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ACH-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.
Verbatim from this product's HC label. Tap a section to expand.
), Return of disease activity (rebound) and severe increase in disability after ACH-Fingolimod discontinuation). PML and IRIS (Immune Reconstitution Inflammatory Syndrome) Immune reconstitution inflammatory syndrome (IRIS) has been reported in patients treated ACH-Fingolimod (Fingolimod Capsules) Page 19 of 64 with S1P receptor modulators, including ACH-Fingolimod, who developed PML and subsequently discontinued treatment.
The time to onset of IRIS in patients with PML was generally within weeks to a few months after S1P receptor modulator discontinuation. IRIS presents as a worsening in neurological status that may be rapid, resulting from sudden reconstitution of immune function.
IRIS can lead to serious neurological complications and may be fatal. Monitoring for development of IRIS and appropriate treatment of the associated inflammatory reaction involving the brain should be undertaken. Prior and Concomitant Treatment with Antineoplastic, Immunosuppressive or Immune- modulating Therapies Co-administration of anti-neoplastic, immunosuppressive or immune-modulating therapies is not recommended due to the risk of additive immune system effects (see 9 Drug Interactions).
For the same reason, corticosteroids should be co-administered with caution and specific decisions as to the dosage and duration of concomitant treatment should be based on clinical judgment. Co-administration of a short course of corticosteroids (up to 5 days as per study protocols) did not increase the overall rate of infection in patients treated with fingolimod in the Phase III clinical trials, compared to placebo.
When switching to or from another disease modifying therapy with immunosuppressive or immune modulating effects, the half-life and mode of action of ACH-Fingolimod and the other therapy must be considered in order to avoid an additive immune effect whilst at the same time minimizing risk of disease reactivation.
g. cytopenia) of the discontinued therapy have resolved. g. cytopenia) from these therapies have resolved. Natalizumab or teriflunomide Elimination of natalizumab usually takes up to 2-3 months following discontinuation. Without an accelerated elimination procedure, clearance of teriflunomide from plasma can take several months (average: 8 months) and up to 2 years.
Due to the long half-life of natalizumab or teriflunomide, caution regarding potential additive immune effects is required when switching patients from these therapies to ACH-Fingolimod. A careful case-by-case assessment regarding the timing of the initiation of ACH-Fingolimod treatment is recommended.
Alemtuzumab Due to the characteristics and duration of alemtuzumab immune suppressive effects described in its Product Monograph, initiating treatment with ACH-Fingolimod after alemtuzumab is not recommended unless the benefits of ACH-Fingolimod treatment clearly outweigh the risks for the individual patient.
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.
Monitoring and Laboratory Tests ACH-Fingolimod (Fingolimod Capsules) Page 20 of 64 The following assessments should be done during treatment with ACH-Fingolimod. • Monitor for signs and symptoms of infections regularly during treatment.
Complete blood count should also be periodically monitored (see 7 Warnings and Precautions, Immune). • Monitor for signs and symptoms of liver injury. See 7 Warnings and Precautions, Hepatic/Biliary/Pancreatic for detailed monitoring recommendations.
• Monitor for suspicious skin lesions regularly during treatment with ACH-Fingolimod, particularly in patients with risk factors for skin cancer (see 7 Warnings and Precautions, Neoplasm). • An ophthalmic evaluation should be performed 3-4 months after treatment initiation in all patients, and at any time in any patient complaining of visual disturbances.
Patients with diabetes mellitus or a history of uveitis are at increased risk for macular edema and should have regular ophthalmic evaluations while receiving ACH-Fingolimod therapy (see 7 Warnings and Precautions, Ophthalmologic).
• Monitor blood pressure regularly in all patients (see 7 Warnings and Precautions, Cardiovascular). Neoplasm For patients treated with immunosuppressive or immune modulating drugs there is potential for an increased risk of lymphomas and other malignancies, particularly of the skin.
5 Post-Market Adverse Reactions). The cases reported were heterogeneous in nature. The incidence of lymphoma (B-cell and T-cell) cases was higher in clinical trials than expected in the general population. 5 Post-Market Adverse Reactions).
5 Post-Market Adverse Reactions). Vigilance for cutaneous neoplasms is recommended in patients receiving ACH- Fingolimod. Health professionals and patients are advised to monitor for suspicious skin lesions before initiating treatment and regularly during treatment with ACH-Fingolimod, particularly for patients with risk factors for skin cancer.
If a suspicious skin lesion is observed, it should be promptly evaluated. Since there is a potential risk of malignant skin growths, […]