Fingolimod 250microgram capsules
Requires a prescription from a doctor or prescriber
Drugs affecting the immune response
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Fingolimod
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Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
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Suspected adverse reactions reported for Fingolimod
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1 branded products available
MHRA licensed products
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Gilenya 0.25mg capsules
WHO defined daily dose (DDD)
500 microgram
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via NHS dm+d BNF mapping files. Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Clinical guidelines and formulary information
British National Formulary
Fingolimod
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
NICE clinical guidance(12)
Fingolimod for the treatment of highly active relapsing–remitting multiple sclerosis (TA254)
Cladribine for treating relapsing–remitting multiple sclerosis (TA616)
Ocrelizumab for treating relapsing–remitting multiple sclerosis (TA533)
Alemtuzumab for treating highly active relapsing–remitting multiple sclerosis (TA312)
Ozanimod for treating relapsing–remitting multiple sclerosis (TA706)
Teriflunomide for treating relapsing–remitting multiple sclerosis (TA303)
Dimethyl fumarate for treating relapsing‑remitting multiple sclerosis (TA320)
Ofatumumab for treating relapsing multiple sclerosis (TA699)
Natalizumab (originator and biosimilar) for treating highly active relapsing–remitting multiple sclerosis after disease-modifying therapy (TA1126)
Beta interferons and glatiramer acetate for treating multiple sclerosis (TA527)
Ponesimod for treating relapsing–remitting multiple sclerosis (TA767)
Multiple sclerosis in adults: management (NG220)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
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Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
6-9 days
Mechanism
Sphingosine‐1‐phosphate (S1P) is an important phospholipid that binds to various…
Food interactions
1 warning
Human targets
7 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
12-16 hours
Half-life
6-9 days
[A38022][L12651]
Protein binding
99.7%
[A38022][L12651]
Volume of distribution
260 L
[A38022][L12651]
Metabolism
Elimination
81%
Clearance
2.3 L/h
[A38022]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
[L12651][L44346]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 580 interactions
[A192906]
Prescribing information for fingolimod does not mention symptoms or management of an overdose [L12651], however, a case report of an intentional overdose with 14mg of fingolimod and 2g phenoxymethylpenicillin resulted in hypotension in bradycardia, resolved by administering atropine.
[A192909]
Since fingolimod has been associated with cardiotoxicity, it would be reasonable to expect cardiac effects such as bradycardia and heart block in the case of an overdose.
[A192912][L12651]
The active form of the drug, fingolimod phosphate, is a sphingosine 1-phosphate receptor modulator that exerts its mechanism of action in MS by binding to various sphingosine 1-phosphate receptors (1, 3, 4, and 5). It suppresses the exit of lymphocytes from lymph nodes, leading to a lower level of lymphocytes circulating in the peripheral circulation. This reduces the inflammation that is associated with MS. The mechanism of action of fingolimod is not fully understood but may be related to reduced lymphocyte circulation into the central nervous system.[A176474][L12651]
Immune modulating treatment such as fingolimod is not typically employed for SARS-CoV-2 pneumonia. Despite this, with the tissue findings of pulmonary edema and hyaline membrane formation, the timely use of immune modulators such as fingolimod can be considered to prevent acute respiratory distress syndrome (ARDS) associated with COVID-19.[L12654]
Fingolimod causes a transient reduction in heart rate and AV conduction during treatment initiation. It has the potential to prolong the QT interval.[L12654]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[A38022]
The Tmax of fingolimod ranges between 12-16 hours and its bioavailability is 90-93%. Steady-state concentrations of fingolimod are achieved within 1-2 months after initiation when it is administered in a single daily dose.
[A38022][L12651]
[A38022][L12651]
[A38022][L12651]
[A38022][L12651]
[A38022][L12651]
[L12651]
[A38022]
Proteins and enzymes this drug interacts with in the body
May play a regulatory role in the transformation of radial glial cells into astrocytes and may affect proliferative activity of these cells
Required for normal chemotaxis toward sphingosine 1-phosphate. Required for normal embryonic heart development and normal cardiac morphogenesis. Plays an important role in the regulation of sprouting angiogenesis and vascular maturation.
Inhibits sprouting angiogenesis to prevent excessive sprouting during blood vessel development. Required for normal egress of mature T-cells from the thymus into the blood stream and into peripheral lymphoid organs. Plays a role in the migration of osteoclast precursor cells, the regulation of bone mineralization and bone homeostasis (By similarity).
Plays a role in responses to oxidized 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine by pulmonary endothelial cells and in the protection against ventilator-induced lung injury
PMID:11923095 PMID:20577214 PMID:23602659 PMID:24929359 PMID:29662056
In contrast to proapoptotic SPHK2, has a negative effect on intracellular ceramide levels, enhances cell growth and inhibits apoptosis .
PMID:16118219
Involved in the regulation of inflammatory response and neuroinflammation. Via the product sphingosine 1-phosphate, stimulates TRAF2 E3 ubiquitin ligase activity, and promotes activation of NF-kappa-B in response to TNF signaling leading to IL17 secretion .
PMID:20577214
In response to TNF and in parallel to NF-kappa-B activation, negatively regulates RANTES induction through p38 MAPK signaling pathway .
PMID:23935096
Involved in endocytic membrane trafficking induced by sphingosine, recruited to dilate endosomes, also plays a role on later stages of endosomal maturation and membrane fusion independently of its kinase activity .
PMID:24929359 PMID:28049734
In Purkinje cells, seems to be also involved in the regulation of autophagosome-lysosome fusion upon VEGFA PMID:25417698
Enzymes involved in drug metabolism — important for understanding drug interactions
Proteins that transport this drug across cell membranes
PMID:14506254 PMID:15265858 PMID:26690923 PMID:7521911
Functions as a symporter that transports one amino acid molecule together with two or three Na(+) ions and one proton, in parallel with the counter-transport of one K(+) ion .
PMID:14506254
Mediates Cl(-) flux that is not coupled to amino acid transport; this avoids the accumulation of negative charges due to aspartate and Na(+) symport .
PMID:14506254
Essential for the rapid removal of released glutamate from the synaptic cleft, and for terminating the postsynaptic action of glutamate (By similarity)
PMID:20477940 PMID:26690923 PMID:28032905 PMID:28424515 PMID:7521911 PMID:8123008
Functions as a symporter that transports one amino acid molecule together with two or three Na(+) ions and one proton, in parallel with the counter-transport of one K(+) ion .
PMID:20477940
Mediates Cl(-) flux that is not coupled to amino acid transport; this avoids the accumulation of negative charges due to aspartate and Na(+) symport .
PMID:20477940
Plays a redundant role in the rapid removal of released glutamate from the synaptic cleft, which is essential for terminating the postsynaptic action of glutamate (By similarity)
PMID:2897240 PMID:35970996 PMID:8898203 PMID:9038218 PMID:35507548
Catalyzes the flop of phospholipids from the cytoplasmic to the exoplasmic leaflet of the apical membrane. Participates mainly to the flop of phosphatidylcholine, phosphatidylethanolamine, beta-D-glucosylceramides and sphingomyelins .
PMID:8898203
Energy-dependent efflux pump responsible for decreased drug accumulation in multidrug-resistant cells PMID:2897240 PMID:35970996 PMID:9038218
PMID:10064732 PMID:11114332 PMID:16230346 PMID:7961706 PMID:9281595
Mediates ATP-dependent transport of glutathione and glutathione conjugates, leukotriene C4, estradiol-17-beta-o-glucuronide, methotrexate, antiviral drugs and other xenobiotics .
PMID:10064732 PMID:11114332 PMID:16230346 PMID:7961706 PMID:9281595
Confers resistance to anticancer drugs by decreasing accumulation of drug in cells, and by mediating ATP- and GSH-dependent drug export .
PMID:9281595
Hydrolyzes ATP with low efficiency .
PMID:16230346
Catalyzes the export of sphingosine 1-phosphate from mast cells independently of their degranulation .
PMID:17050692
Participates in inflammatory response by allowing export of leukotriene C4 from leukotriene C4-synthesizing cells (By similarity). Mediates ATP-dependent, GSH-independent cyclic GMP-AMP (cGAMP) export .
PMID:36070769
Thus, by limiting intracellular cGAMP concentrations negatively regulates the cGAS-STING pathway .
PMID:36070769
Exports S-geranylgeranyl-glutathione (GGG) in lymphoid cells and stromal compartments of lymphoid organs. ABCC1 (via extracellular transport) with GGT5 (via GGG catabolism) establish GGG gradients within lymphoid tissues to position P2RY8-positive lymphocytes at germinal centers in lymphoid follicles and restrict their chemotactic transmigration from blood vessels to the bone marrow parenchyma (By similarity).
Mediates basolateral export of GSH-conjugated R- and S-prostaglandin A2 diastereomers in polarized epithelial cells PMID:9426231
ATC L04AE01
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Fingolimod
Additional database identifiers
Drugs Product Database (DPD)
20671
ChemSpider
97087
BindingDB
50158336
ZINC
ZINC000001542002
HUGO Gene Nomenclature Committee (HGNC)
HGNC:14299
GenAtlas
EDG8
GeneCards
S1PR5
GenBank Gene Database
AF331840
Guide to Pharmacology
279
UniProt Accession
S1PR5_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3165
GeneCards
S1PR1
Guide to Pharmacology
275
UniProt Accession
S1PR1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3167
GeneCards
S1PR3
Guide to Pharmacology
277
UniProt Accession
S1PR3_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:11240
GeneCards
SPHK1
Guide to Pharmacology
2204
UniProt Accession
SPHK1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3024
GenAtlas
DRD3
GeneCards
DRD3
GenBank Gene Database
U32499
GenBank Protein Database
927342
Guide to Pharmacology
216
UniProt Accession
DRD3_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:4852
GenAtlas
HDAC1
GeneCards
HDAC1
GenBank Gene Database
U50079
GenBank Protein Database
1277084
Guide to Pharmacology
2658
UniProt Accession
HDAC1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3170
GeneCards
S1PR4
Guide to Pharmacology
278
UniProt Accession
S1PR4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:11240
GeneCards
SPHK1
Guide to Pharmacology
2204
UniProt Accession
SPHK1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2631
GeneCards
CYP2E1
GenBank Gene Database
J02625
GenBank Protein Database
181360
Guide to Pharmacology
1330
UniProt Accession
CP2E1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2645
GeneCards
CYP4F2
Guide to Pharmacology
1344
UniProt Accession
CP4F2_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:10940
GenAtlas
SLC1A2
GeneCards
SLC1A2
GenBank Gene Database
U03505
GenBank Protein Database
487341
Guide to Pharmacology
869
UniProt Accession
EAA2_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:10941
GenAtlas
SLC1A3
GeneCards
SLC1A3
GenBank Gene Database
L19158
Guide to Pharmacology
868
UniProt Accession
EAA1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:40
GenAtlas
ABCB1
GeneCards
ABCB1
GenBank Gene Database
M14758
GenBank Protein Database
307180
Guide to Pharmacology
768
UniProt Accession
MDR1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:51
GenAtlas
ABCC1
GeneCards
ABCC1
GenBank Gene Database
L05628
GenBank Protein Database
1835659
Guide to Pharmacology
779
UniProt Accession
MRP1_HUMAN
Patent information
7 active patents, 2 expired
Source: DrugBank · CC BY-NC 4.0. Patent data sourced from national patent offices. Expiry dates may not reflect extensions, regulatory exclusivity periods, or legal challenges.
DrugBank citations
If you use DrugBank data in your research, please cite the following publications: