USE

DESMODA (desmopressin acetate) oral solution is a prescription medicine used to treat central diabetes insipidus (CDI) in adults and children.

Limitations of Use

Do not use DESMODA for the treatment of nephrogenic diabetes insipidus.

Who should NOT take DESMODA?

Do not take DESMODA if you:

• Have or have ever had low blood sodium levels (hyponatremia)
• Are allergic to desmopressin or any of the ingredients in DESMODA
• Have moderate to severe reduction in kidney function (creatinine clearance less than 50 mL/min)

IMPORTANT SAFETY INFORMATION

DESMODA can cause low blood sodium levels (hyponatremia), which can be serious and may be life-threatening.

Drinking too much fluid while taking DESMODA can lead to water intoxication and dangerously low sodium levels.

Symptoms of low blood sodium may include: headache, nausea or vomiting, weight gain, tiredness or weakness, confusion, muscle cramps or spasms. Severe symptoms may include seizures, coma, or trouble breathing. Your healthcare provider may recommend limiting how much fluid you drink and may monitor your blood sodium levels during treatment.

Children and older adults may be at higher risk of developing low sodium levels.

DESMODA may cause your body to hold onto (retain) fluid. Tell your healthcare provider if you have heart failure, high blood pressure, or swelling.

Serious allergic reactions, including fatal anaphylaxis, have occurred with desmopressin products. Stop taking DESMODA and seek emergency medical help if you develop symptoms such as trouble breathing, swelling of the face or throat, or severe rash.

DESMODA contains benzoic acid, which could potentially be harmful to low-birth-weight and preterm infants. Use in these patients requires careful monitoring and fluid restriction.

What are the possible side effects of DESMODA?

Other common side effects include GI upset, swelling, high blood pressure, nervous system disorders, and abnormal thinking.