NOCDURNA has been studied for years

Proven clinical trial experience

NOCDURNA has been evaluated in a long-term clinical trial of up to 3 years¹

MOST COMMON ADVERSE REACTIONS

Common adverse reactions taken from the safety database ^1*

Adverse Reaction^†	Placebo (N=173)	NOCDURNA 27.7 mcg (N=196)	Placebo (N=213)	NOCDURNA 55.3 mcg (N=195)
	Women		Men
Dry Mouth	19 (11%)	23 (12%)	27 (13%)	27 (14%)
Hyponatremia or blood sodium decreased	3 (2%)	6 (3%)	1 (<1%)	8 (4%)
Headache	5 (3%)	4 (2%)	3 (1%)	7 (4%)
Dizziness	0	3 (2%)	1 (<1%)	5 (3%)

Adverse Reaction*	Placebo (N=173)	NOCDURNA 27.7 mcg (N=196)
	Women
Dry Mouth	19 (11%)	23 (12%)
Hyponatremia	3 (2%)	6 (3%)
Headache	5 (3%)	4 (2%)
Dizziness	0	3 (2%)

Adverse Reaction*	Placebo (N=213)	NOCDURNA 55.3 mcg (N=195)
	Men
Dry Mouth	27 (13%)	27 (14%)
Hyponatremia	1 (<1%)	8 (4%)
Headache	3 (1%)	7 (4%)
Dizziness	1 (<1%)	5 (3%)

Includes Study 1, Study 2, Study 3, and an open-label extension for Study 3, which studied patients for a duration of up to 3 years.
Includes adverse reactions occurring during up to 3 months of treatment in patients who continued from Study 3 into Study 4.

The most common adverse reactions reported with both the 27.7 mcg/day and 55.3 mcg/day dosages included dry mouth, hyponatremia or blood sodium decrease, headache, and dizziness.¹

The high incidence of dry mouth may have been affected by specific query about dry mouth in Study 3. In Studies 1 and 2 where the adverse reaction was spontaneously reported, the incidence was ≤4%.¹

Reference: 1. NOCDURNA [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.

INDICATION AND IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING ▾

INDICATION

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

WARNING: HYPONATREMIA

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.

CONTRAINDICATIONS

Hyponatremia or a history of hyponatremia
Polydipsia
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.

ADVERSE REACTIONS

Common adverse reactions (>2% incidence) included dry mouth, hyponatremia or blood sodium decreased, and dizziness.

DRUG INTERACTIONS

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 Medication Guide.