OCTOSTIM LIQ INJ. 15MCG/ML 15 MCG — DIN 02024179

What is OCTOSTIM LIQ INJ. 15MCG/ML?

OCTOSTIM LIQ INJ. 15MCG/ML 15 MCG contains DESMOPRESSIN ACETATE : 15 MCG. It is listed in the Health Canada Drug Product Database under DIN 02024179, held by FERRING INC, supplied as SOLUTION for INTRAVENOUS ; SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 31-Dec-1995. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is OCTOSTIM LIQ INJ. 15MCG/ML used for?

OCTOSTIM® (desmopressin acetate injection) is indicated for: - The prevention of bleeding in patients with mild hemophilia A and mild von Willebrand's disease Type I. - The prevention or treatment of bleeding in patients with uremia. Hemophilia A 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. Von Willebrand's Disease (Type I) 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. Other Hemostatic Disorders 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.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

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. Dilution for Infusion 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.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

OCTOSTIM® is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the excipients. Because of the risk of platelet aggregation and thrombocytopenia, OCTOSTIM® should not be used in patients with type II B or platelet-type (pseudo) von Willebrand's disease. OCTOSTIM® should not be used in patients with cardiac insufficiency, or other conditions requiring treatment with diuretic agents. OCTOSTIM® should not be used in cases of habitual and psychogenic polydipsia, presence or a history of hyponatremia or Syndrome of Inappropriate ADH secretion (SIADH).

Warnings and precautions

OCTOSTIM® (desmopressin acetate) treatment without concomitant restriction of water intake may lead to water retention/hyponatremia with or without accompanying signs and symptoms (reduced serum sodium, weight gain, and, in severe cases, convulsions). Other signs include persistent headache and nausea/vomiting. If these symptoms are present, serum sodium must be checked. The fluid intake should be restricted to the least possible and the body weight should be checked regularly. Should there be a gradual increase of the body weight, a decrease of serum sodium to below 130 mmol/L or plasma osmolality to below 270 mOsm/kg body weight, the fluid intake must be reduced drastically and the administration of OCTOSTIM® interrupted. Precautions to prevent fluid overload must be taken in: - the very young and elderly patients - conditions characterized by fluid and/or electrolyte imbalance - patients at risk for increased intracranial pressure Children, elderly and patients with serum sodium levels in the lower range of normal may have an increased risk of hyponatremia. Treatment with desmopressin should be interrupted or carefully adjusted during acute intercurrent illnesses characterized by fluid and/or electrolyte imbalance (such as systemic infections, fever, gastroenteritis), and the fluid and electrolyte balance should be carefully monitored, especially in situations with excessive bleeding. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures, which could lead to coma. OCTOSTIM® must be used with caution in patients prone to vascular headaches, and patients with coronary insufficiency and hypertensive cardiovascular diseases because of possible changes in blood pressure and tachycardia. Rapid infusion rates may result in severe hypotension; therefore, the speed of intravenous infusion of OCTOSTIM® should not be shorter than 20-30 minutes. A maximum dose of 0.3 mcg/kg should not be exceeded. Lack of therapeutic effect has been noted in patients who have been febrile or otherwise “stressed” for several days. Whenever possible, therapeutic efficacy (i.e., Factor VIII response in hemophilia and bleeding time correction in other disorders) should be established in individual patients prior to use and followed throughout the course of treatment. The coincident use of anti-fibrinolytic agents to counteract desmopressin-induced plasminogen activator release has been recommended, however, benefit has not been clearly established. There have been rare reports of thrombotic events (thrombosis, cerebral thrombosis, cerebrovascular accident and disorder (stroke), acute myocardial infarction, angina pectoris and chest pain,) following desmopressin acetate injection in patients predisposed to thrombus formation. No causality has been determined; however, the drug should be used with caution in elderly patients and in patients with risk factors and history of thrombosis, thrombophilia and known cardiovascular disease. Persistently increased endogenous Factor VIII levels are a risk factor for venous thromboembolism (VTE). The evidence for elevated vWF levels as a risk factor for VTE is less strong, but some studies have demonstrated an association. Severe allergic reactions have been reported rarely. Fatal anaphylaxis has been reported in one patient who received intravenous OCTOSTIM®. It is not known whether antibodies to desmopressin acetate are produced after repeated administration. OCTOSTIM® has an antidiuretic effect. Patients receiving this drug should be cautioned to reduce their ingestion of fluids for at least 6 hours after receiving the drug. Patients receiving intravenous fluids must be placed on fluid input/output monitoring.