Side effects of mycophenolate mofetil: Mycophenolate Mofetil (Oral Route) Side Effects
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?
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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
mycophenolate mofetil 500 mg tablet
Color: whiteShape: ovalImprint: 54 135
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 500 mg tablet
Color: lavenderShape: oblongImprint: 265
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 250 mg capsule
Color: brown,blueShape: oblongImprint: 266
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 500 mg tablet
Color: purpleShape: oblongImprint: AHI 500
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 500 mg tablet
Color: pinkish-brownShape: oblongImprint: SAL 725
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 250 mg capsule
Color: peach,light blueShape: oblongImprint:
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 250 mg capsule
Color: peach,light blueShape: oblongImprint: GC1
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 500 mg tablet
Color: light pinkShape: ovalImprint: MYLAN 472
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 250 mg capsule
Color: caramel,lavenderShape: oblongImprint: MYLAN 2250 MYLAN 2250
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 250 mg capsule
Color: ivoryShape: oblongImprint: SAL 726
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 500 mg tablet
Color: peachShape: oblongImprint: E735
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 250 mg capsule
Color: caramel,blueShape: oblongImprint: 54 848 54 848
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 500 mg tablet
Color: lavenderShape: oblongImprint: SZ 327
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 250 mg capsule
Color: white,blueShape: oblongImprint: 655 655
This medicine is a white, oval, tablet imprinted with “54 135”.
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Color: bright orange,light blueShape: oblongImprint: TEVA 7334
This medicine is a white, oval, tablet imprinted with “54 135”.
mycophenolate mofetil 250 mg capsule
Color: bright orange,light blueShape: oblongImprint: 93 7334 93 7334
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.
Side-effects, uses, time to work
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What is mycophenolate?
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Uses
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When and how do I take mycophenolate?
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Side-effects and risks
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Other complications
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What if I miss a dose?
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Effects on other treatments
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Vaccinations
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Surgery
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Alcohol
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Fertility, pregnancy and breastfeeding
Get help
What is mycophenolate?
Mycophenolate is sometimes prescribed under the names mycophenolate mofetil or mycophenolate sodium.
Mycophenolate has a number of uses. When it’s prescribed as a disease-modifying anti-rheumatic drug (DMARD), it should help control your condition and reduce damage to your joints and other organs such as your lungs, kidneys and blood vessels.
Like all DMARDs, mycophenolate slows down how active your condition is, rather than just treating how its symptoms affect you. It works by reducing the activity of your body’s immune system.
When your immune system is working properly, it protects you by fighting off infection and illness. But in inflammatory conditions, your immune system may attack parts of your body by mistake, such as your lungs, kidneys and blood vessels.
Related information
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Disease-modifying anti-rheumatic drugs (DMARDs)
Disease-modifying anti-rheumatic drugs (DMARDs) alter the underlying disease rather than treating symptoms. Learn how long they take, uses and side-effects.
Uses
Mycophenolate is used to treat several different conditions, including:
- lupus and other connective tissue disorders, including scleroderma (skle-ro-derm-a)
- rheumatoid arthritis (roo-ma-toy-d arth-ri-tus)
- psoriatic arthritis (saw-ree-at-ik arth-ri-tis)
- conditions in which there’s inflammation of blood vessels, such as vasculitis (vask-you-lie-tis).
It’s sometimes also used as part of the treatment of inflammatory conditions affecting the eye, such as uveitis (you-ve-eye-tis), or bowel, such as Crohn’s disease (Cr-oh-nz diz-eez).
Mycophenolate is also used after organ transplantation, as it helps stop the immune system rejecting the new organ.
Mycophenolate doesn’t work immediately. It may be up to four months before you notice any benefit.
When and how do I take mycophenolate?
Mycophenolate is usually given as a capsule or as a tablet, depending on the dose you need.
Though it is also manufactured as an injectable infusion and an oral solution.
Usually you’ll be advised to take one dose a day for the first week. This will then go up to two doses a day as your medication is increased.
You shouldn’t crush or chew mycophenolate. You should always swallow them whole. It’s recommended that you take the capsule or tablet with food and water, as this can stop you feeling sick and getting stomach pains. Your doctor or pharmacist will advise you about the correct dose.
It’s important to keep taking mycophenolate even if it doesn’t seem to be working at first. It’s also important to keep taking it when your symptoms start to improve, as this will help control your condition.
Side-effects and risks
Mycophenolate can cause a number of side effects, including:
- feeling sick
- diarrhoea (dy-a-ree-ah)
- vomiting
- stomach pains.
Whilst you’re taking mycophenolate, tell your doctor, rheumatology nurse or pharmacist straight away if you start experiencing any new symptoms or anything that concerns you.
Let them know immediately if you have:
- a sore throat
- a fever
- flu-like symptoms
- a constant cough or problems breathing
- the sensation that your heart is beating unusually
- sudden weight loss
- unexplained bruising or bleeding
- unexplained changes in mood
- headaches – particularly if you don’t usually get them
- acne or a skin rash
- swollen gums or an unusual taste in your mouth.
If any of these symptoms are severe, your doctor may advise you to stop taking mycophenolate. But it’s always best to talk to your doctor or a member of your rheumatology team before making any changes to your treatment.
You should see your doctor as soon as possible if you come into contact with anyone with shingles or chickenpox, or if you get them yourself.
These infections can affect you badly if you’re on mycophenolate. You may need antiviral treatment, and your mycophenolate may be stopped until you’re better.
Tips to reduce your risk of infection
- Try to avoid close contact with people you know have an infection.
- Wash your hands regularly and carry around a small bottle of antibacterial hand gel.
- Keep your mouth clean by brushing your teeth regularly.
- Stop smoking if you’re a smoker.
- Make sure your food is stored and prepared properly.
- Try to keep your house clean and hygienic, especially the kitchen, bathrooms and toilets.
Other complications
Although it’s uncommon, there’s a slightly increased risk of certain types of cancer, such as skin cancer, in people using mycophenolate. However, the link between the two is unclear.
Skin cancers can often be treated successfully when diagnosed early. To be on the safe side, make sure to wear sunscreen and regularly check your skin for any new spots or changes to your freckles or moles.
Very rarely, patients treated with mycophenolate can develop a serious condition called progressive multifocal leukoencephalopathy (pro-gress-iv mul-tee-fo-cul low-ko-en-kef-a-lop-afy), which is also known as PML, which can damage the brain and spinal cord.
You must see your doctor immediately if you notice any of the following symptoms:
- pins and needles
- weakness, shaky movements or unsteadiness
- sight loss
- speech problems
- changes in behaviour or mood
- difficulty moving your face, arms or legs
Mycophenolate can affect the blood count and can sometimes cause liver or kidney problems. As a precaution, your doctor will arrange for you to have a blood test before you start treatment and regular blood tests while you’re taking mycophenolate. Keep a note of when your blood tests are due and remind your doctor about them.
What if I miss a dose?
Take your missed dose as soon as you remember, unless it’s almost time for your next one. If you have missed a tablet, don’t take any more than your regular dose to make up for it.
What if I take too much mycophenolate?
If you take too much of your medication you may experience some of the side effects mentioned previously.
If you think you have taken too much mycophenolate call your rheumatology team or the NHS helpline on 111 immediately and ask for advice.
You can also contact the NHS helpline team through their website at 111.nhs.net.
Effects on other treatments
Mycophenolate may be prescribed along with other drugs to treat your condition. But some drugs can interact with mycophenolate.
Before you start any new medication it’s always a good idea to talk to your doctor first to make sure the treatments are okay to take together.
You can carry on taking non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, or painkillers, if needed, unless your doctor advises otherwise.
However, you shouldn’t take over-the-counter preparations or herbal remedies without first discussing them with your doctor, rheumatology nurse specialist or pharmacist.
You should tell any other healthcare professionals treating you such as doctors, pharmacists, dentists or nurses, that you’re taking mycophenolate.
Related information
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Painkillers and NSAIDs
Painkillers used for arthritis are analgesics and non-steroidal anti-inflammatory drugs (NSAIDs). Learn about risks and side-effects.
Vaccinations
If you’re taking mycophenolate, you should avoid live vaccines, such as yellow fever. However, in certain situations a live vaccine may be necessary, so speak to your pharmacist or doctor about this for their advice.
It’s a good idea to get the pneumococcal vaccine (new-mow-cok-al vak-seen), to protect you against the most common cause of pneumonia, and your yearly flu vaccines. These are both safe to have while you’re being treated with mycophenolate.
Surgery
If you’re going to have an operation, discuss this with your rheumatology team. They will tell you whether you should continue taking your mycophenolate before your operation.
Alcohol
Mycophenolate and alcohol can both affect your liver, so you should only drink alcohol in small amounts.
Government guidelines say both men and women should have no more than 14 units of alcohol a week, and that you should spread these through the week rather than having them all in one go (Drinkaware).
You can find out more about units of alcohol at www.drinkaware.co.uk.
Advice can vary, and some rheumatologists may suggest stricter limits. If you’re concerned you should discuss your alcohol intake with your rheumatology team.
Fertility, pregnancy and breastfeeding
You shouldn’t take mycophenolate while you’re trying for a baby, pregnant or breastfeeding. It does not affect your fertility, but it can affect your unborn child.
Your doctor may discuss your future plans for a family before prescribing mycophenolate. Whether you’re a man or woman, you’ll be advised to use one, if not two, methods of contraception while you’re being treated with mycophenolate.
If you want to try for a baby, you should talk to your doctor first before you stop using contraception.
Women are advised to wait six weeks after stopping treatment before trying to conceive. Men are advised to wait 13 weeks before they stop using contraception. This allows the drug to fully leave your system.
If you’re taking mycophenolate and you think you or your partner may be pregnant, contact your doctor immediately, they will be able to advise you on the best course of action.
If there’s a possibility you may be pregnant, take a pregnancy test before starting mycophenolate.
You shouldn’t breastfeed if you’re on mycophenolate, as the drug may pass into your breastmilk. This could be harmful to your baby.
💊 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 The scientific information provided is general and cannot be used to make decisions. Update date: 2021.09.03 Marketing authorization holder: ALKEM LABORATORIES Ltd. ATX code: L04AA06 (Mycophenolic acid) Active substance: USAN approved for use in the USA Dosage form
Release form, packaging and composition |
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.
5 g 2 times / day in patients after kidney transplantation. However, C max MFC when taking mycophenolate mofetil with meals is reduced by 40%.
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.
| 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.
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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, skin itching.
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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Lek. form
All lek. capsule forms substance-powder tablets, film-coated
Dosage
All dosages 0.