Before starting therapy with trenbolone acetate dosage , in women with childbearing potential must have a negative result pregnancy test. While drug therapy and for at least 2 months after the end of its use, should use reliable methods of contraception. Pregnancy must be excluded before treatment fingolimod. If during treatment with fingolimod pregnancy occurs, the treatment should be discontinued. According to the results of experimental studies, the negative effect of fingolimod on fertility is unlikely.
In appointing the drug doctor should inform women of childbearing age about the potential risk of negative impact of the drug on the fetus during pregnancy. In applying the drug in experimental studies reproductive toxicity, which included fetal death and malformations of organs, especially patent ductus arteriosus and ventricular septal defects were detected. Furthermore receptors sphingosine-1-phosphate, which acts fingolimod, involved in the formation of blood vessels during embryogenesis. At the present time it is not known about the impact of fingolimod on the formation of the cardiovascular system in humans, and there are very limited data on the use of the drug in pregnant women. In clinical trials, cases have been reported 20 pregnancies in patients treated with fingolimod, but these data are insufficient to assess the safety of fingolimod in these patients.
Dosing and Administration
Recommended dosage is one capsule of 0.5 mg orally once daily 1 regardless of mealtime. When you miss the reception the next day medication is applied at the usual time. The drug is intended for long-term use.
Patients treated previously treated with interferon beta and glatiramer acetate, with good tolerability (absence of neutropenia), can be transferred to treatment with trenbolone acetate dosage.
Using the drug months after discontinuation of therapy with natalizumab may increased joint effect on the immune system due to the long half-life of natalizumab. Care must be taken when transferring patients from natalizumab to fingolimod.
After the first dose of the drug , including all patients should be monitored for 6 hours: measurement of heart rate and blood pressure every hour, as well as electrocardiography before the start of treatment and after 6 hours after the first dose of the drug for the purpose of possible early diagnosis of possible manifestations of bradyarrhythmias.
appropriate measures to correct the infringement should be held with the development of bradyarrhythmias on the background of the beginning of drug therapy, if necessary, provided with observation of the patient up to the relief of the condition. When the need for drug therapy during the monitoring period after the first dose of the patient monitoring should be extended at least until the next morning in the hospital. After application of the second dose of the drug Neskler ® in these patients is necessary to repeat the event, as well as after the first dose of the drug.
Additional follow up to the resolution of the state is also required in the following cases:
- if the heart rate at 6 hours after the first dose of the drug is <45 beats / min, or is the lowest value for the entire period of observation;
- the detection of new-onset AV block II degree or higher on the ECG at 6 hours after the first administration of the drug;
- If the QTc interval on the electrocardiogram is > 500 msec.
When you resume drug therapy Neskler ® , after a break in therapy, the need for monitoring of the cardiovascular system, as well as after the first dose, in the case of interruption of therapy:
- at least one day during the first two weeks of therapy;
- more than 7 days at the 3rd or 4th week of treatment;
- more than 2 weeks after the treatment was continued for over a month.
Patients with impaired hepatic function
dose adjustment of the drug in patients with impaired liver function and mild to moderate severity is not required. Treatment with Neskler ® in patients with impaired hepatic function a history should be made with caution. Recommended monitoring liver enzymes for 6 months before the start of drug therapy. In the absence of clinical manifestations of liver disease to determine the level of hepatic transaminases is recommended at 1, 3, 6, 9 and 12 months of treatment and then periodically. Increase in liver transaminases > 5 ULN requires more frequent biochemical analysis of blood serum, including the determination of bilirubin and alkaline phosphatase. When symptoms suggestive of liver dysfunction (vomiting and nausea of unknown etiology, jaundice, abdominal pain, fatigue, anorexia, dark urine) is necessary to determine the activity of liver enzymes. In identifying liver disease drug treatment should be discontinued.
Use of trenbolone acetate dosage in patients with hepatic impairment, severe features (Class C classification Child-Pugh) is contraindicated. Elderly patients (over 65 years) Correction dose in these patients is not required, however, treatment should be undertaken with caution due to the lack of clinical experience with the drug in patients older than 65 years. patients with diabetes Studies on the use of the drug Neskler® in patients with diabetes was conducted. Caution should be exercised when administering the drug in these patients because of the risk of macular edema, to avoid the development of which is required to hold regular ophthalmologic control. Patients with impaired renal function dose adjustment of the drug in patients with renal impairment is not required. Patients younger than 18 years Efficiency and safety of the drug in children and adolescents under the age of 18 years have not been established. Discontinuation of treatment in case of termination of treatment must be considered that the normalization of the number of lymphocytes occurs in 1-2 months after the last use of the drug Since the application of immunosuppressive drugs for 1-2 months after stopping treatment may further depressing effect on the immune system, care must be taken when using immunosuppressants soon after the discontinuation of treatment.
When using fingolimod 0.5 mg were observed following serious adverse events (AEs): infections, macular edema and transient atrioventricular block at treatment initiation. The most common (incidence >10%) when using the drug at a dose of 0.5 mg were observed headache, elevated liver enzymes, diarrhea, cough, flu, sinusitis, and back pain.
B clinical studies, when the use of fingolimod in patients with RRMS treated with short courses of corticosteroids (for five days), there was no increased incidence of infections compared with the placebo group. There is also evidence of other very rare fatal cases caused by infection with the herpes virus, however, the causal link between the death and the use of fingolimod is not established. Neurological disorders There have been reports of rare cases of nervous system in patients treated with fingolimod at higher doses (from 1.25 mg to 5.0 mg), with the development of hemorrhagic and ischemic attacks and rear reversible encephalopathy syndrome. Also, there have been cases of atypical neurological lesions such as ADEM (acute disseminated encephalomyelitis) -like trenbolone acetate dosage state. Violations of the vessels In the treatment of patients fingolimod 1.25 mg marked peripheral arterial occlusive disease.