Ordering

Nymalize Drop Ship Order Placement and Delivery Schedule

As a reminder, Nymalize is ordered through your pharmaceutical wholesaler as a drop ship item
Drop ship orders for Nymalize placed by your pharmacy through your wholesaler that are received by Safecor Health by the 3 _PM EST order cutoff time on Monday through Thursday will be shipped for NEXT DAY delivery to your hospital
Any Nymalize drop ship order placed through your wholesaler and received by Safecor Health after 3 _PM EST, Monday through Wednesday will be shipped the next business day for overnight delivery to your hospital
Nymalize drop ship orders placed through your wholesaler and received by Safecor Health after 3 _PM EST on Thursdays, Fridays, and weekend orders will ship the following Monday by overnight shipping for Tuesday delivery to your hospital
Expedited Saturday shipping for emergency situations is possible. If needed, please call Safecor Health at 1-800-447-1006, Option 4 to arrange

PLEASE NOTE: Expedited Saturday shipments must be requested and orders placed and confirmed by Fridays at 1:30 _PM EST. Any costs associated with Saturday delivery will be billed to the hospital requesting this service.

To place your order for Nymalize, please contact your wholesaler (drop-ship ONLY).

Nymalize oral solution

NDC	Size
24338-230-30	Carton of 12 30 mg/5 mL prefilled ENFit® syringes
24338-260-08	8 oz. (237 mL) bottle
24338-260-12	Carton of 12 60 mg/10 mL prefilled oral syringes

If you have any questions, please contact Safecor Health via email at products@safecorhealth.com or call 1-800-447-1006, Option 4, Monday-Friday, 7:30 _AM-4:30 _PM EST.

You are encouraged to report side effects of prescription drugs to Azurity Pharmaceuticals, Inc. Medical Information at 1-800-461-7449 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

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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