Source: Health Products and Food Branch (CA) Revision Year: 2021
OCTOSTIM (desmopressin acetate injection) is indicated for:
OCTOSTIM is indicated for patients with hemophilia A with Factor VIII levels greater than 5%.
OCTOSTIM will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively, when injected 30 minutes prior to the scheduled procedure.
OCTOSTIM will also stop bleeding in hemophilia A patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding. In certain clinical situations, it may be justified to try OCTOSTIM in patients with Factor VIII levels between 2-5%, however, these patients should be carefully monitored.
OCTOSTIM is indicated for patients with mild to moderate classic von Willebrand’s Disease (Type I) with Factor VIII levels greater than 5%. OCTOSTIM will often maintain hemostasis in surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure.
OCTOSTIM will usually stop bleeding in mild to moderate von Willebrand’s patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.
Those von Willebrand’s disease patients who are least likely to respond are those with severe homozygous von Willebrand’s disease with Factor VIII antigen and von Willebrand’s Factor (ristocetin cofactor) activities less than 1%. Other patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and Factor VIII coagulant activity, Factor VIII antigen and von Willebrand’s Factor activities should be checked during administration of OCTOSTIM to ensure that adequate levels are being achieved.
OCTOSTIM is not indicated for the treatment of severe classic Type I von Willebrand’s disease and Type II B and when there is evidence of an abnormal molecular form of Factor VIII antigen (See CONTRAINDICATIONS.)
OCTOSTIM is indicated for the treatment of prolonged bleeding time in patients with uremia. It will assist in the maintenance of hemostasis in such patients during surgical procedures and post operatively when administered prior to the procedure.
Therapeutic efficacy (i.e. normalization of bleeding time) should be established in individual patients at the time of diagnosis of the bleeding disorder, or at least 72 hours prior to an elective treatment, by administration of a test dose of OCTOSTIM (see Laboratory Tests in WARNINGS AND PRECAUTIONS section).
OCTOSTIM is administered by subcutaneous injection or as an intravenous infusion over 20 to 30 minutes to provide a dose of 0.3 mcg/kg. The maximum intravenous dose is 20 mcg. If OCTOSTIM is used pre-operatively, it should be administered 30 minutes prior to the scheduled procedure. The peak effect is obtained one hour after administration. Response is immediate for bleeding time reduction.
Dilute in sterile physiological saline and infuse slowly over 20 to 30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is used; in children weighing 10 kg or less, 10 mL of diluent is used.
The necessity for repeat administration of OCTOSTIM or use of any blood products for hemostasis should be determined by laboratory response, as well as the clinical condition of the patient. The tendency toward tachyphylaxis (lessening of response) with repeated administration, given more frequently than every 48 hours should be considered in treating each patient.
OCTOSTIM (desmopressin acetate) at excessive doses may cause headaches, abdominal cramps, nausea and facial flushing. In such cases the dosage should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition. Rapid intravenous infusion may cause hypotension. A maximum intravenous dose of 0.3 mcg/kg should not be exceeded. The infusion rate of 20 to 30 minutes should not be exceeded.
There is no known specific antidote for OCTOSTIM. Water intoxication responds rapidly to diuretic therapy (e.g., furosemide) and appropriate replacement fluid support, without interference with hemostatic effects.
Overdosage leads to a prolonged duration of action with an increased risk of fluid retention and hyponatremia.
Although the treatment of hyponatremia should be individualized, the following general recommendations can be given. Asymptomatic hyponatremia is treated with discontinuation of desmopressin treatment and fluid restriction. Infusion of isotonic or hypertonic sodium chloride may be added in cases with symptoms. When fluid retention is serious (convulsions and unconsciousness), treatment with furosemide should be added.
OCTOSTIM should be stored at refrigerator temperature 2-8°C. Do not freeze.
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