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MYCOPHENOLIC ACID is a brand name for Mycophenolic Acid. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Mycophenolic acid is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment with Mycophenolic acid should be initiated and maintained by appropriately qualified transplant specialists. Posology The recommended dose is 720 mg administered twice daily (1,440 mg daily dose). This dose of mycophenolate sodium corresponds to 1 g mycophenolate mofetil administered twice daily (2 g daily dose) in terms of mycophenolic acid (MPA) content.
2. In de novo patients, Mycophenolic acid should be initiated within 72 hours following transplantation. Special population Paediatric population Insufficient data are available to support the efficacy and safety of Mycophenolic acid in children and adolescents.
2). Elderly patients The recommended dose in elderly patients is 720 mg twice daily. 2). 73 m-2) should be carefully monitored and the daily dose of Mycophenolic acid should not exceed 1,440 mg. Patients with hepatic impairment No dose adjustments are needed for renal transplant patients with severe hepatic impairment.
Treatment during rejection episodes Renal transplant rejection does not lead to changes in mycophenolic acid (MPA) pharmacokinetics; dosage modification or interruption of Mycophenolic acid is not required. Method of administration Mycophenolic acid can be taken with or without food.
2). In order to retain the integrity of the enteric coating, Mycophenolic acid tablets should not be crushed. Where crushing of Mycophenolic acid is necessary, avoid inhalation of the powder or direct contact of the powder with skin or mucous membrane.
If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water. This is due to the teratogenic effects of mycophenolate.
4). 3%) receiving Mycophenolic acid for up to 1 year. 6% of maintenance patients. 4). The most common opportunistic infections in de novo renal transplant patients receiving Mycophenolic acid 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 patients Elderly patients 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 Mycophenolic acid reported in the controlled clinical trials in renal transplant patients, in which Mycophenolic acid was administered together with ciclosporin microemulsion and corticosteroids at a dose of 1,440 mg/day for 12 months.
It is compiled according to MedDRA system organ class.
Adverse reactions are listed according to the following categories:
Very common Common Uncommon Rare Very rare ( 1/10) ( 1/100 to <1/10) ( 1/1,000 to <1/100) ( 1/10,000 to <1/1,000) (<1/10,000) 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: Lymphopenia*, neutropenia*, lymphadenopathy* 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* Hepato-biliary 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*, Injury, poisoning and procedural complications Uncommon: Contusion* * event reported in a single patient (out of 372) only.
8). The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. As general advice to minimise the risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
8). Among the opportunistic infections are BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML). These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Mycophenolic acid has a cytostatic effect on B- and T-lymphocytes, therefore an increased severity of COVID-19 may occur, and appropriate clinical action should be considered. There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving mycophenolate sodium in combination with other immunosuppressants.
In some of these cases switching MPA derivatives to an alternative immunosuppressant resulted in serum IgG levels returning to normal. Patients on mycophenolate sodium who develop recurrent infections should have their serum immunoglobulins measured.
In cases of sustained, clinically relevant hypogammaglobulinaemia, appropriate clinical action should be considered taking into account the potent cytostatic effects that mycophenolic acid has on T- and B-lymphocytes. There have been reports of bronchiectasis in patients who received mycophenolate sodium in combination with other immunosuppressants.
In some of these cases switching MPA derivatives to another immunosuppressant resulted in improvement in respiratory symptoms. The risk of bronchiectasis may be linked to hypogammaglobulinaemia or to a direct effect on the lung. 8). It is recommended that patients who develop persistent pulmonary symptoms, such as cough and dyspnoea, are investigated for any evidence of underlying interstitial lung disease.
1. Mycophenolic acid is should not be used in women of child bearing potential (WOCBP) who are not using highly effective contraception methods. 6). 6). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Note: renal transplant patients were treated with 1,440 mg Mycophenolic acid 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:
Rash and agranulocytosis has been identified as adverse drug reactions from post marketing experience. 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 mycobacterial infection.
4). Blood and lymphatic system disorders Neutropenia, pancytopenia. 4).
Immune system disorders:
Hypogammaglobulinaemia has been reported in patients receiving Mycophenolic acid in combination with other immunosuppressants.
Respiratory, thoracic and mediastinal disorders:
There have been isolated reports of interstitial lung disease in patients treated with mycophenolate sodium in combination with other immunosuppressants. […]
Reactivation of hepatitis B (HBV) or hepatitis C (HCV) have been reported in patients treated with immunosuppressants, including the mycophenolic acid (MPA) derivatives mycophenolic acid and mycophenolate mofetil (MMF). Monitoring infected patients for clinical and laboratory signs of active HBV or HCV infection is recommended.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with MPA derivatives (which include mycophenolate mofetil and mycophenolate sodium) in combination with other immunosuppressants. The mechanism for MPA derivatives induced PRCA is unknown.
PRCA may resolve with dose reduction or cessation of therapy. 8). g. 8), which may be related to MPA itself, concomitant medications, viral infections, or some combination of these causes. Patients taking Mycophenolic acid should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year.
g. 5 x 103/μl or anemia) it may be appropriate to interrupt or discontinue Mycophenolic acid. Patients receiving Mycophenolic acid should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
5). Influenza vaccination may be of value. Prescribers should refer to national guidelines for influenza vaccination. Because MPA derivatives have been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration and haemorrhage and perforation, Mycophenolic acid should be administered with caution in patients with active serious digestive system disease.
It is recommended that Mycophenolic acid not be administered concomitantly with azathioprine because concomitant administration of these drugs has not been evaluated. Mycophenolic acid (as sodium salt) and mycophenolate mofetil should not be indiscriminately interchanged or substituted because of their different pharmacokinetic profiles.
Mycophenolic acid has been administered in combination with corticosteroids and ciclosporin. There is limited experience with its concomitant use with induction therapies such as anti-T- lymphocyte globulin or basiliximab. The efficacy and safety of the use of Mycophenolic acid with other immunosuppressive agents (for example, tacrolimus) have not been studied.
The concomitant administration of Mycophenolic acid and drugs which interfere with enterohepatic circulation, for example cholestyramine or activated charcoal, may result in sub-therapeutic systemic MPA exposure and reduced efficacy.
Mycophenolic acid is an IMPDH (inosine monophosphate dehydrogenase) inhibitor. Therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine- guanine […]