NOCTIVA offers 2 microdoses of desmopressin
NOCTIVA offers 2 microdoses of desmopressin

When kidneys work overtime to produce urine at night, think NOCTIVA

The first and only FDA-approved product to treat adults with nocturia due to nocturnal polyuria.1,2

Efficacy

Percentage of patients who reduced their nocturic episodes by half or more per night from baseline1*

*Percentages are weighted averages from 2 individual trials.

See clinical study results in section 14 of full Prescribing Information.


NOCTIVA had a significant impact on patients' daily lives

NOCTIVA 1.66 mcg significantly improved patients’ quality of life, as measured by the impact of Nighttime Urination (INTU) questionnaire.1,3

See clinical study results in section 14 of full Prescribing Information.

†See clinical study results in section 14 of full Prescribing Information.


Mechanism of Action

NOCTIVA is available in 2 microdoses

Nocturnal polyuria is an overproduction of urine in the kidneys at night. NOCTIVA™ (desmopressin acetate) Nasal Spray is a synthetic analog of vasopressin. It selectively binds V2 receptors found primarily on the renal cells in the collecting duct of the kidney. The agonist effects include water reabsorption in the kidney and reduced urine production.1


NOCTIVA works directly in the kidneys

NOCTIVA works in the kidneys to reduce the nocturnal urine volume for some patients.3


Safety

In two clinical trials, 5 out of 695 patients taking NOCTIVA experienced severe hyponatremia (serum sodium ≤125 mmol/L).1

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.

 

See adverse reactions in section 6 of full Prescribing Information.


Pharmacokinetics

NOCTIVA reaches peak plasma concentrations at 15 and 45 minutes, depending on the dose

NOCTIVA is rapidly absorbed, reaching median peak plasma concentrations at 15 (0.83-mcg dose) and 45 (1.66-mcg dose) minutes…


Plasma levels were detectable 4-6 hours after administration with NOCTIVA

…and plasma levels were detectable for 4 to 6 hours, during which time the antidiuretic effects were observed.1

See additional pharmacokinetics information in section 12 of full Prescribing Information.


How to Administer Noctiva

Prime NOCTIVA by pumping 5 times away from the face before the first use

Prime by pumping 5 times away from the face before first use1

NOCTIVA is administered via one spray in either nostril approximately 30 minutes before bed

a single spray in one nostril1

NOCTIVA should be taken 30 minutes before bed

before bed1

If NOCTIVA hasn’t been used for more than 3 days, reprime by pumping 2 times away from the face.

See additional dosing and administration information in section 2 of full Prescribing Information.

References: 1. NOCTIVA [package insert]. Chesterfield, MO: Avadel Specialty Pharmaceuticals, LLC; 2017. 2. US Food and Drug Administration. FDA approves first treatment for frequent urination at night due to overproduction of urine. /www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544877.htm. Accessed February 26, 2018. 3. Data on file. Avadel Specialty Pharmaceuticals, LLC.

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NOCTIVA is available in a 0.83 mcg dose and a 1.66 mcg dose

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For more details about NOCTIVA, download the full Prescribing Information.

INDICATION AND IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
INDICATION AND IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: HYPONATREMIA

See full prescribing information for complete boxed warning.

  • NOCTIVA can cause hyponatremia, which may be life-threatening if severe.
  • 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.
  • Ensure serum sodium is normal before starting or resuming NOCTIVA. Measure serum sodium within seven days and approximately one 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.
  • If hyponatremia occurs, NOCTIVA may need to be temporarily or permanently discontinued.

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.

Contraindications

  • Hyponatremia or a history of hyponatremia
  • Polydipsia
  • Primary nocturnal enuresis
  • 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
  • New York Heart Association (NYHA) Class II-IV congestive heart failure
  • Uncontrolled hypertension

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.
  • Nasal conditions: Discontinue in patients with concurrent nasal conditions that may increase absorption, until resolved.

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.

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 re-uptake inhibitors, chlorpromazine, opiate analgesics, nonsteroidal anti-inflammatories, lamotrigine and carbamazepine).

Use in Specific Populations

  • Pregnancy: Use of NOCTIVA is not recommended.
  • Pediatric: Do not use NOCTIVA for primary nocturnal enuresis in children.

To report SUSPECTED ADVERSE REACTIONS, contact Avadel at 1-877-638-4579 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.