4). 3%) receiving mycophenolate sodium for up to 1 year. 6% of maintenance patients. 4). The most common opportunistic infections in de novo renal transplant patients receiving mycophenolate sodium with other immunosuppressants in controlled clinical trials of renal transplant patients followed for 1 year were cytomegalovirus (CMV), candidiasis and herpes simplex.
9% of maintenance renal transplant patients. Elderly Elderly may generally be at increased risk of adverse drug reactions due to immunosuppression. Other adverse drug reactions Table 1 below contains adverse drug reactions possibly or probably related to mycophenolate sodium reported either in the controlled clinical trials in renal transplant patients, in which mycophenolate sodium was administered together with ciclosporin microemulsion and corticosteroids at a dose of 1,440mg/day for 12 months; or from post-marketing experience.
It is compiled according to MedDRA system organ class.
Adverse reactions are listed according to the following categories:
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known Cannot be estimated from the available data Table 1 Infections and infestations Very common: Viral, bacterial and fungal infections Common: Upper respiratory tract infections, pneumonia Uncommon: Wound infection, sepsis*, osteomyelitis* Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon: Skin papilloma*, basal cell carcinoma*, Kaposi´s sarcoma*, lymphoproliferative disorder, squamous cell carcinoma* Blood and lymphatic system disorders Very common: Leukopenia Common: Anaemia, thrombocytopenia Uncommon: Immune system disorders Not known: Lymphopenia*, neutropenia*, lymphadenopathy* Anaphylactic reactions Metabolism and nutrition disorders Very common: Hypocalcemia, hypokalemia, hyperuricemia Common: Hyperkalemia, hypomagnesemia Uncommon: Anorexia, hyperlipidaemia, diabetes mellitus*, hypercholesterolaemia*, hypophosphataemia Psychiatric disorders Very Common: Anxiety Uncommon: Abnormal dreams*, delusional perception*, insomnia* Nervous system disorders Common: Dizziness, headache Uncommon: Tremor Eye disorders Uncommon: Conjunctivitis*, vision blurred* Cardiac disorders Uncommon: Tachycardia, ventricular extrasystoles Vascular disorders Very common: Hypertension Common: Hypotension Uncommon: Lymphocele* Respiratory, thoracic and mediastinal disorders Common: Cough, dyspnoea Uncommon: Interstitial lung disease, pulmonary congestion*, wheezing*, pulmonary oedema* Gastrointestinal disorders Very common: Diarrhoea Common: Abdominal distension, abdominal pain, constipation, dyspepsia, flatulence, gastritis, nausea, vomiting Uncommon: 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 Common: Liver function tests abnormal Skin and subcutaneous tissue disorders Common Acne, pruritus Uncommon: Alopecia Musculoskeletal and connective tissue disorders Very Common: Arthralgia Common Myalgia Uncommon: Arthritis*, back pain*, muscle cramps Renal and urinary disorders Common: Blood creatinine increased Uncommon: Haematuria*, renal tubular necrosis*, urethral stricture Reproductive system and breast disorders Uncommon: Impotence* General disorders and administration site conditions Common: Asthenia, Fatigue, oedema peripheral, pyrexia Uncommon: Influenza like illness, oedema lower limb*, pain, rigors*, thirst*, weakness*, de novo purine synthesis inhibitors- associated acute inflammatory syndrome Injury, poisoning and procedural complications Uncommon: Contusion* * event reported in a single patient (out of 372) only.
Note: renal transplant patients were treated with 1,440mg mycophenolate sodium daily up to one year. A similar profile was seen in the de novo and maintenance transplant population although the incidence tended to be lower in the maintenance patients.
Adverse drug reactions from post-marketing experience:
Blood and lymphatic system disorders: Agranulocytosis Immune system disorders: Hypersensitivity reactions (including anaphylaxis) Skin and subcutaneous tissue disorders: Rash General disorders and administration site conditions: de novo purine synthesis inhibitors-associated acute inflammatory syndrome with frequency uncommon has been described from post-marketing experience as a paradoxical proinflammatory reaction associated with mycophenolate mofetil and mycophenolic acid, characterised by fever, arthralgia, arthritis, muscle pain and elevated inflammatory markers.
Literature case reports showed rapid improvement following discontinuation of the medicinal product. The following additional adverse reactions are attributed to MPA derivatives as a class effect: Infections and infestations: Serious, life-threatening infections, including meningitis, infectious endocarditis, tuberculosis, and atypical […]