Instruction for use: Gilenia

Dosage form: Capsules

Active substance: Fingolimodum

ATX

L04AA27 Fingolimod

Pharmacological group:

Immunosuppressive means. Means for treating multiple sclerosis [Immunosuppressants]

The nosological classification (ICD-10)

G35 Multiple Sclerosis: Disseminated Sclerosis; Multiple sclerosis; Recurrent multiple sclerosis; Secondary-progressive multiple sclerosis; Exacerbation of multiple sclerosis; Mixed forms of multiple sclerosis

Composition

Capsules - 1 caps.

active substance: Fingolimoda hydrochloride 0.56 mg

(Equivalent to 0.5 mg of phylogenide base)

Auxiliary substances: mannitol - 46.48 mg; Magnesium stearate 0.96 mg

Capsule shell: iron colorant yellow oxide (E172) - 0.164 mg; Titanium dioxide (E171) -1.022 mg; Gelatin - 46.81 mg; Ink black ink (shellac (E904), propylene glycol, potassium hydroxide, iron oxide dye oxide black); Printing ink yellow (shellac (E904), propylene glycol, iron oxide, yellow oxide, titanium dioxide, dimethicone)

Pharmachologic effect

Mode action - anti-inflammatory, immunosuppressive.

Dosing and Administration

Inside, regardless of the time of food intake.

The recommended dose of the drug is 1 caps. (0.5 mg) once a day. In case of missed reception the next day, the Gilenia® preparation is used at the usual time. The drug is intended for long-term treatment.

After taking the first dose of Gilenia®, all patients should be observed for 6 hours, including a measurement of heart rate and blood pressure every hour, and ECG before starting treatment with the drug and 6 hours after taking the first dose of the drug in order to diagnose as early as possible the possible manifestations Bradyarrhythmias.

With the development of bradyarrhythmia against the background of the initiation of therapy with the drug, if necessary, appropriate measures should be taken to correct this disorder, and the patient should be monitored until this condition is relieved. If it is necessary to carry out drug therapy during the monitoring period after the first dose, follow-up of the patient should be continued in the inpatient setting at least until the next morning. After applying the second dose of Gilenia® in such patients, it is necessary to repeat all the measures, as well as after applying the first dose of the drug.

Additional monitoring up to the resolution of the state is also required in the following cases:

- The heart rate after 6 hours after the first administration of the drug is <45 bpm or the lowest value for the entire observation period;

- Detection of the first AV blockade of the 2nd degree or higher according to ECG data 6 hours after the first administration of the drug;

- the QTc interval on the ECG is ≥500 ms.

When the therapy with Gilenia® is resumed, it is necessary to monitor the activity of the CAS, as well as after taking the first dose, in case of interruption of therapy:

- at least 1 day during the first 2 weeks of therapy;

- more than 7 days for the 3rd or 4th week of treatment;

- more than 2 weeks after the treatment lasted more than 1 month.

Special patient groups

Violation of the function of the liver. Correction of a dose of a preparation at patients with disturbance of function of a liver of easy and average degree of gravity is not required. Treatment with Gilenia® for patients with a history of liver failure should be done with caution. It is recommended to monitor the activity of hepatic transaminases during the 6 months preceding the initiation of therapy with the drug. In the absence of clinical manifestations of liver damage, the determination of the level of hepatic transaminases is recommended in 1, 3, 6, 9 and 12 months of treatment, and then periodically. Increased activity of hepatic transaminases ≥5 VGN requires a more frequent biochemical study of serum, including the determination of bilirubin and alkaline phosphatase. When symptoms appear that suggest a violation of liver function (vomiting and nausea of unknown etiology, jaundice, abdominal pain, fatigue, anorexia, dark color of urine), it is necessary to determine the activity of hepatic enzymes. If liver damage is detected, treatment with the drug should be discontinued.

The use of Gilenia® in patients with severe liver failure (class C according to Child-Pugh classification) is contraindicated.

Patients older than 65 years. Correction of the dose of the drug in this category of patients is not required, but treatment should be conducted with caution because of the lack of clinical experience in the use of the drug in patients older than 65 years.

Diabetes. Studies on the use of the drug Gilenia® in patients with diabetes mellitus have not been conducted. Care must be taken when using the drug in this category of patients because of the risk of developing macular edema, in order to exclude the development of which it is required to regularly perform ophthalmic control.

Impaired renal function. Correction of the dose of the drug in patients with impaired renal function is not required.

Patients under the age of 18 years. The effectiveness and safety of Gilenia® in children and adolescents under the age of 18 years have not been established.

Discontinuation of drug treatment

At the termination of treatment by a preparation it is necessary to consider, that normalization of quantity of lymphocytes occurs in 1-2 months after last application of preparation Gilenia®. Since immunosuppressant therapy for 1-2 months after discontinuation of the Gilenia® drug may further suppress the immune system, care must be taken when using them shortly after discontinuation of treatment with the drug.

Release form

Capsules, 0.5 mg. In the blister of PVC / PVDC, 7 or 14 pcs. By 2 or 7 bl. For 14 caps. (Calendar packing); On 1 bl. For 7 caps. (Perforated blister) in a cardboard bundle.

Manufacturer

Novartis Pharma Stein AG, Switzerland.

The owner of the registration certificate: Novartis Pharma AG. Lichtstraße 35, 4056, Basel, Switzerland.

Additional information about the drug can be obtained at: 125315, Moscow

In the case of packaging in the Russian Federation: packaged / issuing quality control: ZAO ORTAT, Russia.

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Gilenia

At a temperature no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Gilenia

2 years.

Do not use after the expiry date printed on the package.