Sandimmun neoral oral solution 100mg/ml Novartis used in solid organ transplants, bone marrow transplantation (50ml)

Dosage form Box X 50ml
Specifications Ciclosporin

Ingredient

Composition information	Content
Ciclosporin	100mg/ml

Uses

Indications

indicated in organ transplants

Special organ transplant

Preventing the removal of pieces after transplanting the same species such as kidneys, liver, heart, lungs, heart-pulp or pancreatic mixture.

Treatment of waste pieces in patients has used other immunosuppressive drugs.

Bone marrow transplant

Preventing the disposal of puzzles after bone marrow transplantation.

Preventing or treating pieces against the host (GVHD).

indicated in non -transplant diseases

endogenous dug inflammation

Treatment of intermediate orchiditis or at the back threatens an infection of non -infected vision in patients whose conventional treatment has failed or caused unacceptable side effects.

Treatment of Behcet dug with recalling inflammation, including retina.

Nephrotic syndrome

Steroid and steroid -resistant kidney syndrome in adults and children due to glomerular diseases such as kidney disease to minimum injury, partial localized glomerular fibrosis or glomerulonephritis.

Sandimmun Neooral can be used to create a relieved effect and maintain a stable disease. It can also be used to maintain the remission due to steroid treatment, allowing steroid stops.

rheumatoid arthritis

Treatment of serious, active rheumatoid arthritis.

Psoriasis

Serious psoriasis treatment in patients but conventional treatment is no longer appropriate or ineffective.

Atopic dermatitis

Use Sandimmun Neoral in patients with serious atopic dermatitis when needing systemic treatment.

Pharmacokic

ciclosporin (also known as Ciclosporin A) is a ring polypeptide of 11 amino acids. A valid immune inhibitor on animals that extend the survival time of the pieces of the same species in the skin, heart, kidney, pancreas, bone marrow, small intestine and lungs. Research shows that Ciclosporin inhibits the growth of intermediaries, including transplant immunity with other individual species, slow sensitivity in the skin, experimental encephalitis, arthritis caused by tons of Freund, a piece of graft against the host (CVHD) and the production of antibodies dependent on cells. Interleukin-2 (TCGF).

Ciclosporin seems to be closed by the lymphocytes with the authority of immunity in G0 or G1 of the cell cycle and inhibiting the lymphocin secretion caused by antigen because T -cells are activated.

All existing evidence shows specific and recovery ciclosporin and recovery on lymphocytes. Unlike cellular needles, ciclosporin does not inhibit hematopoiasis and does not affect the function of phagocytic cells. Patients using Sandimmun Neoral IT have more bacterial infections than when taking cell needles in other immunosuppressive therapy.

Special organ transplants and bone marrow have been successfully carried out on the user of Sandimmun Neooral to prevent and treat the discharge of pieces and pieces against the host. Ciclosporin has been successfully used on both positive or negative liver transplant patients with hepatitis C (HCV) virus. Sandimmun neoral is also useful in many different cases that we have seen or can be considered due to autoimmune cause.

Dynamic pharmacokinetics

When using Sandimmun Neooral, the recruitment of the dosage on the dosage of Ciclosporin exposure (AUCB), more persistent absorption, and less affected by food and daytime biological rhythm, compared to sandimmun. These characteristics combine with less change in pharmacokinetics of ciclosporin by individual patients, and the stronger correlation between the concentration here and the exposure of the whole drug (AUCB). The result of this advantage is that the time to use Sandimmun Neooral during the day does not need to be taken into account. Moreover, the Ciclosporin exposure of Sandimmun Neoral is more stable throughout the day, and from day to day in maintenance treatment.

Soft gelatin cystin Neooral and Sandimmun Neooral oral solution equivalent to biological. Available data shows that after converting 1: 1 from Sandimmun to Sandimmun Neooral, the blood bottom concentration is the same, thereby keeping the desired bottom concentration range. Compared to Sandimmun (blood peak concentration within 1-6 hours), Sandimmun Neooral absorbs faster (reaches TMAX an average of 1 hour earlier, reaching CMAX on average 59% higher) and reaches an average of 29% higher bioavailability.

ciclosporin is widely distributed outside the blood volume. In the blood, 33-47% are present in plasma, 4-9% in cell lymphocytes, 5-12% in granular cells, 41-58% in red blood cells.

In plasma, about 90% of ciclosporin combined with protein-mutations, mainly with lipoprotein. Ciclosporin metabolizes strongly to give about 15 metabolites. There is no main metabolic path. Eliminating mainly through bile, only 6% of oral doses are discharged through urine, only 0.1% excreted through the urine in the form of unprocessed.

There is a great variable in the reporting data on the sale time of ciclosporin depending on the testing technique and the testing complex. The final sale time is about 6.3 hours with a healthy volunteer and up to 20.4 hours for patients with serious liver impairment (see the dose and usage and caution parts).

Special subjects

kidney failure

In a study conducted in patients with end -stage renal failure, after intravenous transmission of 3.5 mg/kg for 4 hours, the average peak concentration in the blood is 1,800 ng/ml (about 1,536 to 2,331 ng/mi). The average distribution volume (VDSS) is 3.49 kg and the body clearance (Cl) is 0.369 I/hour/kg. The clearance of this system (0.369 I/hour/kg) is about 2/3 of the average deity of the God of Mathematics (0.56 I/h/kg) in patients with normal kidney function. Renal failure does not significantly affect the excretion of ciclosporin.

Hepatic failure

In a study conducted in patients with severe hepatic failure with cirrhosis proving a biopsy, the end of the half -life is 20.4 hours (between 10.8 to 48.0 hours) compared to 7.4 to 11.0 hours in healthy people.

Clinical studies

Please see more in the drug tutorial.

Clinical safety data

Please see more in the drug tutorial.

Before taking Sandimmun neoral oral solution 100mg/ml Novartis used in solid organ transplants, bone marrow transplantation (50ml)

How to use

oral

Sandimmun neoral oral drinking solution should be diluted with orange or apples; However, other drinks, such as soft drinks, can be used depending on the taste of each person. It is necessary to stir well right before taking the solution. Because there may be interaction with the enzyme system dependent on Cytochrome P450, it is advisable to avoid using grapefruit juice to dilute (see the drug interaction). Mr. Tiem was not exposed to the solution. If the syringe needs to be cleaned, do not wash, but only wipe the outside with dry cloth (see the user manual and manipulation).

Dosage

Sandimmun neoral daily dose must always be divided into two use.

Due to the significant variation between individuals and in the same individual of absorption and elimination and the ability to interact with pharmacokinetic drugs (see the drug interaction), the dose should be titrated based on clinical response and tolerance.

In organ transplant patients, it is necessary to regularly monitor Ciclosporin concentration in the blood to avoid side effects due to high concentrations and rooms for low concentration (see warning and caution).

In patients treated with non -transplantation, monitoring of ciclosporin levels in the blood is limited except in the case of failed treatment or unexpectedly recurrent treatment, which can be suitable for establishing the capabilities of very low concentrations caused by non -compliance, reduced gastroenter tract absorption or pharmacokinetic interaction (see warning and cautious parts)

General target object

Tibet transplant

Special organ transplant

Treatment with Sandimmun Neooral should start within 12 hours before surgery at a dose of 10-15 mg/kg body weight, divided into 2 times. This dose should be maintained as daily dose, used for 1-2 weeks after surgery, before gradually reducing the dose in accordance with the concentration of the drug in the blood until the maintenance dose reaches about 2-6 mg/kg, divided into 2 times of the day.

If using Sandimmun Neooral with other immunosuppressants (for example, corticosteroids or part of 3-4 drugs), the lower dosage may be used (for example, 36 mg/kg, divided into 2 times in the beginning therapy).

When using a solid sandimmun solution to mix the transmission, the recommended dose is about 1/3 of the appropriate dose of Sandimmun Neooral, and recommend that patients switch to oral form as soon as possible.

Bone marrow transplant

Starting dose to be used on the day before grafting. In many cases, or select Sandimmun intravenous infusion (I.V.) for this purpose. The recommended intravenous dosage is 3-5 mg/kg per day. Continue to transmit this dose in the period right after the transplant for up to 2 weeks, before changing it to the form of oral to maintain with Sandimmun Neooral with a daily dose of about 12.5 mg/kg, divided into 2 use.

Maintenance treatment should continue for at least 3 months (and it will be better if maintained 6 months) before gradually reducing the dose to the number of Confucius in 1 year after grafting.

If using Sandimmun Neoral for initial treatment, the recommended dose is 12.5-15 mg/kg daily, divided into 2 use, starting the day before the organ transplantation.

may need a sandimmun neoral or intravenous doses, when there are gastrointestinal disorders that can reduce drug absorption.

In some patients, there is a piece of graft against the host (GVHD) after stopping the use of Sandimmun Neoral, but usually the patient responds smoothly when the next treatment is. In such cases, the starting dose should be 10 to 12.5 mg/kg, then taken daily with the previous maintenance dose that responds.

Need low doses of Sandimmun Neooral to treat grafting against mild and chronic host.

Cases of not transplantation

When using Sandimmun Neooral in any indicator without organ transplantation, it is advisable to comply with the following general rules:

Before the beginning of treatment, the creatinine level should be established in the basic level reliably because at least two measurements, and it is necessary to regularly evaluate the kidney function throughout the treatment process to adjust the dose (see the warning and cautious part)

The only accepted road is oral (concentrated in the form of unused intravenous transmission), and should be divided daily by daily doses.

Except for patients with endogenous uveitis threatening vision and children with nephrotic syndrome, the daily dose is never exceeded 5 mg/kg.

Maintenance of treatment at the lowest dose and good absorption should be considered for each individual.

In patients for a certain period of time (specifically information viewed below) does not meet the appropriate response or effective doses that are not compatible with safety instructions, should stop treating with Sandimmun Neooral.

endogenous dug inflammation

To help relieve the disease, first for patients to take 5 mg/kg every day, divided into 2 times, use until the remission of inflammation, uvebians operate and improve vision. In case of resistance, the dose may be increased to 7 mg/kg/day for a limited period of time.

To achieve initial remission, or to combat eye inflammation, you can use a systemic corticosteroid with daily doses of 0.2 - 0.6 mg/kg prednisone or equivalent, if only sandimmun neoral is not fully controlled.

Maintenance treatment, gradually reducing the dose until the lowest useful dose and this dose does not exceed 5 mg/kg/day during the retreat.

Nephrotic syndrome

To improve the disease, the recommended dose per day is divided into 2 drinks.

If normal kidney function (except in the case of proteinuria), the following daily recommendations:

5 mg/kg (for adults) and

6 mg/kg (for children).

Should combine Sandimmun Neooral with low -dose corticosteroids for oral, if Sandimmun Neoral alone is not effective enough, especially for steroid resistance patients.

If after 3 months of treatment as above without improving, it is advisable to stop using Sandimmun Neoral.

Doses that need to be adjusted according to the patient, depending on the effect (protein-nigimum) and safety (first of all, Creatinin-Thanh Huyen Thanh), but must not exceed 5 mg/kg/day (in adults) and 6 mg/kg/day (in children).

For maintenance treatment, it is necessary to gradually reduce the dose to the lowest level but still valid.

rheumatoid arthritis

In the first 6 weeks of treatment, the recommended daily dose is 3 mg/kg, taken 2 times a day. If not enough effect, willow daily may gradually increase when the tolerance is allowed, but not exceeding 5 mg/kg per day. To achieve the best effect, it may be necessary to prolong the treatment of Sandimmun Neooral up to 12 weeks.

For maintenance treatment, dosage should be titrated according to the individual patient to the lowest dose effective, based on tolerance.

Can combine Sandimmun Neooral with low doses of corticosteroids and/or of nonsteroidal anti -inflammatory drugs (see the warning and caution). It is also possible to combine Sandimmun Neooral with low doses of methotrexate (used for each week) in patients without adequate response if only used for methotrexate, and first use 2.5 mg/kg

Sandimmun Neoral, divided into 2 drinks a day, with the choice of increasing dose when the tolerance is allowed.

Psoriasis

Due to the change or change of this disease, it is necessary to treat each individual. To help relieve the disease, the recommended starting dose is 2.5 mg/kg daily, orally divided into 2 times. If after 1 month without improving the disease, it may gradually increase the daily dose but do not exceed 5 mg/kg. It is necessary to stop treating patients without responding to psoriasis lesions for 6 weeks used at a dose of 5 mg/kg/day or for patients but the effective dose is not compatible with the prescribed instructions for safety (see the warning and cautious section).

The starting dose of 5 mg/kg has been shown to be true for patients a day that requires rapid improvement. Once the desired response is achieved, the Sandimmun Neooral can be stopped and the recurrence is later controlled by starting to reuse the Neooral Sandimmun Neooral with the previous dosage. For some patients, maintenance treatment may continue.

For maintenance treatment, the dosage needs to be titrated by the lowest dose that takes effect and should not exceed 5 mg/kg daily.

Atopic dermatitis

Due to the change or change of this disease, it is necessary to treat each individual. The recommended dose is 2.5 - 5 mg/kg daily, orally divided into 2 times. If the daily starting dose is 2.5 mg/kg that does not meet the desire in 2 weeks of treatment, the daily dose should increase rapidly to a maximum of 5 mg/kg. In serious cases, the fast and complete control of this disease will be easier to achieve, if the starting dose is 5 mg/kg per day. Once the desired response is achieved, it can gradually reduce the dose and if possible, should stop using Sandimmun Neooral. Can manage the recurrence later with a continuing course of Sandimmun Neoral.

Despite the 8 -week process that may be sufficient to create the effect of the disease, but lasting 1 year also shows good validity and tolerance, as long as it is necessary to follow the monitoring instructions.

Special subjects

kidney failure

all indications

ciclosporin minimum excretion through the kidneys and its pharmacokinetics is not affected by the kidney failure (see the pharmacological part of Lam Sang). However, due to the ability to poison kidney (see the side reaction of the drug), it is recommended to monitor the function carefully (see the warning and cautious part - all indicator).

Non -transplant indications

Patients with renal failure, except for patients with nephrotic syndrome, should not use ciclosporin (see the scene and caution - See the additional part of caution in the indications of not organ transplantation). For patients with kidney failure syndrome, the starting dose should not exceed 2.5 mg/kg/day.

Hepatic failure

ciclosporin metabolizes strongly through the liver. The semi -cancellation time changes between 6.3 hours in healthy volunteers up to 20.4 hours in patients with severe liver failure (see clinical pharmacological part). Dosage should be reduced in patients with severe liver failure to maintain blood levels in the recommended dose range (see the warning and caution and clinical pharmacological parts)

Children

Clinical studies including children from 1 year old using standard ciclosporin dose do not have problems. In many studies, pediatric patients require and tolerating the dose of ciclosporin calculated by higher weight kg in adults.

It is not recommended to use Sandimmun Neooral in children with non -organ transplantation other than nephrotic syndrome (see the warning and cautious part - the additional part of caution in the indications of non -transplantation).

Elderly (≥ 65 years)

Experience in Sandimmun Neooral in the elderly is limited, but when taking the drug in the recommended dose, there is no special problem.

In the clinical trial of rheumatoid arthritis treated with ciclosporin, 17.5% of the age patients are old (≥65). These patients are more likely to experience systolic hypertension and are more likely to increase creatininin-chest to ≥ 50% higher than the basic level after taking 3-4 months.

Clinical research with ciclosporin in people with organ transplantation and psoriasis does not include a full number of people ≥ 65 years old and thereby determining whether they respond to young people. Other clinical experiences reported did not identify the difference in response to the drug when comparing the elderly patients with younger people. In general, the choice of dosage for elderly patients should be cautious, often starting with low doses within the allowed dose range, reflects higher frequency on impaired liver, kidney or heart function in the elderly and accompanying or other medications.

Sandimmun orally to sandimmun neoral

The available data shows that after switching from Sandimmun to Sandimmun Neooral at a dose of 1: 1 ratio, the minimum concentration of ciclosporin in the blood is equivalent.

However, in many patients, the peak concentration of plasma (CMAX) and the total amount of drugs are absorbed (AUC) reaches a higher level. In a few patients, these changes are more significant and may have clinical significance. This level of change depends greatly on the change of ciclosporin absorption in each person due to the previous use of sandimmun, known as a biological use that is easy to change. Patients with minimum or changing drug concentrations or very doses of sandimmun may be poorly absorbed or unstable absorption ciclosporin (such as patients with gallbladder fiber, liver transplant patients with face or poor bile secretion, children or some kidney transplant patients) can be able to absorb well when switching to sandimmun neoral.

Therefore, for the above subjects, the bioavailability of ciclosporin after transferring 1: 1 from the sandimmun form to Sandimmun Neoral may be larger than usual, so it is necessary to adjust the dose down to suit the minimum minimum drug level to be achieved. It should be emphasized that the absorption of ciclosporin from Sandimmun Neoor is less change and the correlation between the minimum ciclosporin level and the amount of drugs absorbed (AUC) is much stronger and sandimmun. This makes the concentration of ciclosporin more unstable and is a reliable parameter during treatment monitoring.

Because the conversion from Sandimmun to Sandimmun Neoor can increase the amount of drugs absorbed, so the following rules must be complied with:

In organ transplant patients, Sandimmun Neooral needs to start treatment with the same dose of sandimmun dose. The bottom concentration of ciclosporin in the whole blood should be monitored in 4-7 days after switching to Sandimmun Neoral. Moreover, clinical safety parameters such as Creatinin-Tuyet and blood pressure should be monitored in the first 2 months after transferring the drug. If the pushing concentration of ciclosporin in the sample exceeds the treatment boundary and/or when the parameters of clinical safety worsens, the dose should be adjusted accordingly.

For patients with indications for not organ transplantation, the starting of the Neooral sandimmun with the same daily dose as used with the previous sandimmun. After transferring the drug 2-4-8 weeks, it is necessary to monitor creatinine levels in serum and blood pressure. If creatinine concentration -The bar or blood pressure exceeds the level before the transition or if the concentration of creatinin -The bar increased by more than 30% compared to the concentration before using sandimmun and measured more than 1 time, it is necessary to reduce the dose of the drug (see the item "Additional caution in the warning and cautious section). Blood.

switch between oral ciclosporin cells

The transfer from oral ciclosporin to another form of oral need to be cautious and supervised by a doctor. With a new form of preparation, the blood concentration in the blood should be adjusted to ensure that the level of ciclosporin remains the same as when using the previous preparatory form.

What to do when overdose? LDSO (intravenous) of ciclosporin is 148 mg/kg (mouse), 104mg/kg (rats) and 46 mg/kg (rabbit).

Symptoms

Experience in acute poisoning with ciclosporin is limited. Oral doses of ciclosporin up to 10 g (about 150 mg/kg) have been absorbed with relatively mild clinical consequences such as vomiting, sleeping, headache, tachycardia and in some patients, impaired renal function of average level, self -recovery. However, dangerous toxic symptoms have been reported by using ciclosporin overdose in the digestive tract in premature babies.

Treatment

In all cases of overdose, general support measures should be adhered and treated with symptoms. Causing vomiting and gastric lavage may work within the first few hours after taking the medication. Ciclosporin cannot be disturbed, nor is it eliminated through dialysis with activated carbon.

What to do when forgetting a dose?

Side Effects

Summary of safety

The main side effects are observed in clinical studies and related to the use of ciclosporin including kidney failure, tremor, hair, hypertension, diarrhea, anorexia, nausea and vomiting.

Many side effects are used by ciclosporin depends on dosage and relieved when reducing the dose. In many different indications, the common spectrum of the side effects is mostly the same; However, there is a difference in frequency and severity. As a result of the higher starting dose and the maintenance time lasts longer due to the demand after organ transplantation, the side effects are more common, more serious for the organ transplant than the people in other indications without organ transplantation.

Anaphylactic reactions have been observed when using intravenous lines (see the warning and cautious section).

Patients taking immunosuppressive drugs, including ciclosporin and treatments with ciclosporin, increases the risk of infection (virus, bacteria, fungi, parasites) (see the warning and cautious section). Both body and local infections can occur.

Infections available can also get worse and the triggers of polyomavirus infections can lead to kidney disease caused by polyomavirus (PVan) or white substance in the progression of JC virus (PML). Severe cases and/or death have been reported.

Patients taking immunosuppressive drugs, including ciclosporin and ciclosporin treatment mode, increases the risk of lymphoma or lymphatic hyperactive disorders and other malignant tumors, especially on the skin. The frequency of malignant tumors increases with intensity and duration of treatment (see the warning and caution). Some malignant tumors can be fatal.

Summary table of side effects of drugs from clinical trials

The side effects of the drug from clinical trials (Table 1) are listed by the Meddra Organization Classification System. In each organization system classification, the side effects of the drug are classified by frequency, first is the most common. In each frequency group, the side effects of the drug are presented in the order of gradual decrease in severity. In addition, the corresponding frequency for each side reaction of the drug is based on the following convention: Very common (≥ 1/10), common (≥1/100, Blood disorders and lymphatic systems Blood

The nervous system disorders Circuit very common hypertension (see the warning and cautious section) Meet

nausea, vomiting, abdominal discomfort, diarrhea, hypertrophy. Bigly)

Skin and subcutaneous disorders The ureter

is very common. > Systemic disorders and medications

The following side effects are derived from experience after circulation of Neoral or Sandimmun Sandimmun through spontaneous reports and medical cases. Because these reactions are voluntarily reported from an unknown size population group, it is not estimated to be a reliable frequency of its frequency, so the classification is unknown. The side effects of the drug are listed based on the Organizational Rating System of Meddra. In each organization system, the side effects of the drug are presented in Table 2 below in the order of gradual decline in severity.

Side reactions of drugs from spontaneous and literary reports (unknown frequency)

Blood and lymphatic disorders

thrombosis capillary, hemolytic syndrome; thrombocytopenia of hemorrhage; anemia; platelet reduction.

Disorders of metabolism and nutrition

Hypergaric hyperkemops, hyperuricemia, hyperkalemia, decreased blood magnesium.

Nervous system disorders

Brain disease syndrome includes recovery (preses), signs and symptoms such as convulsions, confusion, loss of orientation, reduced response, agitation, insomnia, vision disorders, cerebral blindness, coma, weakness, loss of cerebellum, optical disk including gai gai, blind can be secondary due to hypertension of the pagoda and neurological disease; migraine.

Digestive disorders

Acute pancreatitis.

Liver disorders

Hepatitis and liver damage include biliary stasis, hepatitis, jaundice and liver failure with some fatal results (see the warning and caution)

Skin and tissue disorders

Hairy.

Disorders of musculoskeletal and connective tissue

muscle disease; muscle spasm; muscle pain; muscle weakness.

Disorders of reproductive and breast systems

Men's breasts.

Systemic disorders and medical condition

fatigue; weight gain.

Description of the side effects of the drug selected

toxicity on the liver and liver damage

There have been reports after circulation of drugs on liver toxicity and liver damage including bile stasis, jaundice, hepatitis and liver failure in patients treated with ciclosporin. Most reports include patients with additional diseases, previous diseases, and other serious factors including complications of infection and simultaneous use of other drugs that are toxic to other liver. In some cases, mainly in patients with organ transplants, deaths have been reported (see warning and caution).

Acute and chronic kidney toxicity

Patients treated with calcineurin inhibitors (CNLS), including ciclosporin and mode, including ciclosporin, increases the risk of acute and chronic kidney toxicity. There are reports from clinical trials and from experience after circulation of drugs related to the use of Sandimmun Neooral: Cases of acute renal toxicity are reported on electrolytic dysfunction of electrolytes, such as hyperkalemia, blood hyperiemia, hyper urea growth in most cases in the first month of treatment. Cases of reporting on chronic morphological changes include Hyali sclerosis, renal tubular atrophy and interstitial fibrosis (see the warning and cautious section).

Notify the doctor with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Hypersensitivity to ciclosporin or any excipients of Sandimmun Neoor.

Caution when using

Read the instructions carefully before use. If you need more information, please consult your doctor.

This drug is only used by a doctor.

All indications

Medical supervision

Sandimmun Neooral is only prescribed by physicians with experience in immunotherapy and fully monitoring, including regular body tests, blood pressure measurement and testing parameters in the laboratory. Traditional transplant patients need to be easily managed with appropriate and complete laboratories and with medical support sources. The physician is responsible for maintenance treatment that needs all information to monitor patients.

cell lymphoma and other malignant diseases

Like other immunosuppressive drugs, ciclosporin increases the risk of cell lymphoma and other malignant diseases, especially skin tumors. An increase in risk may be more related to the level and time limit for immunosuppressive rather than using specific drugs. Therefore, a treatment regimen contains many immunosuppressive drugs (including ciclosporin), which needs to be used carefully, as it can lead to lymphocytic hyperactive disorders and tumors of concentrated organs, some tumors may be fatal (see the side effect of the drug).

Due to the risk of malignant skin disease, the patient should be warned that the patient uses Sandimmun Neoral to avoid excessive contact with ultraviolet light.

Infections

Like other immunosuppressive drugs, Ciclosporin leads patients to develop many types of bacteria, fungi, parasites and viruses, sometimes due to opportunistic germs.

The hidden activation of the hidden polyomavirus can cause kidney disease caused by polyomavirus (PVan), especially kidney disease caused by BK virus (BKVN), or the progressive multi -noctile white substance disease caused by JC Virus has been observed in patients using ciclosporin. These conditions are also often related to too much immunosuppressive drugs and must be considered in distinguished diagnosis in patients using immunosuppressive drugs that have impaired renal function or have neurological symptoms. Severe cases and/or death have been reported. It is necessary to apply previous and effective prevention strategies, especially for long -term patients with immunosuppressive drugs (see the side effects of the drug).

Acute and chronic kidney toxicity

A common and serious complication is increased creatinine and urea in serum, which can be seen in the first few weeks using Sandimmun Neoral. Those functional changes depend on dosage and recover, often responding when reducing the dose. When long -term treatment, some patients develop the structure of the kidneys (such as hypolent degeneration, renal tubular atrophy, interstitial renal fiber) in kidney transplant patients, which must be distinguished from changes due to chronic discharge (see side effects of the drug). Need to closely monitor kidney function assessment parameters. When encountered abnormal values, the drug should be reduced (see the dose and usage and clinical pharmacological parts).

toxicity on the liver and liver damage

Sandimmun Neooral can also cause an increase in bilirubin-bar depends on dosage and have restoration and increased liver enzymes (see the side reaction of the drug).

Hepatic poisoning and liver damage included on the face, jaundice, hepatitis and liver failure in patients treated with ciclosporin were reported after the drug circulated. Most reports include patients with additional diseases, previous diseases, and other serious factors including complications of infection and simultaneous use of other drugs that are toxic to other liver. In some cases, mainly in patients with organ transplantation, death has been reported (see the side effect of the drug). Need to closely monitor the parameters of liver function assessment. When encountering abnormal values, the drug should be reduced (see the dosage and use and pharmacological parts forestly).

Elderly

In elderly patients, kidney function should be monitored with special caution.

Monitor ciclosporin concentration in organ transplant patients

When using Sandimmun Neooral in organ transplant patients, regularly monitoring Ciclosporin concentration in the blood is an important safety measure (see the amount of bureaucracy and use).

To monitor the concentration of ciclosporin in the whole blood, or use a specific single -line antibody method to measure the main drug; High -performance liquid chromatography (HPLC) is also used to measure the main drug and also be used well. When using plasma or serum, it is necessary to follow the process of standard extraction (time and temperature). To monitor the beginning of liver transplant patients, or can use specific single -line antibodies, or measure in parallel with both specific single -line antibodies and non -specific single -line antibodies to ensure the dosage creates adequate immunosuppressive inhibition.

It should be remembered that the concentration of ciclosporin in the blood, plasma or serum is only one of many factors involved in the patient's clinical condition. Therefore, the results are only helping to guide the dosage related to other clinical and testing parameters (see the dosage and usage).

Hypertension

Need to monitor blood pressure regularly when using Sandimmun Neooral, when having hypertension, an appropriate anti -hypertension drug must be used (see the side effect of the drug). Priority is given to the use of anti -hypertension drugs that do not affect the pharmacokinetics of ciclosporin, such as isradipine (see the drug interaction).

hyperlipidemia

Because Sandimmun Neoral has slightly increased and has a blood lipid recovery, it will be suitable if the patient's lipid indicator is proceeded to determine the patient's lipid indicators before and after the first month of treatment.

When encountering lipid-lipid hyperplasia, it is necessary to limit fat to eat fat and, if appropriate, consider to reduce the dose (see the side reaction of the drug).

Hemorrhage

ciclosporin increases the risk of increased potassium, especially in patients with renal dysfunction (see the side reaction of the drug). It also requires caution when coordinating ciclosporin with potassium drugs (for example: Potassium diuretic, angiotensin transfer inhibitors, angiotensin II receptor antagonists) and potassium -containing drugs, as well as patients according to potassium -rich diets (see drug interaction). Potassium-level concentration should be checked in the above cases.

Magnesi blood reduction

ciclosporin increases the purification of magnesium, which can lead to reduced magnesium concentration of symptoms, especially during the period of organ transplantation (see the side effect of the drug). Therefore, it is necessary to check Magnesi-tancers in the period of organ transplantation, especially when there are nerve symptoms/signs. If considered necessary, can add Magnesi.

Hyperglycemia

Be cautious with patients with hyper uric acid (see the side effect of the drug).

Vacuum Vaccination Reducing Power

While using ciclosporin, vaccinations may be reduced; Need to avoid using poison-reduced live vaccines.

Drug interaction

Be careful when using Lercanidipine with ciclosporin (see the drug interaction).

ciclosporin is a strong PGP inhibitor and can increase the blood concentration of the drugs that are the substrate of p-glycoprotein (PGP) simultaneously used as Dabigatran Etrixilate, Bosentan, Aliskiren, and the increasing level of these substances may be related to serious or life-threatening events. It is not recommended to simultaneously use Sandimmun Neooral with Aliskiren, Bosentan or Dabigatran Ethilate (see the drug interaction).

Special excipients: Ethanol

pay attention to the content of ethanol (see the description and ingredients) when used for pregnant and nursing nursing women, in patients with liver or epilepsy, alcoholic patients, or if using Neoral sandimmun for children.

Cautions in the indications for no organ transplantation

Patients with renal function (except for patients with nephrotic syndrome with the level of renal failure), uncontrolled hypertension or any form of cancer should not use ciclosporin.

Caution in endogenous dug inflammation

Because Sandimmun Neooral can impair kidney function, it is necessary to regularly evaluate the kidney function, and when creatininin -bars increase more than 30% compared to the basic level in more than one quantitative, it is necessary to reduce the dose of Sandimmun Neoor to 25-50%. If increasing by 50% compared to the basic level, the dose reduction should be considered. These recommendations also apply even when the values of the ring are always at a normal level of testing.

Should use cautious sandimmun neoral in patients with neuron syndrome Behcet.

The nervous condition of patients with Behcet neurological syndrome should be carefully monitored.

Not much experience in using Sandimmun Neoral for children with endogenous uveitis.

Be cautious in kidney syndrome

Sandimmun Neooral can impair kidney function, need to evaluate kidney function regularly and when creatininin -bars increase by more than 30% compared to the basic level after measurement more than 1 time, it is necessary to reduce 25-30% of the dose of Sandimmun Neooral. If an increase of more than 50% compared to the basic level, it is advisable to consider reducing additional dose. Patients with kidney function at a basic level often need to start at a daily dose of 2.5 mg/kg and must be monitored very carefully.

In some patients, it may be difficult to detect kidney dysfunction caused by Sandimmun Neooral, because there are changes in renal function related to kidney syndrome. This explains why in rare cases, there is a kidney structure damage due to the use of Sandimmun Neooral without increasing creatinin-bar. Therefore, it is necessary to consider making kidney biopsy for patients with little renal disease dependent on steroids, which has treated Sandimmun Neoral to be maintained for more than 1 year.

For patients with nephrotic syndrome that use immunosuppressive drugs (including ciclosporin), sometimes malignant tumors (including Hodgkin cell lymphoma).

Be cautious in rheumatoid arthritis

Because Sandimmun Neooral can impair the kidney function, it is necessary to determine the basic level of authentication of creatininin-the bar equal to at least 2 tests before treatment and creatinin-bar need to monitor each week, in the first 3 months of treatment and then to test once a month. After 6 months of treatment, Creatinin-Thanh Tuyet needs to be measured every 4-8 weeks depending on the stability of the disease, the combination of drugs and the diseases at the same time. Need to evaluate more often, if there is an increase in the dose

Sandimmun Neooral or when starting in combination with nonsteroidal anti -inflammatory drugs (NSAID) or increasing the dose of NSAID (see the drug interaction).

If Creatinin-The bar increased by more than 30% compared to the basic level in one test, the sandimmun neoral dose was reduced. If creatinine-bars increased more than 50%, it is required to reduce the dose by 50%. These recommendations apply even when the patient's testing values are within normal range. If within 1 month and the reduction of the dose has not yet been reduced to the amount of creatinine, it is necessary to stop using Sandimmun Neoral.

It is also necessary to stop the drug if there is hypertension while using Sandimmun Neoral without controlled by appropriate lowering antihypertensive drugs (see the drug interaction).

As with long -term immunosuppressive drugs (including ciclosporin), attention must be paid to increased risk of lymphocytic hyperactivity disorders. Especially need to be cautious when combining Sandimmun Neooral with methotrexate (see drug interaction)

Be cautious in psoriasis

Because Sandimmun Neooral can impair renal function, it is necessary to determine the level of creatininin-chest at the beginning at least 2 tests before treatment, and creatinin-chest need to be monitored every 2 weeks in the first 3 months of treatment. After that, if creatinine was stable, it was necessary to test the monthly distance. If Creatinin-The Grade increases and retains an increase of> 30% compared to the original in more than 1 test, it must be reduced to 25-50%. If an increase of more than 50% compared to the basic level, it is advisable to consider reducing additional dose. These recommendations apply even if the patient's creatinine values are within normal testing range. If the dose reduction has not been reduced to reduce creatinine within 1 month, the Sandimmun Neoral should be stopped.

also recommends stopping the use of sandimmun neoral when during treatment, there is hypertension without controlled by appropriate therapy (see the drug interaction).

Only for the elderly when psoriasis is difficult to treat and need to monitor the kidney function especially.

Not much experience in using Sandimmun Neoral for children with psoriasis.

With patients with psoriasis using ciclosporin, as well as for users of conventional immunosuppressants, there are malignant tumors (especially in the skin). The skin lesions are not specific to psoriasis, but suspected to be malignant or money-properties should be biopsy before starting the use of Sandimmun Neooral. Patients with malignant skin damage or money-properties can only use Sandimmun Neooral after having appropriate treatment for those lesions and when there is no other choice for effective treatment.

In a few patients with psoriasis use ciclosporin, there is a lymphocytic hypertension disorder and will respond when stopping immediately.

Patients using Sandimmun Neooral are not used with UV radiation B or optical optics Puva.

Caution in atopic dermatitis

Because Sandimmun Neooral can impair the kidney function, it is necessary to determine the concentration of creatininin-chest at the beginning at least 2 tests before treatment and creatininin-bars need to be monitored for each distance of 2 weeks in the first 3 months of treatment. After that, if creatinine is stable, it is necessary to test the monthly distance. If Creatinin-Hat Thanh increases> 30% compared to the original in more than 1 test, it must be reduced by 25-50% of the dose of Sandimmun Neoral. If an increase of more than 50% compared to the basic level, it is advisable to consider reducing additional dose. These recommendations apply even if the patient's creatinine values are within the normal test.

If the dose is reduced but has not given results reducing creatinine within 1 month, the Sandimmun Neoral should be stopped.

It is also necessary to stop using Sandimmun Neooral while taking this medication that has hypertension without controlling with the appropriate therapy (see the drug interaction).

Experience using Sandimmun Neooral in children with atopic dermatitis is still limited.

Only for elderly patients with atopic dermatitis is difficult to treat and must monitor carefully kidney function.

benign lymph nodes are often accompanied by redness in atopic dermatitis and loss of spontaneous or constant or general improvement of the disease. Regular monitoring of lymph nodes encountered when using ciclosporin. If the lymphatic lymphoma still exists, although it has improved dermatitis, it is necessary to observe with a biopsy, as a cautious measure to ensure no lymphoma. Acute Herpes Simplex infection needs to be paid before the beginning of the Neooral Sandimmun, but it is not necessarily the reason for stopping the drug when it is infected, unless seriously infected with herpes.

Staphylococcus aureus infection in the skin is not contraindicated for Sandimmun Neoral therapy, but it is necessary to control staph infection with appropriate antibacterial drugs. Erythromycin should be avoided because this antibiotic increases the concentration of ciclosporin in the blood (see the "interactive" section), or if there is no alternative antibiotic, it is necessary to closely monitor the content of ciclosporin in the blood, kidney function and side effects of ciclosporin.

Patients using Sandimmun Neooral are not combined with drugs with UV irradiation B or use optical optical therapy.

The effect of the drug on driving and operating machinery

There is no data on the effects of Sandimmun Neoral on driving and operating the machine.

Using drugs for women during pregnancy and lactation

Women are likely to be pregnant

There is no special recommendation for women who are likely to be pregnant

Pregnant women

Research on animals shows that drugs are toxic to reproduction in rats and rabbits (see clinical safety data items).

There is a little data on the use of Sandimmun Neooral in pregnant patients. Pregnant women use immunosuppressive drugs after organ transplantation, including ciclosporin and ciclosporin treatment mode is at risk of premature birth (

There have also been a few observations in children exposed to ciclosporin as a fetus is about 7 years old. In those children, kidney function and blood pressure are still normal.

However, there is no adequate data for a pregnant mother and therefore, only sandimmun neoral should be used if pregnant if the benefit is for the mother to exceed the risk of pregnancy.

Ethanol content also needs to pay attention to pregnant women (see the newspaper and caution)

Breastfeeding period

ciclosporin is excreted through breast milk. The ethanol content in the formula of Sandimmun Neooral also needs to notice (see the warning and caution). The mother using Sandimmun Neoral is not breastfeeding. Because Sandimmun's ability

Neor causes serious drugs in newborn children who are breastfeeding, need to decide or avoid breastfeeding or avoiding the use of the drug, paying attention to the importance of the drug with the mother.

Reproduction

Data on the effects of Sandimmun Neooral on human fertility is limited. There is no decline in fertility in studies on male and female mice (see clinical safety data items).

Interactive drug

drugs that interact with ciclosporin below are drugs with actual interactions and are considered clinical significance.

Drug interaction is the result of not recommended simultaneously.

While treating with ciclosporin, immunization may be less effective, so avoid using poison-reducing vaccines (see warning and caution).

Drug interaction is considered

Be cautious when used simultaneously with potassium drugs (such as potassium diuretics, angiotensin transfer inhibitors, angiotensin II receptor antagonists) or potassium -containing drugs because they can lead to increased potassium significance in serum (see warning and cautious section).

After using Ciclosporin and Lercanidipine combination, the area under the concentration curve (AUC) of Lercanidipine tripled and the area under the concentration curve of Ciclosporin increased by 21%. So be careful when using a combination of ciclosporin with lercanidipine (see the warning and caution).

ciclosporin is a strong suppression of PGP and may increase the blood concentration of the drugs that are the substrate of p-glycoprotein (PGP) simultaneously used as Dabigatran Etrixilate, Bosentan or Aliskiren and the high concentration of these drugs may be related to serious or life-threatening events.

When simultaneous use of Ciclosporin and Aliskiren simultaneously, the maximum cmax concentration in Aliskiren's blood increased by 2.5 times and AUC increased by 5 times. However, the pharmacokinetics of ciclosporin has not changed significantly.

Concomitance bosentan with ciclosporin in healthy volunteers, the results show that the concentration of bosetane increased by 2 times and the level of ciclosporin was reduced by 35%.

Use ambrisentan multi -dose with ciclosporin in healthy lover, the results showed that Ambisentan concentration was increased by 2 times while Ciclosporin concentration increased negligible (about 10%).

It is not recommended to simultaneously use Sandimmun Neooral with Aliskiren, Bosentan or Dabigatran Etrixilate. (see the warning and cautious section).

Be careful when using ciclosporin with methotrexate in patients with rheumatoid arthritis due to the risk of kidney toxicity (see the warning and caution).

Interpretation or decrease in ciclosporin levels should be considered

Many other agents are known or increased or reduced the concentration of ciclosporin in serum or ciclosporin levels in the blood rewards due to the inhibition or irritation of enzymes associated with the metabolism of ciclosporin, especially CYP3A4.

If it is impossible to avoid simultaneous use with drugs that have interacted with ciclosporin, should observe the following basic recommendations:

In organ transplant patients: regularly measure the concentration of ciclosporin and, adjust the dose of ciclosporin if necessary, especially while starting or stopping using the drug simultaneously. If the drugs know how to increase the concentration of ciclosporin concentration, it is necessary to regularly evaluate the kidney function and the closely monitoring of side effects related to ciclosporin may be more suitable than measuring blood levels. Sulfadimidine (veins), rifampicin, octreotide, probucol, Orlistat, Hypericum Perforatum (St. John's Wort). ticlopidine, sulfinpyrazone, terbinafine, bosentan.

Medication interactions increase ciclosporin levels

Macrolid antibiotics (for example, erythromycin - see the warning and caution, suburit the additional caution in atopic dermatitis, Azithromycin, Clarithromycin), Ketoconazole, Fluconazole, Itraconazole, Voriconazole, Diltiazem, Nicardipine, Verapamill, Metoclopamid, Metoclopamid, Metoclopamid, Metoclopamid Birth control (oral), danazol, methylprednisolon (high doses), allopurinol, amiodaron, cholic acid and derivative, protease inhibitors, imatinib, colchicines, nefazodone.

Other related drug interactions

Interaction of drugs and food/drinks

There has been a report on the bioavailability of ciclosporin when used simultaneously with grapefruit juice (see the dose and usage)

Drug interaction is capable of increasing kidney toxicity

When combined with a drug with a toxicity to the kidneys, it is necessary to closely monitor the renal function (especially creatinin-chest). If the renal function is noticeable, it is necessary to reduce the dose of the combination drug or consider the medication instead.

Be cautious when taking ciclosporin and other drugs that have a copper effect that increases the toxicity of the kidneys, such as: aminosid antibiotics (including Gentamycin, tobramycin), amphoticin B, Ciprofloxacin, Vancomycin, trimethoprim (+sulfamethoxazole), non -steroid anti -inflammatory drugs (including DiclofenacC, including DiclofenacC, including DiclofenacCac, including Diclofenac Naproxen, sindac), Melphalan, H2 H2 receptor antagonists (for example: cimetidin, ranitidin), methotrexate (see sub -section above the drug interaction is the result of not recommended simultaneously).

Ciclosporin combination with tacrolimus needs to be avoided due to increased toxicity to the kidneys.

Diclofenac in combination with ciclosporin increases the bioavailability of diclofenac, and the consequence that can be encountered is a recovery renal function. The bioavailability of Diclofenac is most likely due to a strong reduction in the effect of the first metabolism. If combined with ciclosporin with nonsteroidal anti -inflammatory drugs have weak metabolic effects (such as acetylsalicylic acid), there is no realization of the bioavailability of anti -inflammatory drugs. For nonsteroidal anti -inflammatory drugs that are strongly metabolized for the first time (for example, diclofenac), the dose should be lower than the dose when not in combination with ciclosporin.

For organ transplant patients, there are cases of significant impaired renal function, but recovery (accompanied by increased creatinin-bar) after coordinating ciclosporin with the derivatives of fibric acid (for example, Bezafibrat, Fenofibrat). Therefore, it is necessary to closely monitor the kidney function in these patients. When there is a clear renal function, the exam must stop coordinating like that.

Interactive drugs increase the increase in productivity

ciclosporin combined with nifedipine may increase the increase in productivity compared to when using only ciclosporin. Nifedipine must be avoided simultaneously in patients with increased development of benefits as a side effect of ciclosporin (see the side effect of the drug)

Interactive drugs increase other drug concentration

ciclosporin is also a CYP3A4 inhibitor and is a transportation out of p-glycoprotein and may increase the plasma concentration of the combined drug is the substrate of the enzyme and/or this transportation.

ciclosporin can reduce the purification of digoxin, colchicin, prednisolon, HMG-CoA-Reductase inhibitors (statins) and Etoposide.

There is a serious toxicity of digitalis during the beginning of using ciclosporin in many patients using digoxin. The report is also met with ciclosporin that increases the toxicity of colchicin such as muscle disease and neuropathy, especially in patients with renal dysfunction. When using digoxin or colchicine with ciclosporin, clinical observation must be closely clinically observed to be able to detect poisonous manifestations of digoxin or colchicin early, to reduce the dose or stop these drugs.

Reports in the literature and after the drug has been marketed to record muscle toxicity, including muscle aches, muscle weakness, muscle inflammation and muscle pattern when coordinating ciclosporin with statins, such as lovastatin, simvastatin, atorvastatin, pravastatin, rare with fluvastatin, so when coordinated as above, it is necessary to reduce the drugs depending on the recommendations of the drug statin.

Using statin should temporarily postpone or stop in patients with signs and symptoms of muscle disease or in people with risk factors that lead to severe and serious kidney failure, including secondary kidney disease after muscle pilot.

When combining ciclosporin with digoxin, colchicine or HMG-CoA-Reductase inhibitors (statin), it is necessary to closely clinically observe to be able to detect the toxic manifestations of these drugs early, so that the dose can be promptly reduced or stop.

There is an increase in creatininin-chest in studies using Everolimus or syrolimus in combination with adequate doses of ciclosporin. When reducing this ciclosporin dose, this toxicity is recovered. Everolimus and Sirolimus have only very weak effects on the dynamics of ciclosporin, but Ciclosporin has significantly increased the concentration of Everolimus and Sirolimus in the blood when coordinated.

ciclosporin may increase the plasma concentration of repaglinide and thus increase the risk of hypoglycemia.

Used in combination with Bosentan and Ciclosporin in healthy volunteers increases about twice the concentration of bosentan and reduces 35% of ciclosporin levels (see the subproject above drug interactions reduces ciclosporin levels).

Use multi -dose Ambrisentan and Ciclosporin in healthy volunteers increasing about twice the concentration of Ambrisentan while ciclosporin levels increased slightly (about 10%).

Observed the concentration of Anthracycline antibiotics increased significant (for example, doxorubicine, mitoxanthrone, daunorubicine) in cancer patients when intravenous injection of Anthracycline antibiotics and very high doses Ciclosporin.

Storage

Sandimmun Neoor oral solution needs to be stored at a temperature of 15 - 30 ° C, but not less than 20 ° C for more than 1 month, because the solution contains natural oils that are prone to solid at low temperatures. It will form like jelly if preserved

This phenomenon does not affect the effect and safety of the drug and must be determined by the pipette to ensure accuracy. After opening, Sandimmun Neooral oral solution should be used for 2 months.

Do not use sandimmun neoral after the expiry date of writing "exp" in the packaging.

Sandimmun Neoral must be out of reach and vision of children.

Instructions for use and operation

Instructions for use and operation of Sandimmun Neoral oral solution: Please see more in the drug number.

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