Name: TEGLUTIK (Riluzol) 5mg/ml 300 ml
Price: 226.0 EUR
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TEGLUTIK (Riluzol) 5mg/ml 300 ml

Product Details

TEGLUTIK (Riluzol) 5mg/ml 300 ml

TEGLUTIK 5 mg/ml oral suspension

Composition:

1 ml of oral suspension contains 5 mg of riluzole

Excipients with known effects: 1 ml of oral suspension contains 400 mg of sorbitol E420 (equivalent to 571.43 mg of liquid sorbitol

Therapeutic indications:

TEGLUTIK is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).

Clinical trials have demonstrated that riluzole extends survival for patients with ALS . Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.

There is no evidence that TEGLUTIK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. TEGLUTIK has not been shown to be effective in the late stages of ALS.

Safety and efficacy of TEGLUTIK has only been studied in ALS. Therefore, TEGLUTIK should not be used in patients with any other form of motor neurone disease.

Pharmacodynamic properties

Pharmacotherapeutic group: other drugs for the treatment of the nervous system, ATC code: N07XX02.

Mechanism of action

Although the pathogenesis of ALS is not fully understood, it is assumed that glutamate (the main excitatory neurotransmitter in the central nervous system) plays a role in cell death in this disease.

It is assumed that riluzole acts by suppressing the processes associated with glutamate. The mechanism of action is unclear.

Clinical efficacy and safety

During the study, 155 patients were randomly assigned to groups receiving riluzole at a dose of 100 mg/day (50 mg twice daily) or placebo, and were monitored for 12-21 months. Survival, as defined in the second paragraph of section 4.1, was significantly higher in patients receiving riluzole compared to patients receiving placebo. The median survival was 17.7 months versus 14.9 months for riluzole and placebo, respectively.

In a variable-dose study, 959 ALS patients were randomly assigned to one of four treatment groups: riluzole 50, 100, 200 mg/day or placebo, and they were followed for 18 months. In patients receiving riluzole 100 mg/day, survival was significantly higher compared to patients receiving placebo. The effect of taking riluzole at a dose of 50 mg / day was not statistically significant compared with placebo, and the effect of taking 200 mg / day was almost comparable to the effect of taking 100 mg / day. The median survival was 16.5 months compared with 13.5 months when taking riluzole at a dose of 100 mg/day and placebo, respectively.

In a parallel study conducted to evaluate the efficacy and safety of riluzole in patients at a late stage of the disease, life expectancy and motor function when taking riluzole did not differ significantly from those when taking placebo. In this study, the majority of patients had less than 60% vital lung capacity.

In a double-blind, placebo-controlled trial conducted to evaluate the efficacy and safety of riluzole in Japanese patients, 204 patients were randomly assigned to a group taking riluzole at a dose of 100 mg/day (50 mg twice daily) or to a placebo group and were followed for 18 months. In this study, efficacy was assessed by indicators such as the inability to walk independently, loss of upper limb function, tracheostomy, the need for mechanical ventilation, gastric tube feeding, or death. The survival rate of patients treated with riluzole without tracheostomy did not differ significantly from that of patients treated with placebo. However, the power of this study to identify differences between treatment groups was low. A meta-analysis including this study and those described above showed a less pronounced effect of riluzole on survival compared with placebo, although the differences remained statistically significant.

Posology

The recommended daily dose in adults or elderly is 100 mg (50 mg every 12 hours). No significant increased benefit can be expected from higher daily doses.

It is recommended to assume 10 ml two times a day of the suspension (i.e. 10 ml corresponds to 50 mg of Riluzole).

Method of administration

The suspension can be given per oral administration and alternatively it is also suitable for administration via enteral feeding tubes.

Dilution with liquids is not necessary.

The suspension is administered by means of graduated dosing syringe.

Special warnings and precautions for use

Impaired liver function:

Riluzole should be prescribed with caution to patients with a history of impaired liver function or to patients with slightly elevated serum transaminases (ALT / ALP; AST / ALP up to 3 times the upper limit of normal (ULN)), bilirubin and / or gamma-glutamyltransferase (GGT). A basic increase in the level of several liver function indicators (especially an increase in bilirubin levels) should prevent the use of riluzole.

Due to the risk of hepatitis, serum transaminases, including ALT, should be measured before and during riluzole therapy. ALT should be measured every month for the first 3 months of treatment, every 3 months for the remainder of the first year, and periodically thereafter. In patients with elevated ALT levels, ALT levels should be measured more frequently.

Riluzole should be discontinued if the ALT level exceeds the upper limit of the norm by 5 times. There is no experience of reducing the dose or re-prescribing the drug to patients whose ALT level exceeded the upper limit of the norm by 5 times. Repeated administration of riluzole to patients in this situation is not recommended.

Neutropenia:

Patients should be warned about the need to inform their doctors about any febrile illnesses. Reporting a febrile illness should prompt doctors to check the number of white blood cells in the blood and stop taking riluzole in case of neutropenia (see section 4.8).

Interstitial lung disease

Cases of interstitial lung disease have been reported in patients taking riluzole, some of them severe (see section 4.8). If respiratory symptoms such as dry cough and/or shortness of breath occur, chest X-rays should be performed, and if signs indicating interstitial lung disease (for example, bilateral diffuse pulmonary opacity) are detected, riluzole should be discontinued immediately. In most of the reported cases, the symptoms disappeared after discontinuation of the drug and symptomatic treatment.

Impaired renal function:

Repeated-dose studies have not been conducted in patients with impaired renal function.

The drug contains liquid sorbitol (E420), so patients with rare hereditary problems of fructose intolerance should not take this medicine.

The drug is not used during pregnancy, breast-feeding and for children. It is prescribed with caution for liver and kidney diseases.

Manufacturer Italfarmaco EFFIK Italy