Desmopressin Acetate

DESMOPRESSIN ACETATE- desmopressin acetate injection, solution
Dr. Reddy’s Laboratories Inc.

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WARNING: HYPONATREMIA

Desmopressin Acetate Injection can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death [see Warnings and Precautions (5.1)].
Desmopressin Acetate Injection is c ontraindicated 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 [see Contraindications (4) and Warnings and Precautions (5.1 )]

Ensure the serum sodium concentration is normal before starting or resuming Desmopressin Acetate Injection. Measure serum sodium within 7 days and approximately 1 month after initiating therapy, 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 [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ]

If hyponatremia occurs, Desmopressin Acetate Injection may need to be temporarily or permanently discontinued [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

1.1 Central Diabetes Insipidus

Desmopressin Acetate Injection is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Limitations of Use:

Desmopressin Acetate Injection is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus.

1.2 Hemophilia A

Desmopressin Acetate Injection is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5% without factor VIII antibodies to:

  • Maintain hemostasis during surgical procedures and postoperatively
  • Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

1.3 von Willebrand’s Disease

Desmopressin Acetate Injection is indicated for patients with mild to moderate von Willebrand’s disease (Type I) with factor VIII levels greater than 5% to:

  • Maintain hemostasis during surgical procedures and postoperatively
  • Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

Limitations of Use

Desmopressin Acetate Injection is not indicated for the treatment of severe von Willebrand’s disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen [ see Warnings and Precautions (5.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment Testing and On-Treatment Monitoring

Diabetes Insipidus

Prior to treatment with Desmopressin Acetate Injection, assess serum sodium, urine volume and osmolality. Intermittently during treatment, assess serum sodium, urine volume and osmolality or plasma osmolality.

Hemophilia A

Prior to treatment with Desmopressin Acetate Injection, verify that factor VIII coagulant activity levels are >5% and exclude the presence of factor VIII autoantibodies. Also assess serum sodium and aPTT prior to treatment. In certain clinical situations, it may be justified to try Desmopressin Acetate Injection in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.

von Willebrand’s Disease (Type I)

Prior to treatment with Desmopressin Acetate Injection, verify that factor VIII coagulant activity levels are >5% and exclude severe von Willebrand’s disease (Type I) and presence of abnormal molecular form of factor VIII antigen. During treatment with Desmopressin Acetate Injection, assess serum sodium, bleeding time, factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand antigen to ensure that adequate levels are being achieved.

For All Patients Receiving Repeated Doses: Restrict free water intake and monitor for hyponatremia.Ensure that serum sodium is normal prior to initiating or resuming treatment with Desmopressin Acetate Injection.

2.2 Recommended Dosage

Initiate fluid restriction during treatment with Desmopressin Acetate Injection [see Warnings and Precautions (5.1), Use in Specific Populations (8.4, 8.5)].

Diabetes Insipidus:
Treatment naïve patients: The recommended starting daily dosage is 2 mcg to 4 mcg administered as one or two divided doses by subcutaneous or intravenous injection. Do not dilute Desmopressin Acetate Injection for the Diabetes Insipidus population. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. Adjust dose based upon response to treatment estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.

Patients changing from intranasal desmopressin: The recommended starting dose of Desmopressin Acetate Injection is 1/10th the daily maintenance intranasal dose administered by subcutaneous or intravenous injection as one or two divided doses

Hemophilia A and von Willebrand’s Disease (Type I):
The recommended dosage is 0.3 mcg/kg actual body weight (to a maximum of 20 mcg) administered by intravenous infusion over 15 minutes to 30 minutes. If used preoperatively, administer 30 minutes prior to the procedure. If used to reduce spontaneous or traumatic bleeding, doses may be repeated after 8 hours to 12 hours and once daily thereafter, if needed, based upon clinical condition and von Willebrand factor and factor VIII levels. The necessity for repeat administration of Desmopressin Acetate Injection or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient.

Tachyphylaxis (lessening of response) with repeated administration (i.e., given more frequently than every 48 hours) may occur. The initial response is reproducible if Desmopressin Acetate Injection is administered every 2 to 3 days.

2.3 Preparation and Administration for Patients with Hemophilia A and von Willebrand’s Disease (Type I)

Prepare the solution for infusion using aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Withdraw the necessary volume of Desmopressin Acetate Injection from the vial and dilute by adding to the infusion bag of 0.9% Sodium Chloride Injection, USP per Table 1. Dilute Desmopressin Acetate Injection in sterile 0.9% Sodium Chloride Injection, USP and infuse slowly over 15 minutes to 30 minutes.

The volume of diluent is weight-based. See Table 1 for volume of diluent to use.

Table 1: Volume of Diluent Required

Patient Weight Volume of 0.9% Sodium Chloride Injection, USP for dilution
10 kg or less 10 mL
More than 10 kg 50 mL

Monitor blood pressure and pulse during infusion.

2.4 Switching Between Desmopressin Acetate Formulations

Desmopressin Acetate is also available as nasal spray and tablet dosage forms.

When switching between formulations, the below text is meant as guidance for starting dose. However, dose should always be titrated individually according to the diuresis (antidiuretic response) and electrolyte status (serum sodium) of the patient.

When switching from Desmopressin Acetate Nasal Spray to Desmopressin Acetate Injection, the starting dose is one-tenth times the Desmopressin Acetate Nasal Spray dose.

When switching from Desmopressin Acetate Tablets to Desmopressin Acetate Injection, titrate dose individually according to the diuresis (antidiuretic response) and electrolyte status (serum sodium) due to the large variability in both PK and PD. Monitor patients closely during the initial dose titration period.

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