medicine: cellcept

cellcept description

Go to trade names and prices








Mycophenolic acid (INN) (pronounced /ˌmaɪkoʊfɨˈnɒlɪk/) or mycophenolate is an immunosuppressant drug used to prevent rejection in organ transplantation. It was initially marketed as the prodrug mycophenolate mofetil (MMF) to improve oral bioavailability. More recently, the salt mycophenolate sodium has also been introduced. Mycophenolic acid is commonly marketed under the trade names CellCept (mycophenolate mofetil; Roche) and myfortic (mycophenolate sodium; Novartis).

Clinical use

Indications

In general, mycophenolate is used for the prevention of organ transplant rejection. Mycophenolate mofetil is indicated for the prevention of organ transplant rejection in adults and renal transplant rejection in children over 2 years; whereas mycophenolate sodium is indicated for the prevention of renal transplant rejection in adults. Mycophenolate sodium has also been used for the prevention of rejection in liver, heart, and/or lung transplants in children >2 years.

An immunosuppressant that has drastically decreased the incidence of acute rejection in solid transplant recipients, mycophenolate is increasingly utilized as a steroid sparing treatment in immune-mediated disorders including immunoglobulin A nephropathy, small vessel vasculitides, and psoriasis.

Its increasing application in treating lupus nephritis has demonstrated more frequent complete response and less frequent complications compared to cyclophosphamide bolus therapy, a regimen with risk of bone marrow suppression, infertility, and malignancy. Further work addressing maintenance therapy demonstrated mycophenolate superior to cyclophosphamide, again in terms of response and side-effects. Walsh et al. even propose that mycophenolate should be considered as a first-line induction therapy for treatment of lupus nephritis in patients without renal dysfunction, suggesting that mycophenolate will be encountered more frequently in medical practice.

Comparison to other agents

Compared with azathioprine it has significantly higher incidence of diarrhoea, and no difference in risk of any of the other side effects. Mycophenolic acid is 15 times more expensive than azathioprine The exact role of mycophenolate vs azathioprine has yet to be conclusively established. In long-term immunosuppression, it may be used to avoid calcineurin inhibitors or steroids.

Potential future uses

Mycophenolate mofetil is beginning to be used in the management of auto-immune disorders such as idiopathic thrombocytopenic purpura (ITP), systemic lupus erythematosus (SLE), and pemphigus vulgaris (PV) with success for some patients.

It is also currently being used as a long-term therapy for maintaining remission of C-ANCA positive (Wegener's) granulomatosis. A combination of mycophenolate and ribavirin has been found to stop infection by and replication of dengue virus in vitro.

Adverse effects

Common adverse drug reactions (≥1% of patients) associated with mycophenolate therapy include diarrhea, nausea, vomiting, infections, leukopenia, and/or anemia. Mycophenolate sodium is also commonly associated with fatigue, headache, and/or cough. Intravenous (IV) administration of mycophenolate mofetil is also commonly associated with thrombophlebitis and thrombosis. Infrequent adverse effects (0.1–1% of patients) include esophagitis, gastritis, gastrointestinal tract hemorrhage, and/or invasive cytomegalovirus (CMV) infection. Several cases of pure red cell aplasia (PRCA) have also been reported.

The U.S. Food and Drug Administration (FDA) has issued an alert that patients on mycophenolate mofetil and mycophenolic acid are at increased risk of opportunistic infections, such as activation of latent viral infections, including BK-virus associated nephropathy. In addition the FDA is investigating 16 patients that developed a rare neurological disease while taking the drug. The neurological condition known as progressive multifocal leukoencephalopathy attacks the brain and central nervous system and is usually fatal.

Mycophenolic acid is associated with miscarriage and congenital malformations when used during pregnancy, and should be avoided whenever possible by women trying to conceive.

Pharmacology

Mycophenolate is derived from the fungus Penicillium stoloniferum. Mycophenolate mofetil is metabolised in the liver to the active moiety mycophenolic acid. It inhibits inosine monophosphate dehydrogenase, the enzyme that controls the rate of synthesis of guanine monophosphate in the de novo pathway of purine synthesis used in the proliferation of B and T lymphocytes.


Mycophenolate is potent and can be used in place of the older anti-proliferative azathioprine. It is usually used as part of a three-compound regimen of immunosuppressants, also including a calcineurin inhibitor (ciclosporin or tacrolimus) and prednisolone.

Trade names

Trade names and prices of cellcept

Name Information Price* Quantity
       
Cellcept 250mg 100 capsules (mycophenolate mofetil) $205 100 capsules
Cellcept 500mg 50 tablets (mycophenolate mofetil) $212 50 tablets
Generic Mycophenolate 250mg 30 capsule $55 30 capsule
Generic Mycophenolate 500mg 50 tablet $167 50 tablet

*) Prices related to some of online drugstores. There are only approximate prices. For some of drugs is needed a prescription.

Tags

Keywords related to cellcept

enlon phenolphthalein asacol propofol l dops celexa enovid levocabastine clonidine ademetionine isothipendyl medetomidine copegus cefizox radiogardase elidel haldol phenglutarimide bretylium medrol bretylol anastrozole benzphetamine diatrizoic acid brifentanil haemaccel abelcet saccharic acid benzydamine fentonium cholecalciferol thiamine pyrophosphate dalgan cardrase bimatoprost ms contin methapyrilene tris 2 chloroethyl amine dacetuzumab silibinin mebutamate triflusal vinblastine dicloxacillin phenazopyridine enflurane technetium 99mtc arcitumomab


  • Related news


    Drug/Medical Device Report Aspreva Pharmaceuticals Corporation (
    CellCept (Mycophenolate Mofetil) [Phase III]. Expected PDUFA: - Roche Holding Ltd. (ADR) (RHHBY) / CellCept. (Mycophenolate Mofetil) ...
    Read full article

    Systemic Lupus Erythematosus Treatment for Severe SLE - Systemic
    Mycophenolate mofetil (CellCept, Myfortic) is now becoming the new standard. Many recent studies have shown that this drug works better than ...
    Read full article

    FDA reviews CellCept and Myfortic safety
    WASHINGTON, April 10 (UPI) -- The US Food and Drug Administration says it is conducting a safety review involving CellCept and Myfortic, ...
    Read full article

    'I've been robbed of my wife after cancer drug mistake'
    two months after was she was incorrectly dispensed Xeloda, a drug for treating colorectal cancer, instead of another drug, Mycophenolate (Cellcept). ...
    Read full article

    Biologic Agents Will Drive the Systemic Lupus Erythematosus Drug
    The off-label use of CellCept, rituximab and other therapies exemplifies the unusual dynamics of the systemic lupus erythematosus market. ...
    Read full article

    Roche: Not So Much Affected By US Health Care Plan
    "We are feeling the impact of the CellCept patent expiry in the US," William Burns, CellCept is to prevent tissue rejection with organ transplants. ...
    Read full article

    Pregnancy Risks of CellCept, Myfortic raise alert.(News) Article
    Pregnancy Risks of CellCept, Myfortic raise alert.(News) find Skin & Allergy News articles. An alert about reports of birth defects and spontaneous ...
    Read full article

    FDA stresses birth defect risks with Roche drug
    FDA said most of the reported problems came from mothers who were taking CellCept before their pregnancies were detected. Some of the patients were taking ...
    Read full article

    CellCept(R) and a Reduced Level of CNI Shows Trend Towards
    TORONTO, June 4 /PRNewswire/ -- The 12-month results from a multicenter trial monitoring CellCept(R) (mycophenolate mofetil) in combination with calcineurin ...
    Read full article

    Sandoz launches generic version of CellCept. Article from Transplant
    Sandoz launches generic version of CellCept. find Transplant News articles. Sandoz, Inc., Princeton, NJ, announced it has introduced mycophenolate ...
    Read full article

    Loislaw Federal District Court Opinions - SMITH v. SHEAHAN (NDIll. 9
    The next morning, August 5, Smith received his first dose of CellCept, but did not receive Gengraf. That evening he received neither CellCept or Gengraf. ...
    Read full article

    Mayo Clinic expertise
    Researchers have had some success using the immunosuppressant drug mycophenolate mofetil (Cellcept) to treat certain types of vasculitis, but are still ...
    Read full article

    Health Highlights: July 15, 2009
    The drugs include CellCept (mycophenolate mofetil) and generics, Myfortic (mycophenolic acid), Rapamune (sirolimus), Sandimmune (cyclosporine) and generics, ...
    Read full article

    Transplant drugs under scrutiny.(NEWS FROM THE FDA) Article from
    CellCept is approved for preventing heart, liver, and kidney trans plant A recently published study compared mycophenolate mofetil (CellCept) with an IV ...
    Read full article

    NATION & WORLD BRIEFING
    At the time, FDA added its most serious warning to CellCept and a similar Novartis AG drug, Myfortic. FDA spokesman Christopher Kelly said the agency has no ...
    Read full article

    At Least Half Of All Kidney Transplant Recipients Benefit From Drug
    The introduction of CellCept containing regimens has allowed doctors to reduce [vi] The Spare the Nephron study showed that a CellCept-based regimen in ...
    Read full article

    FDA Repeats Warning About Transplant Drugs
    The organ transplant drugs CellCept and Myfortic can cause miscarriages and birth Last October, the FDA added its most serious warning to CellCept and ...
    Read full article

    Press Release: Biologic Agents Will Drive the Systemic Lupus
    The off-label use of CellCept, rituximab and other therapies exemplifies the unusual dynamics of the systemic lupus erythematosus market. ...
    Read full article

    Press Release: Frost & Sullivan Lauds Toscana Biomarkers' Outstanding
    Article: Unique Agreement Between Roche and Aspreva to Develop CellCept In PR Newswire; October 22, 2003 ; 700+ words of CellCept in a variety ...
    Read full article

    FDA, Roche Warn On Type Of Anemia With Kidney-Transplant Drug
    VX) kidney-transplant drug Cellcept. The FDA posted a letter from Roche to The drugs, including Cellcept, Myfortic by Novartis AG (NVS) and Wyeth's ...
    Read full article

    Press Release: CellCept(R) and a Reduced Level of CNI Shows Trend
    CellCept(R) and a Reduced Level of CNI Shows Trend Towards Preservation of Kidney Function Versus a Standard-Dose CNI. from PR Newswire. ...
    Read full article

    Roche Holding "buy," target price reduced
    Roche Holding's Pharma sales were short of the estimates due to weakness in Tamiflu and Cellcept and better-than-expected adoption of Avastin in Europe, ...
    Read full article

    Glaxo warns of anemia risk with transplant drug
    VX: Quote, Profile, Research) last month revised the label of transplant drug CellCept to include a new warning about cases of PRCA. ...
    Read full article

    FDA requires label change for some transplant drugs
    The label changes are required for Wyeth's Rapamune; Novartis' Neoral and Myfortic; Roche's Cellcept and Sandimmune, the FDA said in a statement Tuesday ...
    Read full article

    Press Release: Final Results of the CellCept(R) Spare the Nephron
    Final Results of the CellCept(R) Spare the Nephron (STN) Study Show Maintenance Therapy is Associated with Improved Renal Function. from PR Newswire. ...
    Read full article

    Global top 45 multisource branded drugs ranked by dollar sales for
    Brand Names: Adderall XR (Medication); Buderprion XL (Medication); CellCept (Medication); Cialis (Medication); Depakote ER (Medication); ...
    Read full article

    Red tape snags off-label drugs
    His colleague suggested CellCept, which is used for patients who are CellCept is FDA approved as an anti-organ rejection drug and a treatment for ...
    Read full article

    Postmarketing CellCept data prompt stronger pregnancy alert.(Women's
    Postmarketing CellCept data prompt stronger pregnancy alert.(Women's Health) find Family Practice News articles. Postmarketing reports of an increased ...
    Read full article

    Competitors by Product Report
    CellCept is Roche's immunosuppressant or anti-rejection drug used in combination with other immunosuppressive drugs, such as cyclosporine and ...
    Read full article

    Approvals for Generic Versions of Anti-Rejection Medication CellCep
    Mycophenolate Mofetil is the generic name for Roche's CellCept(R), CellCept Tablets, 500 mg, and CellCept Capsules, 250 mg, had annual U.S. sales of ...
    Read full article

    Final Results of the CellCept Spare the Nephron (STN) Study Shows
    The final results of the Spare the Nephron (STN) study, a multicenter trial investigating a novel kidney-sparing treatment protocol using CellCept ...
    Read full article

    Roche's CellCept to Carry US Warning of Infection
    By Larry Liebert and Tom Randall. June 26 (Bloomberg) -- Roche Holding AG's CellCept, given to organ transplant patients to prevent rejection, ...
    Read full article

    CellCept Labeling Changes Reflect PML Risk
    July 1, 2008 (July 2, 2008) Updates have been approved to the safety labeling for mycophenolate mofetil (CellCept, Hoffman-LaRoche, ...
    Read full article

    Sudden loss of the GVL effect following use of the TNF inhibitor
    GVHD prophylaxis used cellcept and tacrolimus. She was transplanted with a 10/10 GVHD prophylaxis again used tacrolimus and cellcept, and BM stem cells ...
    Read full article

    Business & Financial News, Breaking US & International News
    The drugs are Novartis' Myfortic and Roche's CellCept, both of which are used CellCept was approved in 1995 and is used with patients who receive a new ...
    Read full article

    MOTHER'S RAGE LIVES ON
    They thought her best chance would come from two powerful chemotherapy drugs - Cytoxan and Cellcept - but Castro felt the medications were destroying ...
    Read full article

    Quick Study Article from The Washington Post HighBeam Research
    The study was funded by Aspreva Pharmaceuticals, which makes CellCept; four of 11 primary authors received fees from the company, and one was its employee. ...
    Read full article

    Article: CellCept disappoints in large phase III lupus trial.(Across
    CellCept disappoints in large phase III lupus trial.(Across Specialties) find Skin & Allergy News articles. SNOWMASS, COLO. -- In an unexpected major ...
    Read full article

    FDA: CellCept label is updated due to reports of PML
    Designed specifically for the transfusion medicine and cellular therapy community, AABB SmartBrief is a FREE, daily e-mail newsletter. ...
    Read full article

    Final Results of the CellCept(R) Spare the Nephron (STN) Study Show
    TORONTO, June 1 /PRNewswire/ -- The final results of the Spare the Nephron (STN) study, a multicenter trial investigating a novel kidney-sparing treatment ...
    Read full article

    Genentech: Second Raptiva patient has PML
    in patients on the Novartis immunosuppressant drugs--used in transplant patients but also off-label for some lupus sufferers--CellCept and Myfortic; ...
    Read full article

    Company Profile Report
    CellCept is Roche's immunosuppressant or anti-rejection drug used in combination with other immunosuppressive drugs, such as cyclosporine and ...
    Read full article

    Quick Study: New Research on Hypoglycemia, Lupus and Restless Legs
    The study was funded by Aspreva Pharmaceuticals, which makes CellCept; four of 11 primary authors received fees from the company, and one was its employee. ...
    Read full article

    Press Release: MarketsandMarkets: Global Autoimmune Treatment
    Article: Unique Agreement Between Roche and Aspreva to Develop CellCept In PR Newswire; October 22, 2003 ; 700+ words of CellCept in a variety ...
    Read full article

    Roche transplant drug gets anemia warning
    The prescribing information for CellCept will include information about cases of CellCept is used to suppress the immune system to prevent patients' ...
    Read full article

    FDA Reposts Warning About Pregnancy-Related Risks Associated With
    Roche's CellCept and Novartis' Myfortic are used to suppress the body's immune system to avoid organ rejection in people undergoing transplant surgery. ...
    Read full article

    Press Release: Abaxis Point-of-Care Test Panels Gain FDA CLIA-Waived
    Article: Final Results of the CellCept(R) Spare the Nephron (STN) Study PR Newswire; June 1, 2008 ; 700+ words mycophenolate mofetil), ...
    Read full article