Minirin

DDAVP, Stimate

Yes

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Minirin is part of the drug class:

• Vasopressin and analogues

In the U.S.

• DDAVP
• DDAVP Rhinal Tube
• Minirin
• Noctiva
• Stimate

Available Dosage Forms:

• Solution
• Spray

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Vasopressin (class)

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.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

Do not use Noctiva™ together with certain diuretics (eg, furosemide, torsemide, Demadex®, Lasix®) and systemic or inhaled glucocorticoids (eg, dexamethasone, fluticasone, methylprednisolone, prednisolone, prednisone, Cortef®, Medrol®).

This medicine lowers the amount of sodium in your blood. Check with your doctor right away if you have confusion, nausea, vomiting, muscle cramps or spasms, or unusual tiredness or weakness.

Desmopressin may rarely cause severe allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you use this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Applies to desmopressin: injectable solution, nasal solution, nasal spray, oral tablet

Cardiovascular

One review of the literature found that the incidence of thrombotic events associated with the use of DDAVP to reduce blood loss and transfusion requirements in surgical patients was not significantly higher than placebo. In any case, the incidence of thrombosis is rare. One review found only 10 reports of thrombosis over a 4-year period, covering 433,000 doses of DDAVP.[Ref]

Cardiovascular side effects have infrequently included transient and slight elevations or reductions in blood pressure, a compensatory change in heart rate, and facial flushing with injections of desmopressin (DDAVP). Vasodilation and water retention have occurred. There have been rare reports of thrombotic events (acute cerebral thrombosis, acute myocardial infarction) in some patients after DDAVP injection. At least one case of fatal left coronary thrombosis has been associated with the use of DDAVP.[Ref]

Nervous system

Nervous system side effects have included seizures and/or coma as a result of severe water intoxication and hyponatremia. Other nervous system side effects have included headache and dizziness in less than 3% of patients. DDAVP nasal spray has been infrequently associated with somnolence, lethargy, paresthesias, fatigue, confusion, stupor, malaise, diaphoresis, itchy or light-sensitive eyes, insomnia, chills, warm feeling, and agitation.[Ref]

The risk factors for DDAVP-induced hyponatremia include stress, surgery, anesthesia, narcotics (endogenous release of ADH), vomiting (loss of sodium), liver disease (hindered metabolism of DDAVP), overhydration with hyponatremic fluids, and advanced age. In some cases, fluid restriction, avoidance of hyponatremic solutions, and close monitoring of serum electrolytes and urine output for at least 15 to 20 hours after the administration of DDAVP may be beneficial.[Ref]

Hematologic

Hematologic side effects have included platelet aggregation and thrombocytopenia. These have been seen almost uniquely in patients with von Willebrand's disease Type IIB (DDAVP is contraindicated in these patients).[Ref]

Local

Local side effects of injections of DDAVP have included intravenous site erythema, swelling, and burning.[Ref]

Respiratory

Respiratory side effects of intranasal DDAVP have included rhinitis, epistaxis, and nostril pain in 2% to 10% of patients. Apnea and cardiac arrest occurred in one patient.[Ref]

Gastrointestinal

Gastrointestinal side effects have included mild abdominal cramps and nausea in 2% of patients. Dyspepsia and vomiting have rarely been associated with DDAVP nasal spray.[Ref]

Hypersensitivity

Hypersensitivity reactions have rarely included anaphylaxis.[Ref]

Psychiatric

Psychiatric side effects have included a single case of paranoid psychosis associated with the use of DDAVP nasal spray.[Ref]

Some side effects of Minirin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.