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ASN-FINGOLIMOD is a brand name for Fingolimod, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Patients who are hypersensitive to fingolimod or to any ingredient in the formulation of ASN- Fingolimod (fingolimod hydrochloride) or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph.
g. g. immunodeficiency syndrome). , hepatitis, tuberculosis). Patients with known active malignancies, except for patients with basal cell carcinoma. Patients with severe hepatic impairment (Child-Pugh Class C) (see WARNINGS AND PRECAUTIONS, Special Populations; WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic; and ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics-Special Populations and Conditions).
Patients who in the last 6 months had myocardial infarction, unstable angina pectoris, stroke/transient ischemic attack, decompensated heart failure (requiring inpatient treatment), or New York Heart Association Class III/IV heart failure.
Patients with severe cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs (see WARNINGS AND PRECAUTIONS). Patients with second-degree Mobitz type II atrioventricular (AV) block or third-degree AV block, or sick-sinus syndrome, if they do not have a pacemaker (see WARNINGS AND PRECAUTIONS).
Patients with a baseline QTc interval ≥500 msec (see WARNINGS AND PRECAUTIONS). Women (including female adolescents) who are pregnant or of childbearing potential not using effective contraception (see WARNINGS AND PRECAUTIONS).
Pregnancy must be excluded before start of treatment as ASN-Fingolimod may cause fetal harm. WARNINGS AND PRECAUTIONS Page 5 of 64 Varicella vaccination There have been very rare fatal cases of varicella zoster virus (VZV) infections in patients taking fingolimod (at recommended dose or higher doses used in clinical trials).
These patients received prolonged concomitant corticosteroid use (more than 5 days) for treatment of multiple sclerosis relapses. Patients need to be assessed for their immunity to varicella (chickenpox) prior to ASN-Fingolimod treatment.
It is recommended that patients without a health care professional confirmed history of chickenpox or documentation of a full course of vaccination with varicella vaccine undergo antibody testing to varicella zoster virus (VZV) before initiating ASN-Fingolimod therapy.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fingolimod in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
A full course of vaccination for antibody- negative patients with varicella vaccine is recommended (if not contraindicated) prior to commencing treatment with ASN-Fingolimod. If vaccinated, treatment with ASN-Fingolimod should only be initiated 1 month after the patient has been vaccinated to allow full effect of vaccination to occur (see WARNINGS AND PRECAUTIONS, Herpetic infections).
SUMMARY OF IMPORTANT PRECAUTIONS TO BE TAKEN PRIOR TO INITIATING AND DURING TREATMENT WITH ASN-Fingolimod Refer to the WARNINGS AND PRECAUTIONS – Immune, Cardiovascular, Ophthalmologic, Hepatic/Biliary/Pancreatic, Special Populations, DRUG INTERACTIONS, and TOXICOLOGY sections for more complete information.
ASN-Fingolimod should be used under the supervision of a neurologist experienced in the treatment of multiple sclerosis and familiar with the safety and efficacy of fingolimod capsules. All patients should have an electrocardiogram (ECG) performed prior to the first dose and 6 hours after the first dose.
Patients should be monitored closely for signs and symptoms of bradyarrhythmia, with hourly pulse and blood pressure measurements, for at least 6 hours after the first dose. Immune system effects Fingolimod reduces circulating lymphocyte counts to 20-30% of baseline values via reversible retention in lymphoid organs and may increase the risk of infections.
Delay the start of ASN-Fingolimod in patients with severe active infection until resolved. e. within 6 months or after discontinuation of prior therapy) result is available. Instruct patients to promptly report symptoms of infection during treatment and for two months after discontinuation.
Check varicella-zoster virus (VZV) antibody status before starting therapy if there is no health care professional confirmed history of chicken pox or vaccination with varicella vaccine; if negative, vaccination is recommended, with a delay in treatment initiation for 1 month after vaccination to allow full effect of vaccination to occur.
Co-administration of anti-neoplastic, immunosuppressive or immune-modulating therapies is not recommended due to the risk of additive immune system effects. Cardiovascular effects Page 6 of 64 Initiation of fingolimod treatment results in reversible heart rate decrease and has also been associated with atrioventricular (AV) conduction delays, including isolated cases of spontaneously resolving complete AV block (see WARNINGS AND PRECAUTIONS, Bradyarrhythmia; ADVERSE REACTIONS Post Market Adverse Events).
g. hypokalemia, hypomagnesemia or congenital QT prolongation), due to the risk of serious cardiac rhythm disturbances. ASN-Fingolimod should not be used in patients with a history of cardiac arrest, uncontrolled hypertension or severe untreated sleep apnea since significant bradycardia may be […]