Desmopressin

What it is used for

DESMODA is a prescription medicine that contains the medicine desmopressin acetate. Desmopressin acetate is an antidiuretic, also known as vasopressin. DESMODA (desmopressin acetate) is a man-made (synthetic) prescription drug used to replace the body’s antidiuretic hormone to manage central diabetes insipidus in adults and children.

DESMODA is not effective in the treatment of diabetes insipidus related to kidney disease (nephrogenic diabetes insipidus).

The most important thing to know

DESMODA may cause serious side effects, including:

Low levels of salt (sodium) in the blood (hyponatremia). Hyponatremia has happened in people taking desmopressin acetate, an ingredient in DESMODA. Drinking excessive fluids during treatment with DESMODA may lead to water toxicity with hyponatremia. Hyponatremia can lead to death if not treated. Talk to your healthcare provider about fluid limits during treatment with DESMODA.

• Do not drink more than you need to satisfy your thirst. You can have serious side effects such as seizures, coma, and death from drinking too much fluid.

• Children and the elderly are at higher risk for these problems and should follow their healthcare provider’s limits on drinking fluids.

• Tell your healthcare provider if you have any of the following signs or symptoms:

• headache
• restlessness
• loss of appetite
• nausea or vomiting
• tiredness
• irritability
• decreased sodium levels in the blood
• lack of energy
• muscle weakness
• weight gain
• disorientation
• muscle spasms or cramps
• abnormal mental status (hallucinations, decreased consciousness, or confusion)
• weakened reflexes

Your healthcare provider will change the dose of DESMODA depending on your response. Tell your healthcare provider if you cannot swallow medicines by mouth.

People who have taken desmopressin acetate nasal spray previously should start taking the oral solution twelve hours after the last nasal spray dose. Your healthcare provider should monitor you closely during this period.

Your healthcare provider may monitor your sodium levels during your treatment with DESMODA.

See “What are the possible side effects of DESMODA?” for more information about side effects.

How to take it

• Take DESMODA exactly as your healthcare provider tells you to take it.

• Take DESMODA by mouth on an empty stomach, at least 1 hour before or 2 hours after food.

• Take DESMODA using the oral syringe provided by the pharmacy.

• Do not stop taking DESMODA without talking to your healthcare provider.

• If you take too much DESMODA, call your healthcare provider right away or go to the nearest emergency room.

Side effects, and when to stop

DESMODA may cause serious side effects, including:

• fluid retention. Desmopressin acetate, an ingredient in DESMODA, taken as an injection can cause you to retain fluid in the body. This can make existing health problems worse that are affected by changes in your body’s fluid levels.

• allergic reactions. Allergic reactions, including a severe reaction known as anaphylaxis, have happened in people who received desmopressin acetate through a vein (intravenous) or through the nose (nasal). Tell your healthcare provider right away or get emergency medical help if you get any of the following symptoms:
• swelling of the face, lips or tongue
• feeling dizzy or faint
• trouble breathing or swallowing
• rash or hives

• risk of benzyl alcohol toxicity in newborn babies. Serious side effects that can lead to death have happened in low-birth weight and preterm newborns who received medicines through their vein that contained benzyl alcohol. DESMODA contains benzoic acid, a breakdown product of benzyl alcohol.

The most common side effects of DESMODA include:

• headache
• dizziness
• nausea
• stomach pain
• high blood pressure
• diarrhea

These are not all the possible side effects of DESMODA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Who should not take it

Do not take DESMODA if you:

• have or have had low levels of sodium in the blood.

• are allergic to desmopressin acetate or any of the ingredients in DESMODA. See the end of this Medication Guide for a complete list of ingredients in DESMODA.

• have moderate to severe kidney problems.

Before you take DESMODA, tell your healthcare provider about all of your medical conditions, including if you:

• have heart failure or blood circulation problems.

• are thirsty much of the time and drink excessive amounts of fluids (polydipsia).

• have or have had low levels of sodium in your blood.
• have high blood pressure that is not controlled.

• have increased pressure in your brain (increased intracranial pressure).

• have had problems with emptying your bladder (urinary retention).

• are pregnant or plan to become pregnant. It is not known if DESMODA will harm your unborn baby.

• are breastfeeding or plan to breastfeed. DESMODA can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take DESMODA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines, food and drink can affect the way that DESMODA works and may mean that your healthcare provider needs to change the prescribed dose of DESMODA.

Storing it

• Store DESMODA in a refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature up to 77°F (25°C).

• Do not freeze DESMODA.

• After the bottle has been opened, use DESMODA within 120 days. Throw DESMODA away if it has not been used within the 120 days.

Keep DESMODA and all medicines out of the reach of children.

General information about the safe and effective use of DESMODA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DESMODA for a condition for which it was not prescribed. Do not give DESMODA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about DESMODA that is written for health professionals.