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CEPTAVA is a brand name for Mycophenolate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ceptava 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 Ceptava should be initiated and maintained by appropriately qualified transplant specialists. 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 (2g daily dose) in terms of mycophenolic acid (MPA) content.
2. In de novo patients, Ceptava should be initiated within 72 hours following transplantation. Ceptava can be taken with or without food. 2). In order to retain the integrity of the enteric coating, Ceptava tablets should not be crushed.
Where crushing of Ceptava tablets 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.
Paediatric population and adolescents Insufficient data are available to support the efficacy and safety of mycophenolate sodium in children and adolescents. 2). Elderly The recommended dose in elderly patients is 720mg twice daily. 2).
73m-2) should be carefully monitored and the daily dose of Ceptava should not exceed 1,440mg. 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 Ceptava is not required.
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: Lymphopenia*, neutropenia*, lymphadenopathy* Immune system disorders Not known: 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.
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.
Patients receiving Ceptava should be instructed to immediately report any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression. 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 hypogammaglobulinemia in association with recurrent infections in patients receiving Ceptava 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 Ceptava who develop recurrent infections should have their serum immunoglobulins measured.
In cases of sustained, clinically relevant hypogammaglobulinemia, 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 hypogammaglobulinemia 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. Ceptava must 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 1,440mg 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 […]
Reactivation of hepatitis B (HBV) or hepatitis C (HCV) have been reported in patients treated with immunosuppressants, including the mycophenolic acid (MPA) derivatives mycophenolate sodium 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). 8), which may be related to MPA itself, concomitant medications, viral infections, or some combination of these causes. Patients taking Ceptava 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.
5 x 103/μl or anemia) it may be appropriate to interrupt or discontinue Ceptava. 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, Ceptava should be administered with caution in patients with active serious digestive system disease.
It is recommended that Ceptava 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.
Mycophenolate sodium 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 mycophenolate sodium with other immunosuppressive agents (for example, tacrolimus) have not been studied.
Ceptava contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. The concomitant administration of Ceptava and drugs which interfere with enterohepatic circulation, for example cholestyramine or activated charcoal, may result in sub-therapeutic systemic MPA exposure and reduced efficacy.
Mycophenolate sodium is an IMPDH (inosine monophosphate dehydrogenase) inhibitor. Therefore, it should be avoided in patients with […]