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EMULSOFORAL is a brand name for Cyclosporine (also known as Ciclosporin). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Transplantation indications Solid organ transplantation Prevention of graft rejection following solid organ transplantation. Treatment of transplant cellular rejection in patients previously receiving other immunosuppressive agents. Bone marrow transplantation Prevention of graft rejection following allogeneic bone…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dose ranges given for oral administration are intended to serve as guidelines only. The daily doses of ciclosporin should be given in two divided doses equally distributed throughout the day. It is recommended that ciclosporin be administered on a consistent schedule with regard to time of day and in relation to meals.
Ciclosporin should only be prescribed by, or in close collaboration with, a physician with experience of immunosuppressive therapy and/or organ transplantation. Transplantation Solid organ transplantation Treatment with ciclosporin should be initiated within 12 hours before surgery at a dose of 10-15 mg/kg given in 2 divided doses.
This dose should be maintained as the daily dose for 1to2 weeks post-operatively, being gradually reduced in accordance with blood levels according to local immunosuppressive protocols until a recommended maintenance dose of about 2to6 mg/kg given in2 divided doses is reached.
g. g. 3to6 mg/kg given in 2 divided doses for the initial treatment) may be used. Bone marrow transplantation The initial dose should be given on the day before transplantation. In most cases, ciclosporin concentrate for solution for infusion is preferred for this purpose.
The recommended intravenous dose is 3 to 5 mg/kg/day. 5 mg/kg given in 2 divided doses. Maintenance treatment should be continued for at least 3 months (and preferably for 6 months) before the dose is gradually decreased to zero by 1 year after transplantation.
5 to 15 mg/kg given in 2 divided doses, starting on the day before transplantation. Higher doses of ciclosporin,or the use of ciclosporin intravenous therapy, may be necessary in the presence of gastrointestinal disturbances which might decrease absorption In some patients GVHD occurs after discontinuation of ciclosporin treatment, but usually responds favourably to re-introduction of therapy.
5 mg/kg should be given, followed by daily oral administration of the maintenance dose previously found to be satisfactory Low doses of ciclosporin should be used to treat mild, chronic GVHD. Non-transplantation indications When using ciclosporin in any of the established non-transplantation indications, the following general rules should be adhered to: Before initiation of treatment a reliable baseline level of renal function should be established by at least two measurements.
Summary of the safety profile The principal adverse reactions observed in clinical trials and associated with the administration of ciclosporin include renal dysfunction, tremor, hirsutism, hypertension, diarrhoea, anorexia, nausea and vomiting.
Many side effects associated with ciclosporin therapy are dose dependent and responsive to dose reduction. In the various indications the overall spectrum of side effects is essentially the same; there are, however, differences in incidence and severity.
As a consequence of higher initial dose and longer maintenance therapy required after transplantation, side effects are more frequent and usually more severe in transplant patients than in patients treated for other indications. 4).
4). Both generalised and localised infections can occur. Pre-existing infections may also be aggravated and reactivation of Polyomavirus infections may lead to Polyomavirus associated nephropathy (PVAN) or to JC virus associated progressive multifocal leukopathy (PML).
Serious and/or fatal outcomes have been reported.
Neoplasms benign, malignant and unspecified (including cysts and polyps):
Patients receiving immunosuppressive therapies, including ciclosporin and ciclosporin containing regimens, are at increased risk of developing lymphomas or lymphoproliferative disorders and other malignancies, particularly of the skin.
4). Some malignancies may be fatal. Tabulated summary of adverse drug reactions from clinical trials Adverse drug reactions from clinical trials (Table 1) are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
Medicinal supervision Ciclosporin should be prescribed only by physicians who are experienced in immunosuppressive therapy, and can provide adequate follow-up, including regular full physical examination, measurement of blood pressure, and control of laboratory safety parameters.
Transplantation patients receiving this medicinal product should be managed in facilities with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should receive complete information for the follow-up of the patient.
Lymphomas and other malignacies Like other immunosuppressants, ciclosporin increases the risk of developing lymphomas and other malignancies, particularly those of the skin. The increased risk appears to be related to the degree and duration of immunosuppression rather than to the use of specific agents.
A treatment regimen containing multiple immunosuppressants (including ciclosporin) should therefore be used with caution as this could lead to lymphoproliferative disorders and solid organ tumours, some with reported fatalities. In view of the potential risk of skin malignancy, patients on ciclosporin, in particular those treated for psoriasis or atopic dermatitis, should be warned to avoid excess unprotected sun exposure and should not receive concomitant ultraviolet B irradiation or PUVA photochemotherapy.
Infections Like other immunosuppressants, ciclosporin predisposes patients to the development of a variety of bacterial, fungal, parasitic and viral infections, often with opportunistic pathogens. Activation of latent polyomavirus infections that may lead to polyomavirus associated nephropathy (PVAN), especially to BK virus nephropathy (BKVN), or to JC virus associated progressive multifocal leukoencephalopathy (PML), have been observed in patients receiving ciclosporin.
These conditions are often related to a high total immunosuppressive burden and should be considered in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms. Serious and/or fatal outcomes have been reported.
1. 5). g. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The estimated glomerular filtration rate (eGFR) by the MDRD formula can be used for estimation of renal function in adults and an appropriate formula should be used to assess eGFR in paediatric patients. Since ciclosporin can impair renal function, it is necessary to assess renal function frequently.
If eGFR decreases by more than 25% below baseline at more than one measurement, the dosage of ciclosporin should be reduced by 25 to 50%. If the eGFR decrease from baseline exceeds 35%, further reduction of the dose of ciclosporin should be considered.
These recommendations apply even if the patient`s values still lie within the laboratory`s normal range. 4). Regular monitoring of blood pressure is required. The determination of bilirubin and parameters that assess hepatic function are required prior to starting therapy and close monitoring during treatment is recommended.
Determinations of serum lipids, potassium, magnesium and uric acid are advisable before treatment and periodically during treatment. g. g. lack of efficacy or increased drug intolerance such as renal dysfunction). The normal route of administration is by mouth.
If ciclosporin the concentrate for solution for infusion is used, careful consideration should be given to administering an adequate intravenous dose that corresponds to the oral dose. Consultation with a physician with experience of use of ciclosporin is recommended.
Except in patients with sight-threatening endogenous uveitis and in children with nephrotic syndrome, the total daily dose must never exceed 5 mg/kg. For maintenance treatment the lowest effective and well tolerated dosage should be determined individually.
In patients in whom within a given time (for specific information see below) no adequate response is achieved or the effective dose is not compatible with the established safety guidelines, treatment with ciclosporin should be discontinued.
Endogenous uveitis For inducing remission, initially 5 mg/kg/day orally given in 2 divided doses are recommended until remission of active uveal inflammation and improvement in visual acuity are achieved. In refractory cases, the dose can be increased to 7 mg/kg/day for a limited period.
6 mg/kg prednisone or an equivalent may be added if ciclosporin alone does not control the situation sufficiently. After 3 months, the dose of corticosteroids may be tapered to the lowest effective dose. For maintenance treatment, the dose should be slowly reduced to the lowest effective level.
During the remission phases, this should not exceed 5 mg/kg/day. Infectious causes of uveitis should be ruled out before […]
Table 1:
Adverse drug reactions from clinical trials Blood and lymphatic system disorders Common Leucopenia Uncommon: Anaemia, thrombocytopenia.
Rare:
Microangiopathic haemolytic anaemia, haemolytic uraemic syndrome. Not known* Thrombotic microangiopathy, thrombotic thrombocytopenic purpura Metabolism and nutrition disorders Very common: Hyperlipidaemia,.
Common:
Hyperglycaemia,anorexia, hyperuricaemia, hyperkalaemia, hypomagnesaemia.
Nervous system disorders Very common:
Tremor, headache Common: Convulsions,paraesthesia.
Uncommon:
E Encephalopathy including Posterior Reversible Encephalopathy Syndrome (PRES), signs and symptoms such as convulsions, confusion, disorientation, decreased responsiveness, agitation, insomnia, visual disturbances, cortical blindness, coma, paresis and cerebellar ataxia.
Rare:
Motor polyneuropathy.
Very rare:
Optic disc oedema including papilloedema, with possible visual impairment secondary to benign intracranial hypertension. ,.
Rare:
Pancreatitis. 4). 4) .
Skin and subcutaneous tissue disorders Very common Hirsutism Common:
Acne ,hypertrichosis.
Uncommon:
Allergic rashes.
Musculoskeletal and connective tissue disorders Common:
Muscle cramps, myalgia.
Rare:
Muscle weakness, myopathy. 4).
Reproductive system and breast disorders Rare:
Menstrual disturbances, gynecomastia.
General disorders and administration site conditions Common:
Pyrexia,fatigue.
Uncommon:
Oedema, weight increase. * Adverse events reported from post marketing experience where the ADR frequency is not known due to the lack of a real denominator. Other adverse drug reactions from post-marketing experience There have been solicited and spontaneous reports of hepatotoxicity and liver injury including cholestasis, jaundice, hepatitis and liver failure in patients treated with ciclosporin.
Most reports included patients with significant co-morbidities, underlying conditions and other confounding factors including infectious complications and comedications with hepatotoxic potential. 4). Acute and chronic nephrotoxicity Patients receiving calcineurin inhibitor (CNI) therapies, including ciclosporin and ciclosporin-containing regimens, are at increased risk of acute or chronic nephrotoxicity.
There have been reports from clinical trials and from the post- marketing setting associated with the use of ciclosporin. Cases of acute nephrotoxicity reported disorders of ion homeostasis, such as hyperkalaemia, hypomagnesaemia, and hyperuricaemia.
4). Paediatric population Clinical studies have included children from 1 year of age using standard ciclosporin dosage with a comparable safety profile to adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal […]
Effective pre-emptive and therapeutic strategies should be employed, particularly in patients on multiple long-term immunosuppressive therapy. Renal toxicity A frequent and potentially serious complication, an increase in serum creatinine and urea, may occur during ciclosporin therapy.
These functional changes are dose- dependent and are initially reversible, usually responding to dose reduction. g. interstitial fibrosis) which, in renal transplant patients, must be differentiated from changes due to chronic rejection.
8). 8). There have been solicited and spontaneous reports of hepatotoxicity and liver injury including cholestasis, jaundice, hepatitis and liver failure in patients treated with ciclosporin. Most reports included patients with significant co-morbidities, underlying conditions and other confounding factors including infectious complications and co-medications with hepatotoxic potential.
8). 2). Elderly population (age 65 years and above) In elderly patients, renal function should be monitored with particular care. 2) When ciclosporin is used in transplant patients, routine monitoring of ciclosporin blood levels is an important safety measure.
For monitoring ciclosporin levels in whole blood, a specific monoclonal antibody (measurement of parent compound) is preferred; a high-performance liquid chromatography (HPLC) method, which also measures the parent compound, can be used as well.
If plasma or serum is used, a standard separation protocol (time and temperature) should be followed. For the initial monitoring of liver transplant patients, either the specific monoclonal antibody should be used, or parallel measurements using both the specific monoclonal antibody and the non-specific monoclonal antibody should be performed, to ensure a dosage that provides adequate immunosuppression.
g. g. lack of efficacy or increased drug intolerance such as renal dysfunction). It must be remembered that the ciclosporin concentration in blood, plasma, or serum is only one of many factors contributing to the clinical status of the patient.
Results should therefore serve only as a guide to dosage in relationship to other clinical and laboratory parameters. Hypertension Regular monitoring of blood pressure is required. during ciclosporin therapy. If hypertension develops, appropriate antihypertensive treatment must be instituted.
g. 5). Blood lipids increased Sinceciclosporin, has been reported to induce a reversible slight increase in blood lipids It is advisable to perform lipiddeterminations beforetreatment and after the first month of therapy. In the event of increased lipids being found, restriction of dietary fat and, if appropriate, a dose reduction, should be considered.
Hyperkalaemia Ciclosporin enhances the risk of hyperkalaemia, especially in patients with renal […]