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ENFit® Syringe
NOW FDA APPROVED

Nymalize: Ready-to-use (RTU) nimodipine reduces time,
when every moment counts1

Nymalize is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).1

Nymalize is the liquid nimodipine you trust1

Ready to Use

Nymalize offers a range of nimodipine dosing and administration options available to meet your needs1

Innovative Safety

Prefilled ENFit syringes seamlessly connect to ENFit tubing without an adaptor1

Reduces Riska

No need for capsule extraction, potentially lowering risk of fatal medication errors1,2

aThe use of ENFit® syringes may reduce the risk of mediation errors when administering medicines through feeding tube. The ENFit® syringe design is only compatible with ENFit® feeding tubes, reducing the risk of improper
syringe and tube connection during administration.3

Nymalize: Flexible dosing options available as prefilled oral syringes, prefilled ENFit® syringes, and bottles1

Indication and Use

NYMALIZE is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I–V).

Important Safety Information

Blood pressure should be carefully monitored during treatment with Nymalize. Nimodipine may increase the blood pressure-lowering–effect of concomitantly administered anti-hypertensives such as diuretics, beta-blockers, ACE inhibitors, angiotensin receptor blockers, other calcium channel blockers, α-adrenergic blockers, PDE5 inhibitors, and α-methyldopa.

Patients with cirrhosis are at a higher risk of adverse reactions and should be monitored closely and administered a lower dose.

Concomitant use of strong inhibitors of CYP3A4 with nimodipine should generally be avoided because of risk of significant hypotension. These include some macrolide antibiotics (eg, clarithromycin, telithromycin), some HIV protease inhibitors (eg, indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (eg, boceprevir, telaprevir), some azole antimycotics (eg, ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan, delavirdine, and nefazodone.

Concomitant use of strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St John’s wort) and nimodipine should generally be avoided, as nimodipine plasma concentration and efficacy may be significantly reduced.

Nimodipine plasma concentration can also be increased in the presence of moderate and weak inhibitors of CYP3A4. If nimodipine is concomitantly administered with these drugs, blood pressure should be monitored, and a reduction of the nimodipine dose may be necessary.

Grapefruit juice inhibits CYP3A4. Ingestion of grapefruit/grapefruit juice is not recommended while taking nimodipine.

Moderate and weak inducers of CYP3A4 may also reduce the efficacy of nimodipine. Patients on these should be closely monitored for lack of effectiveness, and a nimodipine dosage increase may be required.

Common Adverse Reactions

Most common adverse reactions (incidence ≥1% and ≥1% placebo) were hypotension, headache, nausea, and bradycardia.

The Important Safety Information does not include all the information needed to use Nymalize safely and effectively. For additional safety information, please consult the full Prescribing Information for NYMALIZE.

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

© 2024 Azurity Pharmaceuticals, Inc.

References: 1. NYMALIZE [package insert]. Woburn, MA; Azurity Pharmaceuticals; 2024. 2. US Federal Register. Determination that NIMOTOP (Nimodipine) capsules, 30 milligrams, was not withdrawn from sale for reasons of safety or effectiveness. Accessed April 28, 2024. https://federalregister.gov/a/2014-073323. Guenter P, Lyman B. Nutr Clin Pract. 2016;31(6):769-772. 4. Standardized performance measures for comprehensive stroke centers. Accessed May 2, 2024. https://www.jointcommission.org/-/media/tjc/documents/measurement/performance-measurement/measures/stroke/standardized-performance-measures-for-comprehensive-stroke-centers.pdf 5. Performance and accountability. The Johns Hopkins Hospital Comprehensive Stroke Center website. Accessed August 12, 2024. https://www.hopkinsmedicine.org/neurology-neurosurgery/specialty-areas/cerebrovascular/stroke/performance-accountability 6. Food and Drug Administration. FDA approves Nymalize – first nimodipine oral solution for use in certain brain hemorrhae patients. Accessed June 26, 2024. https://wayback.archive it.org/7993/20170112223036/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352280.htm 7. Billstein-Leber M et al. Am J Health-Syst Pharm. 2018;75(19):1493-1517. 8. Oyler DR et al. Neurocrit Care. 2015;22(1):89-92. 9. Nimotop [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc; 2008. 10. George BP et al. Stroke. 2016;48:420-427. 11. US Federal Register. Determiniation that NYMALIZE (nimodipine), oral solution, 3 milligrams/milliliter, was not withdrawn from sale for reasons of safety or effectiveness. Accessed August 12, 2024. https://www.govinfo.gov/content/pkg/FR-2021-02-17/pdf/2021-03083.pdf 12. Orange book: approved drug products with therapeutic equivalence evaluations. Food and Drug Administration. Accessed August 12, 2024. https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=203340#38939 13. Nimodipine [pacakage insert]. Piscataway, NJ: Camber Pharmaceuticals, Inc.; 2024. 14. Data on file. Azurity Pharmaceuticals, Inc. 15. ISMP. Oral syringes: a crucial and economical risk-reduction strategy that has not been fully utilized. Accessed May 1, 2024. https://www.ismp.org/resources/oral-syringes-crucial-and-economical-risk-reduction-strategy-has-not-been-fully-utilized 16. FDA. The FDA encourages use of enteral device connectors that reduce risk of misconnection and patient injury. Accessed May 1, 2024. https://www.fda.gov/media/115846/download 17. ENFIT Global Conversion Updates & Map. Stay Connected® by GEDSA. 2023. Accessed June 26, 2024. https://stayconnected.org/global-conversion/ 18. GEDSA US conversion rates flyer 2023. Stay Connected® by GEDSA. 2023. Accessed June 26, 2024. https://stayconnected.org/gedsausconversionratesflyer2023

Product labeling, packaging, and imagery are for representation purposes only and shall constitute the property of Azurity.

The information contained herein, including product information, is intended only for residents on the United States.

© 2024 Azurity Pharmaceuticals, Inc. All Rights Reserved. All trademarks referred to are the property of their respective owners.

PP-NYM-US-0833