mycophenolate mofetil

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mycophenolate mofetil

CellCept

mycophenolate mofetil hydrochloride

CellCept Intravenous

mycophenolate sodium

Myfortic

Pharmacologic class: Mycophenolic acid derivative

Therapeutic class: Immunosuppressant

Pregnancy risk category D

FDA Box Warning

• Increased susceptibility to infection and possible lymphoma development may result from immunosuppression. Give drug under supervision of physician experienced in immunosuppressive therapy and management of renal, cardiac, or hepatic transplant patients, in facility with adequate diagnostic and treatment resources. Physician responsible for maintenance therapy should have complete information needed for patient follow-up.

• Use of CellCept during pregnancy is associated with increased risk of pregnancy loss and congenital malformations. Female patients of childbearing potential who are taking CellCept must use contraception.

Action

Inhibits binding of interleukin (IL)-1 to IL-1 receptors, preventing proliferation and differentiation of activated B and T cells. Binds to intracellular proteins to prevent T-cell activation, suppressing immune responses.

Availability

Capsules: 250 mg

Injection: 500 mg/vial

Oral suspension: 200 mg/ml (after constitution)

Tablets: 500 mg

Tablets (delayed-release): 180 mg, 360 mg

Indications and dosages

To prevent organ rejection in patients receiving allogeneic kidney transplants

Adults: 1 g P.O. or I.V. b.i.d. or 720 mg P.O. b.i.d. (delayed-release), given with corticosteroids and cyclosporine

Children: 400 mg/m2 P.O. b.i.d. (delayed-release), up to a maximum of 720 mg b.i.d.; or 600 mg/m2 P.O. b.i.d., up to a maximum daily dosage of 2 g/10 ml (oral suspension). Given with corticosteroids and cyclosporine.

To prevent organ rejection in patients receiving allogeneic heart transplants

Adults: 1.5 g P.O. or I.V. b.i.d., given with corticosteroids and cyclosporine. May start I.V. therapy less than 24 hours after transplantation; switch to P.O. dosing when tolerated.

To prevent organ rejection in patients receiving allogeneic liver transplants

Adults: 1.5 g b.i.d. P.O. or 1 g I.V. b.i.d., given with corticosteroids and cyclosporine

Dosage adjustment

• Severe chronic renal impairment

• Neutropenia

Contraindications

• Hypersensitivity to drug or its components, mycophenolic acid, or polysorbate 80 (I.V. form)

Precautions

Use cautiously in:

• lymphoma, cancer, neutropenia, renal disease, or GI disorders

• elderly patients

• pregnant or breastfeeding patients

• children (indicated for kidney transplant only).

Administration

• Give P.O. form at least 1 hour before or 2 hours after meals. To enhance absorption, don't give with other drugs.

• Give delayed-released tablets whole. Don't let patient crush or chew them.

• Know that pharmacist should mix oral solution before dispensing.

Be aware that drug is teratogenic. Avoid inhaling powder in capsules or letting powder contact skin, mucous membranes, or eyes. If contact occurs, wash skin thoroughly with soap and water or flush eyes with water.

• Know that delayed-release tablets aren't interchangeable with immediate-release tablets, capsules, or oral suspension.

• For I.V. use, reconstitute with dextrose 5% in water and dilute to 6 mg/ml. Administer over 2 hours.

Don't give by rapid I.V. push or bolus.

Adverse reactions

CNS: headache, dizziness, insomnia, asthenia, tremor

CV: chest pain, hypertension, peripheral edema

EENT: pharyngitis, oral moniliasis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, GI hemorrhage

GU: urinary tract infection, hematuria, renal tubular necrosis

Hematologic: anemia, hypochromic anemia, leukocytosis, leukopenia, thrombocytopenia

Metabolic: hypophosphatemia, hyperglycemia, hypokalemia, hyperkalemia

Musculoskeletal: back pain

Respiratory: dyspnea, cough, bronchitis, pneumonia

Skin: acne, rash

Other: pain, fever, opportunistic infections, fatal infections, sepsis, lymphoma and other cancers (especially of skin)

Interactions

Drug-drug. Acyclovir, ganciclovir, other drugs that undergo renal tubular secretion: increased risk of toxicity from either drug

Antacids containing aluminum or magnesium: decreased mycophenolate absorption

Cholestyramine: reduced mycophenolate bioavailability

Hormonal contraceptives: reduced contraceptive efficacy

Phenytoin, theophylline: increased blood levels of both drugs

Probenecid, salicylates: increased mycophenolate blood level

Drug-diagnostic tests. Cholesterol: increased level

Drug-herbs. Astragalus, echinacea, melatonin: interference with immunosuppressant effect

Patient monitoring

• Monitor CBC with white cell differential, electrolyte levels, lipid panel, blood chemistry, and liver function tests frequently.

• Evaluate vital signs. Assess cardiovascular and respiratory status carefully. Watch for signs and symptoms of bronchitis and pneumonia.

Assess all body systems carefully for signs and symptoms of infection.

Monitor patient closely for bleeding tendency.

Patient teaching

• Advise patient to take oral drug at least 1 hour before or 2 hours after meals. Tell him not to crush, break, or chew tablets, not to open or chew capsules, and not to take with other drugs.

If capsule breaks, tell patient not to inhale powder or let it contact skin, mucous membranes, or eyes. If contact occurs, tell him to wash skin thoroughly with soap and water or flush eyes with water.

Instruct patient to take his temperature and promptly report fever or other signs or symptoms of infection. Tell him to immediately report unusual bleeding or bruising.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• Instruct patient to avoid crowds and people with known infections.

• Advise patient not to take herbs without consulting prescriber.

• Tell patient to avoid live-virus vaccines.

Instruct patient to avoid excessive exposure to sunlight and ultraviolet light, because of increased risk of skin cancer.

Tell female patient to use abstinence or two other contraceptive methods during and for 6 weeks after therapy (even if she has a history of infertility). Urge her to report suspected pregnancy immediately.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

n

mycophenolate mofetil

A mycophenolic ester used as a therapeutic immunosuppressant, which is similar to, but less toxic than, azathioprine. Mycophenolate mofetil inhibits purine metabolism in T and B cells, and lymphocyte proliferation in vitro.

Indications
Prevent or manage GVHD, rejection of heart, kidney, lung and other allograft transplants, autoimmune disorders (e.g., Behçet  disease, pemphigus vulgaris, systemic lupus erythematosus).
 
Adverse effects
Hyperglycaemia, hypercholesterolaemia, increased BUN, potassium, leukopaenia, anaemia, diarrhoea, emesis.

mycophenolate mofetil

Immunology A mycophenolic ester derivative that may be better than azathioprine as an immunosuppressive purine analogue; it inhibits purine metabolism in T and B cells, and lymphocyte proliferation in vitro; MMF is used to prevent or manage GVHD, rejection of heart, kidney, lung and other allograft transplants, autoimmune disorders Adverse effects Leukopenia, anemia, diarrhea, emesis. See Heart transplant, Kidney transplant, Lung transplant.

mycophenolate mofetil

An IMMUNOSUPPRESSANT DRUG used to help to prevent rejection of the donated organ after kidney grafting. The drug has also been found to be more effective than cyclophosphamide in causing remission in lupus glomerulonephritis. A brand name is Cellcept.
References in periodicals archive ?
Novartis Pharmaceuticals, a Switzerland-based pharmaceutical company, has agreed to pay USD390m to resolve a civil suit filed by the US Attorney's Office for the Southern District of New York with regard to the company's interactions with specialty pharmacies for Exjade and Myfortic drugs, it was reported yesterday.
Teva has applied to the FDA for permission to market copies of delayed-release Myfortic before the three Novartis patents expire, Novartis alleged in a complaint filed April 20 in a federal court in Wilmington, DE.
In fact, the REMS being developed for CellCept and Myfortic call for physician training and certification and a pregnancy registry, according to an FDA statement.
GlaxoSmithKline Plc and US regulators said on Thursday they had notified healthcare professionals that a type of anemia has been reported in some patients treated with transplant drug Myfortic. The warning involves cases of pure red cell aplasia (PRCA), a type of anemia that can cause fatigue, lethargy or abnormal paleness of the skin.
The two drugs are mycophenolate mofetil (CellCept), made by Roche, and mycophenolic acid (Myfortic), made by Novartis Corp.
"Women taking CellCept and Myfortic and who arc planning to become pregnant should also talk with their doctors about the risks involved and whether alternative immunosuppressive agents can be considered," according to the release.
Request for proposal: Delivery Of The Drug (Myfortic) To Ensure That The Patient Based On The Decision Of The Medical Commission
*A Medicare Advantage (MA) plan covered cyclosporine under its Part B benefit but required prior authorization for Myfortic which is also Part B covered.
* MMF, Zenapax-MMF, Rapamycin-MMF, Myfortic in place of MMF, Simulect in place of Zenapax
Novartis Pharmaceuticals Corporation, East Hanover, NJ, announced the US Food and Drug Administration (FDA) has approved the use of myfortic (mycophenolic acid) delayed release tablets in combination with cyclosporine and corticosteroids to prevent organ rejection.
Novartis Pharma AG, Basel, Switzerland, announced that its application for its new enteric-coated immunosuppressive drug, Myfortic (mycophenolate sodium) successfully completed the European Mutual Recognition Procedure (MRP) in 17 countries.
Today, Novartis says it has the broadest portfolio of immunosuppressants on the market, including such products as Myfortic (mycophenolic acid) delayed-release tablets, indicated for kidney transplants, and Simulect (basiliximab), designed for the prevention of acute organ rejection.