Mycophenolate 500mg Inj, 1 Vial
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 2000
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 have regular blood tests.
How to Use This Medicine
Taking Your Medication Correctly
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully review all accompanying information and follow the instructions provided. This medication is administered as an intravenous infusion, which means it is slowly injected into a vein over a specified period of time.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
Missing a Dose
If you miss a dose, contact your doctor immediately to receive guidance on the next steps to take.
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully review all accompanying information and follow the instructions provided. This medication is administered as an intravenous infusion, which means it is slowly injected into a vein over a specified period of time.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
Missing a Dose
If you miss a dose, contact your doctor immediately to receive guidance on the next steps to take.
Lifestyle & Tips
- Avoid live vaccines while taking this medication.
- Practice good hygiene (frequent hand washing) to reduce the risk of infection.
- Avoid contact with people who are sick or have infections.
- Use sun protection (sunscreen, protective clothing) 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 treatment.
- Males should use condoms during treatment and for at least 90 days after stopping treatment, and should not donate sperm during this period.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Renal Transplant: 1000 mg twice daily (2000 mg/day). Cardiac Transplant: 1500 mg twice daily (3000 mg/day). Hepatic Transplant: 1000 mg twice daily (2000 mg/day) or 1500 mg twice daily (3000 mg/day) depending on protocol.
Dose Range:
1000 - 1500 mg
Condition-Specific Dosing:
renal_transplant:
1000 mg IV twice daily
cardiac_transplant:
1500 mg IV twice daily
hepatic_transplant:
1000 mg IV twice daily or 1500 mg IV twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for IV formulation; oral dosing is weight-based for renal transplant (600 mg/m² twice daily, max 2g/day). IV use in pediatrics is generally a temporary bridge when oral is not feasible, with dose extrapolation from oral.
Adolescent:
Not established for IV formulation; oral dosing is weight-based for renal transplant (600 mg/m² twice daily, max 2g/day). IV use in pediatrics is generally a temporary bridge when oral is not feasible, with dose extrapolation from oral.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed for patients with severe chronic renal impairment (GFR <25 mL/min/1.73 m²) after renal transplant, but careful monitoring is advised.
Moderate:
No dose adjustment needed for patients with severe chronic renal impairment (GFR <25 mL/min/1.73 m²) after renal transplant, but careful monitoring is advised.
Severe:
No dose adjustment needed for patients with severe chronic renal impairment (GFR <25 mL/min/1.73 m²) after renal transplant, but careful monitoring is advised.
Dialysis:
Mycophenolic acid (MPA) is not removed by hemodialysis. However, the inactive metabolite MPAG is removed. No specific dose adjustment for dialysis patients, but monitor closely.
Hepatic Impairment:
Mild:
No dose adjustment needed for renal transplant patients with severe hepatic parenchymal disease. However, for hepatic transplant patients, dose adjustments may be necessary based on individual response and tolerability.
Moderate:
No dose adjustment needed for renal transplant patients with severe hepatic parenchymal disease. However, for hepatic transplant patients, dose adjustments may be necessary based on individual response and tolerability.
Severe:
No dose adjustment needed for renal transplant patients with severe hepatic parenchymal disease. However, for hepatic transplant patients, dose adjustments may be necessary based on individual response and tolerability.
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 an enzyme critical for the de novo synthesis of guanosine nucleotides. Because lymphocytes are highly dependent on this de novo pathway for purine synthesis (unlike other cell types which can utilize salvage pathways), MPA has potent cytostatic effects on lymphocytes (T and B lymphocytes), thereby inhibiting their proliferation and function. It also inhibits antibody formation by B-lymphocytes and glycosylation of lymphocyte and monocyte glycoproteins, which may inhibit adhesion of lymphocytes to endothelial cells.
Pharmacokinetics
Absorption:
Bioavailability:
IV formulation is 100% bioavailable (relative to oral).
Tmax:
Not applicable for IV infusion (peak levels achieved at end of infusion). For oral, Tmax of MPA is 0.8-1.2 hours.
FoodEffect:
Not applicable for IV infusion.
Distribution:
Vd:
Approximately 3.6 L/kg for MPA.
ProteinBinding:
MPA is highly bound to plasma albumin (97-99%).
CnssPenetration:
Limited
Elimination:
HalfLife:
MPA: 11.7 hours (terminal half-life). MPAG: 17.9 hours.
Clearance:
Approximately 11.6 L/hr for MPA.
ExcretionRoute:
Primarily renal (87% of dose excreted in urine, mainly as MPAG; 6% in feces).
Unchanged:
<1% of MPA excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Rapid, as MPA levels are achieved quickly with IV infusion.
PeakEffect:
Correlates with peak MPA levels, typically at the end of infusion.
DurationOfAction:
Related to MPA half-life and sustained therapeutic levels with twice-daily dosing.
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Increased risk of serious infections, including opportunistic infections, leading to hospitalizations or death. Increased risk of development of lymphoma and other malignancies, particularly skin cancer. Increased risk of first trimester pregnancy loss and congenital malformations. Mycophenolate mofetil should not be used in pregnant women unless the benefits outweigh the risks. 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 signs or symptoms, contact your doctor immediately or seek emergency medical attention:
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.
High Blood Sugar: Confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
High or Low Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Skin Infection: Oozing, heat, swelling, redness, or pain.
Cardiovascular Issues: Chest pain or pressure, rapid, slow, or irregular heartbeat.
Bleeding or Bruising: Unexplained bruising or bleeding, vomiting blood or coffee ground-like material, or black, tarry, or bloody stools.
Neurological Symptoms: Burning, numbness, or tingling sensations, muscle cramps, or swelling.
Other Symptoms: Pale skin, white patches in the mouth, vaginal itching or discharge, or yellowing of the skin and eyes.
Rare but Serious Conditions:
Acute Inflammatory Syndrome (AIS): Fever, joint pain or stiffness, or muscle pain. These symptoms usually occur within weeks to months after starting the medication or increasing the dose.
Progressive Multifocal Leukoencephalopathy (PML): Confusion, memory problems, depression, changes in behavior, weakness on one side of the body, speech or thinking difficulties, balance problems, or vision changes. This condition can cause disability or be life-threatening.
BK Virus Infection: In people who have had a kidney transplant, this infection can cause kidney damage or loss. Symptoms include changes in urine output, difficulty or pain while urinating, or blood in the urine.
Lung Problems: Shortness of breath, trouble breathing, new or worsening cough, or fever. These symptoms can be life-threatening.
Common Side Effects:
While many people may not experience side effects, some may have mild or moderate symptoms. If you notice any of the following, contact your doctor 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
Irritation at the injection site
Reporting 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 signs or symptoms, contact your doctor immediately or seek emergency medical attention:
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.
High Blood Sugar: Confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
High or Low Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Skin Infection: Oozing, heat, swelling, redness, or pain.
Cardiovascular Issues: Chest pain or pressure, rapid, slow, or irregular heartbeat.
Bleeding or Bruising: Unexplained bruising or bleeding, vomiting blood or coffee ground-like material, or black, tarry, or bloody stools.
Neurological Symptoms: Burning, numbness, or tingling sensations, muscle cramps, or swelling.
Other Symptoms: Pale skin, white patches in the mouth, vaginal itching or discharge, or yellowing of the skin and eyes.
Rare but Serious Conditions:
Acute Inflammatory Syndrome (AIS): Fever, joint pain or stiffness, or muscle pain. These symptoms usually occur within weeks to months after starting the medication or increasing the dose.
Progressive Multifocal Leukoencephalopathy (PML): Confusion, memory problems, depression, changes in behavior, weakness on one side of the body, speech or thinking difficulties, balance problems, or vision changes. This condition can cause disability or be life-threatening.
BK Virus Infection: In people who have had a kidney transplant, this infection can cause kidney damage or loss. Symptoms include changes in urine output, difficulty or pain while urinating, or blood in the urine.
Lung Problems: Shortness of breath, trouble breathing, new or worsening cough, or fever. These symptoms can be life-threatening.
Common Side Effects:
While many people may not experience side effects, some may have mild or moderate symptoms. If you notice any of the following, contact your doctor 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
Irritation at the injection site
Reporting 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 fatigue, new pain, cough, burning urination.
- Unusual bleeding or bruising, black or tarry stools, pink or red urine (signs of low platelets).
- Pale skin, extreme tiredness, shortness of breath (signs of anemia).
- Severe or persistent nausea, vomiting, diarrhea, or abdominal pain.
- New skin lesions, moles that change in size or color, or lumps under the skin.
- Swollen lymph nodes.
- New or worsening neurological symptoms such as weakness on one side of the body, clumsiness, vision changes, confusion, or memory problems (rare, but serious, signs of PML).
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.
If you have been diagnosed with Lesch-Nyhan or Kelley-Seegmiller syndrome, or 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 a female who can 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 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:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have been diagnosed with Lesch-Nyhan or Kelley-Seegmiller syndrome, or 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 a female who can 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 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 health while taking this medication. If you have diabetes, it is vital to closely monitor your blood sugar levels.
Before receiving any vaccinations, consult your doctor, as certain vaccines may not be effective or may increase the risk of infection 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 your risk of developing skin cancer. To protect yourself, use sunscreen, wear protective clothing, and eyewear that shields you from the sun.
Your doctor may recommend hepatitis B or C testing, as this medication may worsen existing infections. There is a risk of gastrointestinal tract 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 your doctor for guidance on managing 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 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 not be effective in preventing pregnancy. 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 your doctor, as certain vaccines may not be effective or may increase the risk of infection 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 your risk of developing skin cancer. To protect yourself, use sunscreen, wear protective clothing, and eyewear that shields you from the sun.
Your doctor may recommend hepatitis B or C testing, as this medication may worsen existing infections. There is a risk of gastrointestinal tract 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 your doctor for guidance on managing 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 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 not be effective in preventing pregnancy. 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 (leukopenia, neutropenia, anemia, thrombocytopenia)
- Severe gastrointestinal disturbances (nausea, vomiting, diarrhea)
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) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Azathioprine (increased risk of myelosuppression)
- Cholestyramine (decreased MPA exposure)
- Antacids containing magnesium or aluminum hydroxide (decreased MPA absorption if given orally, but less relevant for IV)
- Probenecid (increased MPA and MPAG levels)
- Acyclovir, Ganciclovir (increased levels of both drugs due to competition for tubular secretion)
- Live vaccines (increased risk of infection)
Moderate Interactions
- Oral contraceptives (potential for reduced efficacy of oral contraceptives)
- Rifampin (decreased MPA exposure)
- Tacrolimus (potential for altered MPA exposure, monitor levels)
- Cyclosporine (decreased MPA exposure, monitor levels)
- Sevelamer (decreased MPA exposure)
- Telmisartan (decreased MPA exposure)
- Metronidazole (potential for altered MPA exposure)
Minor Interactions
- Trimethoprim/sulfamethoxazole (potential for altered MPA exposure)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline hematologic parameters and identify pre-existing cytopenias, as mycophenolate can cause myelosuppression (leukopenia, anemia, thrombocytopenia).
Timing: Prior to initiation of therapy
Renal function (serum creatinine, BUN, eGFR)
Rationale: To assess baseline kidney function, although dose adjustment is generally not needed for renal impairment in transplant patients, monitoring is crucial.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, bilirubin, alkaline phosphatase)
Rationale: To assess baseline liver function, especially important for hepatic transplant patients.
Timing: Prior to initiation of therapy
Pregnancy test (for females of reproductive potential)
Rationale: Mycophenolate is teratogenic and contraindicated in pregnancy.
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 thereafter for the first year. Less frequently as clinically indicated.
Target: Maintain WBC > 2.5 x 10^9/L, ANC > 1.5 x 10^9/L, Platelets > 50 x 10^9/L (adjust based on clinical protocol)
Action Threshold: Dose reduction or interruption for persistent or severe leukopenia (ANC < 1.3 x 10^9/L), neutropenia, or other cytopenias.
Renal function (serum creatinine, BUN)
Frequency: Monthly or as clinically indicated.
Target: Within acceptable post-transplant ranges.
Action Threshold: Significant changes may indicate rejection, nephrotoxicity from co-medications, or other issues requiring investigation.
Liver function tests (ALT, AST, bilirubin)
Frequency: Monthly or as clinically indicated.
Target: Within acceptable post-transplant ranges.
Action Threshold: Significant elevations may indicate hepatotoxicity or other liver pathology.
Mycophenolic Acid (MPA) trough levels (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 situation.
Target: Typically 1-3.5 mcg/mL (renal transplant, C0), but target ranges vary widely and are often individualized based on clinical context and concomitant immunosuppression.
Action Threshold: Levels outside target range may prompt dose adjustment, especially if associated with toxicity or rejection.
Signs and symptoms of infection
Frequency: Ongoing, at every clinical visit.
Target: Absence of infection.
Action Threshold: Prompt evaluation and treatment for fever, chills, malaise, new pain, or other signs of infection.
Symptom Monitoring
- Signs of infection (fever, chills, sore throat, unusual fatigue, new pain, cough, dysuria)
- Unusual bleeding or bruising (signs of thrombocytopenia)
- Pale skin, fatigue, shortness of breath (signs of anemia)
- Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain)
- Skin lesions or changes (increased risk of skin cancer)
- Lymphadenopathy or other signs of malignancy
- Signs of progressive multifocal leukoencephalopathy (PML) such as progressive weakness, clumsiness, vision changes, cognitive impairment
Special Patient Groups
Pregnancy
Mycophenolate is highly teratogenic and is contraindicated in pregnancy unless there are no other suitable treatment options. It is associated with a significantly increased risk of first trimester pregnancy loss and congenital malformations, particularly ear and facial abnormalities, and cardiac defects.
Trimester-Specific Risks:
First Trimester:
High risk of spontaneous abortion (45-49%) and major congenital malformations (23-27%), including ear abnormalities (e.g., anotia/microtia), cleft lip/palate, cardiac defects, and limb abnormalities.
Second Trimester:
Continued risk of fetal exposure and potential for adverse effects, though major structural malformations are primarily associated with first trimester exposure.
Third Trimester:
Potential for adverse effects on fetal development and neonatal outcomes, including hematologic effects.
Lactation
Mycophenolate is excreted into breast milk. Due to the potential for serious adverse reactions in the breastfed infant, including immunosuppression and carcinogenicity, breastfeeding is contraindicated during treatment and for 6 weeks after the last dose.
Infant Risk:
L5 (Contraindicated - high risk of adverse effects)
Pediatric Use
Safety and efficacy of mycophenolate mofetil injection have not been established in pediatric patients. Oral formulations are used in pediatric renal transplant patients with weight-based dosing. IV formulation is generally reserved for temporary use when oral administration is not possible, with careful consideration and monitoring.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustments are generally not required based on age alone, but careful monitoring for adverse effects is recommended due to potential for decreased renal/hepatic function and polypharmacy.
Clinical Information
Clinical Pearls
- Mycophenolate mofetil IV is typically used as a temporary bridge therapy (usually <14 days) when oral administration is not feasible, such as immediately post-transplant or during periods of GI intolerance.
- IV infusion must be administered slowly over no less than 2 hours to minimize the risk of infusion-related reactions.
- Reconstituted solution must be further diluted before infusion.
- Always check for compatibility with other IV fluids and medications.
- Therapeutic drug monitoring (TDM) of MPA levels is often employed, especially in the early post-transplant period, in patients with GI disturbances, renal/hepatic impairment, or suspected drug interactions, to optimize dosing and minimize toxicity/rejection.
- Patients should be educated on the critical importance of adherence to therapy and the risks of infection and malignancy.
- Due to the teratogenic risk, strict contraception counseling and adherence are paramount for females of reproductive potential.
Alternative Therapies
- Azathioprine (another antimetabolite immunosuppressant)
- Sirolimus (mTOR inhibitor)
- Everolimus (mTOR inhibitor)
- Belatacept (selective T-cell costimulation blocker)
- Tacrolimus (calcineurin inhibitor)
- Cyclosporine (calcineurin inhibitor)
Cost & Coverage
Average Cost:
Varies widely per 500mg vial
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization and/or step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.