Cellcept


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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.

Cellcept

A brand name for MYCOPHENOLATE MOFETIL.
References in periodicals archive ?
The mycophenolate mofetil hydrochloride (HCl) for injection is the generic version of Roche's CellCept and is the first and currently the only generic injectable available.
G2: (Cyclosporine, Cellcept, IV methyl Prednisolone and oral Prednisolone).
During the Christmas snow, one kidney patient was forced to wait three weeks for Cellcept, a drug he needed to stop his body rejecting a recent transplant.
That compared with nearly 34 percent with a placebo and standard therapies, which typically include immunosuppressant drugs such as Roche's CellCept and steroids such as prednisone.
Azam U: Aspreva completes expanded patient enrollment in phase III clinical trial for CellCept in pemphigus vulgaris.
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.
The Food and Drug Administration and Roche Holding AG last month revised the label of transplant drug CellCept to include a new warning about cases of PRCA.
The required label changes affect the following drugs used to help prevent rejection of transplanted organs:--Rapamune (sirolimus) Sandimmune (cyclosporine) and cyclosporine generics--Neoral (cyclosporine modified), and generics - Cellcept (mycophenolate mofetil) and generics--Myfortic (mycophenolic acid) The FDA is requiring the labeling changes based on its review of reported adverse events.
Organ Transplant Medications (anti-rejection and other) Neoral or Prograf $1,500/month Cellcept $800/month Septra $7.
The plant, which went into commercial scale production around November 2006, is already shipping Cellcept, which is used for the prevention of organ rejection in transplant patients, at full capacity.
CellCept is Roche's leading immunosuppressant or "anti-rejection" drug used in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving heart, kidney and liver transplants.