NOCDURNA 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.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
See full Prescribing Information for complete boxed warning
- NOCDURNA can cause hyponatremia, which may be life-threatening if severe.
- NOCDURNA is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids.
- Ensure serum sodium concentration is normal before starting or resuming NOCDURNA. Measure serum sodium within 1 week and approximately 1 month after initiating therapy and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia.
- If hyponatremia occurs, NOCDURNA may need to be temporarily or permanently discontinued.
- Hyponatremia or a history of hyponatremia
- Concomitant use with loop diuretics or systemic or inhaled glucocorticoids
- Estimated glomerular filtration rate below 50 mL/min/1.73 m2
- Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
- During illnesses that can cause fluid or electrolyte imbalance
- Heart failure
- Uncontrolled hypertension
WARNINGS AND PRECAUTIONS
- Limit fluid intake to a minimum from 1 hour before until 8 hours after administration. Treatment without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia.
- Fluid retention: Not recommended in patients at risk of increased intracranial pressure or history of urinary retention.
Common adverse reactions (>2% incidence) included dry mouth, hyponatremia or blood sodium decreased, and dizziness.
Monitor serum sodium more frequently when NOCDURNA is concomitantly used with drugs that may increase the risk of hyponatremia (e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, thiazide diuretics, carbamazepine, lamotrigine, sulfonylureas, particularly chlorpropamide and NSAIDS).
USE IN SPECIFIC POPULATIONS
Pregnancy: Use of NOCDURNA is not recommended.
Geriatric Use: Increased risk of hyponatremia if 65 years of age or older. Monitor serum sodium more frequently.
To report SUSPECTED ADVERSE REACTIONS, contact Ferring at 1-888-337-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including BOXED WARNING, and natantly.