Erroneous IV administration of nimodipine after capsule extraction can be fatal2
Nymalize is the only 6 mg/mL liquid nimodipine in efficient and flexible RTU dosing options that include bottles, prefilled oral syringes, and prefilled ENFit® syringes to meet the needs of1
Patients
Providers
Hospitals
Product labeling, packaging, and imagery are for representation purposes only and shall constitute the property of Azurity.
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).
Warnings and Precautions:
Hypotension: 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, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), other calcium channel blockers, α-adrenergic blockers, PDE5 inhibitors, and α-methyldopa.
Possible Increased Risk of Adverse Reactions in Patients with Cirrhosis: Patients are at a higher risk of adverse reactions and should be monitored closely and administered a lower dose.
Possible Increased Risk of Hypotension with Strong CYP3A4 Inhibitors: 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.
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.
Possible Reduced Efficacy with Strong CYP3A4 Inducers: 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.
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.
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.
Nymalize is a registered trademark of Azurity Pharmaceuticals, Inc. ENFit® is a registered trademark of Global Enteral Device Supplier Association, Inc. © 2025 Azurity Pharmaceuticals, Inc. All Rights Reserved. All trademarks referred to are the property of their respective owners. PP-NYM-US-0951
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 March 6, 2025. https://federalregister.gov/a/2014-07332 3. Nimodipine [package insert]. Piscataway, NJ. Camber Pharmaceuticals, Inc; 2024. 4. Guenter P, Lyman B. Nutr Clin Pract. 2016;31(6):769-772. 5. Data on file. Azurity Pharmaceuticals, Inc. 6. Nimotop [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc; 2008. 7. Oyler DR et al. Neurocrit Care. 2015;22(1):89-92. 8. George BP et al. Stroke. 2017;48:420-427.
9. Institute for Safe Medication Practices. Oral Syringes: A Crucial and Economical Risk-Reduction Strategy That Has Not Been Fully Utilized. Accessed March 6, 2025. 10. US Federal Register. Determination that Nymalize (nimodipine), oral solution, 3 milligrams/milliliter, was not withdrawn from sale for reasons of safety or effectiveness. Accessed March 6, 2025. https://www.govinfo.gov/content/pkg/FR-2021-02-17/pdf/2021-03083.pdf 11. Orange Book. FDA. Product details for NDA 203340. Accessed July 31, 2024. https://www.accessdata.fda.gov/scripts/cder/ob/results product.cfm?Appl_Type=N&Appl_No=203340#38880 12. Maisel WH. US Food and Drug Administration. The FDA encourages use of enteral device connectors that reduce risk of misconnection and patient injury. Published September 7, 2018. Accessed March 6, 2025. 13. Pharmacy Times. Optimizing Delivery of Nimodipine in Patients With Subarachnoid Hemorrhage. Published January 2025. Accessed March 6, 2025. 14. ENFIT Global Conversion Updates & Map. Stay Connected® by GEDSA. 2023. Accessed March 6, 2025. https://stayconnected.org/global-conversion/ 15. GEDSA US conversion rates flyer 2023. Stay Connected® by GEDSA. 2023. Accessed March 6, 2025. https://stayconnected.org/gedsausconversionratesflyer2023 16. Stay Connected. Implementing the ENFit Initiative for Preventing Enteral Tubing Misconnections. Published March 29, 2017. Accessed March 6, 2025. 17. ISMP. Take action to prevent tubing misconnections—part ii. Published November 14, 2024. Accessed March 6, 2025.
