Mycophenolic Acid

Registered South African indications:

• Prevention of acute transplant rejection

Contraindications

• Hypersensitivity to the active ingredient or to any of its excipients
• Pregnancy
• Breastfeeding
• Women of child bearing age

Cautions

• Severe renal impairment
• Elderly
• Exposure to sunlight and ultraviolet light 
• History of hepatitis B or C
• Sexually active men
• Blood and semen donation
• Galactose intolerance
• Lapp lactase deficiency 
• Glucose-galactose malabsorption 
• Hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase

Forms avail. in SA and covered in this monograph: tab

Prevention acute transplant rejection in allogenic renal transplants

• Oral (tab): 720mg, 12hrly; To be started within 48hrs of transplantation

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Do not cut/crush/chew/dissolve

Not established for use in children

Pregnancy

• FDA Pregnancy Category D 

Breastfeeding

• Contraindicated

Renal Impairment

• Severe: Caution; dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Central Nervous System Disorders

• Dizziness
• Headache
• Tremor
• Anxiety
• Abnormal dreams
• Delusional perception
• Insomnia
• Fatigue
• Weakness

Cardiovascular Disorders

• Tachycardia
• Ventricular extrasystoles
• Hypertension
• Hypotension

Respiratory Disorders

• Cough
• Dyspnoea
• Interstitial lung disease
• Pulmonary congestion
• Wheezing
• Pulmonary oedema

Gastrointestinal Disorders

• Diarrhoea
• Abdominal distension
• Abdominal pain
• Constipation
• Dyspepsia
• Flatulence
• Gastritis
• Nausea and vomiting
• Abdominal tenderness
• Gastrointestinal haemorrhage
• Eructation
• Halitosis
• Ileus
• Lip ulceration
• Oesophagitis
• Subileus
• Tongue discolouration
• Dry mouth
• Gastro-oesophageal reflux disease
• Gingival hyperplasia
• Pancreatitis
• Parotid duct obstruction
• Peptic ulcer
• Peritonitis

Hepatobiliary Disorders

• Abnormal hepatic function tests 

Genitourinary Disorders

• Increased creatinine 
• Haematuria
• Renal tubular necrosis
• Urethral stricture
• Impotence

Endocrine and Metabolic Disorders

• Hypocalcemia
• Hypokalemia
• Hyperuricemia
• Hyperkalemia
• Hypomagnesemia
• Anorexia
• Hyperlipidaemia
• Diabetes mellitus
• Hypercholesterolaemia
• Hypophosphataemia
• Thirst

Musculoskeletal Disorders

• Arthralgia
• Myalgia
• Arthritis
• Back pain
• Muscle cramps

Skin and Subcutaneous Tissue Disorders

• Acne
• Pruritus
• Alopecia
• Peripheral oedema

Immune, Blood and Lymphatic System Disorders

• Leukopenia
• Anaemia
• Thrombocytopenia
• Lymphopenia
• Neutropenia
• Lymphadenopathy
• Viral, bacterial and fungal infections
• Upper respiratory tract infections
• Pneumonia
• Wound infection
• Sepsis
• Oteomyelitis
• Skin papilloma
• Basal cell carcinoma
• Kaposi´s sarcoma
• Lymphoproliferative disorder
• Squamous cell carcinoma
• Fever
• Contusion
• Influenza like illness
• Rigors
• Lymphocoele

Sensory Disorders

• Conjunctivitis
• Blurred vision

• Live attenuated vaccines
• Cholestyramine 
• Activated charcoal
• Aciclovir 
• Ganciclovir
• Magnesium containing products
• Aluminium containing antacids
• High doses of proton pump inhibitors
• Bile acid sequestrates 
• Ciclosporin 
• Tacrolimus

• Full blood count
• Renal function
• Hepatic function
• Pregnancy test

Mycophenolic acid (MPA) is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilize salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells.

Tablet 180mg

• Myfortic (Novartis)

Tablet 250mg

• Cimune 250 fct (Abex Pharma)

Tablet 360mg

• Myfortic (Novartis)

Tablet 500mg

• Cimune 500 fct (Abex Pharma)