFO-RX). How should I store mycophenolate mofetil? Store mycophenolate mofetil capsules and tablets at room temperature between 20° to 25°C (68° to 77°F). Keep mycophenolate mofetil tablets in the light resistant container that they come in. Keep mycophenolate mofetil and all medicines out of the reach of children. General Information about the safe and effective use of mycophenolate mofetil. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate mofetil for a condition for which it was not prescribed. Do not give mycophenolate mofetil to other people, even if they have the same symptoms that you have. It may harm them.   This Medication Guide summarizes the most important information about mycophenolate mofetil. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolate mofetil that is written for health professionals. What are the ingredients in mycophenolate mofetil capsules and tablets? Active Ingredient: mycophenolate mofetil Inactive Ingredients: Mycophenolate mofetil 250 mg capsules: black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD & C Blue No. 2, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. In addition, the imprinting ink contains the following: ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.   Mycophenolate mofetil 500 mg tablets: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide.   Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). The brands listed are trademarks of their respective owners. This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Auro PR Inc. RD 156 Caguas West Industrial Park, Lot 24 Caguas, PR 00725 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-11971 R6 3/23

Mycophenolate Mofetil Capsules, USP are available containing 250 mg of mycophenolate mofetil, USP. The 250 mg capsules are hard-shell gelatin capsules with a caramel opaque cap and a lavender opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 2250 in black ink on both the cap and body. Mycophenolate Mofetil Tablets, USP are available containing 500 mg of mycophenolate mofetil, USP. The 500 mg tablets are light pink, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and 472 on the other side.

Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective, uncompetitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines, whereas other cell types can utilize salvage pathways, MPA has potent cytostatic effects on lymphocytes. MPA inhibits proliferative responses of T- and B-lymphocytes to both mitogenic and allospecific stimulation. Addition of guanosine or deoxyguanosine reverses the cytostatic effects of MPA on lymphocytes. MPA also suppresses antibody formation by B-lymphocytes. MPA prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection. MMF did not inhibit early events in the activation of human peripheral blood mononuclear cells, such as the production of interleukin-1 (IL-1) and interleukin-2 (IL-2), but did block the coupling of these events to DNA synthesis and proliferation.

There is a lack of information regarding the pharmacodynamic effects of MMF.

Warnings and Precautions, Serious Infections ( 5.3 )     10/2021 Warnings and Precautions, Acute Inflammatory Syndrome Associated with Mycophenolate Products ( 5.7 )     10/2021

Blood Dyscrasias (Neutropenia, Red Blood Cell Aplasia): Monitor with blood tests; consider treatment interruption or dose reduction. ( 5.4 ) Gastrointestinal Complications: Monitor for complications such as bleeding, ulceration and perforations, particularly in patients with underlying gastrointestinal disorders. ( 5.5 ) Hypoxanthine-Guanine Phosphoribosyl-Transferase Deficiency: Avoid use of mycophenolate mofetil. ( 5.6 ) Acute Inflammatory Syndrome Associated with Mycophenolate Products: Monitor for this paradoxical inflammatory reaction. ( 5.7 ) Immunizations: Avoid live attenuated vaccines. ( 5.8 ) Blood Donation: Avoid during therapy and for 6 weeks thereafter. ( 5.11 ) Semen Donation: Avoid during therapy and for 90 days thereafter. ( 5.12 ) Potential Impairment on Driving and Use of Machinery: Mycophenolate mofetil may affect ability to drive or operate machinery. ( 5.14 )

NDC 51079-721-20 Mycophenolate Mofetil Capsules, USP 250 mg 100 Capsules (10 x 10) Each capsule contains: Mycophenolate mofetil, USP 250 mg Usual Dosage: See accompanying prescribing information and Medication Guide. CAUTION: Special Handling and Disposal Instructions - see prescribing information. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in Puerto Rico Rx only S-10456 R6 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date.

Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see Human Data ] . Oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.02 to 0.1 times the recommended clinical doses in kidney and heart transplant patients) [see Animal Data ] . Consider alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman. The estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning.