NOCTIVA- desmopressin acetate spray, metered

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)

Dostopno od:

Avadel Specialty Pharmaceuticals, LLC

INN (mednarodno ime):

DESMOPRESSIN ACETATE

Sestava:

DESMOPRESSIN ACETATE 0.83 ug

Pot uporabe:

NASAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

NOCTIVA is indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. Nocturnal polyuria was defined in the NOCTIVA clinical trials as nighttime urine production exceeding one-third of the 24-hour urine production. Before starting NOCTIVA: - Evaluate the patient for possible causes for the nocturia, including excessive fluid intake prior to bedtime, and optimize the treatment of underlying conditions that may be contributing to the nocturia. - Confirm the diagnosis of nocturnal polyuria with a 24-hour urine collection, if one has not been obtained previously. Limitation of Use : NOCTIVA has not been studied in patients less than 50 years of age. NOCTIVA is contraindicated in patients with the following conditions due to an increased risk of severe hyponatremia: - Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1)] - Polydipsia - Primary nocturnal enuresis [see Use in Specific Populations (8.4)] - Concomitant use with

Povzetek izdelek:

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.

Status dovoljenje:

New Drug Application

Navodilo za uporabo

Avadel Specialty Pharmaceuticals, LLC
----------
This Medication Guide has been approved by the U.S. Food
and Drug Administration.
Approved: 03/2017
MEDICATION GUIDE
NOCTIVA™ (nok-tee-va)
(desmopressin acetate) nasal spray
0.83 mcg/0.1 mL and 1.66 mcg/0.1 mL
Important: NOCTIVA is for use in your nose (intranasal) only.
What is the most important information I should know about NOCTIVA?
NOCTIVA may cause serious side effects, including:
•
Low levels of salt (sodium) in your blood (hyponatremia) can happen
with NOCTIVA. If you
develop very low salt levels in your blood, this may lead to serious
or life-threatening side effects,
including seizure, coma, trouble breathing, or death if not treated
early.
Call your doctor if you have any of the following symptoms of low salt
levels in your blood:
•
headache
•
nausea or vomiting
•
feeling restless
•
fatigue
•
drowsiness
•
dizziness
•
muscle cramps
•
change in your mental condition, such as confusion, or decreased
awareness or alertness
Low salt levels in the blood happen more often in people who are
treated with NOCTIVA and are 65
years old or older than in people treated with NOCTIVA who are younger
than 65 years old.
Your doctor should check the salt levels in your blood before you
start taking NOCTIVA, during
treatment with NOCTIVA, before increasing your dose, and before you
restart taking NOCTIVA if your
treatment with NOCTIVA was stopped for a period of time.
To help decrease your risk of developing low levels of sodium in your
blood:
•
Limit the amount of fluids you drink in the evening and nighttime.
•
Stop taking NOCTIVA and tell your doctor right away if you have a
stomach or intestinal virus
with vomiting or diarrhea or if you have an infection or fever.
•
Stop taking NOCTIVA and tell your doctor right away if you develop any
nose problems, such as
a blockage, stuffy nose, runny nose, or drainage.
Your doctor may stop your treatment with NOCTIVA for a period of time
or stop your treatment
completely if you have low levels of salt in

Lastnosti izdelka

NOCTIVA- DESMOPRESSIN ACETATE SPRAY, METERED
AVADEL SPECIALTY PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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.