First FDA-approved IV antiarrhythmic in over 10 years now available

CHICAGO – AltaThera Pharmaceuticals today announced the availability of Sotalol IV (sotalol hydrochloride injection 15mg/mL for intravenous use) in the United States.

Sotalol HydrochlorideThe product is the first FDA-approved IV antiarrhythmic introduced in the U.S. market in over 10 years and one of only two FDA-approved antiarrhythmics available in both oral and IV form.

Antiarrhythmics treat irregular, or abnormally fast or slow heartbeats.

Sotalol IV is included in the 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care: Adult Advanced Cardiovascular Life Support.

AltaThera President and CEO Brandon Kashfian said the release of Sotalol IV – a multi-year effort that required navigating many hurdles typical in making niche injectable products commercially viable – represents a milestone at the heart of the company’s mission.

“This product fills an unmet medical need in a vulnerable patient population,” Kashfian said. “We did not want to let manufacturing challenges stand in the way of making that happen.”

Click here for Full Prescribing Information including Boxed Warning.

About Sotalol IV

Sotalol IV, sotalol hydrochloride injection, 15 mg/mL for intravenous use is an antiarrhythmic agent indicated for substitution for oral sotalol in patients who are unable to take sotalol orally.

Oral sotalol is indicated for maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillation/flutter and treatment of documented life-threatening ventricular arrhythmias.

IMPORTANT SAFETY INFORMATION

WARNING: LIFE THREATENING PROARRHYTHMIA

See full prescribing information for complete boxed warning

  • Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation
  • Do not initiate sotalol therapy if the baseline QTc is longer than 450 ms
  • If the QT interval prolongs to 500 ms or greater, the dose must be reduced, the duration of the infusion prolonged or
    the drug discontinued
  • Patient should be hospitalized in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring
  • Adjust the dosing interval based on creatinine clearance

For the safety of the patient, the safety measures required of oral sotalol administration must also be applied for intravenous route.

As the bioavailability of oral sotalol is between 90% and 100%, the corresponding dose of intravenous sotalol is slightly less than that of the oral dose. 75 mg of intravenous sotalol is approximately equal to 80 mg of oral sotalol. Monitor the effect of the initial intravenous dose and titrate either upward or downward, if needed, based on clinical effect, QT interval or adverse reactions.

Sotalol is contraindicated in patients with sinus bradycardia (<50 bpm), sick sinus syndrome or second or third degree AV block unless a functioning pacemaker is present; in patients with congenital or acquired long QT syndromes, QT interval >450 ms; in patients with cardiogenic shock or uncontrolled heart failure; in patients with creatinine clearance <40 mL/min; in patients with serum potassium <4 meq/L; in patients with bronchial asthma or related bronchospastic conditions; and in patients with known hypersensitivity to sotalol.

Sotalol can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular tachycardia. Factors such as reduced creatinine clearance, gender (female) and larger doses increase the risk of TdP. Calculation of the creatinine clearance must precede administration of the first dose of sotalol.

The use of sotalol in conjunction with other drugs that prolong the QT interval has not been studied and is not recommended.

Sotalol may increase bradycardia in patients with supraventricular arrhythmia. Bradycardia itself increases the risk of Torsades de Pointes. Patients receiving concomitant digoxin must be carefully monitored.

Do not abruptly discontinue treatment. Occasional cases of exacerbation of angina pectoris, arrhythmias, and in some cases, myocardial infarction have been reported after abrupt discontinuation of beta-blocker therapy.

Sotalol may increase the propensity to develop serious arrhythmias in patients with left ventricular dysfunction.

Sotalol should not be used in patients with hypokalemia or hypomagnesemia prior to correction of imbalance, as these conditions increase the potential for Torsades de Pointes. Special attention should be given to electrolyte and acid based balance in patients experiencing severe or prolonged diarrhea or patients receiving concomitant diuretic drugs.

Monitor serum glucose in diabetic patients as sotalol, like all beta-blockers in general, may mask symptoms of hypoglycemia or worsen hyperglycemia.

There is no clinical experience with intravenous sotalol. Because of the similarity in exposure between intravenous sotalol and oral sotalol, adverse reactions should be similar. The most common adverse reactions (>10%) seen with oral sotalol (dose related) are fatigue, dizziness, lightheadedness, headache, asthenia, nausea, dyspnea, bradycardia, chest pain and palpitation.

Please see Full Prescribing Information including Boxed Warning.

About Atrial Fibrillation/Flutter: Atrial fibrillation, according to the American Heart Association, is  a quivering or irregular heartbeat (arrhythmia) that can  lead to blood clots, stroke, heart failure and other complications. Atrial flutter is characterized by very rapid beating of the heart’s upper chambers, or atria.

About Ventricular Fibrillation: Ventricular fibrillation, according to the American Heart Association, is a life threatening cardiac rhythm disturbance  characterized by a quivering of the heart’s lower chambers, preventing the heart from pumping blood.

About AltaThera: AltaThera Pharmaceuticals is a specialty pharmaceutical company focused on critical care therapies to address the unmet medical needs of patients with severe, and often rare, disorders for which few effective treatments are available.

For more information on Sotalol IV, including ordering information, click here.

Contact:
Patricia Dunnigan
Manager, Communications & Marketing
AltaThera Pharmaceuticals
200 S. Wacker Drive
Suite 3100
Chicago, IL 60606
pdunnigan@altathera.com





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