SOTALOL HYDROCHLORIDE INJECTION 15 MG/ML FOR INTRAVENOUS USE

INDICATION

Sotalol hydrochloride 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 hypomagnesemiaprior 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.

News

  • AltaThera Pharmaceuticals Announces FDA Approval for New Indications of Sotalol IV: A New and Faster Way to Initiate Sotalol Therapy for Atrial Fibrillation (AFib) Patients

    – Sotalol IV is now approved for 1-day hospital outpatient initiation of AFib therapy and faster dose escalations for existing patients

    – New FDA-approved dosing, monitoring and evaluation shortens the hospital stay from 3 days to 1 day

    – The new initiation provides physicians with a faster and safe way to start new sotalol patients, potentially reducing hospital costs and improving patient satisfaction

    CHICAGO, March 10, 2020 — AltaThera Pharmaceuticals, LLC, a hospital specialty pharmaceutical company focused on commercializing innovative drugs aimed at improving outcomes and reducing hospital costs, announces that the US Food and Drug Administration (FDA) has approved new indications for Sotalol IV in AFib patients. “The new indications for Sotalol IV represent a significant advance that decreases length of stay for new patients starting sotalol for AFib,” said Jodi Devlin, AltaThera’s CEO. “We are proud to continue our leadership in cardiac and critical care medicine as we work diligently to bring innovative therapies to patients in the United States. We are on target with our commercial launch preparations and expect to launch Sotalol IV’s new indications in the second half of the year.”

    Atrial fibrillation is a common heart arrhythmia in adults.

    Read More
  • IV Sotalol Donated for Veterinary Research on Ventricular Arrhythmias

    Chicago, IL – January 2019 – AltaThera has donated vials of IV sotalol to the Veterinary Program at the University of Pennsylvania to better understand heart arrhythmias in dogs.

    As stated by Professor Anna Gelzer, PhD, Doctor of Veterinary Medicine, “Boxers are at an increased risk of arrhythmogenic right ventricular cardiomyopathy (ARVC), an inherited disease of the heart muscle. We are interested to test [IV sotalol’s] ability to suppress arrhythmia inducibility during an electrophysiologic study.”

    AltaThera remains committed to research in all areas of cardiac arrhythmia and is excited about Dr. Gelzer’s clinical program.”

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  • New patent issued

    Chicago, IL – Dec. 24, 2019 – Today, AltaThera Pharmaceuticals, LLC, a hospital pharmaceutical company focused on commercializing acute-care hospital products, announced that the US Patent and Trademark Office has issued a  new patent covering methods of treatment for Sotalol IV. The patent is effective through August 2038.

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  • Gary Dickey named AltaThera Regional Sales Manager, East

     

    CHICAGO, IL – August 12, 2019 -Gary Dickey has joined AltaThera Pharmaceuticals as Regional Sales Manager, East Region.

    Gary joining the management team is an important step in AltaThera’s commercial efforts, as the company prepares to expand its field force to more effectively serve its hospital-based customers in cardiac electrophysiology.

    Gary, who has more than 20 years of experience in both the medical device and specialty pharmaceutical industry, joins AltaThera after successful leadership roles at Medtronic, AstraZeneca and Covidien. He has extensive experience in the field of electrophysiology which aligns with the company’s vision for the growth of Sotalol IV for treating cardiac arrhythmias.

    About AltaThera: AltaThera Pharmaceuticals is a specialty pharmaceutical company focused on commercializing therapies for unmet medical needs of physicians, hospitals and their patients. AltaThera’s first commercial product is a critically valuable anti-arrhythmic in the hospital space.

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  • AltaThera Partners with Rush University Hospital to Support Arrhythmia Research in Vietnam

    Chicago, IL – 03/28/19  AltaThera Pharmaceuticals has recently partnered with Rush University Medical Center to support arrhythmia research around the world.  Through a charitable donation of the medication IV Sotalol (sotalol hydrochloride injection 15mg/mL for intravenous use), AltaThera is supporting important research regarding prophylaxis for post-op dysrhythmias.  The research is scheduled to take place at Hanoi Heart Hospital in Hanoi, Vietnam over the course of 2019/2020.

     Click here for Full IV Sotalol Prescribing Information, including Boxed Warning

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  • AltaThera selected by FDA to participate in a new regulatory program called Model-Informed Drug Development