atopica

Route of Administration	Dosage Form/Strength	Clinically Relevant Nonmedicinal Ingredients
Oral	Soft Gelatin Capsules 10 mg, 25 mg, 50 mg and 100 mg	Ethanol, maize oil
Oral	Oral Solution 100 mg/mL	Ethanol, maize oil
Intravenous	50 mg/mL concentrate for infusion	Ethanol

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe NEORAL and SANDIMMUNE I.V. (cyclosporine). Patients receiving the drug should be managed in centres staffed with professionals experienced in transplantation and the use of immunosuppressants and equipped with adequate laboratory facilities to monitor cyclosporine levels. The ability to measure cyclosporine blood levels facilitates the management of the patient. The radioimmunoassay (RIA) method has been used most often in clinical trials.

For long-term follow-up, the attending physician should receive complete information from the transplant centre on the patient, to include: recommended NEORAL dosage, target trough levels of cyclosporine and, frequency of determination of these levels. The attending physician should consult with the transplant centre when making dose adjustments to ensure that toxicity is minimized while maintaining adequate immunosuppression. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.

Psoriasis/Rheumatoid Arthritis/Nephrotic Syndrome: Careful monitoring of NEORAL treated patients is mandatory. NEORAL should only be prescribed for psoriasis, rheumatoid arthritis or nephrotic syndrome by physicians experienced with its use. NEORAL is indicated: in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and when the psoriasis is of such severity that the risks inherent in treatment with cyclosporine are justified for that patient; for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents are inappropriate or ineffective; in patients with steroid dependent and steroid resistant nephrotic syndrome.

NEORAL capsules and oral solution and SANDIMMUNE I.V. (cyclosporine) are indicated in the prevention of graft rejection following solid organ transplantation and in the treatment of transplant rejection in patients previously receiving other immunosuppressive agents.

NEORAL capsules and oral solution and SANDIMMUNE I.V. (cyclosporine) are indicated in the prevention of graft rejection following bone marrow transplantation and the prevention or treatment of graft-versus-host disease (GVHD).

NEORAL capsules and oral solution (cyclosporine) are indicated for the treatment of severe psoriasis in patients for whom conventional therapy is ineffective or inappropriate.

NEORAL capsules and oral solution (cyclosporine) are also indicated for the treatment of severe active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents are inappropriate or ineffective.

NEORAL capsules and oral solution (cyclosporine) are indicated in adults and children for steroid dependent and steroid resistant nephrotic syndrome due to glomerular diseases such as minimal change nephropathy; focal and segmental glomerulosclerosis, or membranous glomerulonephritis. NEORAL can be used to induce remissions and to maintain them. It can also be used for maintenance of steroid induced remissions, allowing withdrawal of, or reduction in the dosage of steroids.

NEORAL capsules and oral solution and SANDIMMUNE I.V. (cyclosporine) should be prescribed only by physicians who are experienced in immunosuppressive therapy and management of transplant patients and can provide adequate follow-up, including regular full physical examination, measurement of blood pressure and control of laboratory safety parameters. Patients receiving the drug should be managed in facilities with adequate laboratory and supportive medical resources.

The concentrate for I.V. infusion contains polyoxyethylated castor oil which has been reported to cause anaphylactoid reactions. Patients receiving SANDIMMUNE I.V. should be observed continuously for at least 30 minutes following the start of the infusion and at frequent intervals thereafter.

Patients with impaired renal function (except in nephrotic syndrome patients with a permissible degree of renal impairment), abnormal liver function, uncontrolled hypertension, uncontrolled infections or any kind of malignancy should not receive NEORAL.

NEORAL should only be prescribed for psoriatic patients by physicians experienced with its use. All patients to be treated with NEORAL for psoriasis must have a pre-treatment physical examination to include blood pressure, renal function and careful examination for tumours, particularly of the skin, to establish accurate baseline values and clinical status.

Skin lesions not typical of psoriasis should be biopsied to exclude skin cancers, mycosis fungoides or other pre-malignant conditions.

Discontinuation of the drug is recommended if hypertension developing during NEORAL therapy cannot be controlled with appropriate antihypertensive therapy. As with other long-term immunosuppressive treatments, an increased risk of lymphoproliferative disorders must be borne in mind.

NEORAL should only be prescribed by physicians experienced with its use. All patients to be treated with NEORAL for nephrotic syndrome must have a pre-treatment physical examination to include blood pressure, renal function and screening for malignancies

Appropriate patient and laboratory monitoring is essential to prevent, reverse or minimize the following adverse events: nephrotoxicity; hypertension; the development of malignancies and lymphoproliferative disorders; increased risk of infections; hepatotoxicity; lipoprotein abnormalities; neurotoxicity.

Cyclosporine absorption has significant inter-and intra-patient variability. Cyclosporine whole blood concentrations as well as the effectiveness and the adverse events related to cyclosporine should be appropriately monitored in all patients, particularly in de novo patients undergoing any change in their treatment regimen, to ensure maximum safety and optimal clinical outcome.