Solid organ transplantation Prevention of rejection of transplanted kidneys, liver, heart, lungs, allografts of the pancreas, as well as combined cardiopulmonary graft. Treatment of graft rejection in patients who have previously received other immunosuppressive drugs. Bone marrow transplantation Preventing graft rejection and graft-versus-host (GVHD) reactions after bone marrow transplantation. Treatment of advanced GVHD.
Sandimmun Neoral Composition and form of release
Active ingredient: cyclosporine.
Sandimmun Neoral is produced in the form of soft capsules (25 mg).
It is an immunosuppressive (suppressive immune response) agent. Suppresses cellular-type reactions, incl. allograft rejection, allergic encephalomyelitis, delayed-type allergic reaction, arthritis caused by Freund’s adjuvant, T-lymphocyte-dependent antibody formation, graft versus host reaction. Blocks resting lymphocytes at the cellular level (in phases G0, G1) and inhibits the production and release of lymphokines, induced by the antigen.
In transplantation Sandimmun Neoral is used:
- for the prevention of rejection reaction after transplantation of solid (whole) organs: liver, heart, kidney, cardiopulmonary transplant, lungs, pancreas;
- to prevent graft rejection after bone marrow transplantation;
- for the treatment of a graft rejection reaction in individuals who have previously received other immunosuppressants;
- for the prevention / treatment of graft versus host disease.
For autoimmune diseases:
- with nephrotic syndrome caused by damage to the vascular glomerulus (membranous glomerulonephritis, nephropathy of minimal changes, segmental / focal glomerulosclerosis) – for the induction of remission, its maintenance;
- with endogenous uveitis (active, vision-threatening uveitis of the middle / posterior area of the eye of a non-infectious nature, if standard therapy is ineffective or causes severe adverse reactions; Behcet’s uveitis with a recurrent course affecting the retina);
- in severe rheumatoid arthritis (when the use of standard therapy is impossible or ineffective);
- in psoriasis with severe psoriasis (when the use of standard therapy is impossible or ineffective);
with severe atopic dermatitis, when systemic therapy is indicated.
Do not use Sandimmun Neoral in case of intolerance to the active / auxiliary components.
Patients are contraindicated:
- with impaired renal function;
- with uncontrolled arterial hypertension;
- with an acute infectious disease;
- with a malignant neoplasm.
Application during pregnancy and lactation
The drug Sandimmun Neoral is not used during these periods.
Method of administration and dosage
Sandimmun Neoral is used internally.
The dosage is set individually.
The initial dose for adults for transplantation of solid organs is treated – 10-15 mg / kg (in 2 divided doses) 12 hours before surgery. Over the next 1-2 weeks, it is prescribed daily in the same dose, then the dose is gradually reduced (by monitoring the concentration of cyclosporine in the blood) to a maintenance dose (2-6 mg / kg / day). When used in combination with other immunosuppressants or glucocorticosteroids, the initial dose can be reduced to 3–6 mg / kg.
For bone marrow transplantation, 12.5-15 mg / kg / day is prescribed on the day preceding the transplant, as well as during the transplant period for at least 2 weeks.
Children over one year old are prescribed adult doses (per kg of weight).
With nephrotic syndrome, it is prescribed for adults 5 mg / kg / day, for children – 6 mg / kg (in two doses).
In rheumatoid arthritis, 3-5 mg / kg / day are prescribed in two divided doses. The course is up to 12 weeks.
In psoriasis, 2.5 mg / kg / day is prescribed in two divided doses. In severe cases, 5 mg / kg / day.
With atopic dermatitis – 2.5 mg / kg / day, in severe cases – 5 mg / kg / day.
When the desired clinical effect is achieved, the dose is gradually reduced until completely canceled.
In case of impaired renal function, the starting dose should not exceed 2.5 mg / kg / day.
Possible impaired renal function. If indicated, appropriate treatment is carried out.
- Urinary disorders: increased concentration of creatinine, urea in the blood, interstitial fibrosis.
- Digestive disorders: anorexia, diarrhea, vomiting, abdominal pain, pancreatitis, dose-dependent increase in the level of bilirubin, the activity of liver enzymes.
- Cardiovascular disorders: arterial hypertension (especially after heart transplant).
- Neurological disorders: headache, convulsions, paresthesia, muscle spasm, myopathy, muscle weakness, tremor, encephalopathy, visual impairment, consciousness disorders, impaired motor function.
- Endocrine disorders: dysmenorrhea, amenorrhea.
- Hematological disorders: mild anemia, thrombocytopenia, hemolytic uremic syndrome.
- Allergic reactions: rash.
- Laboratory changes: hypomagnesemia, hyperkalemia, hyperuricemia.
- Others: weight gain, fatigue, hypertrichosis, gingival hypertrophy, edema, reversible hyperlipidemia, the development of malignant, lymphoproliferative diseases.
Storage conditions and periods
Store Sandimmun Neoral at 15–25 ° C for no more than 2 years.