Universal reference book for medicines
Product name: SANDIMMUN ® NEORAL ® (SANDIMMUN ® NEORAL ® )

Active substance: ciclosporin

Type: Immunosuppressive drug

Manufacturer: NOVARTIS PHARMA (Switzerland) manufactured by RPSCHERER (Germany)
Composition, form of production and packaging
Capsules soft
gelatinous, oval, yellowish-white color, marked red in the form of the Sandoz logo (S in the triangle) and code "10 mg".

1 caps.

cyclosporine 10 mg

[PRING] D, L -? - tocopherol - 0.1 mg, ethanol - 10 mg, propylene glycol - 10 mg, mono, di- and triglycerides of corn oil - 34.4 mg, polyoxyl 40 hydrogenated castor oil - 40.5 mg.

The composition of the capsule shell: titanium dioxide (E171), glycerol 85%, propylene glycol, gelatin.

10 pieces.
- blisters (6) - packs of cardboard.
Capsules soft gelatinous, oval, gray-blue color, marked red in the form of the Sandoz logo (S in the triangle) and code "25 mg".

1 caps.

cyclosporin 25 mg

[PRING] D, L -? - tocopherol - 0.25 mg, ethanol 25 mg, propylene glycol 25 mg, mono, di- and triglycerides of corn oil 86 mg, polyoxyl 40 hydrogenated castor oil 101.25 mg.

The composition of the capsule shell: iron oxide black, titanium dioxide (E171), glycerol 85%, propylene glycol, gelatin.

5 pieces.
- blisters (10) - packs of cardboard.
Capsules soft gelatinous, oblong, yellowish-white color, marked red in the form of the Sandoz logo (S in the triangle) and code "50 mg".

1 caps.

cyclosporin 50 mg

[PRING] D, L -? - tocopherol - 0.5 mg, ethanol - 50 mg, propylene glycol - 50 mg, mono, di- and triglycerides of corn oil - 172 mg, polyoxyl 40 hydrogenated castor oil - 202.5 mg.

The composition of the capsule shell: titanium dioxide (E171), glycerol 85%, propylene glycol, gelatin.

5 pieces.
- blisters (10) - packs of cardboard.
Capsules soft gelatinous, oblong, gray-blue color, marked red in the form of the Sandoz logo (S in the triangle) and code "100 mg".

1 caps.

cyclosporine 100 mg

[PRING] D, L -? - tocopherol - 1 mg, ethanol - 100 mg, propylene glycol - 100 mg, mono, di- and triglycerides of corn oil - 344 mg, polyoxyl 40 hydrogenated castor oil - 405 mg.

The composition of the capsule shell: iron oxide black, titanium dioxide (E171), glycerol 85%, propylene glycol, gelatin.

5 pieces.
- blisters (10) - packs of cardboard.
Solution for oral administration is transparent, from yellow to light yellow or from brownish-yellow to light-brownish-yellow color, with a specific smell of oil and ethanol.

1 ml

cyclosporine 100 mg

[PRING] D, L -? - tocopherol - 1.05 mg, absolute ethanol - 94.7 mg, propylene glycol - 94.7 mg, mono, di- and triglycerides of corn oil - 318.85 mg, polyoxyl 40 hydrogenated castor oil - 383.7 mg.

50 ml - bottles of dark glass (1) complete with a set for dosing (a syringe measuring and a tube for drawing a solution from the bottle) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

The immunosuppressive drug is a cyclic polypeptide consisting of 11 amino acids.
Cyclosporine is a selective immunosuppressant that inhibits the activation of luminal calcine neuron in the G 0 or G 1 phase of the cell cycle. Thus, activation of T-lymphocytes is prevented and, at the cellular level, antigen-dependent release of lymphokines, including interleukin-2 (growth factor of T-lymphocytes). Cyclosporine acts on lymphocytes specifically and reversibly. Unlike cytostatics, it does not inhibit hemopoiesis and does not affect the function of phagocytes.
Cyclosporin increases the lifetime of allogeneic grafts of the skin, heart, kidneys, pancreas, bone marrow, small intestine, lungs.
Cyclosporine also inhibits the development of cellular responses to the allograft, delayed-type hypersensitivity skin reactions, experimental allergic encephalomyelitis, Freund's adjuvant-mediated arthritis, graft-versus-host disease (GVHD), and T-lymphocyte-dependent antibody production. The effectiveness of the use of Sandimmunne Neoral with bone marrow transplantation and solid organs in humans for the prevention and treatment of rejection and BFHC was demonstrated, as well as in the treatment of various conditions that are inherently autoimmune or can be considered as such.
Medicinal forms of the drug Sandimmun ® Neoral ® (solution for ingestion and soft capsules, which also contain a solution) have the following feature.
The solution is a microemulsion preconcentrate that forms a microemulsion in the presence of a liquid (a liquid with which the solution is mixed for ingestion before or in the presence of liquids in the stomach when taking the drug in capsule form). This reduces the variability of pharmacokinetic parameters and provides a linear relationship between the dose and the effect of cyclosporine with a more uniform absorption profile and a lesser dependence on simultaneous eating. When studying the microemulsion preconcentrate, it was shown that the correlation between the basal concentration of cyclosporine and its action is more pronounced when using Sandimmun Neoral than with Sandimmun.
PHARMACOKINETICS

Suction

With the use of Sandimmun Neoral, a more linear relationship between the dose and the effect of cyclosporine (AUC B ) is provided, a more consistent absorption profile and a lower dependence on simultaneous eating and daily rhythm that is characteristic of Sandimmun.
These properties together result in a low variability in the pharmacokinetics of cyclosporine in the same patient and a more pronounced correlation between basal and bioavailability (AUC B ). Due to these additional benefits, there is no longer any need to take into account the time of ingestion in the dosage regimen of Sandimune Neoral. In addition, with the use of Sandimmun Neoral, a more even effect of cyclosporine is provided both during the day and during the course of maintenance therapy.
Soft gelatin capsules and solution for oral administration are bioequivalent.

Absolute bioavailability of cyclosporine varies in different populations of patients.

T max is 1.5-2 hours, the absorption of Sandimmunne neoral is rapid, the average C max in plasma is 59% higher and bioavailability is 29% higher compared to Sandimmun.

Distribution

Cyclosporine is distributed mostly outside the bloodstream.
In the blood, 33-47% of cyclosporine is in plasma, 4-9% in lymphocytes, 5-12% in granulocytes and 41-58% in erythrocytes. Binding to plasma proteins (mainly lipoproteins) is approximately 90%.
Metabolism

Cyclosporine is largely biotransformed with CYP3A4 isoenzyme, and, to a lesser extent, in the gastrointestinal tract and kidneys, forming about 15 metabolites.
There is no single main pathway of metabolism.
Excretion

Cyclosporine is excreted primarily with bile and only 6% of the dose taken internally is excreted in the urine (with only 0.1% unchanged).

The values ​​of the final T 1/2 of cyclosporine are very variable, which depends on the method used to determine and the patient's contingent.
The final T 1/2 with unchanged liver function is approximately 6.3 hours; in patients with severe liver disease - approximately 20.4 h.
INDICATIONS

Transplantation

- Transplantation of solid organs: prevention of rejection of allografts of the kidney, liver, heart, lung, pancreas, as well as a combined cardiopulmonary transplant;treatment of transplant rejection in patients who had previously received other immunosuppressants;

- bone marrow transplantation: prevention of graft rejection after bone marrow transplantation;
prevention and treatment of "graft versus host disease".
Indications not related to transplantation

- endogenous uveitis: active vision-impairing middle or posterior uveitis of non-infectious etiology in cases where traditional treatment has no effect or in cases of development of severe side effects;
uveitis of Behcet with repeated attacks of inflammation involving the retina;
- nephrotic syndrome: steroid-dependent and steroid-resistant nephrotic syndrome in adults and children due to glomerular pathology, such as minimal changes nephropathy, focal and segmental glomerulosclerosis, membranous glomerulonephritis.
Sandimmune® Neoral® can be used to induce and maintain remission and to maintain remission caused by glucocorticosteroids, which allows them to be canceled;
- treatment of severe forms of active rheumatoid arthritis;

- treatment of severe forms of psoriasis, when traditional therapy is ineffective or impossible;

- severe forms of atopic dermatitis, when systemic therapy is required.

DOSING MODE

The drug is administered orally, regardless of food intake.

The daily dose of Sandimune Neoral should always be divided into 2 divided doses.

Transition from Sandimmun® to Sandimmun® Neoral®

The available data show that during the transition from taking Sandimmun to taking Sandimuna Neoral, while maintaining the ratio of doses of 1: 1, the values ​​of basal concentrations of cyclosporin, determined in whole blood, are comparable.
In many patients, however, higher values ​​of maximum concentration and prolongation of drug exposure (AUC) can be observed. In a small percentage of patients, these changes are more visible and can be clinically significant. Their value depends to a large extent on the individual differences in the absorption of cyclosporin from the originally used Sandimmune, whose bioavailability is characterized by high variability. In patients with variable basal concentrations or those receiving Sandimmune ® at very high doses (including those with cystic fibrosis, patients with transplanted liver with concomitant cholestasis or poor bile secretion, in children or some patients with kidney transplantation), the absorption of cyclosporine may be low or unstable, however, with the transition to Sandimmun® Neoral®, an improvement in absorption is possible. Consequently, in this population of patients after the transition from taking Sandimmun to taking Sandimmunus neoral, while maintaining the ratio of doses of 1: 1, the increase in the bioavailability of cyclosporine may be more pronounced than is usually observed. Considering this, the dose of Sandimmun Neoral should be reduced by individual selection depending on the range of basal concentrations and the corresponding indications.
Absorption of cyclosporine from Sandimmune Neoral is less variable and the correlation between basal concentration and bioavailability (by AUC values) is much more pronounced than with the use of Sandimmun.
This makes the basal level of the concentration of cyclosporine in the blood a clearer and more reliable parameter for the therapeutic control of the drug.
Because
the transition from Sandimmun to Sandimmun® Neoral® can lead to an increase in the exposure of the drug, the following rules should be observed.
In patients after transplantation, treatment with Sandimmune Neoral should begin with the same daily dose that was used with the previous application of Sandimmun.
The basal concentration of cyclosporine in whole blood should be monitored within 4-7 days after switching to Sandimmun® Neoral®. In addition, clinical safety parameters such as serum creatinine and blood pressure should be monitored within the first 2 months after the transition. If the basal concentration of cyclosporin in the blood is outside the therapeutic range and / or the clinical safety parameters worsen, the dose should be adjusted accordingly.
In patients treated for indications other than transplantation, treatment with Sandimmunom Neoral should begin with the same dose that was administered with Sandimmun.
After 2, 4 and 8 weeks after the transition should monitor the concentration of creatinine in serum and blood pressure. If serum creatinine concentrations or blood levels are markedly increased compared to those before the transition, or if creatinine concentrations have increased by more than 30% compared to before treatment with Sandimmune in more than one measurement, the dose should be reduced by 25-50 %. If the serum concentration increases by more than 50%, then it is necessary to reduce the dose by 50%. In case of development of toxic effects, or if the drug is ineffective, the basal concentrations of cyclosporin in the blood should also be monitored.
The following ranges of oral doses should be considered only as recommendations.
Conventional monitoring of the concentration of cyclosporin in the blood should be performed, for which a radioimmunoassay method based on the use of monoclonal antibodies can be used. Based on the results obtained, determine the dose necessary to achieve the desired concentration of cyclosporine in different patients.
Transplantation

When transplanting solid organs, treatment with Sandimmun Neoral should be started 12 hours prior to surgery at a dose of 10 to 15 mg / kg body weight divided into 2 divided doses.
For 1-2 weeks after the operation, the drug is prescribed daily at the same dose, after which the dose is gradually reduced (under the control of the concentration of cyclosporine in the blood) to a maintenance dose of 2-6 mg / kg / day (in 2 divided doses).
Sandimmune ® Neoral ® is prescribed in combination with other immunosuppressants, including.
with SCS, as well as in the combined three-component (Sandimmun® Neoral® + GCS + azathioprine) or the four-component (Sandimmun® Neoral® + GCS + azathioprine + preparations of mono- or polyclonal antibodies) therapy. The four-component regimen is used in patients with a high risk of developing rejection. In the case of the use of Sandimuna Neoral in combination therapy, its dose can be reduced already at the initial stage of therapy (3-6 mg / kg / day in 2 doses) or adjusted during treatment taking into account the concentration of cyclosporine in the blood plasma and the dynamics of safety indices concentration of urea, serum creatinine, blood pressure).
For bone marrow transplantation, the initial dose should be given on the day preceding the transplant.
In most cases, I / O is preferred; the recommended dose is 3-5 mg / kg / day. Infusion at the same dose is continued for 2 weeks after transplantation, then go on oral maintenance therapy with Sandimmunom Neoral at a daily dose of about 12.5 mg / kg divided into 2 doses. Supportive therapy is performed for at least 3 months (preferably 6 months), after which the dose is gradually reduced to zero within 1 year after transplantation. If Sandimmun® Neoral® is prescribed for the initial phase of therapy, the recommended daily dose is 12.5-15 mg / kg (in 2 divided doses) from the day preceding the transplant.
In the presence of diseases of the gastrointestinal tract leading to a decrease in absorption, higher doses of Sandimmun Neoral or in some cases the use of IV infusions of Sandimmun may be required.

After discontinuation of the administration of Sandimmune, some patients may develop a disease of GVHD, which usually regresses after the resumption of therapy.To treat this condition in its chronic course in a mild form, use Sandimmune ® Neoral ® in low doses.

Indications not related to transplantation

With endogenous uveitis for remission induction, the drug is prescribed in an initial daily dose of 5 mg / kg orally in 2 doses until the signs of active inflammation disappear and visual acuity is improved.
In cases that are difficult to treat, the dose may be increased to 7 mg / kg / day for a short period.
If one can not control the situation with the help of a single Sandimmun Neoral, then to achieve initial remission or to stop an attack of inflammation, you can attach systemic GCS (prednisolone in a daily dose of 0.2-0.6 mg / kg or another glucocorticosteroid in an equivalent dose).

During maintenance therapy, the dose should be slowly reduced to the lowest effective dose, which should not exceed 5 mg / kg / day during the remission period.

With a nephrotic syndrome for induction of remission, the recommended daily intake for adults is 5 mg / kg, for children - 6 mg / kg (in 2 divided doses) with normal kidney function, excluding proteinuria.
In patients with impaired renal function, the initial dose should not exceed 2.5 mg / kg / day.
If one can not achieve a satisfactory effect with the use of a single Sandimmun Neoral, especially in steroid-resistant patients, it is recommended that it be combined with oral glucocorticosteroids in low doses.
If after 3 months of treatment failed to achieve improvement, Sandimmun® Neoral® should be discontinued.
Doses should be selected individually, taking into account the efficacy (proteinuria) and safety (serum creatinine concentration), but do not exceed the dose of 5 mg / kg / day for adults and 6 mg / kg / day for children.

For maintenance therapy, the dose should be gradually reduced to a minimum effective dose.

In rheumatoid arthritis during the first 6 weeks of treatment, the recommended dose is 3 mg / kg / day in 2 divided doses.
In case of insufficient effect, the daily dose can be gradually increased, if tolerability permits, but it should not exceed 5 mg / kg. To achieve full effectiveness, it may take up to 12 weeks of treatment with Sandimmunom Neoral.
For maintenance therapy, the dose should be selected individually, depending on the tolerability of the drug.

Sandimmune ® Neoral ® can be administered in combination with low doses of GCS and / or NSAIDs.
Sandimune ® Neoral ® can also be combined with a weekly course of methotrexate in low doses in patients with an unsatisfactory response to methotrexate monotherapy. The initial dose of Sandimuno Neoral is 2.5 mg / kg / day (in 2 divided doses), and the dose can be raised to a level that is limited by tolerability.
In psoriasis, the dosing regimen should be selected individually.
To induce remission, the recommended initial dose is 2.5 mg / kg / day in 2 divided doses. If no improvement after 1 month treatment daily dose can be gradually increased, but should not exceed 5 mg / kg. The treatment should be discontinued if a satisfactory response from the manifestation of psoriasis has not been achieved after 6 weeks of treatment, a dose of 5 mg / kg / day, or if the effective dose does not meet the safety parameters.
Application of a higher initial dose of 5 mg / kg / day may be justified in patients whose condition requires early improvement. If a satisfactory response is reached, Sandimmune ® Neoral ® can be undone, and the subsequent relapse treated reappointment Sandimmun Neoral at the previous effective dose. Some patients may require long-term maintenance therapy.
Formaintenance therapy dose should be adjusted individually at the minimum effective level, and should not exceed 5 mg / kg / day.
When atopic dermatitis dosing regimen should be adjusted individually. The recommended starting dose of 2.5-5 mg / kg / day in 2 divided doses. If the initial dose of 2.5 mg / kg / day does not achieve a satisfactory response within 2 weeks, the daily dose can be quickly increased to the maximum - 5 mg / kg. In very severe cases, rapid and adequate control of the disease may be achieved by initially applying a dose of 5 mg / kg / day. The dose should be gradually reduced by achieving a satisfactory response, and if possible, Sandimmun ® Neoral ®It should be abolished. A second course of Sandimmun Neoral can be carried out in the event of a relapse.
Despite the fact that the treatment duration of 8 weeks can be enough to cleanse the skin, it has been shown that treatment for up to 1 year, effective and well tolerated, provided the mandatory monitoring of all necessary parameters.
Experience in the use of Sandimmun Neoral in elderly patients is limited.
In clinical studies on the use of cyclosporin for the treatment of rheumatoid arthritis, the proportion of patients aged 65 years or older was 17.5%. It has been shown that these patients are more likely to develop systolic hypertension, as well as more likely to increase in the serum creatinine concentration by more than 50% above baseline after 3-4 months of therapy with cyclosporin.
The number of patients aged 65 years and older included in the clinical studies of Sandimmun Neoral in transplant patients, and in patients with psoriasis, it was not sufficient to determine whether the treatment of the answer is different in these patients the response to treatment in a younger patients. On the basis of other available information on the use of cyclosporine in clinical practice, it can be concluded that the response to treatment in elderly and younger patients is no different.
Dose selection elderly patients should be exercised; Treatment usually begins with the lowest dose, taking into account the greater frequency of liver function, kidney or heart, as well as the concomitant diseases or other concomitant therapy.
Additional guidance on dosing regime at endogenous uveitis, psoriasis and atopic dermatitis
Since Sandimmun ® Neoral ®may interfere with renal function, it must be installed reliable initial concentration in serum creatinine of at least two measurements prior to treatment. The concentration of creatinine should be monitored at 2-week intervals for the first three months of therapy. Further, if the concentration of Creatinine remained stable, measurements should be made monthly. If the creatinine concentration in the serum rises and remains elevated for more than 30% of baseline values ​​in more than one dimension, it is necessary to reduce the dose to 25-50%. These recommendations should be carried out, even if the values ​​of creatinine concentrations remain within laboratory standards. If dose reduction does not lead to a decrease in creatinine concentration within one month, Sandimmun treatment Neoralom should be discontinued.
Discontinuation of treatment is necessary and in the case where during treatment Sandimmun Neoralom occurs uncontrolled increase in blood pressure.
Additional guidance on dosage regimen nephrotic syndrome
Since Sandimmun ® Neoral ® can cause renal dysfunction, it is often necessary to control it. If the concentration of creatinine in serum is increased by more than 30% of the initial values and more than one dimension, the required dose reduction Sandimmun Neoral by 25-50%. For patients with impaired renal function initially initial dose should be 2.5 mg / kg / day. It is necessary to ensure close monitoring of these patients.
Additional information about dosage regimen in rheumatoid arthritis
Since Sandimmun ® Neoral ® may interfere with renal function, it must be installed reliable baseline serum creatinine of at least two measurements prior to treatment. The concentration of creatinine should be monitored at 2-week intervals for the first three months of therapy and in the future - on a monthly basis. After 6 months of therapy in the serum creatinine concentration must be determined every 4-8 weeks depending on the stability of the underlying disease, simultaneously applied therapy and related diseases. More frequent monitoring is required at higher dose Sandimmun Neoral, accession concomitant therapy NSAIDs or increase their dose.
If the concentration of creatinine in serum is increased by more than 30% of the initial values and more than one dimension, it is necessary to reduce the dose. If the concentration of creatinine in serum is increased by more than 50%, the dose should be reduced by 50%. These recommendations should be carried out, even if the values of creatinine concentrations remain within laboratory standards. If dose reduction does not lead to a decrease in creatinine concentration within one month, Sandimmun treatment Neoralom should be discontinued.
Discontinuation of treatment is necessary and in the case where during treatment Sandimmun Neoralom occurs uncontrolled increase in blood pressure.
Terms of use and storage of the drug Sandimmun ® Neoral ®
Instructions for use of the drug in the form of soft capsules
Soft capsules should be left in the blister pack as long as they are needed. After opening the blister there is a characteristic smell. This is normal.
Capsules should be swallowed whole.

Instructions for use of the drug in the form of a solution for oral administration
During initial use:
1. Remove the plastic cover.
2. Completely detach the sealing ring.
3. Remove the black stopper and throw it away.
4. Push the tube firmly with a white stopper into the neck of the bottle.
5. Enter the measuring syringe into the white stopper.
6. Dial the syringe in a measuring volume of the solution corresponding to the prescribed dose.
7. expel all large bubbles repeatedly moving the piston forward and backward, before separate syringe containing volume of the solution in accordance with the intended dose and the vial. The presence of a few tiny bubbles is irrelevant and in no way affects the dose.
8. After use, the syringe should be wiped mer outside only with a dry cloth and put it in a protective case. White stopper and tube should remain in the vial. Close the vial cap.
Upon subsequent use of the solution should begin with claim 5.
Immediately before taking Sandimmun Neoral solution should be drawn from the vial using a syringe mer (as above), transferred into a glass or cup and mixed with orange or apple juice. It is also possible to use other non-alcoholic beverages (according to individual taste). Added drink and should mix well the solution. For dilution should not use grapefruit juice, considering the possibility of interaction with the P450-dependent enzyme system. Avoid contact measuring syringe with a drink mixing. Do not rinse the syringe with water or any other liquid.
Sandimmun ® Neoral ®solution for oral should inwardly used within 2 months from the time the vial opening and kept at a temperature of from 15 ° to 30 ° C, preferably at temperatures below 20 ° C during prolonged storage periods, since the preparation contains oily components of natural origin which tend to hardening at a low temperature. At temperatures below 20 ° C jelly in a transition state, which is replaced by the newly liquid at the temperature is raised to 30 ° C. This may be a small pellet or flake. These phenomena do not affect the efficacy and safety and dosing accuracy with a measuring syringe.
SIDE EFFECT

Many side effects associated with cyclosporin, dose-dependent and reversible in dose reduction.
The spectrum of side effects is generally the same for different indications, although the frequency and severity of side effects may vary. In patients who underwent transplantation, due to higher doses and longer duration of treatment side effects are more frequent and usually more severe than in patients with other indications.
The on / in the introduction of cyclosporine were cases of anaphylactoid reactions. In patients receiving immunosuppressive treatment with cyclosporine or a combined therapy including cyclosporine, an increased risk of local and generalized infections (viral, bacterial, fungal etiologies) and parasitic infestations. It is also possible exacerbation of previously existing infectious diseases. Reported cases of infectious lesions fatal.
In patients receiving immunosuppressive cyclosporin treatment or combination therapy comprising cyclosporin, increased risk of developing lymphoma, lymphoproliferative diseases and malignant tumors, especially skin. The incidence of malignant neoplasms increases with the intensity and duration of immunosuppressive therapy.
The incidence of adverse events was assessed as follows: very common (1/10?), Common (1/100, <1/10?), Sometimes (1/1000, <1/100?), Rarely (1/10 000? <1/1000), very rare (<1/10 000), including isolated reports.
From the urinary system: very often - renal dysfunction.
Cardio-vascular system: very often - increased blood pressure.
On the part of the central nervous system and peripheral nervous system: very often - tremor, headache; often - paresthesia; sometimes - signs of encephalopathy, e.g. seizures, confusion, disorientation, slowness of reaction, agitation, sleep disorders, visual disorders, cortical blindness, coma, paresis, cerebellar ataxia; rarely - motor polyneuropathy; very rarely - papilledema (including optic papilla) secondary to benign intracranial hypertension.
From the digestive system: often - anorexia, nausea, vomiting, abdominal pain, diarrhea, gingival hyperplasia, hepatic dysfunction;
rarely - pancreatitis.
From a metabolism: often - hyperlipidemia; often - hyperuricemia, hyperkalemia, hypomagnesemia;
rarely - hyperglycemia.
On the part of the musculoskeletal system: often - muscle cramps, myalgia;
rarely - muscle weakness, myopathy.
From hemopoiesis system: sometimes - anemia, thrombocytopenia; rarely - microangiopathic hemolytic anemia, hemolytic uremic syndrome.
Dermatological reactions: often - hypertrichosis; sometimes - allergic rash.
On the part of the body as a whole: often - fatigue; sometimes - swelling, increased body mass.
From endocrine system: rarely - menstrual disorders, gynecomastia.
CONTRAINDICATIONS

- Hypersensitivity to cyclosporine and other ingredients.
For indications not related to the transplant
should not be prescribed cyclosporine in patients with impaired renal function (except for patients with nephrotic syndrome with an acceptable degree of these disorders), uncontrolled hypertension, malignant tumors, infectious diseases, not amenable to adequate treatment.
PREGNANCY AND LACTATION

Experience in the use of Sandimmun Neoral in pregnant women is limited. Pregnant women who have undergone organ transplantation and receiving immunosuppressive treatment with cyclosporine or a combined therapy including cyclosporine, there is a risk of preterm delivery (occurring during pregnancy up to 37 weeks). A limited number of observations of the children (up until the age of 7 years), exposed to ciclosporin in utero. Renal function and blood pressure in these children were normal. However, adequate and well-controlled studies in pregnant women have not been conducted, so you should not use the drug during pregnancy unless the expected benefit to the mother justifies the potential risk to the fetus.
In experimental studies,It shows the toxic effect of the preparation on the reproductive function.
Cyclosporin passes into breast milk. Mother receiving Sandimmun ® Neoral ® , should stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER

Should not be administered tacrolimus in patients with impaired renal function (except for patients with nephrotic syndrome with an acceptable degree of these disorders).
In patients with impaired renal function initial dose should not exceed 2.5 mg / kg / day.
APPLICATION IN ELDERLY PATIENTS

Experience in the use of Sandimmun Neoral in elderly patients is limited.
Dose selection elderly patients should be exercised; Treatment usually begins with the lowest dose, taking into account the higher frequency disturbances.
Elderly patients should be particularly careful to carry out monitoring of renal function.
SPECIAL INSTRUCTIONS

Sandimmune ® Neoral ® should only be used by physicians experienced in immunosuppressive therapy and has the ability to provide adequate monitoring of patients, including regular full physical examination, measurement of blood pressure and control of the concentration of creatinine in serum. The patients who underwent transplantation and receiving the drug should only be undertaken in those institutions, which are provided by trained medical personnel, adequate laboratory and other resources.
It should be borne in mind that the application of cyclosporine, as well as other immunosuppressive drugs increases the risk of developing lymphomas and other malignancies, most of the skin. Increased risk of developing this complication is associated with a greater degree and duration of immunosuppression than with the use of a particular drug. Thus, caution should be exercised when using combined modes immunosuppressive therapy, bearing in mind the likelihood of developing lymphoproliferative disorders and solid organ
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