Covis Pharmaceuticals Announces Its New Expanded Dosage Options of LANOXIN® for Cardiac Patients With Mild-to-Moderate Heart Failure

CARY, N.C., Feb. 7, 2014 /PRNewswire/ -- Covis Pharmaceuticals today announced that LANOXIN® is now offered in four dosage strengths, including the new 0.0625mg and 0.1875mg strengths, for the treatment of mild-to-moderate heart failure in adults, and for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Current dosing options of 0.250mg and 0.125mg are still available. These four convenient strengths are currently stocked in all major wholesalers.

The 2013 American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Guidelines now support maintaining a Serum Digoxin Concentration (SDC) in the range of 0.5 to 0.9ng/ml. Some patients may require lower LANOXIN® dosing to achieve the recommended target SDC levels.

In the Digitalis Investigation Group (DIG) study, LANOXIN® was associated with a reduction in hospitalizations, including a 25% reduction in risk for the number of heart failure hospitalizations, and a 6% reduction in number of hospitalizations for any cause, while having no effect on mortality.

LANOXIN® increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, LANOXIN® should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. It is a registered trademark of the GlaxoSmithKline group of companies.

Important Safety Information
CONTRAINDICATIONS: LANOXIN is contraindicated in patients with ventricular fibrillation and in patients with a known hypersensitivity to digoxin or other forms of digitalis. WARNINGS AND PRECAUTIONS: Patients taking digoxin who have atrioventricular (AV) accessory pathway like Wolff-Parkinson-White syndrome are at risk of ventricular fibrillation. Treatment in these patients with digoxin leads to greater slowing of AV node conduction and increases the risk of rapid ventricular response leading to ventricular fibrillation.

Patients with sinus node disease are at risk for severe sinus bradycardia or sinoatrial block. Patients with incomplete AV block are at risk for advanced or complete heart block.

There is a risk of toxicity when taking LANOXIN. Toxicity is usually associated with digoxin levels >2.0ng/mL, although symptoms may also occur at lower levels. Signs and symptoms of digoxin toxicity include anorexia, nausea, vomiting, visual changes and cardiac arrhythmias.  Low body weight, advanced age, impaired renal function and electrolyte abnormalities increase a patient's risk of toxicity. Select the LANOXIN dosage carefully and adjust as the clinical condition of the patient warrants. Measure digoxin levels when signs and symptoms of toxicity are present and adjust the dose or discontinue as necessary.

Patients on digoxin receiving electrical cardioversion are at risk for ventricular arrhythmias. It may be desirable to reduce the dose of, or discontinue, LANOXIN for 1 to 2 days prior to electrical cardioversion of atrial fibrillation to avoid induction of ventricular arrhythmias, but physicians must consider the consequences of all options. If digitalis toxicity is suspected, elective cardioversion should be delayed.

LANOXIN is not recommended in patients with acute myocardial infarction as digoxin may increase myocardial oxygen demand and lead to ischemia. LANOXIN should not be used in patients with myocarditis as it can precipitate vasoconstriction and may promote production of pro-inflammatory cytokines.

Patients with certain disorders involving heart failure associated with preserved left ventricular ejection fraction may experience decreased cardiac output. Such disorders include restrictive cardiomyopathy, constrictive pericarditis, amyloid heart disease, and acute cor pulmonale.

Patients with idiopathic hypertrophic subaortic stenosis may have worsening of the outflow obstruction due to inotropic effects of digoxin. Patients with amyloid heart disease may be at higher risk of digoxin toxicity. Digoxin should generally be avoided in these patients.

Hypocalcemia may reduce digoxin requirements. These interactions are because digoxin can affect contractility and excitability of the heart in a manner similar to that of calcium.

Patients with hypothyroidism may require less digoxin. In patients with heart failure and/or atrial arrhythmias resulting from hypermetabolic or hyperdynamic states (e.g., hypothyroidism, hypoxia, or arteriovenous shunt) the underlying condition should be treated. Atrial arrhythmias associated with hypermetabolic states are particularly resistant to digoxin treatment. Patients with beri beri heart disease may fail to respond adequately to digoxin if the underlying thiamine deficiency is not treated concomitantly.

ADVERSE REACTIONS: In a large clinical trial, the incidence of hospitalization for suspected digoxin toxicity was 2% in patients taking LANOXIN compared to 0.9% in patients taking placebo. The overall incidence of adverse reactions with digoxin has been reported as 5-20%, with 15-20% of adverse events considered serious. Cardiac toxicity accounts for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse events. In general, the adverse reactions of LANOXIN are dose- dependent and occur at doses higher than those needed to achieve a therapeutic effect.

DRUG INTERACTIONS: Digoxin has a narrow therapeutic index; increased monitoring of serum digoxin concentration is necessary when initiating, adjusting or discontinuing drugs that may interact with digoxin. Prescribers should consult the prescribing information for further information on any potential drug interactions with digoxin.

Full Prescribing Information
Full prescribing information can be found here: http://www.covispharma.com/pdfs/lanoxin-tablets-pi.pdf

About Covis Pharmaceuticals
Covis Pharmaceuticals is a specialty pharmaceutical distributor dedicated to improving the lives of people with life-threatening conditions and chronic illnesses. It is our mission to provide our customers with a continuous supply of safe, efficacious, and affordable therapeutic solutions.

Covis Pharma, Sarl, a Switzerland-based specialty pharmaceutical company is a supplier of Covis Pharmaceuticals.

SOURCE Covis Pharmaceuticals, Inc.