Department: Medication Update
New nocturia treatment now available
The FDA-approved nocturia treatment desmopressin acetate (Noctiva) nasal spray is now available from Avadel. The product is indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times per night to void. Desmopressin acetate nasal spray, a vasopressin analog, is formulated for intranasal use as a preservative-free milky white emulsion. The product was approved in March 2017 and was launched in the United States in May 2018.
Desmopressin acetate nasal spray is available in two strengths: 0.83 mcg and 1.66 mcg per spray. Each spray is 0.1 mL.
A boxed warning in the prescribing label advises clinicians to ensure that the serum sodium level is normal before starting or resuming treatment with desmopressin acetate. The serum sodium level must be measured within 7 days and approximately 1 month after starting therapy or increasing the dose and also periodically during treatment. Patients 65 years of age and older and those with increased risk of hyponatremia require more frequent monitoring. The drug has numerous contraindications for patients diagnosed with hyponatremia or those with a history of hyponatremia. Consult product labeling for full prescribing information.
Over-the-counter sensor approved to support asthma medication management
The FDA approved Adherium's SmartTouch sensor for over-the-counter (OTC) sale for use with Astra Zeneca's asthma and chronic obstructive pulmonary disease (COPD) treatment, Symbicort. The SmartTouch sensor attaches to the user's inhaler, and three buttons on the sensor help patients access audiovisual reminders, battery status, and Bluetooth wireless technology.
SmartTouch tracks daily usage, recording date and time of device use, and automatically transmits the information to an app on the patient's phone or tablet. SmartTouch archives patients' medication usage patterns so that healthcare providers can review the information and make informed treatment decisions.
The SmartTouch sensor will be available OTC through pharmacies and online.
Trelegy Ellipta gains new COPD indication and loses boxed warning
The FDA has granted approval for an expanded indication for fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta) to include long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is also indicated to reduce COPD exacerbations in patients with a history of exacerbations. Trelegy Ellipta is a product of GlaxoSmithKline.
The FDA also removed a boxed warning regarding asthma-related deaths from the Trelegy Ellipta labeling in line with recent updates to the inhaled corticosteroids/long-acting beta-agonists class (www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm590021.htm).
FDA warns of potentially fatal immune reaction to lamotrigine
The FDA warned that the seizure and bipolar disorder treatment lamotrigine (Lamictal) is linked with the rare but potentially life-threatening immune reaction hemophagocytic lymphohistiocytosis (HLH). According to the FDA, a review of adverse event reports submitted to the agency and reports from the literature yielded data about eight patients worldwide since 1994; five of these patients were diagnosed with HLH and three patients were suspected of having HLH. All eight patients required hospitalization, and one patient died.
The risk of experiencing HLH is being added to lamotrigine labeling and prescribing information. HLH can occur within days to weeks after starting treatment with lamotrigine, which has been on the market for 24 years.
If the reaction is not diagnosed and treated quickly, severe inflammation through the body can occur, leading to hospitalization and death. The FDA warns that diagnosis is often complicated because early signs and symptoms, such as fever and rash, are not specific.