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).
Additional Important Safety Information
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 (ARBs), 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.
© 2024 Azurity Pharmaceuticals, Inc.
PP-NYM-US-0897
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