Mycophenolate mofetil

Mycophenolate mofetil Brand Names- CellCept | Myfortic

What is Mycophenolate mofetil

Mycophenolate mofetil (MMF, RS-61443, CellCept), a prodrug for Mycophenolic acid (MPA), and mycophenolate sodium (Myfortic), a delayed-release tablet of MPA are used in conjunction with cyclosporine and corticosteroids for the prevention of rejection in patients with a renal allograft.

Mycophenolic acid (MPA) is an immunosuppressive drug. Mycophenolic acid was isolated in 1898 from a Penicillium culture; however, it was not studied as an immunosuppressive agent until the 1970s.

Twice daily oral administration of mycophenolate sodium 720 mg and MMF 1000 mg were found to be therapeutically equivalent, which was defined as the incidence of biopsy-proven acute rejection, graft loss, death, or loss to follow-up.

Similar percentages of patients that received MMF or mycophenolate sodium developed delayed graft function and drug-related adverse events. Also, the percentage of de novo and maintenance renal transplant patients that developed a fungal or viral infection was similar for those that received MMF compared with mycophenolate sodium.

The rate of rejection in renal allograft recipients during MMF therapy was lower than during therapy with azathioprine, both given in combination with cyclosporine and corticosteroids.

However, the use of MMF for acute renal allograft rejection has shown no statistically significant benefit compared with standard therapy.

The incidence of nephrotoxicity appears to be less with MMF than with cyclosporine, and lower doses of cyclosporine can be used when mycophenolate therapy is added, thereby reducing the risk of cyclosporine-induced nephrotoxicity.

Mycophenolic acid has been successful in patients with rheumatoid arthritis, including patients resistant to methotrexate.

Mycophenolate products may increase the risk of fetal harm (birth defects) and miscarriage in the first trimester of pregnancy; the Mycophenolate REMs program has been established to manage these risks.

Females of reproductive potential must receive pregnancy testing before and after starting treatment, and routinely during follow-up visits with the prescriber.

More information is available at www.mycophenolaterems.com.

Indications

• atopic dermatitis
• graft-versus-host disease (GVHD)
• heart transplant rejection prophylaxis
• kidney transplant rejection
• kidney transplant rejection prophylaxis
• liver transplant rejection prophylaxis
• lupus nephritis
• myasthenia gravis
• pemphigus
• psoriasis
• rheumatoid arthritis
• systemic lupus erythematosus (SLE)
• uveitis

For the treatment of refractory acute kidney transplant rejection

Side Effects

• abdominal pain
• acne vulgaris
• agitation
• agranulocytosis
• alopecia
• amblyopia
• anemia
• angina
• anorexia
• anxiety
• apnea
• arrhythmia exacerbation
• arthralgia
• ascites
• asthenia
• atrial fibrillation
• atrial flutter
• azotemia
• back pain
• BK virus-associated nephropathy
• bladder spasm
• blurred vision
• bradycardia
• bullous rash
• candidiasis
• cardiac arrest
• cataracts
• chest pain (unspecified)
• chills
• cholangitis
• cholestasis
• coagulopathy
• colitis
• confusion
• conjunctivitis
• constipation
• cough
• Cushing’s syndrome
• dehydration
• delirium
• depression
• diabetes mellitus
• diarrhea
• dizziness
• drowsiness
• dyspepsia
• dysphagia
• dysphonia
• dyspnea
• dysuria
• ecchymosis
• edema
• elevated hepatic enzymes
• emotional lability
• epistaxis
• esophageal ulceration
• esophagitis
• fatigue
• fever
• flatulence
• gastritis
• gastroesophageal reflux
• GI bleeding
• GI perforation
• gingival hyperplasia
• gingivitis
• gout
• hallucinations
• headache
• hearing loss
• heart failure
• hematemesis
• hematuria
• hemoptysis
• hepatitis
• hiccups
• hirsutism
• hyperbilirubinemia
• hypercalcemia
• hypercholesterolemia
• hyperglycemia
• hyperkalemia
• hyperlipidemia
• hyperphosphatemia
• hypertension
• hypertonia
• hyperuricemia
• hyperventilation
• hypervolemia
• hypocalcemia
• hypochloremia
• hypoglycemia
• hypokalemia
• hypomagnesemia
• hyponatremia
• hypophosphatemia
• hypotension
• hypothyroidism
• hypovolemia
• hypoxia
• ileus
• immunosuppression
• impaired wound healing
• impotence (erectile dysfunction)
• increased urinary frequency
• infection
• influenza
• insomnia
• jaundice
• lacrimation
• leukocytosis
• leukoencephalopathy
• leukopenia
• lymphocele
• lymphoma
• malaise
• melena
• meningitis
• metabolic acidosis
• metabolic alkalosis
• muscle cramps
• myalgia
• myasthenia
• nasal congestion
• nausea
• neutropenia
• new primary malignancy
• nocturia
• ocular hemorrhage
• oliguria
• oral ulceration
• orthostatic hypotension
• osteoporosis
• otalgia
• pallor
• palpitations
• pancreatitis
• pancytopenia
• paresthesias
• pelvic pain
• peptic ulcer
• pericardial effusion
• peripheral edema
• peripheral neuropathy
• peripheral vasodilation
• petechiae
• pharyngitis
• phlebitis
• pleural effusion
• pneumonitis
• pneumothorax
• polycythemia
• polydipsia
• post-transplant lymphoproliferative disorder (PTLD)
• pruritus
• psychosis
• pulmonary edema
• pulmonary fibrosis
• pulmonary hypertension
• rash
• red cell aplasia
• renal failure (unspecified)
• renal tubular necrosis
• rhinitis
• seizures
• sinus tachycardia
• sinusitis
• skin cancer
• skin ulcer
• spontaneous fetal abortion
• stomatitis
• supraventricular tachycardia (SVT)
• syncope
• teratogenesis
• testicular swelling
• throat irritation
• thrombocytopenia
• thrombosis
• tinnitus
• tremor
• urinary incontinence
• urinary retention
• ventricular tachycardia
• vertigo
• vesicular rash
• visual impairment
• vomiting
• weight gain
• weight loss
• xerostomia

Monitoring Parameters

• CBC
• pregnancy testing
• serum electrolytes
• skin cancer screening exam

Contraindications

• accidental exposure
• activities requiring coordination and concentration
• anemia
• blood donation
• bone marrow suppression
• breast-feeding
• children
• cholestasis
• contraception requirements
• diabetes mellitus
• diarrhea
• driving or operating machinery
• fungal infection
• gallbladder disease
• geriatric
• GI bleeding
• GI disease
• GI perforation
• gout
• hepatic disease
• hepatic encephalopathy
• hepatitis
• herpes infection
• hypoalbuminemia
• hypotension
• immunosuppression
• infants
• infection
• intravenous administration
• Lesch-Nyhan syndrome
• leukopenia
• lymphoma
• male-mediated teratogenicity
• nephrolithiasis
• neutropenia
• new primary malignancy
• ocular exposure
• peptic ulcer disease
• phenylketonuria
• post-transplant lymphoproliferative disorder (PTLD)
• pregnancy
• pregnancy testing
• prevention of pregnancy
• progressive multifocal leukoencephalopathy
• red cell aplasia
• renal failure
• renal impairment
• reproductive risk
• requires a specialized care setting
• requires an experienced clinician
• skin cancer
• sperm donation
• sunlight (UV) exposure
• thrombocytopenia
• tremor
• uremia
• vaccination
• varicella
• viral infection

Interactions

• Acyclovir
• Amlodipine; Telmisartan
• Amoxicillin
• Amoxicillin; Clarithromycin; Lansoprazole
• Amoxicillin; Clarithromycin; Omeprazole
• Amoxicillin; Clavulanic Acid
• Antacids
• Anticoagulants
• Aspirin, ASA; Citric Acid; Sodium Bicarbonate
• Azathioprine
• Basiliximab
• Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
• Bismuth Subsalicylate; Metronidazole; Tetracycline
• Calcium Carbonate
• Calcium Carbonate; Magnesium Hydroxide
• Calcium Carbonate; Risedronate
• Calcium Carbonate; Simethicone
• Carboplatin
• Cefuroxime
• Charcoal
• Chlorambucil
• Cholestyramine
• Ciprofloxacin
• Colchicine; Probenecid
• Colesevelam
• Colestipol
• Cyclosporine
• Daclizumab
• Daunorubicin
• Dichlorphenamide
• Doxorubicin
• Drospirenone; Ethinyl Estradiol
• Drospirenone; Ethinyl Estradiol; Levomefolate
• Echinacea
• Ethinyl Estradiol
• Ethinyl Estradiol; Desogestrel
• Ethinyl Estradiol; Ethynodiol Diacetate
• Ethinyl Estradiol; Etonogestrel
• Ethinyl Estradiol; Levonorgestrel
• Ethinyl Estradiol; Levonorgestrel; Ferrous bisglycinate
• Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate
• Ethinyl Estradiol; Norelgestromin
• Ethinyl Estradiol; Norethindrone
• Ethinyl Estradiol; Norethindrone Acetate
• Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate
• Ethinyl Estradiol; Norethindrone; Ferrous fumarate
• Ethinyl Estradiol; Norgestimate
• Ethinyl Estradiol; Norgestrel
• food
• Fosphenytoin
• Ganciclovir
• Hydrochlorothiazide, HCTZ; Telmisartan
• Infliximab
• Iron
• Iron Salts
• Isavuconazonium
• Isoniazid, INH; Pyrazinamide, PZA; Rifampin
• Isoniazid, INH; Rifampin
• Lanthanum Carbonate
• Live Vaccines
• Melphalan
• Mestranol; Norethindrone
• Metronidazole
• Micafungin
• Natalizumab
• Norfloxacin
• Omeprazole; Amoxicillin; Rifabutin
• Omeprazole; Sodium Bicarbonate
• Phenytoin
• Platelet Inhibitors
• Polysaccharide-Iron Complex
• Probenecid
• Proton pump inhibitors
• Rifampin
• Salicylates
• Segesterone Acetate; Ethinyl Estradiol
• Sevelamer
• Sirolimus
• Sodium Bicarbonate
• Sodium Ferric Gluconate Complex; ferric pyrophosphate citrate
• Sulfinpyrazone
• Tacrolimus
• Telmisartan
• Temozolomide
• Theophylline, Aminophylline
• Tobramycin
• Valacyclovir
• Valganciclovir