Mycophenolate 250mg Capsules
WARNING: Use of this drug during pregnancy may cause birth defects or death of the unborn baby. If you are able to become pregnant, you must use birth control that you can trust to prevent pregnancy while taking this drug. Your doctor must talk with you about how to avoid getting pregnant while taking this drug. A pregnancy test will be done right before starting this drug and repeated 8 to 10 days later to show that you are NOT pregnant. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away.This drug may raise the chance of getting cancer like lymphoma or skin cancer. Call your doctor right away if you have a change in color or size of a mole, a skin lump or growth, a big weight loss, night sweats, or swollen glands.You may have more of a chance of getting an infection. Some infections have been severe or deadly. Wash hands often. Stay away from people with infections, colds, or flu.Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal. @ COMMON USES: It is used to keep the body from harming the organ after an organ transplant.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Immunosuppressant
Pharmacologic Class
Inosine Monophosphate Dehydrogenase (IMPDH) Inhibitor
Pregnancy Category
Not available
FDA Approved
May 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mycophenolate is a medicine used to prevent your body from rejecting a transplanted organ (like a kidney, heart, or liver). It works by weakening your immune system so it doesn't attack the new organ. Because it weakens your immune system, it's very important to be careful about infections and to protect your skin from the sun.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Take your medication on an empty stomach, at least 1 hour before or 2 hours after meals, unless your doctor has advised you differently.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Take your medication at the same time every day to establish a routine.
If you are taking an antacid that contains aluminum or magnesium, take it at least 2 hours after taking your medication.
Swallow your medication whole; do not chew, open, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
If the capsule is opened or broken, avoid touching the contents. If you accidentally touch the contents or get them in your eyes, wash your hands or eyes immediately.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is almost time for your next dose (less than 2 hours), skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Take your medication on an empty stomach, at least 1 hour before or 2 hours after meals, unless your doctor has advised you differently.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Take your medication at the same time every day to establish a routine.
If you are taking an antacid that contains aluminum or magnesium, take it at least 2 hours after taking your medication.
Swallow your medication whole; do not chew, open, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
If the capsule is opened or broken, avoid touching the contents. If you accidentally touch the contents or get them in your eyes, wash your hands or eyes immediately.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is almost time for your next dose (less than 2 hours), skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take exactly as prescribed, do not miss doses.
- Avoid live vaccines (e.g., MMR, varicella, nasal flu vaccine) while on this medication.
- Practice good hygiene (frequent hand washing) to reduce infection risk.
- Avoid contact with people who are sick or have infections.
- Limit exposure to sunlight and UV light (tanning beds). Wear protective clothing (long sleeves, hats) and use high-SPF sunscreen (SPF 30 or higher) when outdoors, even on cloudy days, to reduce the risk of skin cancer.
- Females of reproductive potential must use two reliable forms of contraception before, during, and for 6 weeks after stopping this medication due to severe birth defect risk.
- Males must use condoms during treatment and for at least 90 days after stopping this medication.
- Do not donate blood during treatment and for at least 6 weeks after stopping.
- Do not donate semen during treatment and for at least 90 days after stopping.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Renal Transplant: 1 g orally twice daily (2 g/day). Cardiac Transplant: 1.5 g orally twice daily (3 g/day). Hepatic Transplant: 1.5 g orally twice daily (3 g/day).
Dose Range:
1000 - 3000 mg
Condition-Specific Dosing:
renal_transplant:
1 g orally twice daily
cardiac_transplant:
1.5 g orally twice daily
hepatic_transplant:
1.5 g orally twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Renal Transplant (≥3 months to 18 years): 600 mg/m² orally twice daily (up to a maximum of 2 g/day). Cardiac Transplant (≥3 months to 18 years): 600 mg/m² orally twice daily (up to a maximum of 3 g/day). Hepatic Transplant (≥3 months to 18 years): 600 mg/m² orally twice daily (up to a maximum of 3 g/day).
Adolescent:
Renal Transplant (≥3 months to 18 years): 600 mg/m² orally twice daily (up to a maximum of 2 g/day). Cardiac Transplant (≥3 months to 18 years): 600 mg/m² orally twice daily (up to a maximum of 3 g/day). Hepatic Transplant (≥3 months to 18 years): 600 mg/m² orally twice daily (up to a maximum of 3 g/day).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for renal transplant patients with severe chronic renal impairment (GFR <25 mL/min/1.73 m²).
Moderate:
No adjustment needed for renal transplant patients with severe chronic renal impairment (GFR <25 mL/min/1.73 m²).
Severe:
No adjustment needed for renal transplant patients with severe chronic renal impairment (GFR <25 mL/min/1.73 m²). Monitor for adverse effects. Avoid in acute renal failure.
Dialysis:
Mycophenolic acid (MPA) is not removed by hemodialysis to a clinically significant extent. Mycophenolic acid glucuronide (MPAG) is removed. No dose adjustment needed for patients on dialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed for renal transplant patients with severe parenchymal liver disease.
Moderate:
No dose adjustment needed for renal transplant patients with severe parenchymal liver disease.
Severe:
No dose adjustment needed for renal transplant patients with severe parenchymal liver disease.
Pharmacology
Mechanism of Action
Mycophenolate mofetil (MMF) is a prodrug that is rapidly hydrolyzed to its active metabolite, mycophenolic acid (MPA). MPA is a potent, selective, uncompetitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), an enzyme critical for the de novo synthesis of guanosine nucleotides. Lymphocytes are highly dependent on this pathway for proliferation, whereas other cell types can utilize salvage pathways. By inhibiting IMPDH, MPA depletes guanosine nucleotides, thereby inhibiting DNA synthesis and proliferation of T and B lymphocytes, and suppressing antibody formation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 94% (oral MMF converted to MPA)
Tmax:
0.8-1.2 hours (for MPA after oral MMF)
FoodEffect:
Food decreases Cmax of MPA by 40% and AUC by 20%, but this is not considered clinically significant for efficacy. May be taken with or without food.
Distribution:
Vd:
Approximately 3.6 L/kg (for MPA)
ProteinBinding:
97% (MPA, primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
11.7 hours (for MPA)
Clearance:
11.6 L/hr (for MPA)
ExcretionRoute:
Mainly renal (87% as MPAG), small amount in feces (6% as MPA)
Unchanged:
Less than 1% (MPA)
Pharmacodynamics
OnsetOfAction:
Not directly applicable for immunosuppression; effects are sustained with chronic dosing.
PeakEffect:
Peak MPA concentrations occur within 1-2 hours post-dose.
DurationOfAction:
Sustained immunosuppression with twice-daily dosing.
Safety & Warnings
BLACK BOX WARNING
Increased risk of infections: Mycophenolate mofetil (MMF) increases the risk of developing serious bacterial, viral, fungal, and protozoal infections, including opportunistic infections and viral reactivations (e.g., BK virus-associated nephropathy, JC virus-associated progressive multifocal leukoencephalopathy [PML], cytomegalovirus [CMV] disease). These infections can lead to hospitalization and death. Increased risk of malignancy: MMF increases the risk of developing lymphomas and other malignancies, particularly of the skin. Patients should be advised to limit exposure to sunlight and UV light by wearing protective clothing and using a sunscreen with a high SPF. Increased risk of pure red cell aplasia (PRCA): Cases of PRCA have been reported in patients treated with MMF in combination with other immunosuppressive agents. This effect is reversible upon dose reduction or discontinuation of MMF. Teratogenicity: MMF is associated with an increased risk of first trimester pregnancy loss and congenital malformations, especially external ear and facial abnormalities, and abnormalities of the cardiovascular, renal, and nervous systems. Females of reproductive potential must use highly effective contraception before, during, and for 6 weeks after stopping MMF. Males must use condoms during treatment and for at least 90 days after stopping MMF.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of electrolyte problems: mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of skin infection: oozing, heat, swelling, redness, or pain.
Chest pain or pressure.
Abnormal heartbeat (fast, slow, or irregular).
Unexplained bruising or bleeding.
Vomiting blood or coffee ground-like material.
Black, tarry, or bloody stools.
Abnormal sensations (burning, numbness, or tingling).
Muscle cramps.
Swelling.
Pale skin.
White patches in the mouth.
Vaginal itching or discharge.
Yellowing of the skin or eyes.
Additional Serious Conditions
Acute inflammatory syndrome (AIS): This condition can occur within weeks to months after starting this medication or after a dose increase. Seek medical help immediately if you experience fever, joint pain or stiffness, or muscle pain.
Progressive multifocal leukoencephalopathy (PML): This rare brain condition can cause disability or be life-threatening. Contact your doctor right away if you notice confusion, memory problems, depression, changes in behavior, weakness on one side of the body, speech or thinking difficulties, balance problems, or vision changes.
BK virus infection: In people who have had a kidney transplant, this viral infection can cause kidney damage or loss. Seek medical help immediately if you experience changes in urine output, difficulty or pain while urinating, or blood in the urine.
Lung problems: Although rare, this medication can cause lung problems, which can be life-threatening. Contact your doctor right away if you experience shortness of breath, trouble breathing, new or worsening cough, or fever.
Other Side Effects
Most people do not experience severe side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Back pain.
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite.
Headache.
Gas.
Dizziness, fatigue, or weakness.
Shakiness.
* Sleep disturbances.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of electrolyte problems: mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of skin infection: oozing, heat, swelling, redness, or pain.
Chest pain or pressure.
Abnormal heartbeat (fast, slow, or irregular).
Unexplained bruising or bleeding.
Vomiting blood or coffee ground-like material.
Black, tarry, or bloody stools.
Abnormal sensations (burning, numbness, or tingling).
Muscle cramps.
Swelling.
Pale skin.
White patches in the mouth.
Vaginal itching or discharge.
Yellowing of the skin or eyes.
Additional Serious Conditions
Acute inflammatory syndrome (AIS): This condition can occur within weeks to months after starting this medication or after a dose increase. Seek medical help immediately if you experience fever, joint pain or stiffness, or muscle pain.
Progressive multifocal leukoencephalopathy (PML): This rare brain condition can cause disability or be life-threatening. Contact your doctor right away if you notice confusion, memory problems, depression, changes in behavior, weakness on one side of the body, speech or thinking difficulties, balance problems, or vision changes.
BK virus infection: In people who have had a kidney transplant, this viral infection can cause kidney damage or loss. Seek medical help immediately if you experience changes in urine output, difficulty or pain while urinating, or blood in the urine.
Lung problems: Although rare, this medication can cause lung problems, which can be life-threatening. Contact your doctor right away if you experience shortness of breath, trouble breathing, new or worsening cough, or fever.
Other Side Effects
Most people do not experience severe side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Back pain.
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite.
Headache.
Gas.
Dizziness, fatigue, or weakness.
Shakiness.
* Sleep disturbances.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of infection: fever, chills, sore throat, body aches, flu-like symptoms, unusual cough, painful urination, skin sores.
- Unusual bleeding or bruising.
- Extreme tiredness or weakness.
- Pale skin.
- Swollen glands in neck, armpit, or groin.
- New skin lesions, moles that change in size or color, or non-healing sores.
- Severe diarrhea, nausea, vomiting, or abdominal pain.
- Signs of kidney problems (e.g., changes in urination, swelling in ankles/feet).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with Lesch-Nyhan or Kelley-Seegmiller syndrome, or if you have a rare inherited deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT).
If you are currently taking any of the following medications: Azathioprine, cholestyramine, colesevelam, colestipol, norfloxacin with metronidazole, or sevelamer.
If you are taking another medication that contains the same active ingredient as this drug.
If you are able to become pregnant and are not using two forms of birth control.
If you are breastfeeding or plan to breastfeed.
This list is not exhaustive, and it is crucial to discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with Lesch-Nyhan or Kelley-Seegmiller syndrome, or if you have a rare inherited deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT).
If you are currently taking any of the following medications: Azathioprine, cholestyramine, colesevelam, colestipol, norfloxacin with metronidazole, or sevelamer.
If you are taking another medication that contains the same active ingredient as this drug.
If you are able to become pregnant and are not using two forms of birth control.
If you are breastfeeding or plan to breastfeed.
This list is not exhaustive, and it is crucial to discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.
Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your health while taking this medication. If you have diabetes, it is vital to closely monitor your blood sugar levels.
Before receiving any vaccinations, consult with your doctor, as certain vaccines may increase the risk of infection or reduce their effectiveness when taken with this medication.
You may experience an increased risk of bleeding, so it is crucial to be cautious and avoid injuries. To minimize this risk, use a soft toothbrush and an electric razor.
Prolonged exposure to sunlight, sunlamps, and tanning beds may increase the risk of skin cancer. To protect yourself, avoid excessive sun exposure, use sunscreen, and wear protective clothing and eyewear.
Your doctor may recommend hepatitis B or C testing, as this medication may worsen existing infections.
There is a risk of gastrointestinal complications, including bleeding, holes, and ulcers, which may require hospitalization. Discuss any concerns with your doctor.
This medication may cause diarrhea. If you experience diarrhea, consult with your doctor to explore ways to manage this side effect. Do not stop taking this medication without consulting your doctor.
You may need to avoid donating blood while taking this medication and for a certain period after stopping it. Discuss this with your doctor.
If you are a male patient, you may need to avoid donating sperm while taking this medication and for a certain period after stopping it. If you have questions or concerns, consult with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are a female patient of childbearing age, it is essential to use birth control while taking this medication and for at least 6 weeks after your last dose. Note that birth control pills and other hormone-based birth control methods may be less effective. If you use hormone-based birth control, consider using an additional method, such as condoms, during this time. If you become pregnant, notify your doctor immediately.
If your partner may become pregnant, use birth control while taking this medication and for at least 90 days after your last dose. If your partner becomes pregnant, notify the doctor immediately.
Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your health while taking this medication. If you have diabetes, it is vital to closely monitor your blood sugar levels.
Before receiving any vaccinations, consult with your doctor, as certain vaccines may increase the risk of infection or reduce their effectiveness when taken with this medication.
You may experience an increased risk of bleeding, so it is crucial to be cautious and avoid injuries. To minimize this risk, use a soft toothbrush and an electric razor.
Prolonged exposure to sunlight, sunlamps, and tanning beds may increase the risk of skin cancer. To protect yourself, avoid excessive sun exposure, use sunscreen, and wear protective clothing and eyewear.
Your doctor may recommend hepatitis B or C testing, as this medication may worsen existing infections.
There is a risk of gastrointestinal complications, including bleeding, holes, and ulcers, which may require hospitalization. Discuss any concerns with your doctor.
This medication may cause diarrhea. If you experience diarrhea, consult with your doctor to explore ways to manage this side effect. Do not stop taking this medication without consulting your doctor.
You may need to avoid donating blood while taking this medication and for a certain period after stopping it. Discuss this with your doctor.
If you are a male patient, you may need to avoid donating sperm while taking this medication and for a certain period after stopping it. If you have questions or concerns, consult with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are a female patient of childbearing age, it is essential to use birth control while taking this medication and for at least 6 weeks after your last dose. Note that birth control pills and other hormone-based birth control methods may be less effective. If you use hormone-based birth control, consider using an additional method, such as condoms, during this time. If you become pregnant, notify your doctor immediately.
If your partner may become pregnant, use birth control while taking this medication and for at least 90 days after your last dose. If your partner becomes pregnant, notify the doctor immediately.
Overdose Information
Overdose Symptoms:
- Severe myelosuppression (e.g., leukopenia, neutropenia, thrombocytopenia)
- Gastrointestinal disturbances (e.g., severe diarrhea, nausea, vomiting)
What to Do:
There is no specific antidote. Treatment is supportive. Hemodialysis is not effective in removing MPA. Cholestyramine may be used to increase MPA excretion by interrupting enterohepatic recirculation. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Contraindicated Interactions
- Live attenuated vaccines (due to immunosuppression)
- Azathioprine (increased risk of myelosuppression)
Major Interactions
- Acyclovir/Ganciclovir (increased concentrations of both drugs, risk of myelosuppression)
- Cholestyramine (decreased MPA exposure)
- Antacids containing magnesium or aluminum hydroxide (decreased MPA absorption)
- Proton pump inhibitors (e.g., pantoprazole, lansoprazole) (decreased MPA exposure)
- Oral contraceptives (decreased efficacy of oral contraceptives)
- Rifampin (decreased MPA exposure)
- Telmisartan (decreased MPA exposure)
- Sevelamer (decreased MPA absorption)
- Tacrolimus (potential for altered MPA exposure, monitor)
Moderate Interactions
- Norfloxacin/Metronidazole (decreased MPA exposure)
- Ciprofloxacin/Amoxicillin-clavulanic acid (decreased MPA exposure)
- Trimethoprim/sulfamethoxazole (potential for myelosuppression)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline hematologic parameters and monitor for myelosuppression (leukopenia, neutropenia, anemia, thrombocytopenia).
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function.
Timing: Prior to initiation of therapy
Renal Function Tests (serum creatinine, BUN)
Rationale: To assess baseline renal function.
Timing: Prior to initiation of therapy
Pregnancy test (for females of reproductive potential)
Rationale: Mycophenolate is highly teratogenic.
Timing: Within 1 week prior to initiation of therapy
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Weekly for the first month, twice monthly for the second and third months, then monthly for the first year, and periodically thereafter.
Target: Maintain WBC and platelet counts within acceptable limits (e.g., WBC >2.5 x 10^9/L, platelets >100 x 10^9/L).
Action Threshold: Dose reduction or interruption for significant leukopenia (e.g., ANC <1.3 x 10^9/L) or other cytopenias.
Liver Function Tests (LFTs)
Frequency: Periodically (e.g., monthly or as clinically indicated).
Target: Within normal limits or stable for patient.
Action Threshold: Significant elevations may require investigation or dose adjustment.
Renal Function Tests (serum creatinine, BUN)
Frequency: Periodically (e.g., monthly or as clinically indicated).
Target: Stable or within acceptable limits for transplant patient.
Action Threshold: Significant changes may indicate renal dysfunction or drug toxicity.
Therapeutic Drug Monitoring (TDM) of MPA (AUC or C0)
Frequency: Often performed in the early post-transplant period, or in cases of suspected toxicity, rejection, or drug interactions. Frequency varies by institution and clinical need.
Target: Target AUC0-12h typically 30-60 mcg*h/mL (renal transplant), 35-60 mcg*h/mL (cardiac/hepatic transplant). Target C0 (trough) typically 1-3.5 mcg/mL.
Action Threshold: Levels outside target range may warrant dose adjustment.
Signs and symptoms of infection
Frequency: Ongoing clinical assessment.
Target: Absence of fever, chills, malaise, localized pain, or other signs of infection.
Action Threshold: Prompt investigation and treatment of any suspected infection.
Skin examination for malignancy
Frequency: Annually or as clinically indicated.
Target: Absence of suspicious lesions.
Action Threshold: Referral to dermatology for any suspicious skin changes.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Unusual bleeding or bruising
- Fatigue
- Weakness
- Diarrhea
- Nausea
- Vomiting
- Abdominal pain
- Skin rash
- New skin lesions or changes in existing moles
- Swollen glands
- Signs of opportunistic infections (e.g., shingles, oral thrush, CMV symptoms)
Special Patient Groups
Pregnancy
Mycophenolate mofetil is highly teratogenic and is associated with a significantly increased risk of first trimester pregnancy loss and congenital malformations. It should not be used during pregnancy unless there are no appropriate alternative treatments and the potential benefit justifies the potential risk to the fetus. Females of reproductive potential must use highly effective contraception.
Trimester-Specific Risks:
First Trimester:
High risk of miscarriage (45-49%) and severe congenital malformations (23-27%), including external ear and facial abnormalities (e.g., cleft lip/palate), cardiac defects (e.g., septal defects), esophageal, renal, and nervous system abnormalities.
Second Trimester:
Continued risk of fetal exposure and potential for adverse effects, though major structural malformations are typically established in the first trimester.
Third Trimester:
Continued risk of fetal exposure and potential for adverse effects, including myelosuppression in the neonate.
Lactation
Mycophenolic acid (MPA) is excreted into breast milk. Due to the potential for serious adverse reactions in the breastfed infant (e.g., immunosuppression, carcinogenicity), breastfeeding is contraindicated during treatment with mycophenolate mofetil and for 6 weeks after the last dose.
Infant Risk:
L5 (Contraindicated - significant documented risk to infant)
Pediatric Use
Dosing is weight/body surface area (BSA) based. Pediatric patients are at increased risk of certain infections (e.g., CMV, EBV-associated post-transplant lymphoproliferative disorder [PTLD]) and gastrointestinal adverse events. Close monitoring is required.
Geriatric Use
No specific dose adjustment is generally required based on age alone. However, elderly patients may be more susceptible to adverse effects due to age-related decline in renal or hepatic function, or concomitant medications. Close monitoring for infections and other adverse effects is recommended.
Clinical Information
Clinical Pearls
- Mycophenolate mofetil is a prodrug; its active form is mycophenolic acid (MPA).
- Always emphasize the critical importance of contraception for females of reproductive potential and condom use for males due to severe teratogenicity.
- Patients should be educated on signs of infection and malignancy, and the importance of sun protection.
- GI side effects (diarrhea, nausea, vomiting) are common, especially at higher doses. Taking with food may help, but can slightly reduce absorption.
- Therapeutic drug monitoring (TDM) of MPA levels is often used, especially in the early post-transplant period, in patients with GI side effects, or suspected non-adherence, though routine TDM is not universally recommended for all patients.
- Pure Red Cell Aplasia (PRCA) is a rare but serious adverse effect; monitor CBC closely.
- Switching between mycophenolate mofetil and mycophenolic acid (Myfortic) requires careful dose conversion and monitoring due to different salt forms and absorption profiles.
Alternative Therapies
- Azathioprine
- Sirolimus
- Everolimus
- Belatacept
- Tacrolimus (as part of a regimen, not a direct alternative for IMPDH inhibition)
- Cyclosporine (as part of a regimen, not a direct alternative for IMPDH inhibition)
Cost & Coverage
Average Cost:
Varies widely (e.g., $100-$500+) per 30 capsules (250mg)
Generic Available:
Yes
Insurance Coverage:
Tier 3 (preferred brand) or Tier 1/2 (generic), often requires prior authorization for transplant indication.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.