Edoxaban
Clinical data | |
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Trade names | Savaysa, Lixiana, Roteas, others |
Other names | DU-176b |
AHFS/Drugs.com | Monograph |
MedlinePlus | a614055 |
License data | |
Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status | |
Elimination half-life | 10–14 hours[6] |
Excretion | 62% feces, 35% urine |
Identifiers | |
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Edoxaban, sold under the brand name Lixiana among others, is an
Compared with warfarin it has fewer drug interactions.[6]
It was developed by
Medical uses
In the United States, edoxaban is
In the European Union, edoxaban is indicated for preventing blood clots in people with nonvalvular atrial fibrillation who also have at least one risk factor, such as having had a previous
Contraindications and notes
Edoxaban is often contraindicated in people (incomplete list):
- with active pathological bleeding[12]
- who are pregnant or breastfeeding[12]
- who have conditions that increase bleeding risks. Examples: spinal injury, recent brain, spinal or ophthalmic surgery, known or suspected esophageal varices, arteriovenous malformations, aneurysms or major intraspinal or intracerebral vascular abnormalities[12]
- who have uncontrolled and severe high blood pressure[12]
- who use any other anticoagulants[12]
Edoxaban (incomplete list):
- is enhanced by the following strong St. John's Wort. If these medications are used with edoxaban, caution is advised.[12]
- interacts with SNRIs.[12]
- inferior to creatinine clearance (CrCl) greater than 95 ml/min.[3]
Adverse effects
May affect up to 1 in 10 people:[12]
- stomach ache
- abnormal results of blood tests that measure liver function
- anemia
- bleeding from the skin, nose, vagina, bowel, mouth, throat or stomach
- rash
- bloody urine
- dizziness
- feeling sick
- headache
- itching
May affect up to 1 in 100 people:[12]
- bleeding in the eyes, brain, after a surgical operation or other types of bleeding
- blood in the spit when coughing
- reduced number of platelets in blood
- allergic reaction
- hives
May affect up to 1 in 1000 people: bleeding in the muscles, joints, abdomen, heart or inside the skull.[12]
Overdose
Edoxaban overdose can cause serious bleeding.[4] No approved antidotes for edoxaban overdose exist as of April 2021[update].[4] Hemodialysis does not significantly contribute to edoxaban clearance.[3][12] Andexanet alfa has been studied as an antidote for edoxaban overdose, but has only been approved for reversing rivaroxaban and apixaban effects by the FDA and the EMA as of 2019.[13][14]
Mechanism of action
Edoxaban is a direct,
Pharmacokinetics
In human, 15–150 mg oral doses of edoxaban reach their maximum concentrations in blood 1–2 hours after ingestion. With 60 mg doses of isotope labeled edoxaban, 97% of the total radiation was detected after oral administration, with 62% from feces and 35% from urine. 49% of the total radiation from the feces and 24% from the urine were from edoxaban, the rest from its metabolites.[6]
Metabolism occurs mostly via
References
- ^ "Product monograph brand safety updates". Health Canada. February 2024. Retrieved 24 March 2024.
- ^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
- ^ a b c d e f g "Savaysa- edoxaban tosylate tablet, film coated". DailyMed. 24 April 2020. Retrieved 23 July 2020.
- ^ a b c d e "Lixiana EPAR". European Medicines Agency (EMA). Retrieved 23 July 2020.
- ^ "Roteas EPAR". European Medicines Agency (EMA). Retrieved 25 September 2020.
- ^ PMID 26620048.
- ^ "First market approval in Japan for Lixiana (Edoxaban)". Daiichi Sankyo Europe GmbH (Press release). 22 April 2011. Archived from the original on 6 November 2013.
- ^ O'Riordan M (9 January 2015). "FDA Approves Edoxaban for Stroke Prevention in AF and DVT/PE Prevention". Medscape. Retrieved 10 January 2015.
- ^ "Drug Approval Package: Savaysa (edoxaban tosylate) Tablets NDA #206316". U.S. Food and Drug Administration (FDA). 13 February 2015. Retrieved 23 July 2020.
- hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
- PMID 30383133.
- ^ a b c d e f g h i j k "Lixiana, INN-edoxaban" (PDF). Archived (PDF) from the original on 6 November 2019. Retrieved 6 November 2019.
- ^ Ovanesov M (3 August 2017). "Summary basis for regulatory action - ANDEXXA". Food and Drug Administration. Retrieved 6 November 2019.
- ^ "Ondexxya". European Medicines Agency. 27 February 2019. Archived from the original on 16 July 2019. Retrieved 6 November 2019.