Adult Dosing

Kidney transplant rejection prophylaxis

• 1 g PO bid

Heart transplant rejection prophylaxis

• 1.5 g PO bid

Liver transplant rejection prophylaxis

• 1.5 g PO bid

Kidney transplant rejection prophylaxis

Myfortic

• Usual dose: 720 mg PO bid on an empty stomach, 1 hour prior or two hours after food intake
• Max: 720 mg PO bid

Note:

• Do not cut, crush or chew before ingesting, should be swallowed whole

Pediatric Dosing

Kidney transplant rejection prophylaxis

• Child 3 mo-18 yrs
• 600 mg/m² PO bid
• Alt: 750 mg PO bid for body surface area 1.25 m² to 1.5 m², 1 g PO bid for body surface area > 1.5 m²

Kidney transplant rejection prophylaxis

Myfortic

• Usual dose: 400mg/m² body surface area (BSA) PO bid
• Patients with BSA of 1.19-1.58 m² 3 tabs of 180 mg or 1 tab of 180 mg + 1tab of 360 mg PO bid (1080mg daily dose)
• Patients with BSA of >1.58 m² 4 tabs of 180 mg or 2 tabs of 360 mg PO bid (1440 mg daily dose)
• BSA <1.19 m² cannot be accurately administered using currently available formulations

[Outline]

• Adult Dosing
• Pediatric Dosing

CellCept, mycophenolate mofetil

• Prophylaxis of organ rejection used concomitantly with cyclosporine and corticosteroids in patients receiving allogeneic renal, cardiac, or hepatic transplants

Myfortic, mycophenolic acid

• Prophylaxis of organ rejection used concomitantly with cyclosporine and corticosteroids in patients receiving allogeneic renal transplants

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to polysorbate 80
• Pregnancy
• Lesch-Nyhan syndrome
• Kelly-Seegmiller syndrome

• Therapy may increase risks of first trimester pregnancy loss and congenital malformations. Advise females of reproductive potential (FRP) regarding pregnancy prevention and planning
• Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should prescribe mycophenolate. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient

Renal Dose Adjustment

Renal transplant patients, delayed graft function immediate postop

• No dose adjustments

Renal transplant patients, outside immediate post transplant period

• CrCl < 25 mL/min: Max: 1 g bid, Monitor for adverse events

Hepatic Dose Adjustment

• Renal transplant with severe hepatic parenchymal disease: No dose adjustments
• Hepatic impairment with other etiologies: Dosage adjustment not defined

• Therapy may cause fetal harm and is associated with an increased risk of first trimester pregnancy loss and congenital malformations, especially external ear, facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. Advise females of reproductive potential (FRP) regarding pregnancy prevention and planning [US Black Box Warning]
• Administer only under supervision of physicians experienced in immunosuppressive therapy and management of renal, cardiac, or hepatic transplant patients in an adequate medical facility. Physicians responsible for maintenance therapy should have all information needed for pt follow-up [US Black Box Warning]
• Increased susceptibility to infection and possible development of lymphoma may occur due to immunosuppression [US Black Box Warning]
• Mycophenolate mofetil in combination with cyclosporine and corticosteroids is indicated for prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants
• It is contraindicated in hypersensitivity to mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, or any other component of the product
• Patients receiving immunosuppressive agents are at an increased risk of developing lymphomas and other malignancies. Limit exposure to sunlight and UV light by wearing protective clothing
• Immunosuppressants can increase susceptibility to opportunistic infections, fatal infections and sepsis
• Latent viral infections including progressive multifocal leukoencephalopathy (PML) and BK virus-associated nephropathy (BKVAN) have been occurred in patients receiving immunosuppressants
• Severe neutropenia has been reported in renal, cardiac, and hepatic transplant patients receiving mycophenolate. Monitor for neutropenia, and if develops consider dose reduction, interruption or manage patient appropriately
• Perform pregnancy test < 1wk prior to starting therapy in women of childbearing potential. Women planning to conceive should consider immunosuppressants with less potential for embryofetal toxicity
• Use two reliable forms of contraception for 4 wks before therapy, during tx, and for 6 wks after discontinuation in women of childbearing potential
• Monitor creatinine at baseline; CBC qwk x 1mo, then twice monthly for two months, then qmo throughout the first year

Cautions: Use cautiously in

• Severe chronic renal impairment (careful monitoring required)
• Active serious pathology of the GI tract
• Hx of GI bleeding
• Hx of PUD
• Phenylketonuria
• Delayed graft function following transplantation
• Elderly patients
• Patients with childbearing potential

Myfortic interacts with :

	Aciphex
	Amoxicillin/clavulanate
	Antacids
	Augmentin
	Augmentin ES-600
	Augmentin XR
	Axid
	Axid AR
	Calcium Polycarbophil
	Carafate
	Cholestyramine
	Cimetidine
	Colestid
	Colestipol
	Dexilant
	Dexlansoprazole
	Esomeprazole
	Famotidine
	Flagyl
	Flagyl ER
	Flagyl IV
	Fluxid
	Iron
	Kapidex
	Lansoprazole
	Locholest
	Locholest Light
	MetroCream
	MetroGel
	MetroGel-Vaginal
	MetroLotion
	Metronidazole
	Nexium
	Nexium IV
	Nizatidine
	Noritate
	Omeprazole
	Pantoprazole
	Pepcid
	Pepcid AC
	Pepcid RPD
	Prevacid
	Prevacid 24 HR OTC
	Prevalite
	Prilosec
	Prilosec OTC
	Protonix
	Protonix IV
	Questran
	Questran Light
	Rabeprazole
	Ranitidine
	Renagel
	Renvela
	Sevelamer
	Sucralfate
	Tagamet
	Tagamet HB
	Vandazole
	Zantac
	Zantac 150
	Zantac 25
	Zantac 300
	Zantac 75

Pregnancy Category:D

Breastfeeding: Safety unknown, an alternate drug may be preferred, especially while nursing a newborn or preterm infant based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 12 February 2011).Because of the potential for possible serious adverse reactions in nursing infants, manufacturer recommends discontinuation of breastfeeding, or postponing of treatment (taking into account the importance of the drug to the mother).

• CNS: Progressive multifocal leukoencephalopathy, anxiety, dizziness, headache, insomnia, paresthesia, tremor
• CV: Peripheral edema, hypertension, hypotension, tachycardia
• IMMU: Immunosuppression
• DERM: Rashes, acne
• ENDO: Hypercholesterolemia, hyperglycemia, hyperkalemia, hypocalcemia, hypokalemia, hypomagnesemia
• GI: GI bleeding, GI ulceration, GI perforation, colitis, anorexia, constipation, diarrhea, nausea, vomiting, abdominal pain, dyspepsia
• GU: Renal dysfunction, BK virus-associated nephropathy, pregnancy loss, 1st trimester, congenital malformations
• HEMA: Neutropenia, leukocytosis, leukopenia, thrombocytopenia, anemia, pure red cell aplasia
• RESP: Cough, dyspnea, interstitial lung disease
• MISC: Opportunistic infections, fever, severe/fatal infection, tremor, risk of malignancy, PML, lymphoma, lymphoproliferative disorders

• Immunosuppressant agent; inhibits proliferation of B- and T-lymphocyte
• Mycophenolate is a prodrug which is converted to mycophenolic acid (MPA)
• MPA is metabolized to MPAG by glucuronyl transferase
• Renally excreted: 93%; feces: 6%
• Half-life: MPA: 17.9 hrs (range: 8-16 hrs)

US Trade Name(s)

• Cellcept
• Myfortic

US Availability

mycophenolate mofetil (generic)

• CAPS: 250 mg
• TABS: 500 mg

mycophenolic acid (generic)

• Delayed Release TABS: 180, 360 mg

CellCept (mycophenolate mofetil)

• CAPS: 250 mg
• TABS: 500 mg
• SUSP: 200 mg/mL

Myfortic (mycophenolic acid)

• Delayed Release TABS: 180, 360 mg

Canadian Trade Name(s)

• Cellcept

Canadian Availability

CellCept

• CAP: 250 mg
• TABS: 500 mg
• PWDR for SUSP: 200 mg/mL

UK Trade Name(s)

• Arzip
• Cellcept
• Myfortic

UK Availability

mycophenolate mofetil (generic)

• CAPS: 250 mg
• TABS: 500 mg

Arzip

• CAP: 250 mg
• TABS: 500 mg

CellCept

• CAP: 250 mg
• TABS: 500 mg
• PWDR for SUSP: 1 g/5 mL

Myfortic

• ETABS: 180, 360 mg

Australian Trade Name(s)

• Cellcept
• Myfortic

Australian Availability

CellCept

• CAP: 250 mg
• TABS: 500 mg
• PWDR for SUSP: 1 g/5 mL

Myfortic

• ETABS: 180, 360 mg

[Outline]

Allergy & Immunology

Immunosuppressants

Pricing data from www.DrugStore.com in U.S.A.

• Mycophenolate Mofetil 250 MG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
  30 mg = $35.99
  100 mg = $109.98
• Myfortic 360 MG TBEC [Bottle] (NOVARTIS)
  120 mg = $949
  360 mg = $2812.07

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Myfortic 180 MG Enteric Coated Tablet

Ingredient(s): Mycophenolic Acid

Imprint: C

Color(s): Green

Shape: Round

Size (mm): 10.00

Score: 1

Inactive Ingredient(s): silicon dioxide / crospovidone / hypromellose / fd&c blue no. 2 / ferric oxide yellow / anhydrous lactose / magnesium stearate / povidone k30 / starch, corn / titanium dioxide

Drug Label Author:
Novartis Pharmaceuticals Corporation

DEA Schedule:
Non-Scheduled

Drug Name: Myfortic 360 MG Enteric Coated Tablet

Pill Image:

[
See full size image]

Ingredient(s): Mycophenolic Acid

Imprint: CT

Color(s): Orange

Shape: Oval

Size (mm): 18.00

Score: 1

Inactive Ingredient(s): silicon dioxide / crospovidone / hypromellose / ferric oxide red / ferric oxide yellow / anhydrous lactose / magnesium stearate / povidone k30 / starch, corn / titanium dioxide

Drug Label Author:
Novartis Pharmaceuticals Corporation

DEA Schedule:
Non-Scheduled