Genentech: CellCept® (mycophenolate mofetil) – Information for Patients

Full Prescribing Information

Medication Guide

Medication Guide Announcement

Support & Resources

What it Treats

• CELLCEPT^® (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.
• CELLCEPT is used with other medicines containing cyclosporine and corticosteroids.

Important Safety Information

What is the most important information I should know about CELLCEPT?

CELLCEPT can cause serious side effects, including:

Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take CELLCEPT 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 CELLCEPT. You should have 1 pregnancy test immediately before starting CELLCEPT 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 CELLCEPT treatment and for 6 weeks after stopping CELLCEPT, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. CELLCEPT 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 CELLCEPT, and you could become pregnant. If you take birth control pills while using CELLCEPT you must also use another form of birth control. Talk to your doctor about other birth control methods that you can use while taking CELLCEPT.
• If you are a sexually active male whose female partner can become pregnant while you are taking CELLCEPT, use effective contraception during treatment and for at least 90 days after stopping CELLCEPT.
• 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 CELLCEPT, do not stop taking CELLCEPT. 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
• o by visiting the Risk Evaluation and Mitigation Strategy (REMS) website at 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 CELLCEPT 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
• 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. CELLCEPT weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with CELLCEPT 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 CELLCEPT 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, CELLCEPT 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 that you usually care about (apathy)
  • you are confused or have problems thinking
  • you can not control your muscles

• Fungal infections. Yeasts and other types of fungal infections can happen with CELLCEPT and can cause serious tissue and blood infections (See “What are the possible side effects of CELLCEPT?”).

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 CELLCEPT?” for information about other serious side effects.

Who should not take CELLCEPT?

Do not take CELLCEPT if you are allergic to mycophenolate mofetil or any of the ingredients in CELLCEPT.

What should I tell my doctor before taking CELLCEPT?

Tell your doctor about all of your medical conditions, including if you:

• have any digestive problems, such as ulcers.
• have Phenylketonuria (PKU). CELLCEPT oral suspension contains aspartame (a source of phenylalanine).
• have Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome, or another rare inherited deficiency hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take CELLCEPT if you have one of these disorders.
• plan to receive any vaccines. People taking CELLCEPT should not receive live vaccines. Some vaccines may not work as well during treatment with CELLCEPT.
• are pregnant or plan to become pregnant. See “What is the most important information I should know about CELLCEPT?”
• are breastfeeding or plan to breastfeed. It is not known if CELLCEPT passes into breast milk. You and your doctor will decide if you will take CELLCEPT or breastfeed.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Some medicines may affect the way CELLCEPT works, and CELLCEPT 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 CELLCEPT?”
• sevelamer (Renagel®, Renvela™). These products should be taken at least 2 hours after taking CELLCEPT.
• acyclovir (Zovirax®), valacyclovir (Valtrex®), ganciclovir (CYTOVENE®-IV, Vitrasert®), valganciclovir (Valcyte®).
• rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®).
• antacids that contain magnesium and aluminum (CELLCEPT 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 CELLCEPT?

• Take CELLCEPT exactly as prescribed.
• Do not stop taking CELLCEPT or change the dose unless your doctor tells you to.
• If you miss a dose of CELLCEPT, or you are not sure when you took your last dose, take your prescribed dose of CELLCEPT 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 CELLCEPT capsules, tablets and oral suspension on an empty stomach, unless your doctor tells you otherwise. Do not crush CELLCEPT tablets.
• Do not open or crush CELLCEPT capsules.
• If you are not able to swallow CELLCEPT tablets or capsules, your doctor may prescribe CELLCEPT Oral Suspension. This is a liquid form of CELLCEPT. Your pharmacist will mix the medicine before you pick it up from a pharmacy.
• Do not mix CELLCEPT Oral Suspension with any other medicine. CELLCEPT Oral Suspension should not be mixed with any type of liquids before taking the dose.
• Do not breathe in (inhale) or let CELLCEPT 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 CELLCEPT, call your doctor or the poison control center right away.

What should I avoid while taking CELLCEPT?

• Avoid becoming pregnant. See “What is the most important information I should know about CELLCEPT?”
• Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take CELLCEPT have a higher risk of getting skin cancer. (See “What is the most important information I should know about CELLCEPT?”) 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 CELLCEPT and for at least 6 weeks after stopping CELLCEPT.
• You should not donate sperm while taking CELLCEPT and for 90 days after stopping CELLCEPT.

CELLCEPT may influence your ability to drive and use machines (See “What are the possible side effects of CELLCEPT?”). If you experience drowsiness, confusion, dizziness, tremor, or low blood pressure during treatment with CELLCEPT, you should be cautious about driving or using heavy machines.

What are the possible side effects of CELLCEPT?

CELLCEPT can cause serious side effects, including:

• See “What is the most important information I should know about CELLCEPT?”
• Low blood cell counts. People taking high doses of CELLCEPT 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 CELLCEPT and during treatment with CELLCEPT 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 CELLCEPT?”), 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 CELLCEPT. 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 CELLCEPT 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 CELLCEPT starts or if your dose is increased. Call your doctor right away if you experience these symptoms.

The most common side effects of CELLCEPT include:

• diarrhea
• blood problems including low white and red blood cell counts
• infections
• blood pressure problems
• fast heart beat
• 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 CELLCEPT 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 CELLCEPT. 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 Genentech at 1-888-835-2555.

Mycophenolate Mofetil Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

Mycophenolate may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn’t go away, fever, chills, cough, burning/painful/urgent urination, change in the amount of urine).

Mycophenolate may rarely cause cancer (such as lymphoma, skin cancer). Protect your skin from the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you have any of the following symptoms of cancer: swollen glands, sudden weight loss, night sweats, change in appearance or size of moles, or unusual skin changes/growth.

Mycophenolate may harm an unborn baby. When using mycophenolate, men and women of childbearing age must use reliable forms of birth control. See also Precautions section.

Warnings:

Mycophenolate may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn’t go away, fever, chills, cough, burning/painful/urgent urination, change in the amount of urine).

Mycophenolate may rarely cause cancer (such as lymphoma, skin cancer). Protect your skin from the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you have any of the following symptoms of cancer: swollen glands, sudden weight loss, night sweats, change in appearance or size of moles, or unusual skin changes/growth.

Mycophenolate may harm an unborn baby. When using mycophenolate, men and women of childbearing age must use reliable forms of birth control. See also Precautions section.

… Show More

Uses

Mycophenolate is used in combination with other medications to keep your body from attacking and rejecting your transplanted organ (such as kidney, liver, heart). It belongs to a class of medications called immunosuppressants. It works by weakening your body’s defense system (immune system) to help your body accept the new organ as if it were your own.

How to use mycophenolate mofetil oral

Read the Medication Guide provided by your pharmacist before you start taking mycophenolate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually twice daily on an empty stomach, 1 hour before or 2 hours after meals.

Swallow the medication whole. Do not crush or chew. If you are taking the capsules, do not open them before swallowing.

If the capsule comes apart or if there is dust from the tablets, avoid inhaling the powder or dust, and avoid direct contact with the skin or eyes. If contact occurs, wash the affected skin area well with soap and water or rinse your eyes with plain water. Consult your pharmacist for details.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets or powder from the capsules.

The dosage is based on your medical condition and response to treatment. In children, it is also based on body size.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Keep taking this medication even if you feel well. Do not stop taking mycophenolate without first talking to your doctor.

Certain products may make it harder for your body to absorb mycophenolate if they are taken at the same time. Do not take this medication at the same time as antacids containing aluminum and/or magnesium, cholestyramine, colestipol, or calcium-free phosphate binders (such as aluminum products, lanthanum, sevelamer). Ask your pharmacist for more details.

Do not change brands or forms of mycophenolate unless directed by your doctor.

Side Effects

See also Warning section.

Constipation, nausea, headache, diarrhea, vomiting, stomach upset, gas, tremor, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual tiredness, fast/irregular heartbeat, easy bleeding/bruising, swelling of the feet or ankles, joint pain/stiffness, muscle pain.

Get medical help right away if you have any very serious side effects, including: stomach/abdominal pain that doesn’t go away, black stools, vomit that looks like coffee grounds, chest pain, shortness of breath/rapid breathing.

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before taking mycophenolate mofetil, tell your doctor or pharmacist if you are allergic to it; or to mycophenolic acid; or to mycophenolate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, liver disease (such as hepatitis B, hepatitis C), kidney disease, current/past infections (such as herpes, shingles), stomach/intestinal problems (such as ulcers), rare genetic disorders (such as Lesch-Nyhan or Kelley-Seegmiller syndromes).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Mycophenolate can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using mycophenolate mofetil before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not donate blood while using mycophenolate and for 6 weeks after stopping this drug. Do not donate sperm while using mycophenolate and for 90 days after stopping this drug.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets or powder from the capsules.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may order a pregnancy test before starting this medication, after 8 to 10 days on treatment, and during routine follow-up visits. You should not become pregnant while using mycophenolate. Mycophenolate may harm an unborn baby. Women of childbearing age should ask about reliable forms of birth control while using this medication and for 6 weeks after the last dose. Men with female partners of childbearing age should use reliable forms of birth control while using this medication and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. If you are using hormonal birth control, you should use an additional non-hormonal form of birth control while using this medication. Discuss your options with your doctor or pharmacist. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Does mycophenolate mofetil oral interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as blood counts, drug levels, kidney function, pregnancy test) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Attend a transplant education class or support group. Learn to recognize the signs and symptoms of organ rejection and tell your doctor right away if they occur.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

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This medicine is a white, oval, tablet imprinted with “54 135”.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Mycophenolate mofetil instructions for use: indications, contraindications, side effects – description Mycophenolate mofetil caps. 250 mg: 10 pcs. (45784)

💊 Composition of the drug Mycophenolate mofetil ✅ The use of the drug Mycophenolate mofetil Keep for yourself Search for analogues Interaction Description of the active ingredients of the preparation Mycophenolate mofetil (Mycophenolate mofetil) The scientific information provided is general and cannot be used to make decisions. decisions about the use of a particular drug. Update date: 2021.09.03 Marketing authorization holder: ALKEM LABORATORIES Ltd. (India) ATX code: L04AA06 (Mycophenolic acid) Active substance: mycophenolate mofetil (mycophenolate mofetil) USAN approved for use in the USA Dosage form Mycophenolate mofetil Caps. 250 mg: 10 pcs. reg. No.: LP-004231 dated 05. 04.17 – Active Release form, packaging and composition Mycophenolate mofetil No. 1 hard gelatin capsules, brown body, printed “266” in black ink and blue cap; the contents of the capsules are a granular powder of white or almost white color. Excipients : croscarmellose sodium – 2 mg, pregelatinized starch – 37.5 mg, povidone K90 – 7.5 mg, magnesium stearate – 3 mg. The composition of the capsule body: iron oxide red – 0.36%, iron oxide yellow – 0.6%, titanium dioxide – 2.4375%, gelatin – 82.02%, water – 14.5% sodium lauryl sulfate – 0.08% capsules: titanium dioxide 2.4375%, dye indigo carmine – 0.018%, gelatin 82.96%, water – 14.5%, sodium lauryl sulfate – 0.08%. Ink content: shellac, dehydrated alcohol*, isopropyl alcohol*, butyl alcohol*, propylene glycol*, concentrated ammonia solution*, black iron oxide, potassium hydroxide, purified water*. * Substances that are removed during the process of inking capsules and are not present in the finished dosage form. 10 pcs. – PVC/PVDC blisters (1) – cardboard packs. Clinical and pharmacological group: immunosuppressive drug Pharmacotherapeutic group: Immunosuppressive agent Pharmacological action Immunosuppressive agent. Mycophenolate mofetil (MMF) is the 2-morpholinoethyl ester of mycophenolic acid (MPA). MPA is a potent, selective, non-competitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH) that inhibits de novo synthesis of guanosine nucleotides . The mechanism by which MPA inhibits the enzymatic activity of IMPDH appears to be due to the fact that MPA structurally mimics both the nicotinamide dinucleotide phosphate co-factor and the catalyzing water molecule. This prevents the oxidation of IMP to xanthose-5-monophosphate, the most important step in the biosynthesis of guanosine nucleotides de novo. MPA has a more pronounced cytostatic effect on lymphocytes than on other cells, since the proliferation of T- and B-lymphocytes is very dependent on de novo purine synthesis, while other types of cells can switch to bypass metabolic pathways. Pharmacokinetics After oral administration, there is a rapid and complete absorption and complete first pass metabolism of MMF with the formation of the active metabolite – MPA. Oral bioavailability of MMF, according to area AUC IFC is, on average, 94% of that when administered intravenously. After oral administration, plasma concentrations of MMF are not determined (below the detection threshold – 0.4 μg / ml). In the early post-transplant period (up to 40 days after kidney, heart or liver transplantation), the average AUC values ​​were approximately 30% lower, and C max approximately 40% lower than in the late post-transplant period (3-6 months after transplant). Food intake does not affect the degree of absorption of MMF (UC IFC ) when used at a dose of 1. 5 g 2 times / day in patients after kidney transplantation. However, C max MFC when taking mycophenolate mofetil with meals is reduced by 40%. Typically, approximately 6-12 hours after ingestion of mycophenolate mofetil, a secondary increase in plasma MFC concentrations is observed, indicative of hepatic recirculation of MMF. With the simultaneous use of cholestyramine, the AUC of MFC is reduced by approximately 40%, which indicates an interruption of the hepato-intestinal recirculation. At clinically relevant concentrations, MPA is 97% bound to plasma albumin. MPA is metabolized mainly by glucuronyl transferase (UGT gene isoform 1A9) to form the pharmacologically inactive phenolic glucuronide MPA (MPCG). In vivo, MFC is converted back to free MFC during hepato-intestinal recycling to form an acylglucuronide, which has pharmacological activity and may be the cause of some of the side effects of MFC (diarrhea, leukopenia). After oral administration of radioactively labeled MMF, 93% of the dose is excreted in the urine, 6% in the feces. Most (about 87%) of the administered dose is excreted in the urine as MFCG. Minor amounts of MMF (<1% of the dose) are excreted in the urine as MFC. Clinically detectable concentrations of MPA and MFCG are not removed by hemodialysis. However, at higher concentrations of MFCG (>100 µg/mL), some of it may be removed. Bile acid sequestrants such as cholestyramine reduce AUC IFC , interrupting hepato-intestinal recirculation. The distribution of MPA is dependent on several transporters: the organic anion transport polypeptide (TPOA) and the multidrug resistance-associated protein-2 (BAMLU-2). TPOA, BAMLU-2 isoforms, as well as breast cancer resistance protein (BRRM) are transporters associated with glucuronide excretion through bile. The multidrug resistance-1 protein may also be involved in the transport of MFC, but its participation is limited to the absorption process. MPA and its metabolites have the potential to react with organic anion transporters in the kidneys. Indications of the active substances of the drug Mycophenolate mofetil Mycophenolate mofetil is used in combination therapy with cyclosporine and corticosteroids. Adults and children with body surface area >1.5 m 2 (approximate childhood age over 14 years): prevention of acute graft rejection in patients after allogeneic kidney transplantation. Adults: prevention of acute transplant rejection in allogeneic heart transplant patients; prevention of acute graft rejection in patients after allogeneic liver transplantation. Open list of ICD-10 codes Z94.0 Presence of a transplanted kidney Z94.1 Presence of a transplanted heart Z94. 4 Presence of a transplanted liver Dosage regimen The method of administration and dosing regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed. Int. Used as part of combination therapy with cyclosporine and corticosteroids. The dosage regimen is set individually, depending on the indications, the therapy regimen and the age (body surface area) of the patient. Side effects Hypersensitivity reactions: angioedema, anaphylactic reactions. Infectious diseases: very often – sepsis, gastrointestinal candidiasis, urinary tract infections, herpes simplex, herpes zoster; often – pneumonia, influenza, respiratory tract infections, respiratory moniliasis, gastrointestinal infections, candidiasis, gastroenteritis, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candidiasis, vaginal candidiasis, rhinitis. Benign, malignant and unspecified neoplasms (including cysts and polyps): often – skin cancer, benign neoplasm of the skin. From the side of the hematopoietic system: very often – leukopenia, thrombocytopenia, anemia; often – pancytopenia, leukocytosis. From the side of metabolism: often – acidosis, hyperkalemia, hypokalemia, hyperglycemia, hypomagnesemia, hypocalcemia, hypercholesterolemia, hyperlipidemia, hypophosphatemia, hyperuricemia, gout, anorexia. From the side of the psyche: often – agitation, confusion, depression, anxiety, impaired thinking, insomnia. From the nervous system: often – convulsions, hypertonicity, tremor, drowsiness, myasthenic syndrome, dizziness, headache, paresthesia, dysgeusia. From the side of the cardiovascular system: often – tachycardia, arterial hypotension, arterial hypertension, vasodilation. Respiratory side: often – pleural effusion, shortness of breath, cough. From the digestive system: very often – vomiting, abdominal pain, diarrhea, nausea; often – gastrointestinal bleeding, peritonitis, intestinal obstruction, colitis, stomach ulcer, duodenal ulcer, gastritis, esophagitis, stomatitis, constipation, dyspepsia, flatulence, belching. From the side of the liver and biliary tract: often – hepatitis, jaundice, hyperbilirubinemia. Skin and subcutaneous tissues: often – skin hypertrophy, rash, acne, alopecia. From the side of laboratory parameters: often – increased activity of liver enzymes, increased blood creatinine, increased LDH levels in the blood, increased blood urea levels, increased activity of alkaline phosphatase in the blood. Other: arthralgia, renal failure, edema, fever, chills, pain, malaise, asthenia, weight loss. Contraindications for use Hypersensitivity to mycophenolate mofetil. Deficiency of hypoxanthine-guanine phosphoribosyltransferase (a rare genetic disease caused by hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase – Lesch-Nychen and Kelly-Sigmiller syndromes). Co-administration with azathioprine. Children with body surface area <1.5 m 2 (approximate child age under 14). Pregnancy, breastfeeding period. Women of childbearing potential who are not using highly effective contraceptive methods. Women of childbearing potential without a previous pregnancy test to rule out inadvertent use of mycophenolate mofetil during pregnancy. With caution: diseases of the gastrointestinal tract in the acute phase. Switching from combination therapy, including immunosuppressants that have an effect on the hepato-intestinal recycling of MFC, such as cyclosporine, to therapy with drugs that lack this effect, such as tacrolimus, sirolimus, and belatacept, and vice versa. Simultaneous use of drugs that affect the hepato-intestinal cycle of MPA, for example, colestyramine, sevelamer, antibiotics, and glucuronidation, for example, isavuconazole. Use in pregnancy and lactation Contraindicated in pregnancy (due to the mutagenic and teratogenic potential of mycophenolate mofetil). The use of mycophenolate mofetil is contraindicated during breastfeeding due to the possibility of serious adverse reactions in breastfed infants. The use of mycophenolate mofetil is contraindicated in women of childbearing potential who are not using highly effective contraceptive methods. Before starting therapy, patients with reproductive potential should be informed about the increased risk of fetal death and congenital malformations; consultation should be held on measures to prevent pregnancy and its planning. Use in impaired renal function In kidney transplant patients with severe chronic renal failure (glomerular filtration rate less than 25 ml / min / 1.73 m 2 ) outside the immediate post-transplant period, doses above 1 g should be avoided 2 times/day Dose adjustment is not recommended in patients with delayed renal graft function, but such patients require close medical supervision. Use in children Use is contraindicated in children with a body surface area <1. 5 m 2 (estimated children under 14 years of age). In children with body surface area >1.5 m 2 mycophenolate mofetil is used to prevent acute graft rejection after allogeneic kidney transplantation. Use in the elderly Elderly patients (≥65 years) may have an increased risk of adverse events such as certain infections (including tissue invasive forms of overt cytomegalovirus infection), gastrointestinal bleeding and pulmonary edema compared with younger patients . Special instructions Patients taking mycophenolate mofetil have an increased risk of developing lymphomas and other malignant tumors, in particular skin cancer. Limit exposure to the sun and ultraviolet rays by wearing appropriate protective clothing and using sunscreens with a high protection factor. With the use of mycophenolate mofetil, there is an increased risk of developing opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis. Such cases include reactivation of a latent viral infection, such as hepatitis B or C, or an infection caused by polyomaviruses (VC-associated nephropathy, JC-virus-associated PML). Cases of hepatitis due to reactivation of hepatitis B or C viruses have been reported in patients carrying hepatitis B or C viruses receiving immunosuppressive therapy. These infections are often associated with a high overall immunosuppressive burden and can lead to serious impairment or death, which should be considered in the differential diagnosis of patients with immunosuppression and worsening renal function or neurological symptoms. Cases of hypogammaglobulinemia in recurrent infections have been observed with the use of mycophenolate mofetil in combination with other immunosuppressants. In some of these cases, switching from mycophenolate mofetil to an alternative immunosuppressant resulted in normalization of serum IgG levels. Serum immunoglobulin levels should be measured in patients with recurrent infections receiving mycophenolate mofetil. With sustained, clinically significant hypogammaglobulinemia, appropriate clinical measures should be applied, taking into account the possible cytostatic effects that MFC has on T and B lymphocytes. There are data on the development of bronchiectasis in adults and children who received mycophenolate mofetil in combination with other immunosuppressants. In some of these cases, switching from mycophenolate mofetil to another immunosuppressant resulted in a reduction in respiratory symptoms. The risk of developing bronchiectasis may be associated with hypogammaglobulinemia or with direct effects on the lungs. There are isolated reports of interstitial lung disease and pulmonary fibrosis, some of which have been fatal. It is recommended to evaluate patients with persistent pulmonary symptoms such as cough and dyspnea. Cases of PCCA have been observed in patients taking mycophenolate mofetil in combination with other immunosuppressive drugs. The mechanism for the development of PCCA with the use of mycophenolate mofetil is not known, as well as the contribution of other immunosuppressants and their combination. In some cases, PKKA was reversible after reduction in the dose of mycophenolate mofetil or its withdrawal. However, in transplant patients, decreased immunosuppression may compromise the graft. Patients receiving MMF should be advised to report any signs of infection, sudden onset of bruising, bleeding, or other signs of bone marrow depression to their physician immediately. In the treatment of MMF, it is necessary to determine the expanded blood formula during the first month weekly, during the second and third months of treatment – 2 times a month, and then during the first year – monthly. Particular attention should be paid to the possibility of developing neutropenia. Neutropenia may be due to both MMF and other drugs, viral infections, or a combination of these causes. If neutropenia occurs (absolute neutrophil count <1.3×10 3 /µl) treatment with MMF should be interrupted or the dose reduced while closely monitoring these patients. Patients receiving mycophenolate mofetil should not donate blood during treatment and for at least 6 weeks after the last dose. Vaccination may be less effective during treatment with MMF; Live attenuated vaccines should be avoided. Influenza vaccination can be given according to national guidelines. Taking MMF may be accompanied by adverse reactions from the gastrointestinal tract (ulceration of the gastrointestinal mucosa, gastrointestinal bleeding, gastrointestinal perforation). Caution should be exercised when using MMF in patients with acute gastrointestinal disease. MMF is an inhibitor of IMPDH and should not be used in patients with rare genetically determined hypoxanthine-guanine phosphoribosyltransferase deficiency (Lesch-Nychen and Kelly-Sigmiller syndromes). Mycophenolate is a potent human teratogen. There have been cases of spontaneous abortions (with a frequency of 45% to 49%) and congenital malformations (estimated frequency of 23% to 27%) with the use of MMF during pregnancy. The healthcare provider should ensure that a woman taking mycophenolate understands the risk of harm to the baby, the need for effective contraception, and the need to consult a healthcare provider immediately if pregnancy is likely. Women of childbearing potential should use at least one reliable method of contraception before starting, during treatment, and for 6 weeks after stopping therapy with mycophenolate mofetil if abstinence from sexual activity is not possible. It is preferable to use 2 complementary methods of contraception at the same time to minimize the possibility of ineffective contraception and the onset of an unplanned pregnancy. Sperm donation is not permitted during the treatment period and for 90 days after the last dose of mycophenolate mofetil. Influence on the ability to drive vehicles and mechanisms During the period of treatment, patients should avoid driving vehicles and other activities that require a high concentration of attention and speed of psychomotor reactions. Drug Interactions Higher plasma concentrations of acyclovir have been observed with concomitant use of MMF and acyclovir than with acyclovir alone. Changes in pharmacokinetic parameters (namely, an increase in the concentration of MFCG by 8%) MFCG (phenolic glucuronide MPA) were minimal and are not considered clinically significant. Since plasma concentrations of MFCG, like aciclovir, are increased in renal failure, it is possible that MMF and aciclovir (or its prodrugs, such as valaciclovir) compete for tubular secretion, which may lead to a further increase in the concentration of both drugs. Co-administration of mycophenolate mofetil with antacids (aluminum and magnesium hydroxide) and with proton pump inhibitors (lansoprazole and pantoprazole) has been associated with a decrease in MPA levels. However, there was no significant difference between the rates of graft rejection in patients taking mycophenolate mofetil with and without proton pump inhibitors. This conclusion theoretically applies to all antacids, since when magnesium and aluminum hydroxide are taken simultaneously with mycophenolate mofetil, the concentration of MFC decreases to a much lesser extent than when mycophenolate mofetil is taken simultaneously with proton pump inhibitors. Caution should be exercised when using drugs that affect the hepato-intestinal circulation (eg cholestyramine, cyclosporine, antibiotics) due to their potential to reduce the effectiveness of mycophenolate mofetil. Caution should be exercised when co-administering cholestyramine due to the potential for decreased efficacy of mycophenolate mofetil. MMF does not affect the pharmacokinetics of ciclosporin. However, with the termination of the simultaneous use of cyclosporine, an increase in AUC 9 should be expected.0088 IFC by about 30%. Cyclosporine interferes with the hepatic intestinal recycling of MPA, which may result in a reduction in MPA exposure of approximately 30-50% in kidney transplant patients receiving mycophenolate mofetil and cyclosporine. On the contrary, when switching patients from cyclosporine therapy to therapy with immunosuppressants that do not affect the hepatic intestinal recycling of MPA, a change in MPA exposure should be expected. Antibiotics that kill bacteria that produce β-glucuronidase in the intestine (eg, antibiotics from the group of aminoglycosides, cephalosporins, fluoroquinolones, and penicillins) may interfere with the hepatic intestinal recycling of MFCG/MFK, which, in turn, may lead to a decrease in systemic exposure to IFC. When used simultaneously with drugs that inhibit MPA glucuronidation (isavuconazole and telmisartan), its exposure may increase. In patients not taking cyclosporine, concomitant use of mycophenolate mofetil and rifampicin resulted in an 18-70% reduction in MPA exposure (AUC 0-12 ). It is recommended to control the exposure of MPA and adjust the dose of mycophenolate mofetil to maintain the clinical effect when used together. Simultaneous use of sevelamer and MPA in adults and children reduced C max and AUC 0-12 MFC by 30% and 25%, respectively, without any clinical consequences (for example, graft rejection). However, it is recommended that mycophenolate mofetil be taken at least 1 hour before or 3 hours after taking sevelamer to minimize the effect on MPA absorption. There are no data on the use of mycophenolate mofetil with phosphate binders other than sevelamer. Liver transplant patients initiated on mycophenolate mofetil and tacrolimus therapy had no significant effect on AUC and C max MFC (active metabolite of mycophenolate mofetil). In contrast, in patients with a liver transplant after multiple doses of mycophenolate mofetil at a dose of 1.5 g 2 times / day, the AUC of tacrolimus increased by approximately 20%. In kidney transplant patients, the use of mycophenolate mofetil did not appear to affect tacrolimus concentrations. Live attenuated vaccines should not be given to patients who are immunosuppressed. Antibody formation in response to other vaccines may be reduced. Keep If you want to place a link to the description of this drug – use this code Mycophenolate mofetil . Description of the drug in the reference book Vidal.

Mycophenolate mofetil – description of the substance, pharmacology, use, contraindications, formula

Contents

• Structural formula

• Russian name

• English name

• Latin name

• chemical name

• Gross formula

• Pharmacological group of the substance Mycophenolate mofetil

• Nosological classification

• CAS code

• pharmachologic effect

• Characteristic

• Pharmacology

• Application of the substance Mycophenolate mofetil

• Contraindications

• Use during pregnancy and lactation

• side effects of mycophenolate mofetil

• Interaction

• Overdose

• Dosage and administration

• Precautionary measures

• Trade names with the active substance Mycophenolate mofetil

Russian name

Mycophenolate mofetil

English name

Mycophenolate mofetil

Latin name

Mycophenolatis Mofetilum ( born Mycophenolatis Mofetilum)

Chemical name

Morpholinoethyl(E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate

Gross formula

C ₂₃ H ₃₁ NO ₇

Pharmacological group of the substance Mycophenolate mofetil

Immunosuppressants

Nosological classification

ICD-10 code list

CAS code

115007-34-6

Pharmacological action

Pharmacological action –

immunosuppressive .

Characteristic

White or off-white crystalline powder, sparingly soluble in water (solubility increases with acidification of the medium), soluble in methanol, partially soluble in ethanol, very soluble in acetone.

Pharmacology

Selectively inhibits inosine monophosphate dehydrogenase and inhibits the synthesis of nucletoid guanosine de novo. It has a pronounced cytostatic effect on lymphocytes, inhibits their proliferation in response to both mitogenic and allospecific stimulation. It also inhibits the formation of antibodies by B-lymphocytes. Prevents glycosylation of lymphocytic and monocytic glycoproteins involved in intercellular interaction with the endothelium, and reduces the migration of lymphocytes to the foci of inflammation and transplant rejection, blocks the effect of mononuclear cells on DNA synthesis and proliferation.

When taken orally, it is rapidly absorbed and completely presystemically hydrolyzed, forming mycophenolic acid (active metabolite). Its absolute bioavailability is 94% (mycophenolate mofetil is practically not detected in plasma). The time to reach max “> C _max (24.5 μg / ml) is 0.8–0.9 hours. 50% lower. Mycophenolic acid is 97% bound to plasma albumin. The average volume of distribution is 3.6-4.0 l / kg. In tissues, it turns into a glucuronide (binds to albumin – 82%). At high plasma concentrations of glucuronide, competition for protein binding sites is possible. After 6–12 hours, a second peak is determined in the blood, due to enterohepatic circulation. T _1/2 is 17.9 h, plasma Cl is 193 ml/min. About 87% of the administered dose is excreted by the kidneys, 6% by the intestines. Mainly glucuronide is excreted, 3 more metabolites and less than 1% of mycophenolic acid are found in the urine.

In combination with azathioprine and cyclosporine, as well as with an induction course of antithymocyte globulin, reduces the incidence of adverse outcomes in the first 6 months after transplantation.

Use of the substance Mycophenolate mofetil

Prevention of acute organ rejection and treatment of allogeneic transplant rejection (in combination with cyclosporine and glucocorticoids).

Contraindications

Hypersensitivity, exacerbation of peptic ulcer of the stomach and duodenum and other diseases of the gastrointestinal tract, pregnancy, breast-feeding, childhood.

Use in pregnancy and lactation

FDA fetal category D.

Side effects of Mycophenolate mofetil substance

Nausea, vomiting, diarrhea, constipation, leukopenia or leukocytosis, anemia, thrombocytopenia , increased frequency of infectious and septic complications; headache, insomnia, tremor, fever, asthenia, lumbago, hypertension, cough, pharyngitis, shortness of breath, peripheral edema, oropharyngeal candidiasis, hematuria, tubular necrosis, impotence, acne, hyper- or hypokalemia, hyperglycemia, hypophosphatemia, hypercholesterolemia, allergic reactions, rash, pruritus.

Interactions

Probenecid and other drugs that affect tubular secretion increase the plasma concentration of mycophenolic acid. Antacids containing magnesium and aluminum hydroxides reduce absorption. Drugs that change the flora of the gastrointestinal tract can disrupt the enterohepatic circulation. May reduce the effectiveness of oral contraception. Azathioprine increases the risk of developing lymphomas, especially of the skin.

Overdose

Symptoms: increased frequency of gastrointestinal and hematological (particularly neutropenia) side effects.

Treatment: dose reduction or drug withdrawal. To accelerate excretion, bile acid sequestrants may be prescribed. Small amounts of glucuronide can be removed by hemodialysis (mycophenolic acid is not dialyzed).

Dosage and administration

Inside . For the prevention of graft rejection – 1 g 2 times / day (the initial dose should be taken within 3 days after transplantation) in combination with corticosteroids and cyclosporine. For the treatment of rejection reaction refractory to other therapies, 1.5 g 2 times / day, also in combination.

Precautions

It is necessary to take into account the possibility of an increased risk of developing lymphoproliferative processes (about 1% of cases), regularly monitor the composition of peripheral blood, with a decrease in the number of neutrophils below 1.3 10 ³ /μl, dose reduction or a break in treatment is indicated ( and appropriate therapy). In case of a decrease in the glomerular filtration rate below 25 ml / min, it is not recommended to use more than 2 times a day. During and within 6 weeks after the end of the course, reliable contraception is required; if pregnancy does occur, termination should be considered.

Trade names with the active substance Mycophenolate mofetil

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