For: Nocturia
Noctiva (desmopressin acetate) is vasopressin analog nasal spray indicated for the treatment of nocturia due to nocturnal polyuria.How Supplied
NOCTIVA (desmopressin acetate) nasal spray is available in a 3.5 mL amber glass bottle (nominal volume) fitted with a nasal actuator, a cartridge pump, and a dip tube, delivering a dose of either 0.83 mcg or 1.66 mcg of desmopressin acetate (equivalent to 0.75 mcg or 1.5 mcg of desmopressin) per spray (0.1 mL). Each bottle contains a target amount of 3.8 g formulation with 30 effective doses in addition to the initial priming (5 actuations), equivalent to 30 days of medication when used as 1 spray once a day.
0.83 mcg/0.1 mL of desmopressin acetate, trade bottle NDC 71758-106-55
0.83 mcg/0.1 mL of desmopressin acetate, sample bottle NDC 71758-106-56
1.66 mcg/0.1 mL of desmopressin acetate, trade bottle NDC 71758-107-55
1.66 mcg/0.1 mL of desmopressin acetate, sample bottle NDC 71758-107-56
16.2 Storage and Handling
Before opening, store upright in a refrigerator, 2�C to 8�C (36�F to 46�F); excursion permitted between 0�C and 15�C (32�F and 59�F) [See USP Controlled Cold Temperature].
After opening, store upright at room temperature 20�C to 25�C (68�F to 77�F).
Discard NOCTIVA 60 days after opening. These highlights do not include all the information needed to use NOCTIVA� safely and effectively. See full prescribing information for NOCTIVA.
NOCTIVA (desmopressin acetate) nasal spray, for intranasal use
Initial U.S. Approval: 1978
WARNING: HYPONATREMIA
See full prescribing information for complete boxed warning.
NOCTIVA can cause hyponatremia, which may be life-threatening if severe. (5.1, 6.1)
NOCTIVA 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. (4, 5.1)
Ensure serum sodium is normal before starting or resuming NOCTIVA. Measure serum sodium within 7 days and approximately 1 month after initiating therapy or increasing the dose, 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. (2.3, 5.1)
If hyponatremia occurs, NOCTIVA may need to be temporarily or permanently discontinued. (5.1)
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. (1)
Limitation of Use: Not studied in patients younger than 50 years of age. (1)
DOSAGE AND ADMINISTRATION
Prime with 5 actuations before initial use. Re-prime with 2 actuations if not used for more than 3 days. (2.1)
For patients <65 years of age who are not at increased risk for hyponatremia: Use 1 spray of 1.66 mcg in either nostril nightly approximately 30 minutes before going to bed. (2.2)
For patients ?65 years of age or younger patients at risk for hyponatremia: Use 0.83 mcg nightly, which can be increased to 1 spray of 1.66 mcg after at least 7 days, if needed, provided the serum sodium has remained normal. (2.2)
DOSAGE FORMS AND STRENGTHS
Preservative-free nasal spray delivering 0.83 mcg of desmopressin acetate (equivalent to 0.75 mcg desmopressin) or 1.66 mcg of desmopressin acetate (equivalent to 1.5 mcg desmopressin) in each spray (0.1 mL). (3)
CONTRAINDICATIONS
Hyponatremia or a history of hyponatremia (4)
Polydipsia (4)
Primary nocturnal enuresis (4)
Concomitant use with loop diuretics or systemic or inhaled glucocorticoids (4)
Estimated glomerular filtration rate below 50 mL/min/1.73 m2 (4)
Syndrome of inappropriate antidiuretic hormone secretion (SIADH) (4)
During illnesses that can cause fluid or electrolyte imbalance (4)
New York Heart Association (NYHA) Class II-IV congestive heart failure (4)
Uncontrolled hypertension (4)
WARNINGS AND PRECAUTIONS
Fluid retention: Not recommended in patients at risk of increased intracranial pressure or history of urinary retention. Monitor volume status in patients with NYHA Class I congestive heart failure. (5.2)
Nasal conditions: Discontinue in patients with concurrent nasal conditions that may increase absorption, until resolved. (5.3)
ADVERSE REACTIONS
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. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Avadel at 1-877-638-4579 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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 reuptake inhibitors, chlorpromazine, opiate analgesics, nonsteroidal anti-inflammatories, lamotrigine, and carbamazepine). (7.2)
USE IN SPECIFIC POPULATIONS
Pregnancy: Use of NOCTIVA is not recommended. (8.1)
Pediatric: Do not use NOCTIVA for primary nocturnal enuresis in children. (4, 8.4)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 12/2017
