MYCOPHENOLATE MOFETIL

MYCOPHENOLATE MOFETIL
(my-co-phen'o-late mo'fe-till)
CellCept
MYCOPHENOLATE ACID
Myfortic
Classifications: biologic response modifier; immunosuppressant;
Therapeutic: immunosuppressant

Prototype: Cyclosporine
Pregnancy Category: C

Availability

250 mg capsules; 500 mg tablets; 180 mg, 360 mg delayed-release tablets; 500 mg injection; 200 mg/mL oral solution

Action

Prodrug with immunosuppressant properties; inhibits T- and B-lymphocyte proliferation responses; inhibits antibody formation, and blocks the generation of cytotoxic T cells.

Therapeutic Effect

Antirejection effects attributed to decreased number of activated lymphocytes in the graft site. Synergistic with cyclosporine.

Uses

Prophylaxis of organ rejection in patients receiving allogenic kidney, liver, or heart transplants.

Unlabeled Uses

Treatment of rheumatoid arthritis and psoriasis.

Contraindications

Hypersensitivity to mycophenolate mofetil; vaccination, varicella; pregnancy (category C), lactation; children <5 y.

Cautious Use

Viral or bacterial infections; presence or history of carcinoma; bone marrow suppression; active peptic ulcer disease; cholestasis; gallbladder disease; GI disease, severe diarrhea; malabsorption syndromes; hepatic encephalopathy, hepatic or renal impairment; renal failure, uremia; herpes infection, infection; hypoalbuminemia; PKU; lactase deficiency.

Route & Dosage

Note: CellCept and Myfortic are not interchangeable.

Prophylaxis for Kidney Transplant Rejection
Adult: PO/IV Start within 24 h of transplant, 1 g (mofetil) or 720 mg (sodium) b.i.d. in combination with corticosteroids and cyclosporine
Child: PO 600 mg/m2 (mofetil) or 400 mg/m2 (sodium) b.i.d. (max: 2 g/d mofetil, 720 mg/d sodium)

Prophylaxis for Heart/Liver Transplant Rejection
Adult: PO/IV 1.5 g (mofetil) b.i.d. started within 24 h of transplant

Administration

Oral
  • Give oral drug on an empty stomach.
  • Adjust dosage with severe chronic kidney failure.
  • Do not open or crush capsules; avoid contact with powder in capsules, and wash thoroughly with soap and water if contact occurs.
Intravenous

PREPARE: IV Infusion: Reconstitute each vial with 14 mL D5W. Further dilute each 500 mg in an additional 70 mL of D5W to yield 6 mg/mL.  

ADMINISTER: IV Infusion: Slowly infuse over ≥2 h. Avoid rapid injection.  

INCOMPATIBILITIES Solution/additive & Y-site: Do not mix or infuse with other medications.

  • Begin IV mycophenolate mofetil within 24 h of transplant and continued for up to 14 d.
  • Switch patient to oral drug as soon as possible.
  • Store at 15°–30° C (59°–86° F).

Adverse Effects (≥1%)

CNS: Headache, tremor, insomnia, dizziness, weakness. CV: Hypertension. Endocrine: Hyperglycemia, hypercholesterolemia, hypophosphatemia, hypokalemia, hyperkalemia, peripheral edema. GI: Diarrhea, constipation, nausea, anorexia, vomiting, abdominal pain, dyspepsia. Urogenital: UTI, hematuria, renal tubular necrosis, burning, frequency, vaginal burning or itching, vaginal bleeding, kidney stones. Hematologic: Leukopenia, anemia, thrombocytopenia, hypochromic anemia, leukocytosis. Respiratory: Respiratory infection, dyspnea, increased cough, pharyngitis. Skin: Rash. Body as a Whole: Leg or hand cramps, bone pain, myalgias, sepsis (bacterial, fungal, viral).

Interactions

Drug: Acyclovir, ganciclovir may increase mycophenolate serum levels. antacids, cholestyramine decreases mycophenolate absorption. Mycophenolate may decrease protein binding of phenytoin or theophylline, causing increased serum levels.

Pharmacokinetics

Absorption: Rapidly from GI tract; 94% reaches systemic circulation; absorption decreased by food. Onset: 4 wk. Metabolism: In liver to active form, mycophenolic acid. Elimination: 87% in urine. Half-Life: 11 h.

Nursing Implications

Assessment & Drug Effects

  • Prior to initiating therapy: baseline CBC with differential.
  • Withold dose and notify physician if neutropenia develps (ANC <1.3 x 103/mcL).
  • Lab tests: Monitor CBC weekly for first month, biweekly for second and third months, then once per month for first year; periodic kidney function tests, LFTs, serum electrolytes, lipase, amylase, blood glucose, and routine urinalysis.
  • Monitor for and report any S&S of sepsis or infection.

Patient & Family Education

  • Comply exactly with dosing regimen and scheduled laboratory tests.
  • Report to physician immediately S&S of infection, such as UTI or respiratory infection, or signs of bleeding (e.g., black tarry stools, blood in urine, easy bruising).
  • Report all troubling adverse reactions (e.g., blood in urine and swelling in arms and legs) to physician as soon as possible.
  • Avoid taking OTC antacids simultaneously with mycophenolate mofetil. Separate the two drugs by 2 h.
  • Women should use effective contraception during and for 6 wk after treatment is completed.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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