Arbor Pharma Launches New Nymalize (Nimodipine) Oral Solution 10 Ml (30 Mg) Unit Dose For The Treatment Of Subarachnoid Hemorrhage
Published: Sep 20, 2017
ATLANTA, Sept. 20, 2017 /PRNewswire/ -- Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, announced today that Nymalize® (nimodipine) Oral Solution will now be available in a 10 mL (30 mg) unit dose cup. This new packaging option is designed specifically for patients whom require a dosage that is lower than the standard 20 mL (60 mg) dose. Nymalize provides accurate, consistent dosing in a ready-to-use form for subarachnoid hemorrhage (SAH) patients who cannot swallow capsules.
Nymalize is the first and only nimodipine oral solution indicated for the improvement of neurological outcome in adult patients with SAH1 and is available as a 473 mL (16 oz) bottle and as a carton of twelve individually wrapped 10 mL (30 mg) or 20 mL (60 mg) unit dose cups. Packaging of Nymalize meets the medication-storage provision of The Joint Commission on Accreditation of Healthcare. The product was approved by the U.S. Food and Drug Administration (FDA) in 2013 following a fast track designation and priority review.2
Patients with cirrhosis are at a higher risk of adverse reactions associated with SAH and should be administered a lower dose of nimodipine.1
"Arbor is committed to patient safety and recognized the need for additional ready-to-use options for specific patient populations. We are proud to add the Nymalize 10 mL unit dose cup to our growing portfolio of approved prescription products that can support the needs of patients," said Ed Schutter, President and CEO of Arbor.
According to the State of Pharmacy Automation 2017 survey, most facilities are purchasing more than 70% of their medications in a bar code, unit dose format3 which demonstrates the need for more ready-to-use options from manufacturers.
Nymalize was developed by Arbor Pharmaceuticals. For more information, visit www.Nymalize.com.
About Subarachnoid Hemorrhage (SAH)
SAH is a serious, life-threatening condition that occurs in differing clinical contexts, the most common being head trauma, and refers to the leakage of blood into the subarachnoid space in the brain between the pial and arachnoid membranes. SAH familiarly refers to the spontaneous hemorrhages which occur with a ruptured cerebral aneurysm or arteriovenous malformation (AVM).
Nymalize is the first and only FDA-approved ready-to-use oral solution of nimodipine. This solution offers an effective alternative to capsule extraction for SAH patients who cannot swallow capsules. Nymalize is available in a 473mL (16 oz) bottle and 20mL (60mg), and 10mL (30mg) unit dose cups.
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 IV).
IMPORTANT SAFETY INFORMATION
Blood pressure should be carefully monitored during treatment with Nymalize. Nimodipine may increase the blood pressure-loweringeffect of concomitantly administered anti-hypertensives such as diuretics, beta-blockers, ACE inhibitors, angiotensin receptor blockers, other calcium channel blockers, -adrenergic blockers, PDE5 inhibitors, and -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 (e.g., clarithromycin, telithromycin), some HIV protease inhibitors (e.g., indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (e.g., boceprevir, telaprevir), some azole antimycotics (e.g., ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan, delavirdine, and nefazodone.
Concomitant use of strong CYP3A4 inducers (e.g., 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.
For additional safety information, consult the full Perscribing Information for Nymalize here.
ABOUT ARBOR PHARMACEUTICALS, LLC
Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the cardiovascular, neurology, hospital and pediatric markets as well as generics through its Wilshire division. The company has approximately 750 employees, with over 625 sales professionals that promote its products to hospitals and physicians. In addition to an extensive pipeline, the company continues to actively pursue growth through acquisition or licensing of marketed or late-stage development products. Arbor currently markets twenty-two approved NDA and ANDA products, and, along with Wilshire, has over forty products in development. For more information regarding Arbor Pharmaceuticals or any of its products, visit www.arborpharma.com or send email inquiries to firstname.lastname@example.org.
1 Nymalize [package insert]. Atlanta, GA: Arbor Pharmaceuticals.
2 U.S. Food and Drug Administration. News release, May 14, 2013. FDA approves Nymalize first nimodipine oral solution for use in certain brain hemorrhage patients.
3 State of Pharmacy Automation 2017. Pharmacy Purchasing & Products. August 2017.
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SOURCE Arbor Pharmaceuticals LLC