Noctiva

IV Administration

Dilute appropriate dose in 10 mL NS for children <10 kg or 50 mL NS for adults and children >10 kg

Infuse slowly over 15-30 min

Monitor blood pressure and pulse during infusion

Intranasal Administration

Only administer intranasally; do not shake bottle  

If dose is missed, do not double dose at next use  

Two sprays of 0.83 mcg are not interchangeable with one spray of 1.66 mcg; nasal spray of 1.66 mcg/0.1 mL bottle for patients who are or will be taking 1.66 mcg dose  

Contraindicated in patients with hyponatremia or history of hyponatremia; check serum sodium concentrations prior to initiating or resuming therapy or increasing dose  

If patient develops hyponatremia, therapy may need to be temporarily or permanently discontinued, and treatment for hyponatremia instituted, depending on clinical circumstances, including the duration and severity of hyponatremia

Intranasal preservative-free (Noctiva)

• Prime with 5 actuations before initial use; re-prime with 2 actuations if not used for more than 3 days
• Two sprays of 0.83 mcg are not interchangeable with one spray of 1.66 mcg; nasal spray of 1.66 mcg/0.1 mL bottle for patients who are or will be taking 1.66 mcg dose

Storage

Injection: Refrigerate between 2-8°C (36-46°F)

Intranasal products

• DDAVP, Minirin, Stimate: Store at controlled room temperature 20-25°C (68-77°F) in upright position
• DDAVP, Minirin: Discard after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 mcg of drug
• Stimate: Discard 6 months after opening
• Noctiva
  • Before opening, store upright in a refrigerator, 2-8°C (36-46°F); excursion permitted between 0°C and 15°C (32°F and 59°F)  
  • After opening, store upright at room temperature 20-25ºC (68-77ºF)  
  • Discard 60 days after opening

Dosage Forms And Strengths

• Preservative-free desmopressin acetate nasal spray.
• Each spray delivers 0.1 mL of NOCTIVA.
• Each spray of the 0.83 mcg/0.1 mL strength of desmopressin acetate contains 0.83 mcg of desmopressin acetate (equivalent to 0.75 mcg of desmopressin).
• Each spray of the 1.66 mcg/0.1 mL strength of desmopressin acetate contains 1.66 mcg of desmopressin acetate (equivalent to 1.5 mcg of desmopressin).

Storage And Handling

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 one spray once a day.

0.83 mcg/0.1 mL of desmopressin acetate NDC 0023-5227-35
1.66 mcg/0.1 mL of desmopressin acetate NDC 0023-5670-35

• 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.

Manufactured by: Renaissance Lakewood, LLC for Serenity, Renaissance Lakewood, LLC, Lakewood, NJ, U.S.A. Serenity Pharmaceuticals, LLC, Milford, PA, U.S.A. Revised: March 2017

Noctiva is part of the drug class:

• Vasopressin and analogues

Desmopressin nasal spray is used to treat central cranial diabetes insipidus. This is a condition that causes the body to lose too much fluid and become dehydrated. It is also used to control frequent urination and increased thirst caused by certain types of brain injury or brain surgery. The Stimate® nasal spray is used to treat bleeding in patients with hemophilia A or von Willebrand disease (Type I).

Noctiva™ nasal spray is used to treat nocturnal polyuria in adults who awaken two or more times to urinate at night. Nocturnal polyuria is a condition where your body makes too much urine at night. Your doctor will need to measure your urine and the times that you urinate for 24 hours to determine if you have nocturnal polyuria.

Desmopressin is similar to a hormone that is produced in the body. It acts on the kidneys to reduce the flow of urine. For bleeding, desmopressin increases the blood levels of factor VIII and von Willebrand factor. This results in less bleeding for patients who have low levels of these agents.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of desmopressin nasal spray for diabetes insipidus in children 3 months of age and older.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Stimate® to treat hemophilia A and von Willebrand disease in children 11 months of age and older. However, use is not recommended in children younger than 11 months of age.

Appropriate studies have not been performed on the relationship of age to the effects of Noctiva™ in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of desmopressin nasal spray in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving desmopressin.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Noctiva™ in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood), which may require caution and an adjustment in the dose for patients receiving Noctiva™.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alclometasone
• Aldosterone
• Amcinonide
• Beclomethasone
• Betamethasone
• Budesonide
• Bumetanide
• Ciclesonide
• Clobetasol
• Clobetasone
• Clocortolone
• Cortisone
• Deflazacort
• Desonide
• Desoximetasone
• Dexamethasone
• Diflorasone
• Diflucortolone
• Difluprednate
• Ethacrynic Acid
• Flucloronide
• Fludrocortisone
• Flumethasone
• Flunisolide
• Fluocinolone
• Fluocinonide
• Fluocortin
• Fluocortolone
• Fluorometholone
• Flurandrenolide
• Fluticasone
• Furosemide
• Halcinonide
• Halobetasol
• Hydrocortisone
• Loteprednol
• Medrysone
• Methylprednisolone
• Mometasone
• Paramethasone
• Prednicarbate
• Prednisolone
• Prednisone
• Rimexolone
• Torsemide
• Triamcinolone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Alfentanil
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anileridine
• Aspirin
• Bromfenac
• Bufexamac
• Buprenorphine
• Butorphanol
• Carbamazepine
• Celecoxib
• Chlorpromazine
• Choline Salicylate
• Citalopram
• Clomipramine
• Clonixin
• Codeine
• Desipramine
• Dexibuprofen
• Dexketoprofen
• Dezocine
• Diacetylmorphine
• Dibenzepin
• Diclofenac
• Difenoxin
• Diflunisal
• Dihydrocodeine
• Diphenoxylate
• Dipyrone
• Doxepin
• Droxicam
• Escitalopram
• Ethylmorphine
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Hydrocodone
• Hydromorphone
• Ibuprofen
• Imipramine
• Indomethacin
• Ketobemidone
• Ketoprofen
• Ketorolac
• Lamotrigine
• Levorphanol
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Meperidine
• Meptazinol
• Methadone
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Nalbuphine
• Naproxen
• Nepafenac
• Nicomorphine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Opipramol
• Opium
• Opium Alkaloids
• Oxaprozin
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Papaveretum
• Parecoxib
• Paregoric
• Paroxetine
• Pentazocine
• Phenylbutazone
• Piketoprofen
• Piritramide
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Protriptyline
• Remifentanil
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sertraline
• Sodium Salicylate
• Sufentanil
• Sulindac
• Tapentadol
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Tilidine
• Tolfenamic Acid
• Tolmetin
• Tramadol
• Trimipramine
• Valdecoxib
• Vilazodone
• Vortioxetine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clotting problems or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Tachycardia (increased heart rate)—Use with caution. May make these conditions worse.

• Coronary artery disease or
• Cystic fibrosis or
• Heart failure or
• Kidney problems or
• Polydipsia (excessive thirst), habitual or psychogenic—Use with caution. May cause side effects to become worse.

• Congestive heart failure or
• Head injury or
• Hypertension (high blood pressure), uncontrolled or
• Urinary retention, or history of—Noctiva™ can cause fluid retention, and should not be used in patients with these conditions.

• Gastroenteritis or
• Infection (systemic) or
• Polydipsia (excessive thirst) or
• Primary nocturnal enuresis (bed-wetting at night) or
• Salt-wasting nephropathies or
• Syndrome of inappropriate antidiuretic hormone (SIADH), known or suspected—Noctiva™ should not be used in patients with these conditions.

• Hyponatremia (low sodium in the blood), or history of or
• Kidney disease, moderate to severe—Should not be used in patients with these conditions.

• Nose problems (eg, nasal mucosa atrophy, rhinitis)—Use with caution. May increase risk for more serious side effects.

• Type IIB von Willebrand disease—Stimate® should not be used in patients with this condition.

This section provides information on the proper use of a number of products that contain desmopressin. It may not be specific to Noctiva. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine should only be used in the nose.

Your doctor may limit the amount of fluid or water you drink. Follow the instructions carefully to prevent unwanted effects.

To use the nasal spray:

• When used for the first time, the spray must be primed. Press the pump down 4 times. If the spray is not used for 1 week, prime the pump again by pressing once.
• Gently blow your nose before using the spray. Tilt your head back slightly and insert the tip of the nose piece into your nostril.
• Close the opposite nostril with a finger. Release one spray and breathe in gently at the same time.
• Hold your breath for a few seconds then breathe out slowly through the mouth.
• If a second dose is needed, spray the opposite nostril using the same steps.
• Do not blow your nose or tip your head back after using the spray.
• Wipe the tip of the bottle with a clean, dry tissue and replace the cap.
• Throw away any unused medicine after 25 sprays (Stimate®) or 50 sprays (DDAVP® or desmopressin generic).

To use the DDAVP® Rhinal Tube nasal system:

• The rhinal tube applicator is a soft, flexible plastic tube with numbers printed on the side. The numbers represent the dose.
• Place the correct amount of medicine in the tube by inserting the tip of the container in the end of the tube that is marked with an arrow.
• Put the end of the tube that is marked with an arrow into one nostril and put the other end into your mouth.
• Hold your breath, tilt the head back, and blow with a short, strong puff until all the medicine is sprayed into the nose.
• Do not let medicine run into your throat.
• For young children, an adult must blow the medicine into the nose.
• Wash the tube with water and shake it to remove all of the water.
• Put the seal back on the container tip and replace the plastic cap.

To use the Noctiva™ nasal spray:

• When used for the first time, the spray must be primed. Press the pump down 5 times. If the spray is not used for more than 3 days, prime the pump again by pressing two times.
• Do not shake the bottle.
• Gently blow your nose before using the spray. Tilt your head back slightly and insert the nasal applicator into your left or right nostril.
• Close the opposite nostril with a finger. Release one spray and breathe in gently at the same time.
• Wipe the nasal applicator with a clean, dry tissue and replace the cap.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (nasal spray):
  • For treatment of diabetes insipidus:
    • Adults and children 13 years of age and older—0.1 to 0.4 milliliter (mL) given as a single dose or divided into 2 or 3 doses per day. The dose is given in one nostril or divided and given in both nostrils. Your doctor may adjust the dose as needed.
    • Children 3 months to 12 years of age—0.05 to 0.3 mL given as a single dose or divided into 2 doses per day. The dose is given in one nostril or divided and given in both nostrils. Your doctor may adjust the dose as needed.
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.
  • For treatment of hemophilia A or won Willebrand disease:
    • Adults and children 13 years of age and older—One spray (0.1 milliliter) in each nostril as a single dose per day. Your doctor may adjust the dose as needed.
    • Children 11 months to 12 years of age—Use and dose must be determined by your doctor.
    • Children younger than 11 months of age—Use is not recommended.
  • For treatment of nocturnal polyuria:
    • Adults younger than 65 years of age who are not at increased risk for hyponatremia—One spray (1.66 micrograms [mcg]) in either left or right nostril 30 minutes before going to bed.
    • Older adults 65 years of age or older—At first, one spray (0.83 mcg) in either left or right nostril 30 minutes before going to bed. After 7 days, your doctor will increase your dose to 1.66 mcg as needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of Noctiva™, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

DDAVP® or desmopressin generic: Store at room temperature in an upright position.

DDAVP® Rhinal Tube System: Store in the refrigerator in an upright position. For travelers, the product is good for up to 3 weeks at room temperature.

Stimate®: Store at room temperature in an upright position. Throw bottle away 6 months after it is used for the first time.

Noctiva™: Keep the unopened nasal spray bottle in the refrigerator in an upright position. You may store the opened bottle at room temperature. Throw away 60 days after opening.