Safety data

Overall rates of hyponatremia were low in both the 12‑week clinical trials and a 126‑week extension study.1,2

IN TWO 12-WEEK CLINICAL TRIALS, 5 OUT OF 695 PATIENTS TAKING NOCTIVA™ (DESMOPRESSIN ACETATE) NASAL SPRAY EXPERIENCED HYPONATREMIA WITH SERUM SODIUM ≤125 mmol/L1
1.5%  5/341
NOCTIVA 1.66 mcg
0%  0/354
NOCTIVA 0.83 mcg
0.3%  1/349
Placebo
NOCTIVA resulted in 0 cases of hyponatremia with serum sodium ≤125 mmol/L in an extension study of 2+ years (1.66 mcg).2

Serum sodium levels below normal range in patients younger than 65 years old1

Serum sodium
concentration (mmol/L)
NOCTIVA 1.66 mcg
(n=146)
NOCTIVA 0.83 mcg
(n=148)
Placebo
(n=144)
130-134 14 (9.6%) 8 (5.4%) 7 (4.9%)
126-129 0 2 (1.4%) 0
≤125 0 0 0

Serum sodium levels below normal range in patients 65 years old and older1*

Serum sodium
concentration (mmol/L)
NOCTIVA 1.66 mcg
(n=195)
NOCTIVA 0.83 mcg
(n=206)
Placebo
(n=205)
130-134 28 (14.4%) 25 (12.1%) 11 (5.4%)
126-129 7 (3.6%) 6 (2.9%) 0
≤125 5 (2.6%)* 0 1 (0.5%)

*Of the 5 patients on NOCTIVA with serum sodium ≤125 mmol/L, all were 65 or older and 4 were men. Onset of hyponatremia ranged from 6 days to 12 weeks after the start of dosing.1

  • 4 patients were taking concomitant systemic or inhaled glucocorticoids, which are contraindicated1
  • 4 of the 5 patients were asymptomatic2

NOCTIVA was studied in clinical trials with over 1000 patients1

NOCTIVA had an overall low rate of adverse reactions.1

COMMON ADVERSE REACTIONS REPORTED IN ≥2% OF NOCTIVA PATIENTS AND AT A HIGHER INCIDENCE WITH THE 1.66 mcg DOSE THAN WITH PLACEBO1

Adverse reactions NOCTIVA 1.66 mcg
(n=341)
NOCTIVA 0.83 mcg
(n=354)
Placebo
(n=349)
Nasal discomfort 20 (5.9%) 12 (3.4%) 17 (4.9%)
Nasopharyngitis 13 (3.8%) 8 (2.3%) 10 (2.9%)
Nasal congestion 10 (2.9%) 5 (1.4%) 5 (1.4%)
Sneezing 9 (2.6%) 8 (2.3%) 5 (1.4%)
Hypertension/blood
pressure increased
9 (2.6%) 6 (1.7%) 4 (1.1%)
Back pain 8 (2.3%) 4 (1.1%) 3 (0.9%)
Epistaxis 7 (2.1%) 7 (2.0%) 4 (1.1%)
Bronchitis 7 (2.1%) 3 (0.8%) 3 (0.9%)
Dizziness 6 (1.8%) 7 (2.0%) 5 (1.4%)

Low incidence of serious adverse reactions1

During these trials, serious adverse reactions were reported in 2%, 2%, and 3% of patients with nocturia due to nocturnal polyuria treated with NOCTIVA 1.66 mcg, NOCTIVA 0.83 mcg, and placebo, respectively. There was 1 case of hyponatremia in the 1.66 mcg group and 1 case in the placebo group classified as serious adverse reactions.

Adverse reactions leading to discontinuation1

Among patients with nocturia due to nocturnal polyuria, the discontinuation rate due to adverse reactions was 4.4% with NOCTIVA 1.66 mcg, 4.0% with NOCTIVA 0.83 mcg, and 2.3% with placebo.

In some cases, the nasal discomfort experienced by patients in the trial decreased with continued use of NOCTIVA.2

In 2 clinical studies, adverse reactions occurred at an overall low rate comparable to placebo.1

Take action

Many of your patients could be waking up tonight because of nocturia due to nocturnal polyuria. With NOCTIVA, you could reduce its impact.1

Take action

Many of your patients could be waking up tonight because of nocturia due to nocturnal polyuria. With NOCTIVA, you could reduce its impact.1

Next up

See dosing and administration instructions for NOCTIVA.

Dosing
REFERENCES

1. NOCTIVA [package insert]. Chesterfield, MO: Avadel Specialty Pharmaceuticals, LLC; 2017. 2. Data on file. Avadel Specialty Pharmaceuticals, LLC.

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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.

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.