mycophenolate (Rx)Brand and Other Names:CellCept, Myfortic, more...MMF

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 250mg

tablet

  • 500mg

oral suspension

  • 200mg/mL

powder for injection

  • 500mg/vial

tablet, delayed release

  • 180mg
  • 360mg
more...

Kidney Transplant

Prophylaxis of organ rejection in patients receiving allogeneic renal transplants; use concomitantly with cyclosporine and corticosteroids

Mycophenolate mofetil (MMF): 1 g PO/IV q12hr, infused over ≥2 hours

Mycophenolic acid (MPA): 720 mg PO q12hr

Heart Transplant

Prophylaxis of organ rejection in patients receiving allogeneic cardiac transplants; use concomitantly with cyclosporine and corticosteroids

MMF: 1.5 g PO/IV q12hr, infused over ≥2 hours

Liver Transplant

Prophylaxis of organ rejection in patients receiving allogeneic hepatic transplants; use concomitantly with cyclosporine and corticosteroids

MMF (IV): 1 g q12hr; infused over ≥2 hours

MMF (PO): 1.5 g q12hr

Dosing Modifications

Renal impairment

  • MMF: In severe renal impairment (glomerular filtration rate [GFR] <25 mL/min/1.73 m²), not to exceed 1 g q12hr
  • No dosage adjustment needed in renal transplant patients experiencing delayed graft function postoperatively

Lupus Nephritis (Off-label)

Induction therapy for lupus nephritis (MMF)

Induction: 1 g PO q12hr with a glucocorticoid or 2-3 g for 6 months with glucocorticoids

Maintenance: 0.5-3 g/day or 1 g PO q12hr or 1-2 g daily

Administer with initial IV corticosteroid pulse for 3 days, then prednisone 0.5-1 mg/kg/day PO; not to exceed 10 mg/day; after a few weeks, prednisone may be tapered to lowest effective dose

Dosage Forms & Strengths

capsule

  • 250mg

tablet

  • 500mg

oral suspension

  • 200mg/mL

tablet, extended release

  • 180mg
  • 360mg
more...

Kidney Transplant

<3 months

  • Safety and efficacy not established

>3 months

  • Prophylaxis of organ rejection in patients receiving allogeneic renal transplants
  • MMF (suspension): 600 mg/m² PO q12hr; not to exceed 2 g/day 
  • MMF: BSA 1.25-1.5 m²: 750 mg capsule PO q12hr
  • MMF: BSA >1.5 m²: 1 g capsule/tablet PO q12hr
  • Extended-release MPA: 400 mg/m² PO q12hr; not to exceed 720 mg q12hr
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Interactions

Interaction Checker

mycophenolate and

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    Contraindicated

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            Adverse Effects

            >10%

            Hyperglycemia (44%)

            Hypercholesterolemia (41%)

            Hypomagnesemia (39%)

            Dyspnea (37%)

            Back pain (35%)

            Increased blood urea nitrogen (BUN) (35%)

            Leukopenia (34%)

            Pleural effusion (34%)

            Urinary tract infection (34%)

            Increasing frequency of cough (31%)

            Hypocalcemia (30%)

            Hypertension (28%)

            Abdominal pain (27%)

            Peripheral edema (27%)

            Anemia (26%)

            Fever (23%)

            Nausea (23%)

            Hyperkalemia (22%)

            Diarrhea (21%)

            Infection (21%)

            Headache (16%)

            1-10%

            Melanoma (1.6-4.2%)

            Other malignancies (0.7-2.1%)

            Lymphoma (0.4-1%)

            Opportunistic infection (including herpes)

            Neutropenia

            GI bleeding

            Pulmonary fibrosis

            Progressive multifocal leukoencephalopathy

            Postmarketing Reports

            BK virus-associated nephropathy

            Congenital malformations, including ear, facial, cardiac and nervous system malformations and an increased incidence of first trimester pregnancy

            Colitis (sometimes caused by cytomegalovirus), pancreatitis, isolated cases of intestinal villous atrophy

            Cases of pure red cell aplasia (PRCA) and hypogammaglobulinemia reported when administered in combination with other immunosuppressive agents

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            Warnings

            Black Box Warnings

            Increased susceptibility to infection as consequence of immunosuppression

            Drug should be prescribed only by healthcare providers experienced in immunosuppressive therapy and management of renal, cardiac, or hepatic transplant patients

            Patients receiving drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources

            Drug increases risk of developing lymphoma and risk of skin malignancy

            Myfortic and CellCept dosage form absorbed differently; not for use interchangeably

            Healthcare provider responsible for maintenance therapy should have all information required for follow-up

            Risk of first-trimester miscarriage and congenital malformations; after negative pregnancy test and follow-up, women of child-bearing age should use 2 forms of reliable contraception (hormone plus barrier) during entire course of mycophenolate therapy and continue until 6 weeks after drug discontinuance

            Contraindications

            Hypersensitivity

            IV formulation (CellCept) in patients allergic to polysorbate 80

            Cautions

            Pure red-cell aplasia reported in patients treated with MMF or MPA in combination with other immunosuppressive agents

            Avoid use in hypoxanthine-guanine phosphoribosyltransferase (HGPRT) deficiency (Lesch-Nyhan, Kelley-Seegmiller syndrome)

            Risk of miscarriage and congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney and nervous system (see Black Box Warnings)

            MMF PO suspension contains aspartame

            MPA not indicated for hepatic or cardiac transplants

            Use may be rarely associated with gastric or duodenal ulcers, GI bleeding and/or perforation

            Safety and effectiveness of MPA for de novo pediatric renal transplant not established

            Neutropenia may occur (may require dose reduction)

            Must not be administered by rapid or bolus IV injection

            Toxicity may increase in renal impairment; use caution

            Serious infections and viral reactivation

            • Increased risk of developing bacterial, fungal, protozoal, and new or reactivated viral infections, including opportunistic infections
            • Because of danger of oversuppression of immune system, which can increase susceptibility to infection, combination immunosuppressant therapy should be used with caution
            • May increase risk of new or reactivated viral infections, including polyomavirus-associated nephropathy (PVAN), JC virus-associated progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV) infections, and reactivation of hepatitis B or C
            • PVAN, especially when due to BK virus infection, is associated with serious outcomes, including deteriorating renal function and renal graft loss
            • PML, which is sometimes fatal, typically presents with hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia
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            Pregnancy & Lactation

            Pregnancy category: D

            Can cause fetal harm when administered to pregnant female; use of MMF during pregnancy is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of distal limbs, heart, esophagus, kidney and nervous system

            Lactation: Unknown whether drug is excreted in breast milk; avoid using, or do not nurse

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits T- and B-cell proliferation, as well as antibody production

            Acts as noncompetitive, selective, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH)

            Absorption

            Bioavailability: 94% (CellCept); 72% (Myfortic)

            Peak plasma time: 1.5 hr

            Distribution

            Protein bound: 82-97%

            Vd (MMF): IV, 3.6 L/kg; PO, 4.0 L/kg

            Vd (MPA): Steady state, 54 L; elimination phase, 112 L

            Metabolism

            Metabolized via enterohepatic recirculation

            Metabolites: MPA (active form; MMF is prodrug)

            Elimination

            Half-life (MMF): PO, 18 hr; IV, 17 hr

            Half-life (MPA): PO, 8-16 hr; MPA glucuronide (MPAG), 13-17 hr

            Excretion as metabolites: Urine; feces

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            Administration

            Drug is taken on empty stomach 1 hour before or 2 hours after meals

            Once dosage is stabilized, MMF can be taken with food after kidney transplant

            Solid PO forms should be swallowed whole and not chewed, crushed, or split; capsules must not be opened

            IV Preparation

            Does not contain antibacterial preservative; therefore, reconstitution and dilution must be done aseptically in vertical laminar flow hood, with same precautions as for antineoplastic agents

            Step 1

            • To prepare 1-g dose, use 2 vials; to prepare 1.5-g dose, use 3 vials
            • Reconstitute contents of each vial by injecting 14 mL D5W, then gently shake to dissolve
            • Before diluting further, inspect resulting slightly yellow solution for particulate matter and discoloration; discard if either is observed

            Step 2

            • To prepare 1-g dose, further dilute contents of 2 reconstituted vials into 140 mL D5W; to prepare 1.5-g dose, further dilute contents of 3 reconstituted vials into 210 mL D5W; final concentration of both solutions is 6 mg/mL
            • Inspect infusion solution for particulate matter and discoloration; discard if either is observed

            IV Administration

            Infuse over ≥2 hours

            Do not administer via rapid or bolus injection

            Storage

            Infusion solution is stable for 4 hours after reconstitution and dilution

            Store solution at 15-30°C (59-86°F)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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