CellCept: 250 mg Capsules, 500 mg Tablets. Myfortic: 180, 360 mg Tablets

By | March 11, 2016

Mycophenolate Mofetil (mye-koe-fee-noe-late moe-fe-til) [CellCept]

Mycophenolic Acid (mye-koe-fee-noe-lik) [Myfortic]

Drug Classification

(The therapeutic classification, which categorizes drugs by the disease state they are used to treat, appears first, followed by the pharmacologic classification, which is based on the drug’s mechanism of action.)

Therapeutic class: immunosuppressants

Pregnancy Category (pregnancy categories (A, B, C, D, and X) provide a basis for determining a drug’s potential for fetal harm): C (mycophenolic acid), D (mycophenolate mofetil)

Drug Indications

(Medications are approved by the FDA for specific disease states. This section identifies the diseases or conditions for which the drug is commonly used and includes significant unlabeled uses as well.)

Mycophenolate mofetil: Prevention of rejection in allogenic renal, hepatic, and cardiac transplantation (used concurrently with cyclosporine and corticosteroids). Mycophenolic acid: Prevention of rejection in allogenic renal transplantation (used concurrently with cyclosporine and corticosteroids).

Drug Action

(This section contains a concise description of how the Drug produces the desired therapeutic effect.)

Inhibits the enzyme inosine monophosphate dehydrogenase, which is involved in purine synthesis. This inhibition results in suppression of T- and B-lymphocyte proliferation.

Therapeutic Effects of Drug: Prevention of heart, kidney, or liver transplant rejection.

Pharmacokinetics

(Pharmacokinetics refers to the way the body processes a medication by absorption, distribution, metabolism, and excretion. Also includes information on the drug’s half-life.)

Absorption: Following oral and intravenous (IV) administration, mycophenolate mofetil is rapidly hydrolyzed to mycophenolic acid (MPA), the active metabolite. Absorption of enteric-coated mycophenolic acid (Myfortic) is delayed compared to mycophenolate mofetil (CellCept).

Distribution: Cross the placenta and enter breast milk.

Protein Binding: MPA — 97%.

Metabolism and Excretion: MPA is extensively metabolized; <1% excreted unchanged in urine. Some enterohepatic recirculation of MPA occurs.

Half-life: MPA — 8-18 hours.

Time/Action Profile (the table provides the onset of Drug action, its peak effect, and its duration of activity) (blood levels of MPA)

Route Onset Peak
Mycophenolate mofetil-PO rapid 0.25-1.25 hours
mycophenolic acid rapid 1.5-2.75 hours

Contraindications/Precautions

(Situations in which Drug use should be avoided or alternatives strongly considered are listed as contraindications. In general, most drugs are contraindicated in pregnancy or lactation. The precautions portion includes disease states or clinical situations in which drug use involves particular risks or in which dosage modification may be necessary.)

Contraindicated in: Hypersensitivity; Hypersensitivity to polysorbate 80 (for intravenous (IV) mycophenolate mofetil); Obstetric Pregnancy or lactation.

Use Cautiously in: Active serious pathology of the gastrointestinal tract (including history of ulcer disease or gastrointestinal bleeding); Phenylketonuria (oral suspension contains aspartame); Severe chronic renal impairment (dose not to exceed 1 g twice daily (CellCept) if creatinine clearance < 25 ml/min/1.73 m2); careful monitoring recommended; Delayed graft function following transplantation (observe for increased toxicity); Geriatric: Increased risk of adverse reactions related to immunosuppression; Obstetric Pregnancy or patients with childbearing potential; Lactation: Lactation (safety not established) ; Pediatric: Children (mycophenolate mofetil approved in children >3 month for renal transplant; mycophenolic acid approved in children >5 year for renal transplant; safety not established for other age groups).

Adverse Reactions/Side Effects of Drug

(Although it is not possible to include all reported reactions, major side effects for all drugs are included.)

Central Nervous System (CNS): anxiety, dizziness, headache, insomnia, paresthesia, tremor. Cardiovascular: edema, hypertension, hypotension, tachycardia. Dermatologic: rashes. Endocrine: hypercholesterolemia, hyperglycemia, hyperkalemia, hypocalcemia, hypokalemia, hypomagnesemia. Gastrointestinal (GI): gastrointestinal bleeding, anorexia, constipation, diarrhea, nausea, vomiting, abdominal pain. Genitourinary: renal dysfunction. Hematologic: leukocytosis, leukopenia, thrombocytopenia, anemia. Respiratory: cough, dyspnea. Misc: fever, infection, increased risk of malignancy.

Interactions

(Drug interactions are a significant risk for patients. As the number of medications a patient receives increases, so does the likelihood of drug-drug interactions. This section provides the most important drug-drug interactions and their physiological effects.)

Drug-Drugs: Combined use with azathioprine is not recommended (effects unknown). Acyclovir and ganciclovir compete with MPA for renal excretion and, in patients with renal dysfunction, Drug may reduce each other’s toxicity. Magnesium and aluminum hydroxide antacids reduce the absorption of MPA (avoid simultaneous administration). Cholestyramine and colesti-pol reduce the absorption of MPA (avoid concurrent use). May interfere with the action of oral contraceptives (additional contraceptive method should be used). Drug may reduce the antibody response to and increase risk of adverse reactions from livevirus vaccines, although influenza vaccine may be useful.

Drug-Food: When administered with food, peak blood levels of MPA are significantly reduce (should be administered on an empty stomach).

Drug Dosage / Route

(Routes of administration are grouped together and include recommended doses for adults, children, and other. Dosage units are expressed in the terms in which they are usually prescribed. Dosing intervals also are provided in the manner in which they are frequently ordered.)

Mycophenolate Mofetil (CellCept)

Renal Transplantation

PO (by mouth, orally), Intravenous (Adults): 1 g twice daily; intravenous (IV) should be started 14 days). PO (Children 3 month-18 yr): 600 mg/m2 twice daily (not to exceed 2 g/day).

Hepatic Transplantation PO (by mouth, orally), Intravenous (Adults): 1 g twice daily Intravenous (IV), or 1.5 g twice daily PO. Intravenous (IV) should be started 14 days).

Cardiac Transplantation PO (by mouth, orally), Intravenous (Adults): 1.5 g twice daily; intravenous (IV) should be started 14 days).

Renal Impairment

PO (by mouth, orally), Intravenous (Adults): creatinine clearance

Mycophenolic Acid (Myfortic)

Mycophenolate mofetil and mycophenolic acid should not be used interchangeably without the advice of a health care professional

Renal Transplantation

PO (by mouth, orally) (Adults): 720 mg Drug twice daily.

PO (by mouth, orally) (Children 5-16 yr and >1.19m2): 400 mg/m2 twice daily (not to exceed 720 mg Drug twice daily).

Package & Price of Drug in Pharmacies of the US

(This lists the strengths and concentrations of available dose forms. Such information is useful in planning more convenient regimens (fewer tablets / capsules, less injection volume). General availability and average wholesale prices of commonly prescribed drugs have also been added as an aid to nurses with prescriptive authority.)

Mycophenolate Mofetil (Cellcept)

Capsules: 250 mg. Drug Tablets: 500 mg. Oral suspension (fruit flavor): 200 mg/ml in 225 ml bottles. Powder for injection: 500 mg vial.

Mycophenolic acid (Myfortic)

Delayed-release tablets (Myfortic): 180 mg, 360 mg.

Nursing Implications for Drug

(This section helps the nurse apply the nursing process to pharmacotherapeutics. The subsections provide a step-by-step guide to clinical assessment, implementation (Drug administration), and evaluation of the outcomes of pharmacologic therapy.)

Assessment

(This section includes guidelines for assessing patient history and physical data before and during drug therapy. Assessments specific to the drug’s various indications are also included.)

• Assess for symptoms of organ rejection throughout therapy.

Lab Test Considerations: Monitor complete blood count with differential weekly during the 1st month, twice monthly for the 2nd and 3rd month of therapy, and then monthly during the 1st year. Neutropenia occurs most frequently from 31-180 days post-transplant. If ANC (absolute neutrophil count) is < 1000/mm3, dose should be reduced or discontinued.

• Monitor hepatic and renal status and electrolytes periodically during therapy. May cause

I serum alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactic dehydrogenase (LDH), blood urea nitrogen (BUN), and creatinine. May also cause hyperkalemia, hypokalemia, hypocalcemia, hypomagnesemia, hyperglycemia, and hyperlipidemia.

Potential Nursing Diagnoses

(The two or three most pertinent NANDA diagnoses that potentially apply to a patient receiving the Drug are listed. Each diagnosis includes the pharmacologic effect from which the diagnosis has been derived.)

Risk for infection (Adverse Reactions)

Drug Implementation

(Guidelines specific for Drug administration)

• The initial dose of mycophenolate (usually intravenous) should be given within 24 hours of transplant.

• Women of childbearing years should have a negative serum or urine pregnancy test within 1 week prior to initiation of therapy.

Per Os/By Mouth: Administer on an empty stomach, 1 hour before or 2 hours after meals. Capsules and delayed-release tablets should be swallowed whole; do not open, crush, or chew. Mycophenolate may be teratogenic; contents of capsules should not be inhaled or come in contact with skin or mucous membranes.

• Do not administer mycophenolate concurrently with antacids containing magnesium or aluminum.

Intravenous Administration

Intravenous: intravenous (IV) route should only be used for patients unable to take oral medication and should be switched to oral dose form as soon as patient can tolerate capsules or tablets

• Intermittent infusion: Diluent: Reconstitute each vial with 14 ml of D5W (5% dextrose in water). Shake gently to dissolve. Solution is slightly yellow; discard if solution is discolored or contains particulate matter. Dilute contents of 2 vials (1-g dose) further with 140 ml of D5W (5% dextrose in water) or 3 vials (1.5-g dose) with 210 ml of D5W (5% dextrose in water). Concentration: 6 mg/ml. Solution is stable for 4 hours. Rate: Administer via slow intravenous (IV) infusion over 2 hours.

Y-Site Incompatibility: Do not admix or administer mycophenolate in same catheter as other medications.

Drug: Patient/Family Teaching

(This section includes information that should be taught to patients. Side effects that should be reported, information on minimizing and managing side effects of Drug, details on administration, and follow-up requirements are presented. Home Care Issues discusses aspects to be considered for medications taken in the home setting.)

• Instruct patient to take medication as directed, at the same time each day. Do not skip or double up on missed doses. Do not discontinue without consulting health care professional.

• Reinforce the need for lifelong therapy to prevent transplant rejection. Review symptoms of rejection for the transplanted organ, and stress need to notify health care professional immediately if signs of rejection or infection occur.

• Inform female patients of the importance of simultaneously using two reliable forms of contraception, unless abstinence is the chosen method, prior to beginning, during, and for 6 week following discontinuation of therapy.

• Advise patient to avoid contact with persons with contagious diseases.

• Inform patient of the increased risk of lymphoma and other malignancies. Advise patient to use sunscreen and wear protective clothing to decrease risk of skin cancer.

• Advise patient to consult health care professional prior to taking other medications concurrently with mycophenolate.

• Emphasize the importance of routine follow-up laboratory tests.

Drug: Evaluation / Desired Outcomes

(Outcome criteria for determination of the effectiveness of Drug are provided.)

• Prevention of rejection of transplanted organs.

 

Selections from the book: “Davis’s Drug Guide for Nurses. Eleventh Edition”. Judith Hopfer Deglin, PharmD; April Hazard Vallerand, PhD, RN, FAAN. 2008

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