Nymalize is the liquid nimodipine you know and trust for your patients with SAH^1,2,4-6

The only RTU liquid nimodipine offering multiple dosing and administration options¹

American Society of Health-System Pharmacists guidelines recommend the use of ready-to-use medications whenever possible to reduce situations requiring manipulations and prevent errors⁷

Nymalize has efficient and flexible RTU dosing options that include prefilled oral syringes, prefilled ENFit syringes, and bottles to meet the needs of patients, providers, and hospitals alike.¹

About nimodipine: a trusted molecule since 1988⁸

Nimodipine reduces the incidence and severity of brain function loss in stroke patients.¹ Nimodipine was originally only available as liquid-filled gel capsules, but most stroke patients have difficulty swallowing capsules.⁹ Dysphagia is a common occurrence after stroke, happening in ≥65% of stroke patients¹⁰
Before Nymalize, the practice of extracting nimodipine from capsules was the only option^6,9
If the capsule cannot be swallowed, the contents of the capsule are extracted into a syringe using a needle and administered via a nasogastric tube⁹

Timeline of Nimodipine Advancement

1988⁸

Nimodipine  oral capsule

2010²

FDA issues safety communication warning against intravenous use of nimodipine oral capsules

2013¹¹

Discontinued 2020¹¹

2020¹²

NYMALIZE HAS BEEN REFORMULATED TO INCLUDE

Higher concentration (6 mg/mL) per dose^1,13
50% reduction in liquid volume per dose^1,13
44% less polyethylene glycol per 60 mg dose^14,a

^a6.6 grams polyethylene glycol/60 mg dose.

2024¹

When it comes to extracting nimodipine, the chance for errors is high²

For the standard dose of 60 mg (2 x 30 mg capsules every 4 hours), liquid nimodipine must be extracted from 12 capsules per day⁹

Potential risk for needle sticks during the extraction process⁸
Pharmacy is required to prepare extracted liquid nimodipine in advance or forces the ICU nurse to perform a bed-side extraction to ensure appropriate nimodipine treatment initiation per comprehensive stroke center (CSC) quality metrics^4,15

≈25%

There is a potential for ≈25% dose reduction with each 60 mg dose⁸

Capsule extraction is time-consuming and exposes patients to potentially lethal medication errors^2,9

Pharmacy prepares extracted liquid nimodipine in advance

ICU nurse performs a  bed-side extraction

Capsule Extraction Methods¹⁵

Between 1989 and 2013, 36 nimodipine-related medication errors were reported; 27 of these were associated with erroneous IV administration, and 5 of these cased resulted in death.²

Reducing risk to patients is a priority, using Nymalize provides precision and may reduce dosing and administration inaccuracy¹

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.

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/2014-07332  3. 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.

PP-NYM-US-0833

Nymalize is the liquid nimodipine you know and trust for your patients with SAH1,2,4-6

The only RTU liquid nimodipine offering multiple dosing and administration options1

American Society of Health-System Pharmacists guidelines recommend the use of ready-to-use medications whenever possible to reduce situations requiring manipulations and prevent errors7

About nimodipine: a trusted molecule since 19888