Mycophenolate Mofetil

A to Z Drug Facts

Mycophenolate Mofetil

	Action
	Indications
	Contraindications
	Route/Dosage
	Interactions
	Lab Test Interferences
	Adverse Reactions
	Precautions
Patient Care Considerations
	Administration/Storage
	Assessment/Interventions
	Patient/Family Education

(my-koe-FEN-oh-late moE-feh-till)

CellCept

Class: Immunosuppressive

Action Inhibits immune-mediated inflammatory responses, but exact mechanism not known.

Indications In combination with cyclosporine and corticosteroids for prophylaxis of organ rejection in patients receiving allogenic renal or cardiac transplants.

Contraindications Hypersensitivity to the drug, mycophenolic acid, or any component of the drug product; persons with a sensitivity to polysorbate 80 (Tween) (IV only).

Route/Dosage

Renal Transplantation

ADULTS: PO/IV 1 g administered over ³ 2 hours bid (daily dose of 2 g).

Cardiac Transplantation

ADULTS: PO/IV 1.5 g administered over ³ 2 hours bid (daily dose of 3 g).

Interactions

Acyclovir: Possible increased plasma concentrations of both drugs. Antacids containing magnesium and aluminum hydroxides: Decreased absorption of mycophenolate; do not administer simultaneously. Azathioprine: Avoid use due to lack of clinical studies. Cholestyramine: Decreased mycophenolate plasma concentrations; do not give mycophenolate with cholestyramine or other agents that may interfere with enterohepatic recirculation. Ganciclovir: Possible increased plasma concentrations of both drugs. Probenecid: May increase plasma concentrations of mycophenolate. Salicylates: Coadministration increased the free fraction of MPA. Phenytoin: MPA decreased protein binding of phenytoin and may, therefore, increase free phenytoin levels. Theophylline: MPA decreased protein binding of theophylline and may, therefore, increase free theophylline levels.

Lab Test Interferences None well documented.

Adverse Reactions

CV: Hypertension; hypotension; orthostatic hypotension; peripheral edema; tachycardia; chest pain; palpitations; ventricular extrastystole; CHF; upraventricular tachycardia; ventricular tachycardia; atrial flutter; pulmonary hypertension; heart arrest; venous pressure increase; syncope; supraventricular extrasystoles; extrastystoles; pallor; vasospasm. CNS: Headache; tremor; insomnia; dizziness; anxiety; depression; somnolence; aresthesia; emotional lability; neuropathy; convulsion; hallucinations; abnormal thinking; vertigo. DERM: Acne; rash; alopecia; pruritis; sweating; hemorrhage; skin carcinoma. EENT: Amblyopia; cataracts; conjunctivitis; rhinitis; sinusitis; pharyngitis; ar pain; deafness; ear disorder; tinnitus; abnormal vision; lacrimation disorder; ye hemorrhage. GI: Diarrhea; constipation; nausea; abdominal pain; dyspepsia; vomiting; oral moniliasis; anorexia; esophagitis; flatulence; gastritis; GI hemorrhage; gingivitis; ingival hyperplasia; ileus; GI disorder; liver damage; dysphagia; jaundice; tomatitis; thirst. GU: Urinary tract infection or disorder; hematuria; kidney tubular necrosis; ysuria; impotence; pyelonephritis; urinary frequency; nocturia; kidney failure; rine abnormality; hematuria; urinary incontinence; prostatic diorder; urinary retention. HEMA: Anemia; hypochromic anemia; leukopenia; thrombocytopenia; leukocytosis. HEPA: Elevated liver function tests. META: Hypercholesterolemia; hypophosphatemia; hypokalemia; hyperkalemia; yperglycemia; edema. RESP: Infection; dyspnea; cough; bronchitis; asthma; pulmonary edema; leural effusion; pneumonia; meningitis; infectious endocarditis; tuberculosis; atypical mycobaterial infection; atelectasis; hiccup; pneumothorax; increased sputum; epistaxis; apnea; voice alteration; pain; hemoptysis; neoplasm; respiratory acidosis. OTHER: Body/back pain; fever; chills; infection; sepsis; asthenia; arthralgia; yalgia; leg cramps; myasthenia; lymphoma/lymphoproliferative disease; nonmelanoma skin carcinoma; Cushing's syndrome; hypothyroidism; neck pain; cellulitis; ncreased prothrombin; decreased thromboplastin; petechia; phlebitis; thrombosis; eight gain/loss; abnormal healing; dehydration.

Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. Women of childbearing potential: Should have a negative serum or urine pregnancy test within 1 week of beginning therapy; effective contraception (abstinence or two reliable methods) ust be used before, during and for 6 weeks following discontinuation of therapy. Lymphomas/malignancies: Patients receiving immunosuppressive regimens involving combinations of drugs are at increased risk of developing lymphomas and other malignancies, particularly of the skin. Risk appears to be related to intensity and duration of immunosuppression rather than to any specific agent. Infection: Suppression of the immune system increases susceptibility to infection. Neutropenia: Monitor patients for neutropenia; dosage changes may be indicated. Monitoring: Complete blood counts should be performed weekly during the first month, twice monthly during the second and third months, then monthly through the first year. GI hemorrhage: GI tract hemorrhage has been observed; administer with caution to patients with active serious digestive system disease. Impaired renal function: Do not exceed 2 g per day doses in patients with GFR < 25 ml/min/1.73 m²; carefully monitor these patients.

PATIENT CARE CONSIDERATIONS

Administration/Storage

Initial oral dose as soon as possible following transplantation.
Oral medication is most effective on an empty stomach.
Medication should be used concurrently with cyclosporine and corticosteroids.
Do not open or crush capsules. Avoid inhalation or direct contact with skin or mucous membranes of the capsule powder. If contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Store at room temperature.

Assessment/Interventions

Obtain patient history.
Obtain baseline laboratory tests, including BUN, creatinine, lipid levels, potassium, WBC with diff and CBC. Perform and evaluate these tests periodically during treatment.
Assess for any signs of infection, bleeding or bruising.
Maintain medical asepsis and eliminate any potential sources of environmental contamination.
Monitor for signs and symptoms of organ rejection.

OVERDOSAGE: SIGNS & SYMPTOMS
	Nausea, vomiting, diarrhea, neutropenia

Patient/Family Education

Instruct patient not to change dose or discontinue medication without consulting health care provider.
Instruct patient to check with healthcare provider before taking any otc or prescription medications, and vaccinations.
Instruct patient to report any serious side effects to health care provider, including: tremors, headaches, diarrhea, hypertension, nausea and low urine output.
Inform patient of need for frequent laboratory tests while taking this medication. Be sure to keep appointments.
Instruct patient to avoid contact with others who may have infections.
Instruct patient to use a soft toothbrush and to practice frequent oral hygiene.
Instruct patient to take medication 30 minutes before or 2 hours after meals. If medication causes GI upset, take with a full glass of water. May be taken with food, but is less effective.
Instruct women of childbearing potential to use effective contraception before beginning therapy, during therapy and for 6 weeks after stopping therapy.
Instruct patients with increased risk for skin cancer to limit exposure to sunlight and UV light by wearing protective clothing and using a strong sunscreen.