Mycophenolate 500mg Tablets
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
Category D
FDA Approved
May 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mycophenolate is an immunosuppressant 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 follow all instructions from your doctor.
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 closely. 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. Establish a routine by taking your medication at the same time every day.
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, break, or crush it. If you have difficulty swallowing, consult your doctor for guidance.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, 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. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is less than 2 hours until your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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 closely. 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. Establish a routine by taking your medication at the same time every day.
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, break, or crush it. If you have difficulty swallowing, consult your doctor for guidance.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, 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. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is less than 2 hours until your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Avoid live vaccines (e.g., MMR, varicella, nasal flu vaccine) while taking this medication.
- Protect yourself from the sun by wearing protective clothing, hats, and using high SPF sunscreen, as this medication increases your risk of skin cancer.
- Practice good hygiene (frequent hand washing) to reduce the risk of infection.
- Females of childbearing potential must use two reliable forms of contraception starting 4 weeks before treatment, during treatment, and for 6 weeks after stopping mycophenolate due to severe birth defect risks.
- Do not donate blood during treatment and for at least 6 weeks after stopping.
- Do not donate semen during treatment and for 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:
2000 - 3000 mg
Condition-Specific Dosing:
renalTransplant:
1 g twice daily
cardiacTransplant:
1.5 g twice daily
hepaticTransplant:
1.5 g twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Renal Transplant (≥3 months to 18 years): 600 mg/m² orally twice daily (maximum 2 g/day).
Adolescent:
Renal Transplant: 600 mg/m² orally twice daily (maximum 2 g/day).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for renal transplant patients.
Moderate:
No adjustment needed for renal transplant patients.
Severe:
For renal transplant patients with severe chronic renal impairment (CrCl < 25 mL/min), avoid doses exceeding 1 g twice daily. Monitor for toxicity.
Dialysis:
Not significantly removed by hemodialysis. No supplemental dose needed after dialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed for renal transplant patients with severe hepatic parenchymal disease.
Moderate:
No dose adjustment needed for renal transplant patients with severe hepatic parenchymal disease.
Severe:
No dose adjustment needed for renal transplant patients with severe hepatic parenchymal disease. Specific guidance for hepatic transplant patients may vary.
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). IMPDH is a key enzyme in the de novo pathway of guanosine nucleotide synthesis. Lymphocytes are highly dependent on this de novo pathway for purine synthesis, 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, leading to potent cytostatic effects on lymphocytes.
Pharmacokinetics
Absorption:
Bioavailability:
94%
Tmax:
0.5-1.5 hours (for MPA)
FoodEffect:
Food decreases MPA Cmax by 33-40% and AUC by 10-20%, but generally not clinically significant for overall exposure. Can be taken with or without food.
Distribution:
Vd:
3.6 L/kg (for MPA)
ProteinBinding:
97% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
11-18 hours (for MPA); 13-17 hours (for MPAG)
Clearance:
Not available
ExcretionRoute:
Primarily renal excretion of MPAG (87%), with a small amount of MPA excreted in urine (<1%). Significant enterohepatic recirculation of MPA occurs.
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Immunosuppressive effects begin shortly after administration, with full therapeutic effect achieved with consistent dosing.
PeakEffect:
Correlates with peak MPA levels (0.5-1.5 hours post-dose).
DurationOfAction:
Related to MPA half-life and sustained inhibition of IMPDH.
Safety & Warnings
BLACK BOX WARNING
Increased risk of serious infections (bacterial, viral, fungal, protozoal), including opportunistic infections and viral reactivation (e.g., BK virus nephropathy, JC virus-associated PML, CMV). Increased risk of lymphoproliferative disorders and other malignancies, particularly skin cancer. Increased risk of first-trimester pregnancy loss and congenital malformations (e.g., ear abnormalities, cleft lip/palate, heart defects). Females of reproductive potential must use effective contraception.
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 or seek medical attention immediately:
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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, 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 changes, 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
Yellow skin or eyes
Additional Serious Side Effects
Acute inflammatory syndrome (AIS): a rare but potentially serious condition that may require hospitalization. If you experience fever, joint pain or stiffness, or muscle pain, contact your doctor immediately.
Progressive multifocal leukoencephalopathy (PML): a rare and potentially deadly brain condition. If you notice symptoms such as confusion, memory problems, depression, changes in behavior, weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes, contact your doctor right away.
BK virus infection: a viral infection that can cause severe kidney problems, particularly in people who have had a kidney transplant. If you experience changes in urine output, difficulty or pain while urinating, or blood in the urine, contact your doctor immediately.
Lung problems: some people have experienced severe and potentially life-threatening lung problems while taking this medication. If you notice symptoms such as shortness of breath, worsening cough, or fever, contact your doctor right away.
Other Side Effects
Not everyone will experience side effects, and many people may only have mild or minor side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
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 potential 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 or seek medical attention immediately:
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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, 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 changes, 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
Yellow skin or eyes
Additional Serious Side Effects
Acute inflammatory syndrome (AIS): a rare but potentially serious condition that may require hospitalization. If you experience fever, joint pain or stiffness, or muscle pain, contact your doctor immediately.
Progressive multifocal leukoencephalopathy (PML): a rare and potentially deadly brain condition. If you notice symptoms such as confusion, memory problems, depression, changes in behavior, weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes, contact your doctor right away.
BK virus infection: a viral infection that can cause severe kidney problems, particularly in people who have had a kidney transplant. If you experience changes in urine output, difficulty or pain while urinating, or blood in the urine, contact your doctor immediately.
Lung problems: some people have experienced severe and potentially life-threatening lung problems while taking this medication. If you notice symptoms such as shortness of breath, worsening cough, or fever, contact your doctor right away.
Other Side Effects
Not everyone will experience side effects, and many people may only have mild or minor side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
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 potential 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, unusual fatigue, new cough, painful urination.
- Unusual bleeding or bruising.
- Severe or persistent diarrhea, nausea, vomiting, or abdominal pain.
- New skin lesions, moles that change in size or color, or any suspicious lumps.
- Swollen glands.
- Any signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing).
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 conditions and situations before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. 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 the enzyme 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 a female of childbearing potential and are not using two forms of birth control to prevent pregnancy.
If you are breastfeeding or plan to breastfeed.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. 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 conditions and situations before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. 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 the enzyme 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 a female of childbearing potential and are not using two forms of birth control to prevent pregnancy.
If you are breastfeeding or plan to breastfeed.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. 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 condition. 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, use sunscreen, wear protective clothing, and eyewear that shields you from the sun.
Your doctor may recommend testing for hepatitis B or C, 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 this side effect, consult with your doctor to explore ways to manage it. Do not stop taking this medication without consulting your doctor.
You may be advised to avoid donating blood while taking this medication and for a certain period after stopping it. Similarly, 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, discuss them 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 who may become pregnant, 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 during this time. If you use hormone-based birth control, consider using an additional method, such as condoms. 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 condition. 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, use sunscreen, wear protective clothing, and eyewear that shields you from the sun.
Your doctor may recommend testing for hepatitis B or C, 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 this side effect, consult with your doctor to explore ways to manage it. Do not stop taking this medication without consulting your doctor.
You may be advised to avoid donating blood while taking this medication and for a certain period after stopping it. Similarly, 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, discuss them 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 who may become pregnant, 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 during this time. If you use hormone-based birth control, consider using an additional method, such as condoms. 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 gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea)
- Bone marrow suppression (e.g., leukopenia, neutropenia, thrombocytopenia)
What to Do:
There is no specific antidote. Management is supportive. Hemodialysis is unlikely to remove significant amounts of MPA. Activated charcoal may be used to reduce absorption if ingestion is recent. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Live attenuated vaccines (due to immunosuppression)
Major Interactions
- Azathioprine (additive myelosuppression)
- Cholestyramine, Colestipol, Activated Charcoal (reduce MPA absorption)
- Antacids containing magnesium/aluminum hydroxide (decrease MPA absorption)
- Acyclovir, Ganciclovir, Valganciclovir (competition for tubular secretion, increasing levels of both drugs)
- Proton Pump Inhibitors (PPIs) (may decrease MPA exposure)
- Cyclosporine (impairs enterohepatic recirculation of MPA, leading to lower MPA exposure)
- Tacrolimus (variable effect on MPA exposure)
Moderate Interactions
- Oral Contraceptives (MMF may reduce AUC of some oral contraceptives)
- Rifampin (decreases MPA exposure)
- Sevelamer (decreases MPA absorption)
- Telmisartan (decreases MPA plasma concentrations)
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 establish baseline hepatic function.
Timing: Prior to initiation of therapy.
Renal Function (BUN, Creatinine)
Rationale: To establish baseline renal function and monitor for changes.
Timing: Prior to initiation of therapy.
Pregnancy Test
Rationale: Mycophenolate is highly teratogenic; must confirm non-pregnant status in females of childbearing potential.
Timing: Within 1 week prior to initiation of therapy.
Viral Serologies (CMV, EBV, HBV, HCV)
Rationale: To assess baseline viral status and risk for reactivation under immunosuppression.
Timing: Prior to initiation of therapy.
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Weekly for the first month, then twice monthly for the second and third months, then monthly thereafter.
Target: Maintain WBC and platelet counts within acceptable range (e.g., WBC > 2.5 x 10^9/L, ANC > 1.5 x 10^9/L, Platelets > 50 x 10^9/L).
Action Threshold: Dose reduction or interruption for significant leukopenia (ANC < 1.3 x 10^9/L), neutropenia, or thrombocytopenia.
Renal Function (BUN, Creatinine)
Frequency: Periodically (e.g., monthly or as clinically indicated).
Target: Maintain within normal limits or stable baseline.
Action Threshold: Significant increase may require dose adjustment or investigation of other causes.
Liver Function Tests (ALT, AST, Bilirubin)
Frequency: Periodically (e.g., monthly or as clinically indicated).
Target: Maintain within normal limits or stable baseline.
Action Threshold: Significant elevation may require dose adjustment or investigation.
Mycophenolic Acid (MPA) Levels (Therapeutic Drug Monitoring - TDM)
Frequency: Not routinely recommended for all patients, but may be useful in select cases (e.g., severe GI toxicity, unexpected rejection, renal impairment, drug interactions, non-adherence).
Target: Varies by center and indication; typical trough (C0) target 1-3.5 mcg/mL or AUC 30-60 mcg*hr/mL.
Action Threshold: Levels outside target range may warrant dose adjustment or investigation.
Signs and Symptoms of Infection
Frequency: Ongoing, at every clinical visit.
Target: Absence of infection.
Action Threshold: Fever, chills, sore throat, unusual fatigue, new cough, dysuria, or any signs of opportunistic infection require immediate evaluation and treatment.
Signs and Symptoms of Malignancy
Frequency: Ongoing, at every clinical visit.
Target: Absence of new or suspicious lesions/growths.
Action Threshold: New skin lesions, swollen lymph nodes, or other suspicious findings require prompt dermatologic or oncologic evaluation.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Unusual bleeding or bruising
- Persistent diarrhea
- Severe abdominal pain
- Nausea
- Vomiting
- New skin lesions or changes in existing moles
- Swollen glands
- Unusual fatigue or weakness
Special Patient Groups
Pregnancy
Mycophenolate is contraindicated in pregnancy due to a high risk of teratogenicity. It is associated with a significantly increased risk of first-trimester pregnancy loss and congenital malformations (e.g., ear malformations, facial dysmorphia, heart defects, esophageal atresia, neural tube defects).
Trimester-Specific Risks:
First Trimester:
High risk of major congenital malformations (e.g., ear abnormalities, cleft lip/palate, heart defects) and spontaneous abortion.
Second Trimester:
Continued risk of adverse fetal outcomes, though specific malformations are typically established in the first trimester.
Third Trimester:
Potential for adverse effects on fetal development and neonatal outcomes, including bone marrow suppression.
Lactation
Mycophenolate is contraindicated during breastfeeding. Mycophenolic acid is excreted in breast milk, and there is a potential for serious adverse reactions in the breastfed infant, including immunosuppression.
Infant Risk:
High risk of serious adverse effects (e.g., immunosuppression, bone marrow suppression, increased infection risk) in the breastfed infant.
Pediatric Use
Dosing is often based on body surface area (BSA) for pediatric renal transplant patients. Pediatric patients may be at increased risk for certain infections, such as Epstein-Barr virus (EBV)-associated post-transplant lymphoproliferative disorder (PTLD). Close monitoring for adverse effects is essential.
Geriatric Use
Geriatric patients may be at increased susceptibility to adverse effects, particularly infections and gastrointestinal disturbances, due to age-related decline in immune function and renal/hepatic function. Careful monitoring and potentially lower starting doses may be warranted.
Clinical Information
Clinical Pearls
- Mycophenolate mofetil tablets should not be crushed, chewed, or broken. Patients should be instructed to swallow them whole.
- Handle tablets with care; avoid direct skin contact with crushed or broken tablets, especially for pregnant women, due to teratogenic risks.
- Always take mycophenolate consistently, either with or without food, but avoid taking it with antacids containing magnesium/aluminum hydroxide, cholestyramine, or sevelamer, as these can significantly reduce absorption.
- Patients must be extensively counseled on the serious risks of infection, malignancy, and teratogenicity, and the importance of adherence to therapy and monitoring.
- Regular blood monitoring (CBC, renal, liver function) is crucial to detect and manage potential adverse effects.
- Adherence to the prescribed dosing regimen is paramount for preventing organ rejection and ensuring transplant success.
Alternative Therapies
- Azathioprine
- Sirolimus
- Everolimus
- Belatacept
- Tacrolimus
- Cyclosporine
Cost & Coverage
Average Cost:
Varies widely by pharmacy and insurance plan per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Specialty Tier (for brand), Tier 1 or 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.