Gilenya; Norw. : Gilenya; Spain: Gilenya; Swed.: Gilenya; reintroduction of fingolimod if treatment has been stopped Oxerutins (BAN) for more than 2 weeks, and the precautions for re�initiating Switz.: Gilenya; Turk.: Gilenya; UK: Gilenya; USA: Gilenya. treatment outlined above should be followed. Hidroxileti!rut6sidos; Hydroxyethyir�tosides; Oxerutlnas: Fingolimod may increase the risk of developing 0Kcepynmot infections due to the reduction in peripheral lymphocyte Flavonoid Compounds Description. Oxerutins consist of a mixture of 5 different count (see Uses and Administration, p. 2504.3), and 0-(P-hydroxyethyl)rutosides, not less than 45% of which is mo f!avonoides; 8iofiavonoids; Flavonoides: Vitarnin treatment should not be started in patients without a recent P troxerutin (trihydroxyethylrutoside, below), but which also Substances; Vitamlnas full blood count taken within the previous 6 months. P; <DnqBOHOMj:jol. includes monohydroxyethylrutoside, dihydroxyethylruto­ Fingolimod should not be started in patients with active side, and tetrahydroxyethylrutoside. acute or chronic infections. Patients should be monitored Benzquercin (r!NN) for signs and symptoms of infection during treatment and Quercetin for 2 months after treatment has stopped. Stopping Benzqueccina; Benzquercine; Benzquercinum; 6et!3KB€PLi�H. fingolimod should be considered if a patient develops a 3,3',4';5,7-Pentakis(benzyloxy) flavone. Quercetina; Keep:.;erv.H: 3,3',4',5,7-Pentahydroxyftavone. serious infection during treatment, and then the risks versus C,oKNJ0,=752.9 2-(3,4-Dihydroxyphenyl)-3,5,7-trihy droxy�4H- 1 -benzopyran- benefits reassessed before treatment is resumed. 4--one, Patients without a history of chickenpox or who have not C4$ - 13157-90-9. received varicella Mzoster vaccination should be tested for UN/! - 499L710 905. C:sH",0,=302.2 antibodies to varicella-zoster virus. Vaccination should be 015 - 117-39·5. - considered in antibody-negative patients before starting Diosmin (BAN, r/NN) dihydraUN/I te). 91KMOi5T!£ (quercetin); 53803V78AI5 {quercetin fingolimod treatment. which should then be delayed for one Barosmin; Buchu Resin; Diosmetin -Rutinoside; Diosmiini; month after vaccination. Giving any live attenuated vaccine 7 should be avoided during, and for 2 months after stopping, Dlosmln�; Diosmtnas; Dios.mlr:e; Diosminum; Oiozmlr.; Rutoside (BAN, r!NN! fingolimod treatment because of the risk of infection. ,[jHOCMl1H. Rutin; Rutina; Rutosid; Rutosid:Trihydrat; IMoside trihydrat�; Macular oedema has been reported in some patients Trihydroxy:4'-meth oxyflavone [6-0·(6-deoxy-;:H­ 3'.5 .7- 7- Rutosidi; Rutosiditrih�dro.iitti; Rut6sido; Rutosic!trihyc! rat; taking fingolimod, and ophthalmologic evaluation should mannopyranosylj-p,c;-glucopyraf!oside]. Rutosidurn; Rutosidurn Trihydricum: Rutozidas trihidratas; be carried out before starting treatment and routinely about Rutozid�<rihi<;lrat; Rutozyd;. Rutyr1a; 3 to 4 months later, and at any time if patients report visual C23K3:-0,,.,608.5 Pyro3V!g. · disturbances during treatment. Patients with a history of 015 - 52M7-4. 2-(3,4-Dihydroxyphenyf)-3,S.?�trihyclroxY-4-oxoc4H-chro'­ -- uveitis and those with diabetes mellitus are at increased risk ATC (050103. men-3-yl rutinoside trihydrate; 2'\3.4-Dlhydro�yphenyll- 5,/· of developing macular oedema during treatment with ATC Ve t-QC05CA 03. dihydroxy-4-oxo-4H-chromen-3-yl -rharnnosyl)'l3-o- 6-0-(a-L· fingolimod. UNil -7QM776 W.I5N. glucoside. Dyspnoea has been reported with fingolimod and a Pharmacopoeias. In Bur. (see p. vii) and US. C27H300,.,,3H,0=664.6 decrease in lung function tests has been seen in patients as Ph. Eur. 8: (Diosmin). A greyish-yellow or light yellow CA S - 153, 18·4 (anhydrous rurdside) . early as 1 month after starting treatment. When considered hygroscopic powder. Practically insoluble in water and in clinically appropriate, spirometric evaluation of respiratory ATC - C05C401. alcohol; soluble in dimethyl sulfoxide. It dissolves in dilute - function and evaluation of diffusion lung capacity for ATC Ve t QC05CA01. solutions of alkali hydroxides. Store in airtight containers. - carbon monoxide should be obtained. UN/I 5G06NY3R7 /anhydrous rutoside); RF4N03853G USP 36: (Diosmin). Store in airtight containers. {ru toside · trihydrare). Fingolimod may increase liver transaminases and Description. Rutoside is a flavonoid obtained from treatment should not be started without results of recent buckwheat, Fagopyrum esculentum (Polygonaceae), or from transaminase and bilirubin levels taken within the previous Ethoxazorutoside (r!NN! other sources which include the flower buds of the Japanese 6 months. Liver enzymes should also be monitored during pagoda-tree, Sophora japonica, and the leaves of several treatment in patients with signs and symptoms of hepatic f\ethoxazorutin; Aethox<ll!orutoslde; Et hoxazorutin; tthox­ species of Eucalyptus. impairment, and treatment stopped if significant impair­ azorutoside: Ethoxazbrutosidum; 6toxazorvt6sido: Oxaruti­ ment occurs. The risk of adverse effects with fingolimod nu(T1; 3TOKCll30P)'l'Cm1A. Pharmacopoeias. In Bur. (see p. vii) and Viet. may be greater in patients with severe hepatic impairment 2-MorphoHnoethylrutm. Ph. Eur. 8: (Rutoside Trihydrate). A yellow or greenish­ and consequently they should be monitored closely or C,H,;NO,F723.7 yellow crystalline powder. Practically insoluble in water; treatment avoided. sparingly soluble in dehydrated alcohol; practically 0\S - 3085 1-76-4. Hypertension has been reported in patients treated with insoluble in dichloromethane; soluble in methyl alcohoL fingolimod and blood pressure should therefore be It dissolves in solutions of alkali hydroxides. Protect from monitored during treatment. Flavodate Sodium {r!NNM) light. Fiavodate de Socllum; Flavodate Disodivm; Flavodato Breast feeding. Although there are no human data for s6dico; Natril Flavodas; Ha'rpvu4 <llnaaoAOBaR. Troxerutin (BAN, r!NN) excretion of fingolimod in breast milk, it is excreted in the Disodium (4.-oxo-2-phenyi·4i+chromene-5.7"diyldioxy) milk of rats; therefore, because of the potential for serious THR; Trihidroxietilrutina; Trihydrm:yethylrutoside; Trioxietil­ diacetate. adverse reactions in a nursing infant, licensed product rutina; Triox)'ethylrutin; Trokserutiini; Trokserutyna; Troxer· C'"H'"Na,0,=\!4.3 information recommends that fingolimod is not compati­ utina; Troxerutine; Troxerutinum; TpoKcepyTIAH. ble with breast feeding. 0\S -- 3747()- 13-6 {flavodic add); 13358-62-8 (fla vodate 3'A' 7-Tris[0-(2-hydroxyethyi)]rutin; 5,[1ydroxy-7·(2·hydro­ disodlum). : xyethoxy)-2-[3,4-bis(2·hydroxyethoxy)phenyf]-4'oxo-4H" Pregnancy. Although there are only limited human data chrornen+yl rutinoside for use of fingolimod in pregnancy, developmental toxicity C,lH4;Dr"=742.T has been shown in rats and rabbits, and since the sphingo­ Hesperidin � sine !-phosphate receptor is involved in vascular forma­ C4S 708S-55-4. tion during embryogenesis, US licensed product informa­ Hesperidiini; Hesperidina; Hespeddinum; rtesperydyna; ATC - C05CA04. ecneoHAl!IH. ..,-- tion recommends that fingolimod should only be used f ATC Ve t QC05CA04., during pregnancy if the potential benefit outweighs poten­ S+:lydroxy-2-(3-hydroxy-4-rnethoxyphenyl)-4-oxo-4H-chro­ UN!! - 7Y4N i IPX08. Description. Troxerutin is the principal component of tial risks to the fetus, which may persist for 2 months after men:7-yl rutinpsicle. oxerutins, above. stopping treatment. Additionally, women of child-bearing potential are advised to use effective contraception during C;�H3,.0r:s:;;;610.6 merhyi Pharmacopoeias. In Bur. (see p. vii). 015 - 52()-26-3 (hesperidin); 24292·52-2 (hesperidin fingolimod treatment and for 2 months after treatment cholcone}. Ph. Eur. 8: (Troxerutin). A yel1owish-green, hygroscopic, stops. crystalline powder. Freely soluble in water; slightly soluble UN/I ·'- £750006 Y6b. Description. Hesperidin is a flavonoid isolated from the in alcohol; practically insoluble in dichloromethane. Store Interactions rind of certain citrus fruits. in airtight containers. Protect from light. Fingolimod should be used with caution at the same time as Profile antineoplastics, immunosuppressants, and immunomodu­ Leucocianidol (r!NN) lators because of the increased risk of immunosuppression. Flavonoids are naturally occurring phenolic compounds Caution should also be exercised when switching patients to Leucociariidoium; Leucocyanidin; Leucocyanldo!; JleC!­ that are widely distributed in plants, occurring in the free fingolimod from long-acting drugs such as natalizumab and KOL\I1aHH;:tOn. state and also as glycosides. The main types of flavonoids are mitoxantrone. 2-(3i4cDihydroxyphenyi)chroman-3.4,5,7:tetrof. anthocyanins, chalcones, flavonols, flavones, and flavo­ Ketoconazole increases the blood concentrations of Ccsii�<0,=306.3 nones. Flavonoids act as antoxidants and claims have been fingolimod and fingolimod phosphate, and so patients C4S made for many medicinal uses. Preparations containing taking the two drugs together should be closely monitored. natural or semisynthetic flavonoids are thought to improve Patients taking beta blockers, or class la or class (!Nfi - capillary function by reducing abnormal leakage. They have antiarrhythmics should be closely monitored when givenill been given to relieve capillary impairment and venous fingolimod because of the risk of decreased heart rate (see Monoxerutin (r/NN) insufficiency of the lower lhnbs, and for haemorrhoids. Adverse Effects and Precautions, p. 2504.3).