CellCept
Generic Name
Mycophenolate Mofetil
Manufacturer
Roche (Original Manufacturer)
Country
Switzerland
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| cellcept 500 mg tablet | ৳ 96.00 | ৳ 960.00 |
Description
Overview of the medicine
CellCept (mycophenolate mofetil) is an immunosuppressant medication used to prevent rejection of transplanted organs (kidney, heart, or liver) by the body. It works by weakening the body's immune system.
Uses & Indications
Dosage
Adults
Kidney transplant: 1 g orally twice daily (total 2 g/day). Heart transplant: 1.5 g orally twice daily (total 3 g/day). Liver transplant: 1.5 g orally twice daily (total 3 g/day).
Elderly
No specific dose adjustment required based on age alone, but caution and close monitoring for adverse effects are recommended.
Renal_impairment
For kidney transplant patients with severe chronic renal impairment (GFR <25 mL/min/1.73 m²), avoid doses >1 g twice daily. Monitor patients carefully.
How to Take
CellCept tablets should be taken on an empty stomach, usually one hour before or two hours after a meal, to ensure consistent absorption. Swallow tablets whole; do not crush, chew, or split them. Administer twice daily.
Mechanism of Action
Mycophenolate mofetil is a prodrug that is rapidly metabolized to mycophenolic acid (MPA). MPA is a potent, selective, non-competitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), an enzyme essential for the *de novo* synthesis of guanosine nucleotides. Lymphocytes are critically dependent on this pathway for proliferation, whereas other cell types can utilize salvage pathways. By inhibiting IMPDH, MPA selectively inhibits the proliferation of B and T lymphocytes, thus suppressing immune responses involved in transplant rejection.
Pharmacokinetics
Onset
Immunosuppressive effects develop over several days to weeks, as it's a chronic therapy for rejection prophylaxis. Not for acute onset action.
Excretion
The majority of MPA (approximately 87%) is excreted in the urine as MPAG. A small amount is excreted in the feces.
Half life
The elimination half-life of mycophenolic acid (MPA) is approximately 17 hours.
Absorption
Rapid and extensive absorption after oral administration, followed by complete presystemic metabolism to the active metabolite, mycophenolic acid (MPA). Peak plasma concentrations (Cmax) of MPA are reached approximately 1-2 hours post-dose. Bioavailability of MPA from mycophenolate mofetil is approximately 94%.
Metabolism
MPA is primarily metabolized by glucuronyl transferase to its phenolic glucuronide, mycophenolic acid glucuronide (MPAG), which is pharmacologically inactive. An enterohepatic recirculation occurs, leading to a secondary MPA peak.
Side Effects
Contraindications
- Hypersensitivity to mycophenolate mofetil, mycophenolic acid, or any component of the formulation.
- Pregnancy, due to the significant risk of teratogenicity and embryo-fetal toxicity.
Drug Interactions
Cholestyramine
Significantly decreases MPA exposure by interfering with enterohepatic recirculation. Concomitant use is not recommended.
Oral Contraceptives
Concomitant use may reduce the efficacy of oral contraceptives due to altered enterohepatic recirculation. Additional birth control methods are recommended.
Acyclovir/Ganciclovir
Concomitant use may result in increased plasma concentrations of both drugs due to competition for tubular secretion. Monitor patients carefully.
Antacids (containing magnesium and aluminum)
May decrease the absorption of mycophenolate mofetil, leading to reduced MPA exposure. Separate administration by at least 2 hours.
Storage
Store below 30°C (86°F). Protect from moisture. Keep out of reach of children.
Overdose
Limited data are available on overdose. Expected symptoms would likely be exaggerated side effects, such as gastrointestinal disturbances, bone marrow suppression (leukopenia, anemia), and increased risk of infection. Hemodialysis is not effective in removing MPA, but MPAG (its inactive metabolite) can be removed. Treatment is supportive; manage symptoms and monitor blood counts.
Pregnancy & Lactation
CellCept is contraindicated in pregnancy due to the high risk of severe birth defects (e.g., ear, facial, heart, and limb abnormalities), miscarriage, and embryo-fetal toxicity. Effective contraception must be used before, during, and for at least 6 weeks after discontinuing treatment in women of childbearing potential. Breastfeeding is not recommended due to the potential for serious adverse reactions in the infant.
Side Effects
Contraindications
- Hypersensitivity to mycophenolate mofetil, mycophenolic acid, or any component of the formulation.
- Pregnancy, due to the significant risk of teratogenicity and embryo-fetal toxicity.
Drug Interactions
Cholestyramine
Significantly decreases MPA exposure by interfering with enterohepatic recirculation. Concomitant use is not recommended.
Oral Contraceptives
Concomitant use may reduce the efficacy of oral contraceptives due to altered enterohepatic recirculation. Additional birth control methods are recommended.
Acyclovir/Ganciclovir
Concomitant use may result in increased plasma concentrations of both drugs due to competition for tubular secretion. Monitor patients carefully.
Antacids (containing magnesium and aluminum)
May decrease the absorption of mycophenolate mofetil, leading to reduced MPA exposure. Separate administration by at least 2 hours.
Storage
Store below 30°C (86°F). Protect from moisture. Keep out of reach of children.
Overdose
Limited data are available on overdose. Expected symptoms would likely be exaggerated side effects, such as gastrointestinal disturbances, bone marrow suppression (leukopenia, anemia), and increased risk of infection. Hemodialysis is not effective in removing MPA, but MPAG (its inactive metabolite) can be removed. Treatment is supportive; manage symptoms and monitor blood counts.
Pregnancy & Lactation
CellCept is contraindicated in pregnancy due to the high risk of severe birth defects (e.g., ear, facial, heart, and limb abnormalities), miscarriage, and embryo-fetal toxicity. Effective contraception must be used before, during, and for at least 6 weeks after discontinuing treatment in women of childbearing potential. Breastfeeding is not recommended due to the potential for serious adverse reactions in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture, depending on storage conditions.
Availability
Globally available
Approval Status
FDA Approved
Patent Status
Off-patent (original compound), generics available
WHO Essential Medicine
YesClinical Trials
CellCept has been extensively studied in numerous clinical trials to establish its efficacy and safety in preventing organ rejection following kidney, heart, and liver transplantation. These trials have demonstrated its ability to significantly reduce the incidence of acute rejection episodes when used in combination with other immunosuppressants.
Lab Monitoring
- Complete Blood Count (CBC) with differential, weekly for the first month, twice monthly for the second and third months, then monthly thereafter.
- Renal function tests (creatinine, GFR) and liver function tests (ALT, AST, bilirubin).
- Therapeutic Drug Monitoring (TDM) of MPA levels may be performed, especially in specific patient populations (e.g., children, renal impairment, gastrointestinal disorders).
Doctor Notes
- Strict adherence to dosage and monitoring schedule is crucial for optimal outcomes and minimizing adverse effects.
- Educate patients thoroughly on the importance of infection prevention, cancer screening, and contraception.
- Consider therapeutic drug monitoring (TDM) in patients with fluctuating renal function, gastrointestinal issues, or suspected non-adherence.
Patient Guidelines
- Take CellCept exactly as prescribed by your doctor; do not change your dose or stop taking it without consulting your doctor.
- Always use effective contraception during treatment and for at least 6 weeks after stopping CellCept, if you are a woman of childbearing potential.
- Report any signs of infection (fever, sore throat, unusual bruising or bleeding) or skin lesions immediately to your doctor.
- Avoid excessive sun exposure and use protective clothing and sunscreen, as CellCept can increase the risk of skin cancer.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
CellCept may cause dizziness, tremors, or somnolence. Patients should be cautious when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain strict personal hygiene to minimize infection risk.
- Avoid contact with people who are sick or have infections.
- Do not receive live vaccines while on CellCept without consulting your doctor.
- Use sun protection (sunscreen, protective clothing) to reduce the risk of skin cancer.
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