Strongbridge Biopharma
Dear [Name],
Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. We are building a strong foundation to connect patients with new treatments, and are looking forward to partnering with healthcare providers to provide education, treatment, and support for patients with rare diseases.
Strongbridge Biopharma acquired the U.S. rights to KEVEYIS® (dichlorphenamide), and is now making this important treatment available to current and appropriate new patients. We are excited about the addition of KEVEYIS, the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis (PPP), as the foundation of our rare neuromuscular disease franchise. We at Strongbridge are dedicated to working with patients, caregivers, healthcare providers, advocacy groups, payers, and policy makers in support of the primary periodic paralysis community.
Primary periodic paralysis, a rare neuromuscular disorder, is a physically disabling and unpredictable episodic condition that impacts the lives of ~5,000-6,000 individuals in the U.S. Symptoms of PPP are often nonspecific with varying clinical presentations, making diagnosis challenging. For some patients, this means that a diagnosis can take many years. Until recently, there was no FDA-approved treatment for primary periodic paralysis. Studied in 2 placebo-controlled clinical trials, KEVEYIS was shown to reduce the number, duration, and severity of attacks of primary periodic paralysis. The most common adverse reactions seen in clinical trials with an incidence ≥ 10% and greater than placebo include paresthesias, cognitive disorder, dysgeusia, and confusional state.
If you have a patient with primary periodic paralysis and are interested in prescribing KEVEYIS:
  1. Please complete the downloadable KEVEYIS Start Form for current or new patients.
  2. Fax the form to 844-KEV-1030.
Strongbridge Biopharma CareConnection
We are proud to offer a full-range of services to patients with primary periodic paralysis who are taking KEVEYIS.
Strongbridge CareConnection is a comprehensive patient and family support program that provides a wide range of services including personalized case management and access assistance. Please call 844-KEVEYIS for more information.
To learn more about PPP and treatment with KEVEYIS, please contact us at keveyis@strongbridgebio.com and one of our Strongbridge sales representatives will reach out to you.
Please click here for Full Prescribing Information
Important Safety Information
Contraindications
  • Hypersensitivity to dichlorphenamide or other sulfonamides
  • Concomitant use of KEVEYIS and high-dose aspirin
  • Severe pulmonary disease, limiting compensation to metabolic acidosis caused by KEVEYIS
  • Hepatic insufficiency: KEVEYIS may aggravate hepatic encephalopathy
Warnings and Precautions
  • Hypersensitivity/Anaphylaxis/Idiosyncratic Reactions
    • Fatalities associated with the administration of sulfonamides have occurred due to adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias.
    • Pulmonary involvement can occur in isolation or as part of a systemic reaction.
    • Discontinue KEVEYIS at the first appearance of skin rash or any sign of immune-mediated or idiosyncratic adverse reaction.
  • Concomitant Use of Aspirin
    • Anorexia, tachypnea, lethargy, and coma have been reported with concomitant use of dichlorphenamide and high-dose aspirin.
    • The concomitant use of KEVEYIS and high-dose aspirin is contraindicated.
    • Use with caution in patients receiving low-dose aspirin.
  • Hypokalemia
    • KEVEYIS increases potassium excretion and can cause hypokalemia.
    • The risk of hypokalemia is greater when KEVEYIS is used in patients with conditions associated with hypokalemia (eg, adrenocortical insufficiency, hyperchloremic metabolic acidosis, or respiratory acidosis), and in patients receiving other drugs that may cause hypokalemia (eg, loop diuretics, thiazide diuretics, laxatives, antifungals, penicillin, and theophylline).
    • Baseline and periodic measurements of serum potassium are recommended.
    • If hypokalemia develops or persists, consider reducing the dose or discontinuing KEVEYIS.
  • Metabolic Acidosis
    • KEVEYIS can cause hyperchloremic non–anion gap metabolic acidosis.
    • Concomitant use of KEVEYIS with other drugs that cause metabolic acidosis may increase the severity of metabolic acidosis.
    • Baseline and periodic measurements of serum bicarbonate are recommended.
    • If metabolic acidosis develops or persists, consider reducing the dose or discontinuing KEVEYIS.
  • Falls
    • KEVEYIS increases the risk of falls; risk is greater in the elderly and with higher doses.
    • Consider dose reduction or discontinuation of KEVEYIS in patients who experience falls while treated with KEVEYIS.
Pregnancy and Lactation
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known in humans whether dichlorphenamide is excreted in human milk; exercise caution when administered to a nursing woman.
Adverse Reactions
The most common adverse reactions seen in clinical trials (incidence ≥ 10% and greater than placebo) include paresthesias, cognitive disorder, dysgeusia, and confusional state.
Indication
KEVEYIS is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.

The entire Strongbridge team is passionate about making a positive difference in the lives of patients with PPP and we look forward to partnering with you to achieve this goal.

Sincerely,
The Strongbridge KEVEYIS Team
KEVEYIS®
Please click here for Full Prescribing Information
If you wish to stop receiving these e-mails, click here to unsubscribe.
Click here to view the privacy statement.
Strongbridge Biopharma KEVEYIS®
900 Northbrook Drive, Suite 200
Trevose, PA 19053
United States
www.KEVEYIS.com
www.strongbridgebio.com

© 2017 Strongbridge Biopharma plc

STRONGBRIDGE BIOPHARMA™ is a trademark of Strongbridge Biopharma plc.
KEVEYIS® is a registered trademark licensed exclusively in the US to Strongbridge Biopharma

KEV070-01 04/2017