Fingolimod
Fingolimod
Klass: C
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Fingolimod Glenmark, Fingolimod Mylan, Fingolimod Teva,......
Fingolimod Glenmark, Fingolimod Mylan, Fingolimod Teva, Fingolimod Zentiva, GILENYA, GilenyaATC-koder
L04AA27
L04AA27Substanser
fingolimod, fingolimodhydroklorid
fingolimod, fingolimodhydrokloridSammanfattning
Den skovförebyggande effekten av fingolimod vid skovvis förlöpande Multipel Skleros har visats vara bättre än placebo hos både kvinnor och män. Kvinnligt kön har förknippats med en ökad risk för lymfopeni och fler infektioner under behandling med fingolimod jämfört med män. Förändrade transaminasnivåer har noterats i högre utsträckning bland män. Uppmärksamhet på biverkningar avseende den ökade risken för lymfopeni och infektionskänslighet hos kvinnor och för transaminasstegring hos män rekommenderas.
Fingolimod ska inte användas av gravida. För mer information, se kunskapsstödet Janusmed fosterpåverkan.
Background
Multiple Sclerosis (MS) is more common in women than in men [1, 2]. The gender gap in prevalence has been increasing and is today estimated to be two to three times more common in women than in men [1-3]. Visa hela bakgrundstexten
Several risk factors of MS have been suggested to have a larger impact on women. Sunlight deprivation, vitamin D deficiency, overweight, low urate levels, and smoking are such risk factors that increase the risk more in women than in men. Suggested mechanisms are that smoking yields increased levels of mature peripheral functioning T cells (OKT3+) in women [1]. Men have a worse prognosis and the role of sex hormones have been discussed [1, 2].
In a biomarker study of MS patients (30 men, 70 women) and healthy controls (24 men, 51 women), insulin growth factor binding protein1 (IGFBP1) was higher in women with MS compared to men [4]. The authors suggest this could reflect different MS progression pathways in men and women.
Pharmacokinetics and dosing
According to the manufacturer, there are no sex differences in the pharmacokinetics of fingolimod or the active metabolite fingolim......
Försäljning på recept
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Fler kvinnor än män hämtade ut läkemedel innehållande fingolimod (ATC-kod L04AA27) på recept i Sverige år 2017, totalt 654 kvinnor och 359 män [18].
Referenser
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Bove R, Chitnis T. The role of gender and sex hormones in determining the onset and outcome of multiple sclerosis. Mult Scler. 2014;20:520-6.
Voskuhl RR, Gold SM. Sex-related factors in multiple sclerosis susceptibility and progression. Nat Rev Neurol. 2012;8:255-63.
Johnson KM, Zhou H, Lin F, Ko JJ, Herrera V. Real-World Adherence and Persistence to Oral Disease-Modifying Therapies in Multiple Sclerosis Patients Over 1 Year. J Manag Care Spec Pharm. 2017;23:844-852.
Al-Temaimi R, AbuBaker J, Al-Khairi I, Alroughani R. Remyelination modulators in multiple sclerosis patients. Exp Mol Pathol. 2017;103(3):237-241.
Vlahiotis A, Sedjo R, Cox ER, Burroughs TE, Rauchway A, Lich R. Gender differences in self-reported symptom awareness and perceived ability to manage therapy with disease-modifying medication among commercially insured multiple sclerosis patients. J Manag Care Pharm. 2010;16:206-16.
Fox RJ, Salter A, Alster JM, Dawson NV, Kattan MW, Miller D et al. Risk tolerance to MS therapies: Survey results from the NARCOMS registry. Mult Scler Relat Disord. 2015;4(3):241-9.
GILENYA (fingolimod). Summary of Product Characteristics. European Medicines Agency (EMA); 2018.
David OJ, Kovarik JM, Schmouder RL. Clinical pharmacokinetics of fingolimod. Clin Pharmacokinet 2012 Jan 1;51(1):15-28
Kappos L, Radue EW, O'Connor P, Polman C, Hohlfeld R, Calabresi P et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362(5):387-401.
Calabresi PA, Radue EW, Goodin D, Jeffery D, Rammohan KW, Reder AT et al. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(6):545-56.
Devonshire V, Havrdova E, Radue EW, O'Connor P, Zhang-Auberson L, Agoropoulou C et al. Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study. Lancet Neurol. 2012;11(5):420-8.
Cohen JA, Barkhof F, Comi G, Hartung HP, Khatri BO, Montalban X et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):402-15.
Manni A, Direnzo V, Iaffaldano A, Di Lecce V, Tortorella C, Zoccolella S et al. Gender differences in safety issues during Fingolimod therapy: Evidence from a real-life Relapsing Multiple Sclerosis cohort. Brain Behav. 2017;7(10):e00804.
Baharnoori M, Gonzalez CT, Chua A, Diaz-Cruz C, Healy BC, Stankiewicz J et al. Predictors of hematological abnormalities in multiple sclerosis patients treated with fingolimod and dimethyl fumarate and impact of treatment switch on lymphocyte and leukocyte count. Mult Scler Relat Disord. 2018;20:51-57.
Warnke C, Dehmel T, Ramanujam R, Holmen C, Nordin N, Wolfram K et al. Initial lymphocyte count and low BMI may affect fingolimod-induced lymphopenia. Neurology. 2014;83(23):2153-7.
Simula S, Laitinen T, Laitinen TM, Tarkiainen T, Hartikainen P, Hartikainen JE. Effect of fingolimod on cardiac autonomic regulation in patients with multiple sclerosis. Mult Scler. 2016;22(8):1080-5.
Miyazaki Y, Niino M, Kanazawa I, Suzuki M, Mizuno M, Hisahara S et al. Fingolimod suppresses bone resorption in female patients with multiple sclerosis. J Neuroimmunol. 2016;298(1):24-31.
Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2018-02-02.]
- Bove R, Chitnis T. The role of gender and sex hormones in determining the onset and outcome of multiple sclerosis. Mult Scler. 2014;20:520-6.
- Voskuhl RR, Gold SM. Sex-related factors in multiple sclerosis susceptibility and progression. Nat Rev Neurol. 2012;8:255-63.
- Johnson KM, Zhou H, Lin F, Ko JJ, Herrera V. Real-World Adherence and Persistence to Oral Disease-Modifying Therapies in Multiple Sclerosis Patients Over 1 Year. J Manag Care Spec Pharm. 2017;23:844-852.
- Al-Temaimi R, AbuBaker J, Al-Khairi I, Alroughani R. Remyelination modulators in multiple sclerosis patients. Exp Mol Pathol. 2017;103(3):237-241.
- Vlahiotis A, Sedjo R, Cox ER, Burroughs TE, Rauchway A, Lich R. Gender differences in self-reported symptom awareness and perceived ability to manage therapy with disease-modifying medication among commercially insured multiple sclerosis patients. J Manag Care Pharm. 2010;16:206-16.
- Fox RJ, Salter A, Alster JM, Dawson NV, Kattan MW, Miller D et al. Risk tolerance to MS therapies: Survey results from the NARCOMS registry. Mult Scler Relat Disord. 2015;4(3):241-9.
- GILENYA (fingolimod). Summary of Product Characteristics. European Medicines Agency (EMA); 2018.
- David OJ, Kovarik JM, Schmouder RL. Clinical pharmacokinetics of fingolimod. Clin Pharmacokinet 2012 Jan 1;51(1):15-28
- Kappos L, Radue EW, O'Connor P, Polman C, Hohlfeld R, Calabresi P et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362(5):387-401.
- Calabresi PA, Radue EW, Goodin D, Jeffery D, Rammohan KW, Reder AT et al. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(6):545-56.
- Devonshire V, Havrdova E, Radue EW, O'Connor P, Zhang-Auberson L, Agoropoulou C et al. Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study. Lancet Neurol. 2012;11(5):420-8.
- Cohen JA, Barkhof F, Comi G, Hartung HP, Khatri BO, Montalban X et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):402-15.
- Manni A, Direnzo V, Iaffaldano A, Di Lecce V, Tortorella C, Zoccolella S et al. Gender differences in safety issues during Fingolimod therapy: Evidence from a real-life Relapsing Multiple Sclerosis cohort. Brain Behav. 2017;7(10):e00804.
- Baharnoori M, Gonzalez CT, Chua A, Diaz-Cruz C, Healy BC, Stankiewicz J et al. Predictors of hematological abnormalities in multiple sclerosis patients treated with fingolimod and dimethyl fumarate and impact of treatment switch on lymphocyte and leukocyte count. Mult Scler Relat Disord. 2018;20:51-57.
- Warnke C, Dehmel T, Ramanujam R, Holmen C, Nordin N, Wolfram K et al. Initial lymphocyte count and low BMI may affect fingolimod-induced lymphopenia. Neurology. 2014;83(23):2153-7.
- Simula S, Laitinen T, Laitinen TM, Tarkiainen T, Hartikainen P, Hartikainen JE. Effect of fingolimod on cardiac autonomic regulation in patients with multiple sclerosis. Mult Scler. 2016;22(8):1080-5.
- Miyazaki Y, Niino M, Kanazawa I, Suzuki M, Mizuno M, Hisahara S et al. Fingolimod suppresses bone resorption in female patients with multiple sclerosis. J Neuroimmunol. 2016;298(1):24-31.
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2018-02-02.]
Uppdaterat
Litteratursökningsdatum 2/10/2018
Litteratursökningsdatum 2/10/2018Se även
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