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DDAVP Injection (desmopressin acetate)

BOXED WARNING

Not indicated for hemophilia A with factor VIII coagulant activity levels ≤5%, or for hemophilia B, or in patients who have factor VIII antibodies.

THERAPEUTIC CLASS

Synthetic vasopressin analogue

DEA CLASS

RX

INDICATIONS

Hemophilia A with factor VIII coagulant activity levels >5%. Mild to moderate classic von Willebrand's disease (Type 1) with factor VIII levels >5%. As antidiuretic replacement therapy in management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in pituitary region.

ADULT DOSAGE

Hemophilia A

Use in patients w/ hemophilia A w/ factor VIII coagulant activity levels >5%

Usual: 0.3mcg/kg IV over 15-30 min

Preoperative Use:
Administer 30 min prior to scheduled procedure. Repeat administration or use of any blood products for hemostasis should be determined by lab response and patient's clinical condition

von Willebrand's Disease

Use in patients w/ mild to moderate classic von Willebrand's disease (Type I) w/ factor VIII levels >5%

Usual: 0.3mcg/kg IV over 15-30 min

Preoperative Use:
Administer 30 min prior to scheduled procedure. Repeat administration or use of any blood products for hemostasis should be determined by lab response and patient's clinical condition

Central Cranial Diabetes Insipidus

Antidiuretic Replacement Therapy:
Usual:
0.5-1mL/day (2-4mcg/day) SQ/IV in 2 divided doses
Separately adjust am and pm doses for adequate diurnal rhythm of water turnover

Switching from Intranasal DDAVP:
Give 1/10 the intranasal dose

Other Indications

Management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region

PEDIATRIC DOSAGE

Hemophilia A

Use in patients w/ hemophilia A w/ factor VIII coagulant activity levels >5%

≥3 Months of Age:
Usual: 0.3mcg/kg IV over 15-30 min

Preoperative Use:
Administer 30 min prior to scheduled procedure. Repeat administration or use of any blood products for hemostasis should be determined by lab response and patient's clinical condition

von Willebrand's Disease

Use in patients w/ mild to moderate classic von Willebrand's disease (Type I) w/ factor VIII levels >5%

≥3 Months of Age:
Usual: 0.3mcg/kg IV over 15-30 min

Preoperative Use:
Administer 30 min prior to scheduled procedure. Repeat administration or use of any blood products for hemostasis should be determined by lab response and patient's clinical condition

Central Cranial Diabetes Insipidus

Antidiuretic Replacement Therapy:
≥12 Years:

Usual: 0.5-1mL/day (2-4mcg/day) SQ/IV in 2 divided doses
Separately adjust am and pm doses for adequate diurnal rhythm of water turnover

Switching from Intranasal DDAVP:
Give 1/10 the intranasal dose

Other Indications

Management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region

DOSING CONSIDERATIONS

Elderly
Start at lower end of dosing range

ADMINISTRATION

IV/SQ route

IV
Dilute in sterile physiological saline
≤10kg: Use 10mL of diluent
>10kg: Use 50mL of diluent

HOW SUPPLIED

Inj: 4mcg/mL [1mL, 10mL]

CONTRAINDICATIONS

Moderate to severe renal impairment (CrCl <50mL/min), hyponatremia, or history of hyponatremia.

WARNINGS/PRECAUTIONS

Not indicated for the treatment of severe classic von Willebrand's disease (Type 1) and with evidence of abnormal molecular form of factor VIII antigen. May cause water intoxication and/or hyponatremia; fluid restriction is recommended. May decrease plasma osmolality, resulting in seizures or coma. Avoid with Type IIB von Willebrand's disease; may induce platelet aggregation. For injection use only. Caution with habitual or psychogenic polydipsia, conditions associated with fluid and electrolyte imbalance (eg, cystic fibrosis, heart failure, renal disorders), coronary artery insufficiency and/or hypertensive cardiovascular disease (CVD). Thrombotic events reported in patients predisposed to thrombus formation. Severe allergic reactions reported (rare). Caution in elderly.

ADVERSE REACTIONS

Transient headache, nausea, mild abdominal cramps, vulval pain, facial flushing, BP changes, local erythema, swelling, burning pain, allergic reactions.

DRUG INTERACTIONS

Carefully monitor with other pressor agents. Caution with drugs that may increase the risk of water intoxication with hyponatremia (eg, TCAs, SSRIs, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine, carbamazepine). Hyponatremic convulsions (rare) reported with concomitant oxybutynin and imipramine.

PREGNANCY AND LACTATION

Category B, caution in nursing.

MECHANISM OF ACTION

Synthetic vasopressin analog; antidiuretic hormone affecting renal water conservation.

PHARMACOKINETICS

Absorption: Tmax=90 min-2 hrs. Elimination: Urine; T1/2=3 hrs.

ASSESSMENT

Assess for renal function, hyponatremia, history of hyponatremia, habitual or psychogenic polydipsia, hemophilia B, presence of factor VIII antibodies, Type IIB von Willebrand's disease, coronary artery insufficiency, hypertensive CVD, fluid/electrolyte imbalance disorders, risk factors for thrombus formation, hypersensitivity to drug, pregnancy/nursing status, and possible drug interactions. In patients with hemophilia A, assess that factor VIII coagulant activity is >5% prior to initiation of therapy.

MONITORING

Monitor for water intoxication, decrease in plasma osmolality, thrombotic events, and hypersensitivity reactions. In patients with hemophilia A, monitor factor VIII coagulant levels, factor VIII antigen levels, factor VIII ristocetin cofactor (von Willebrand) levels, and activated PTT. In patients with von Willebrand's disease, monitor factor VIII coagulant activity levels, factor VIII ristocetin cofactor activity levels, and factor VIII von Willebrand factor antigen levels. In patients with diabetes insipidus, monitor urine volume and osmolality and plasma osmolality.

PATIENT COUNSELING

Inform of risks/benefits of therapy. Instruct to contact physician if signs/symptoms of hyponatremia, allergic reactions, or if a thrombotic event occurs.

STORAGE

2-8°C (36-46°F).

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