Cellcept 500mg Tablet

Uses of Cellcept 500mg Tablet

• Used to prevent your body from rejecting a transplanted organ (such as a kidney, heart, or liver)

How does Cellcept 500mg Tablet work?

Cellcept 500mg Tablet falls under the category of immunosuppressants, which work to suppress the body's immune system and thereby prevent the rejection of transplanted organs.

Side Effects of Cellcept 500mg Tablet

• Diarrhea
• Vomiting
• Infections
• Low white blood cell (WBC) count
• Red blood cell (RBC) count

Quick Suggestions:

• Your doctor has prescribed Mycophenolate mofetil to prevent your body from rejecting a transplanted organ, such as a kidney, heart, or liver.
• It might take around 6 to 12 weeks for Mycophenolate mofetil to begin its effects. Keep taking it as directed.
• Take it with food to reduce potential side effects like nausea and stomach discomfort.
• This medication can make you more susceptible to infections. Avoid contact with individuals who are infected.
• If you notice symptoms such as a sore throat, high fever, or any signs of infection, consult your doctor promptly.
• Due to the risk of birth defects, it's important for females of reproductive age to use effective birth control methods.
• To shield yourself from direct sunlight, wear protective clothing and apply sunscreen with a high sun protection factor (SPF).
• Your doctor may schedule regular blood tests to monitor your blood cell levels.
• Inform your doctor if you experience symptoms like unexplained bruising or bleeding, mouth ulcers, sore throat, or fever.

Indication

Mycophenolate Mofetil acts as an immunosuppressive agent by functioning as an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). This action hinders the de novo pathway of guanosine nucleotide synthesis without affecting DNA incorporation. As a result, Mycophenolic acid exerts cytostatic effects on lymphocytes. It has demonstrated its ability to prevent acute rejection following kidney and heart allograft transplantation. Additionally, it reduces the production of antibodies.

Pharmacology

The active compound mycophenolic acid, derived from mycophenolate mofetil, functions by inhibiting inosine monophosphate dehydrogenase (IMPDH), an enzyme crucial for the de novo synthesis of guanosine nucleotides. This inhibition interrupts the production of necessary substrates for DNA and RNA synthesis. Lymphocytes, particularly T and B cells, rely heavily on this de novo pathway for generating guanosine nucleotides, making them more vulnerable to the effects of mycophenolic acid compared to other cell types that can utilize alternative pathways.

Mycophenolic acid acts as a non-competitive and reversible inhibitor of IMPDH. Its mechanism of action involves mimicking both the nicotinamide adenine dinucleotide cofactor and a catalytic water molecule, thereby hindering the oxidation of inosine monophosphate (IMP) to xanthose-5’-monophosphate. This step is essential in the de novo biosynthesis of guanosine nucleotides. The resultant reduction in intracellular levels of guanosine triphosphate (GTP) and deoxyguanosine triphosphate (dGTP) curtails the proliferation of lymphocytes, particularly T and B cells, due to their heavy reliance on the de novo guanosine synthesis pathway.

The pharmacodynamic effects of mycophenolic acid involve inhibiting mixed lymphocyte responses and the proliferation of human peripheral blood lymphocytes induced by various mitogens and antigens. However, mycophenolic acid does not impact GTP concentrations in human neutrophils. This selective inhibition of lymphocyte proliferation underpins its immunosuppressive action, making it particularly effective in preventing transplant organ rejection.

Dosage & Administration of Cellcept 500mg Tablet

Transplant Patients:

Prophylaxis of Renal Rejection:

• Adults: Take 1 gram orally twice daily (total daily dose of 2 grams).
• Children (body surface area 1.25 to 1.5 m2): Take 750 mg twice daily (total daily dose of 1.5 grams).
• Children (body surface area >1.5 m2): Take 1 gram twice daily (total daily dose of 2 grams).

Prophylaxis of Cardiac Rejection:

• Adults: Take 1.5 grams orally twice daily (total daily dose of 3 grams).
• Children: No data is available for pediatric cardiac transplant patients.

Prophylaxis of Hepatic Rejection:

• Adults: Take 1.5 grams orally twice daily (total daily dose of 3 grams).
• Children: No data is available for pediatric hepatic transplant patients.

Treatment of First or Refractory Renal Rejection:

• Adults: Take 1.5 grams orally twice daily (total daily dose of 3 grams).
• Children: No data is available for pediatric renal transplant patients.

Lupus Nephritis Patients:

Induction Therapy:

• Adults: Take 750 mg to 1.5 grams orally twice daily (total daily dose up to 3 grams).
• Children: Take 600 mg/m2 orally twice daily (maximum of 2 grams daily).

Maintenance Therapy:

• Adults: Take 500 mg to 1 gram orally twice daily.
• Children: Take 300 mg/m2 orally twice daily.

Mycophenolate Mofetil should be used alongside corticosteroids. The dosage should be introduced gradually and adjusted based on clinical response. Therapeutic drug monitoring may be helpful to prevent sub-therapeutic exposure (Cmin≥3.0 mg/L or inter-dose AUC ≥35 h*mg/L). Follow your physician's advice for taking Cellcept 500mg Tablet. Swallow the tablets with water, do not crush or chew them. Dosage varies based on your transplant type. Do not stop the medication abruptly without consulting your doctor.

Interaction

Before taking Cellcept 500mg Tablet, it's important to inform your doctor if you are taking any of the following medications:

• Azathioprine, tacrolimus, belatacept, cyclosporine A (immunosuppressants used after transplant)
• Cholestyramine (for high cholesterol)
• Rifampicin (for infections like TB)
• Ulcer medications (antacids or proton pump inhibitors)
• Phosphate binders (for chronic renal failure) like ferric citrate, calcium acetate, sevelamer
• Antibiotics: amoxicillin and clavulanic acid, doxycycline, ciprofloxacin, clindamycin, metronidazole, azithromycin, trimethoprim/sulfamethoxazole, amikacin, cefadroxil, norfloxacin
• Isavuconazole (for fungal infections)
• Telmisartan (for high blood pressure)
• Activated charcoal (for digestive problems)
• Acyclovir or ganciclovir (for viral infections)
• Oral contraceptives (ethinylestradiol and levonorgestrel, for birth control)
• Probenecid (for gout)
• Iron salts (ferrous sulfate, for iron deficiency)

Discuss these medications with your doctor before starting Cellcept 500mg Tablet to ensure safe and effective treatment.

Contraindications

Do not take Cellcept 500mg Tablet if:

• You have a known allergy to mycophenolate or any other component of this medicine.
• You are pregnant or planning to conceive.
• There is any chance that you may be pregnant.
• You are not using an effective contraception method.
• You breastfeed your baby.

Pregnancy & Lactation

Mycophenolate Mofetil is contraindicated in pregnancy and during breastfeeding. The safe use of Mycophenolate Mofetil during labor and delivery has not been established.

Precautions & Warnings

Mycophenolic acid tablets should be used with caution because they:

• Can increase the risk of new or reactive viral infections, including latent viral reactivation such as hepatitis B or hepatitis C reactivation, or infections caused by polyomaviruses.
• Can lead to blood dyscrasias, including a condition called pure red cell aplasia (PRCA).
• May cause serious complications in the gastrointestinal tract, such as gastrointestinal bleeding, perforations, and ulcers.
• May increase the risk of developing lymphomas and other malignancies, especially of the skin.
• The use of live vaccines should be avoided while undergoing treatment with Mycophenolic acid.
• Patients should not donate blood during the course of therapy.

Special Populations:

• Geriatric population: Elderly patients may be more susceptible to adverse events such as certain infections (including cytomegalovirus tissue invasive disease) and potentially gastrointestinal hemorrhage and pulmonary edema, in comparison to younger individuals.

Overdose:

In case you have taken an excessive amount of this medicine, it's important to contact your doctor or seek medical attention at the nearest hospital immediately.

Missed Dose:

If you have missed a dose of this medicine, take it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.

Storage Conditions

Store in a cool and dry place away from sunlight