Enoxaparin sodium
 | ||
 | ||
| Clinical data | ||
|---|---|---|
| Trade names | Lovenox, Clexane, Xaparin, others | |
| Biosimilars | Arovi, Axberi,[1] Axberi HP,[1] Exarane,[2] Exarane Forte,[2] Enoxapo,[3] Inclunox, Inclunox HP, Inhixa, Noromby, Noromby HP, Redesca, Redesca HP, Thorinane | |
| AHFS/Drugs.com | Monograph | |
| MedlinePlus | a696006 | |
| License data |
| |
| Pregnancy category | ||
intravenous | ||
| ATC code | ||
| Legal status | ||
| Legal status | ||
ECHA InfoCard | 100.029.698 | |
| Chemical and physical data | ||
| Formula | (C26H40N2O36S5)n | |
| Molar mass | 4500 g/mol (average) | |
  (what is this?) (verify) | ||
Enoxaparin sodium, sold under the brand name Lovenox among others, is an
Common side effects include bleeding, fever, and
Enoxaparin was first made in 1981 and approved for medical use in 1993.
Medical uses
- Treatment of unstable angina (UA) and non-ST elevated myocardial infarction (NSTEMI), administered concurrently with aspirin
- DVT and pulmonary embolism prophylaxis in bed-ridden patients
- DVT prophylaxis in knee replacement surgery
- DVT prophylaxis in hip replacement surgery
- DVT prophylaxis in abdominal surgery
- Treatment of DVT with or without pulmonary embolism
- Treatment of DVT inpatient, with ST-segment elevation myocardial infarction (STEMI)[9]
- Bridging treatment for those with INR below therapeutic range
Monitoring
Enoxaparin has predictable absorption,
Reversal agent
Protamine sulfate is less effective at reversing enoxaparin compared to heparin, with a maximum neutralization of approximately 60% of the anti-factor Xa effect.[9]
Pregnancy
- Enoxaparin is a FDA pregnancy category B drug which means enoxaparin is not expected to cause harm to an unborn baby when used during pregnancy.[9]
- Enoxaparin does not cross the placenta therefore it is unlikely an unborn baby would be exposed to it.[9]
- Some fetal deaths have been reported by women who used enoxaparin during pregnancy, but it is unclear if enoxaparin caused these deaths.[9]
- The multiple-dose vials of the brand name enoxaparin (Lovenox) contain 15 mg benzyl alcohol per 1 mL as a preservative. Premature infants who have been given large amounts of benzyl alcohol (99–405 mg/kg/day) have experienced "gasping syndrome".[9][15]
- Although enoxaparin is used to prevent blood clots, pregnancy alone can raise a woman's risk of clotting.[9]
Side effects
Uncommon (<1%)
- In people with unstable angina or non-Q-wave myocardial infarction:
- Atrial fibrillation, heart failure, lung edema, pneumonia: ≥ 0.5%v
Common (>1%)
- Thrombocytopenia, i.e. can be associated with heparin-induced thrombocytopenia (0.5-5.0% of persons treated for at least five days)[16]
- Elevations in serum aminotransferases: 5.9%-6.1%[9]
- In people undergoing abdominal or colorectal surgery:
- Bleeding, anemia, ecchymosis: ≥ 2%[9]
- Bleeding, anemia,
- In persons undergoing hip or knee replacement:
- In persons with severely restricted mobility during acute illness:
- Dyspnea, thrombocytopenia, confusion, diarrhea, nausea: ≥ 2%[9]
- In people being treated for deep vein thrombosis:
Frequency under investigation
- Local reactions: local irritation, pain, hematoma, ecchymosis, erythema[9]
- Bleeding[9]
- Hyperkalemia[9]
- Transaminitis[9]
- Hemorrhage[9]
Boxed warning
The FDA issued a revision to the boxed warning for enoxaparin in October 2013.[17] The revision recommends exercising caution regarding when spinal catheters are placed and removed in persons taking enoxaparin for spinal puncture or neuroaxial anesthesia.[18] It may be necessary to delay anticoagulant dosing in these persons in order to decrease the risk for spinal or epidural hematomas, which can manifest as permanent or long-term paralysis.[18] Persons at risk for hematomas may present with indwelling epidural catheters, concurrent use of medications that worsen bleeding states such as non-steroidal anti-inflammatory drugs (NSAIDs), or a past medical history of epidural or spinal punctures, spinal injury, or spinal deformations.[17] The FDA recommends that at-risk persons be monitored for bleeding and neurological changes.[17][19]
Pharmacology
Mechanism of action
Enoxaparin binds to and potentiates
Pharmacokinetics
Absorption: Bioavailability (subcutaneous injection) ~ 100%[17]
Distribution: Volume of distribution (anti-Factor Xa activity) = 4.3 liters[17]
Metabolism: Enoxaparin is metabolized in the liver into low molecular weight species by either or both desulfation and depolymerization.[17]
Elimination: A single dose of a subcutaneous injection of enoxaparin has an elimination half-life of 4.5 hours.[17] Approximately 10–40% of the active and inactive fragments from a single dose are excreted by the kidneys.[17] Dose adjustments based on kidney function are necessary in persons with reduced kidney function.[17]
Drug class
Enoxaparin belongs to the class of drugs known as low molecular weight heparins. Other drugs in this class include
Biosimilars
In September 2016, Inhixa and Thorinane were approved for use in the European Union.[10][23] Thorinane was withdrawn from the market in October 2019.[24]
In March 2017, Enoxaparin BECAT, Laboratorios ROVI (Spain) obtained marketing authorization in twenty six countries in Europe. The product is now available in Europe.[25]
In October 2020, Noromby and Noromby HP, were approved for medical use in Canada.[26]
In November 2020, Inclunox and Inclunox HP were approved for medical use in Canada.[27]
In December 2020, Redesca and Redesca HP were approved for medical use in Canada.[28]
References
- ^ a b "Summary Basis of Decision (SBD) for Axberi/Axberi HP". Health Canada. 26 January 2024. Archived from the original on 24 February 2024. Retrieved 24 February 2024.
- ^ a b c d https://www.tga.gov.au/resources/auspmd/exaraneexarane-forte Archived 2 January 2024 at the Wayback Machine [bare URL]
- ^ a b c "Enoxapo Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 28 February 2020. Archived from the original on 26 February 2020. Retrieved 17 August 2020.
- ^ "Enoxaparin Use During Pregnancy". Drugs.com. 15 July 2019. Archived from the original on 27 October 2020. Retrieved 16 August 2020.
- FDA. Retrieved 22 October 2023.
- ^ "AusPAR: Exarane/Exarane Forte". Therapeutic Goods Administration (TGA). 4 March 2024. Retrieved 31 March 2024.
- ^ "Summary Basis of Decision - Elonox/Elonox HP". Health Canada. 28 March 2023. Archived from the original on 25 April 2023. Retrieved 24 April 2023.
- ^ a b "Clexane Forte Syringes - Summary of Product Characteristics (SmPC)". emc. Archived from the original on 26 September 2018. Retrieved 12 October 2020.
- ^ a b c d e f g h i j k l m n o p q r s "Lovenox- enoxaparin sodium injection". DailyMed. U.S. National Library of Medicine. 28 April 2020. Archived from the original on 4 August 2020. Retrieved 16 August 2020.
- ^ a b c "Inhixa EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 29 October 2020. Retrieved 2 April 2020.
- ^ a b c d e f g h i j "Enoxaparin Sodium". The American Society of Health-System Pharmacists. Archived from the original on 21 December 2016. Retrieved 8 December 2016.
- ^ ISBN 9780470750353. Archivedfrom the original on 20 December 2016.
- hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
- ^ "Enoxaparin - Drug Usage Statistics". ClinCalc. Archived from the original on 7 November 2022. Retrieved 7 October 2022.
- PMID 7133084.
- S2CID 25103749.
- ^ a b c d e f g h i "ENOXAPARIN SODIUM- enoxaparin sodium injection". DailyMed. U.S. National Library of Medicine. Archived from the original on 19 October 2015. Retrieved 5 November 2015.
- ^ a b "Drug Safety and Availability - FDA Drug Safety Communication: Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins". Center for Drug Evaluation and Research. U.S. Food and Drug Administration. Archived from the original on 30 October 2015. Retrieved 5 November 2015.
- ^ Office of the Commissioner. "Safety Information - Lovenox (enoxaparin sodium) injection". U.S. Food and Drug Administration. Archived from the original on 4 March 2016. Retrieved 5 November 2015.
- ISBN 978-1-60913-713-7.
- ISBN 978-0-07-176401-8.
- from the original on 28 August 2015. Retrieved 5 November 2015.
- ^ "Thorinane EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 30 December 2019. Retrieved 2 April 2020.
- ^ "Public statement on Thorinane: Cessation of validity of the marketing authorisation in the European Union" (PDF). Archived (PDF) from the original on 28 August 2021. Retrieved 2 April 2020.
- ^ "To The National Stock Market Commission" (PDF). Archived (PDF) from the original on 28 August 2021. Retrieved 29 May 2020.
- ^ "Summary Basis of Decision (SBD) for Noromby/Noromby HP". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
- ^ "Summary Basis of Decision (SBD) for Inclunox/Inclunox HP". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
- ^ "Summary Basis of Decision (SBD) for Redesca/Redesca HP". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
