Mycophenolate 200mg/ml Susp 160ml

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, leading to potent cytostatic effects on lymphocytes and immunosuppression.

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, 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 Conditions

Acute inflammatory syndrome (AIS): This condition can occur within weeks to months after starting this medication or after a dose increase. If you experience fever, joint pain or stiffness, or muscle pain, contact your doctor immediately.
Progressive multifocal leukoencephalopathy (PML): This rare brain condition can cause disability or be life-threatening. Seek medical help right away if you notice confusion, memory problems, depression, changes in behavior, weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes.
BK virus infection: In people who have had a kidney transplant, this viral infection can cause kidney damage or loss. If you experience changes in urine output, difficulty or pain while urinating, or blood in the urine, contact your doctor immediately.
Lung problems: Although rare, this medication can cause lung problems, which can be life-threatening. Seek medical help right away if you experience shortness of breath, trouble breathing, new or worsening cough, or fever.

Other Side Effects

Not everyone who takes this medication will experience side effects, and many people may only have mild symptoms. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

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.

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, such as foods or drugs. 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 condition known as hypoxanthine-guanine phosphoribosyltransferase (HGPRT) deficiency.
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.
If you are breastfeeding or plan to breastfeed.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.

Until you know how this medication affects you, avoid driving and other activities that require you to be alert. Regularly check your blood work and other lab tests as instructed by your doctor to monitor your condition.

If you have diabetes, closely monitor your blood sugar levels, as this medication may affect them. Before receiving any vaccines, consult your doctor, as some vaccines may not work as well or may increase the risk of infection when taken with this medication.

You may be at a higher risk of bleeding, so be cautious and avoid injuries. Use a soft toothbrush and an electric razor to minimize the risk of bleeding. Additionally, be aware that this medication may increase the risk of skin cancer. To reduce this risk, limit your exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear.

Your doctor may recommend testing for hepatitis B or C, as this medication may worsen these conditions. There is also a risk of bleeding, holes, and ulcers in the gastrointestinal tract, which may require hospitalization. If you experience any symptoms, discuss them with your doctor.

This medication may cause diarrhea. If you experience this side effect, talk to your doctor about ways to manage it. Do not stop taking the medication without consulting your doctor. If you have phenylketonuria (PKU), inform your doctor, as some products may contain phenylalanine.

You may need to avoid donating blood while taking this medication and for a period after stopping it. Similarly, you may need to avoid donating sperm while taking this medication and for a 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 woman who may become pregnant, use effective 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 work as well to prevent pregnancy. If you use hormone-based birth control, consider using an additional method, such as condoms, during this time. If you become pregnant, contact your doctor immediately.

If your partner may become pregnant, use effective birth control while taking this medication and for at least 90 days after your last dose. If your partner becomes pregnant, contact the doctor right away.

• Live attenuated vaccines (due to risk of infection in immunosuppressed patients)
• Azathioprine (increased risk of myelosuppression)

• Acyclovir/Ganciclovir (increased MPA and acyclovir/ganciclovir concentrations, risk of toxicity)
• Cholestyramine and other bile acid sequestrants (decreased MPA absorption)
• Antacids containing magnesium and aluminum hydroxide (decreased MPA absorption)
• Proton pump inhibitors (e.g., pantoprazole, lansoprazole) (may decrease MPA exposure)
• Rifampin (decreased MPA exposure)
• Tacrolimus (may alter MPA exposure, monitor MPA levels)
• Cyclosporine (decreased MPA exposure, monitor MPA levels)
• Oral contraceptives (may decrease efficacy of oral contraceptives, use alternative contraception)

• Metronidazole (may decrease MPA exposure)
• Norfloxacin and Metronidazole (may decrease MPA exposure)
• Telmisartan (decreased MPA exposure)
• Sevelamer (decreased MPA absorption)
• Iron preparations (decreased MPA absorption)

• Not specifically categorized as minor, but general caution with drugs affecting renal function or GI motility.

• Fever
• Chills
• Sore throat
• Unusual bleeding or bruising
• Extreme tiredness or weakness
• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• New skin lesions or changes in existing moles
• Swollen glands
• Signs of infection (e.g., cough, dysuria, localized pain/redness)

Mycophenolate mofetil is highly teratogenic and is contraindicated in pregnancy. It is associated with an increased risk of first trimester pregnancy loss and congenital malformations, particularly ear and facial abnormalities, and heart defects. Females of reproductive potential must use two reliable forms of contraception prior to, during, and for 6 weeks after stopping therapy. A negative pregnancy test is required before starting treatment.

Mycophenolic acid (MPA) is excreted into breast milk in rats. It is unknown if MPA is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, including immunosuppression and carcinogenicity, breastfeeding is contraindicated during treatment with mycophenolate mofetil and for 6 weeks after the last dose.

Dosing is weight/body surface area-based for pediatric kidney transplant patients (≥3 months). Safety and efficacy in pediatric heart and liver transplant patients have not been fully established. Pediatric patients may be at increased risk for certain infections (e.g., CMV, EBV-associated PTLD).

No specific dosage adjustment is required based on age alone. However, elderly patients may be more susceptible to adverse effects (e.g., gastrointestinal, hematologic, infections) due to age-related decline in renal function or comorbidities. Monitor closely.

• Mycophenolate mofetil (MMF) is a prodrug; its active form is mycophenolic acid (MPA).
• Always administer on an empty stomach if possible, or consistently with food, to minimize variability in absorption.
• The suspension formulation must be reconstituted prior to dispensing. Ensure patients/caregivers understand proper reconstitution, storage (refrigerated), and administration (shake well before each use, use oral syringe).
• Patients should be advised not to open, crush, or chew tablets/capsules, and to avoid direct contact with the powder from capsules/suspension, as it can be irritating to skin and mucous membranes. If contact occurs, wash thoroughly with soap and water.
• Therapeutic drug monitoring (TDM) of MPA levels is often employed, especially in the early post-transplant period, in patients with suspected non-adherence, drug interactions, or signs of rejection/toxicity. However, routine TDM is not universally recommended for all patients.
• Patients should be educated on the critical importance of adherence to prevent organ rejection.
• Due to the increased risk of skin cancer, patients should be advised to limit exposure to sunlight and UV light, and to use protective clothing and high-SPF sunscreen.
• Consider dose reduction or interruption for significant myelosuppression (e.g., severe neutropenia, anemia, thrombocytopenia).

• Azathioprine (another antimetabolite immunosuppressant)
• Sirolimus (mTOR inhibitor)
• Everolimus (mTOR inhibitor)
• Belatacept (selective T-cell costimulation blocker)
• Tacrolimus (calcineurin inhibitor)
• Cyclosporine (calcineurin inhibitor)

If your symptoms or health issues persist or worsen, it's 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, which provides crucial information for patients. 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 consult 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 quantity, and the time it occurred.