References: 1. NOCTIVA [package insert]. Chesterfield, MO: Avadel Specialty Pharmaceuticals, LLC; 2017. 2. US Food and Drug Administration. Orange Book Noctiva. https://www.acessdata.fda.gov/scripts/cder/ob/search_product.cfm. Accessed August 13, 2018. 3. Data on file. Avadel Specialty Pharmaceuticals, LLC.
See full prescribing information for complete boxed warning.
Indications and usage
NOCTIVA is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.
Limitation of Use: Not studied in patients younger than 50 years of age.
Warnings and Precautions
Common adverse reactions in clinical trials (incidence >2%) included nasal discomfort, nasopharyngitis, nasal congestion, sneezing, hypertension / blood pressure increased, back pain, epistaxis, bronchitis and dizziness.
Monitor serum sodium more frequently when NOCTIVA is concomitantly used with drugs that may cause water retention and increase the risk for hyponatremia (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, nonsteroidal anti-inflammatories, lamotrigine and carbamazepine).
Use in Specific Populations
To report SUSPECTED ADVERSE REACTIONS, contact Avadel at 1-877-638-4579 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.