Nymalize
Generic: NIMODIPINE
Basic Information
Manufacturer
Azurity Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
e660fa26-b5c4-4d6d-8887-9e22b6666a10
Indications & Usage
1 INDICATIONS AND USAGE 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).
NYMALIZE is a dihydropyridine calcium channel blocker 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 a dihydropyridine calcium channel blocker 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 )
Adverse Reactions
6 ADVERSE REACTIONS The safety and efficacy of NYMALIZE (nimodipine oral solution) in the treatment of patients with SAH is based on adequate and well-controlled studies of nimodipine oral capsules in patients with SAH.
NYMALIZE (nimodipine oral solution) has comparable bioavailability to nimodipine oral capsules.
The following clinically significant adverse reaction appears in other sections of the labeling: Hypotension [see Warnings and Precautions (5.1) ].
Most common adverse reactions (incidence ≥1% and ≥1% placebo) were hypotension, headache, nausea, and bradycardia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc.
at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In clinical trials of nimodipine oral capsules in patients with SAH, eleven percent (92 of 823) of nimodipine-treated patients reported adverse events compared to six percent (29 of 479) of placebo-treated patients.
The most common adverse event was decreased blood pressure in 4.4% of nimodipine-treated patients.
The events reported with a frequency greater than 1% are displayed in Table 1 by dose.
Table 1: Adverse Events [n (%)] reported with a frequency > 1% in four clinical trials (Study 1, Study 2, Study 3, and Study 4) Placebo (n=479) Nimodipine dose every 4 hours 0.35 mg/kg (n=82) 30 mg (n=71) 60 mg (n=494) 90 mg (n=172) 120 mg (n=4) Decreased Blood Pressure 6 (1.2) 1 (1.2) 0 19 (3.8) 14 (8.1) 2 (50.0) Edema 3 (0.6) 0 0 2 (0.4) 2 (1.2) 0 Diarrhea 3 (0.6) 0 3 (4.2) 0 3 (1.7) 0 Rash 3 (0.6) 2 (2.4) 0 3 (0.6) 2 (1.2) 0 Headache 1 (0.2) 0 1 (1.4) 6 (1.2) 0 0 Gastrointestinal Symptoms 0 2 (2.4) 0 0 2 (1.2) 0 Nausea 0 1 (1.2) 1 (1.4) 6 (1.2) 1 (0.6) 0 Dyspnea 0 1 (1.2) 0 0 0 0 EKG Abnormalities 0 0 1 (1.4) 0 1 (0.6) 0 Tachycardia 0 0 1 (1.4) 0 0 0 Bradycardia 0 0 0 5 (1.0) 1 (0.6) 0 Muscle Pain/Cramp 0 0 1 (1.4) 1 (0.2) 1 (0.6) 0 Acne 0 0 1 (1.4) 0 0 0 Depression 0 0 1 (1.4) 0 0 0 SAH is frequently accompanied by alterations in consciousness that may lead to an under-reporting of adverse experiences.
As a calcium channel blocker, nimodipine may have the potential to exacerbate heart failure in susceptible patients or to interfere with A-V conduction, but these events were not observed in SAH trials.
NYMALIZE (nimodipine oral solution) has comparable bioavailability to nimodipine oral capsules.
The following clinically significant adverse reaction appears in other sections of the labeling: Hypotension [see Warnings and Precautions (5.1) ].
Most common adverse reactions (incidence ≥1% and ≥1% placebo) were hypotension, headache, nausea, and bradycardia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc.
at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In clinical trials of nimodipine oral capsules in patients with SAH, eleven percent (92 of 823) of nimodipine-treated patients reported adverse events compared to six percent (29 of 479) of placebo-treated patients.
The most common adverse event was decreased blood pressure in 4.4% of nimodipine-treated patients.
The events reported with a frequency greater than 1% are displayed in Table 1 by dose.
Table 1: Adverse Events [n (%)] reported with a frequency > 1% in four clinical trials (Study 1, Study 2, Study 3, and Study 4) Placebo (n=479) Nimodipine dose every 4 hours 0.35 mg/kg (n=82) 30 mg (n=71) 60 mg (n=494) 90 mg (n=172) 120 mg (n=4) Decreased Blood Pressure 6 (1.2) 1 (1.2) 0 19 (3.8) 14 (8.1) 2 (50.0) Edema 3 (0.6) 0 0 2 (0.4) 2 (1.2) 0 Diarrhea 3 (0.6) 0 3 (4.2) 0 3 (1.7) 0 Rash 3 (0.6) 2 (2.4) 0 3 (0.6) 2 (1.2) 0 Headache 1 (0.2) 0 1 (1.4) 6 (1.2) 0 0 Gastrointestinal Symptoms 0 2 (2.4) 0 0 2 (1.2) 0 Nausea 0 1 (1.2) 1 (1.4) 6 (1.2) 1 (0.6) 0 Dyspnea 0 1 (1.2) 0 0 0 0 EKG Abnormalities 0 0 1 (1.4) 0 1 (0.6) 0 Tachycardia 0 0 1 (1.4) 0 0 0 Bradycardia 0 0 0 5 (1.0) 1 (0.6) 0 Muscle Pain/Cramp 0 0 1 (1.4) 1 (0.2) 1 (0.6) 0 Acne 0 0 1 (1.4) 0 0 0 Depression 0 0 1 (1.4) 0 0 0 SAH is frequently accompanied by alterations in consciousness that may lead to an under-reporting of adverse experiences.
As a calcium channel blocker, nimodipine may have the potential to exacerbate heart failure in susceptible patients or to interfere with A-V conduction, but these events were not observed in SAH trials.