Octostim Liq Inj. 15mcg/mL: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

OCTOSTIM^® is used to treat bleeding disorders called hemophilia A and von Willebrand’s disease.

OCTOSTIM^® is used by people who have mild to moderate hemophilia A or von Willebrand’s disease to help increase clotting factors when they have medical, dental or minor surgical procedures done.

OCTOSTIM ^® is also used by people who have uremia (urea in the blood) to help control bleeding during surgical procedures and after their operations.

How does it work?

OCTOSTIM ^® contains a hormone called desmopressin. In mild to moderate hemophilia A, desmopressin helps to stop and control bleeding by increasing the amount of clotting Factor 8 from the cells which line the blood vessels.

In von Willebrand’s disease, desmopressin helps your body make more von Willebrand factor to reduce blood loss during women’s menstrual periods, and to help control bleeding episodes. Because the effects of this medicine can vary, your doctor will prescribe it on a trial basis to see how much it increases the amount of clotting factors in your blood and to monitor side effects.

What is hemophilia?

Hemophilia is a rare genetic bleeding disorder that almost always occurs in males. A person with hemophilia inherits problems with certain blood-clotting factors, making them unable to work properly. Blood-clotting factors are needed to help stop bleeding after a cut or injury and to prevent spontaneous bleeding. The hemophilia gene can contain many different errors, leading to different degrees of abnormality in the amount of clotting factors produced. Diseases in this category include:

• hemophilia A
• hemophilia B

• von Willebrand’s disease

  Hemophilia A is the most common type of hemophilia. It is caused by a deficiency of active clotting Factor 8. About 80% of all people with hemophilia have type A, and most of these cases are severe. Approximately 1 out of every 5,000 male babies is born with hemophilia A.

  Hemophilia B (Christmas disease) is caused by a lack of active clotting Factor 9. It is less common, occurring in 1 out of every 30,000 male babies, and does not respond to OCTOSTIM.

  When a person with hemophilia is injured, he does not bleed harder or faster than a person without hemophilia; he bleeds longer. Small cuts or surface bruises are usually not a problem, but more traumatic injuries may result in serious problems and potential disability after bleeding episodes.

  There are different levels of hemophilia: mild, moderate and severe. These three levels of hemophilia can overlap. The severity of the disease is defined by how much clotting factor is produced and in what situations bleeding most often occurs.

  Mild hemophilia: Clotting Factor 8 or clotting Factor 9 level is 5% of normal or greater. Mild hemophilia might not be discovered until there is excessive bleeding after major injury or surgery. The first episode may not occur until adulthood.

  Moderate hemophilia: Clotting Factor 8 or clotting Factor 9 level is 1% to 5% of normal. People with moderate hemophilia tend to have bleeding episodes after injuries (a fall, sprain or strain). They may also experience occasional bleeding episodes without obvious cause. These are called spontaneous bleeding episodes.

  Severe hemophilia: Clotting Factor 8 or clotting Factor 9 is less than 1% of normal. People with severe hemophilia have bleeding following minor injury and may have frequent spontaneous bleeding episodes, often into joints and muscles.

  The percentage of clotting factors stays about the same throughout a person’s life. All family members who have hemophilia will usually have similar forms.

  What causes hemophilia?

  Hemophilia A and hemophilia B are caused by an inherited defect in a chromosome. The defect affects how much clotting factor a person will produce and how the factor will function. Hemophilia is mild when the clotting factor functions are close to normal and the amount of clotting factor is only somewhat reduced. The less normal the function and the amount of clotting factor, the more severe the hemophilia.

  What are the symptoms?

  Symptoms of hemophilia are usually first noticed during infancy or childhood. However, some people who have milder forms of hemophilia may not develop symptoms until later in life.

The following are signs of hemophilia that may be noticed shortly after birth:

• Bleeding into the muscle, resulting in a deep bruise after receiving a routine vitamin K shot
• Prolonged bleeding after a boy is circumcised
• In rare cases, prolonged bleeding after the umbilical cord is cut at birth.

Other symptoms of hemophilia include:

• Bleeding into a joint or muscle that causes pain and swelling
• Abnormal bleeding after an injury or surgery
• Easy bruising
• Blood in the urine
• Bleeding after dental work

How is hemophilia diagnosed?

Blood tests will determine whether you have hemophilia. Genetic tests are available if you want to know whether you are a carrier of hemophilia (only females can be carriers).

What is the treatment for hemophilia?

Hemophilia treatment varies depending on the severity of your condition.

Mild hemophilia A: Treatment involves slow injection of a hormone, desmopressin (OCTOSTIM ^®) by your doctor into one of the veins to stimulate a release of more of your own clotting factor to stop the bleeding.

Moderate to severe hemophilia A or hemophilia B: Your bleeding may stop only after an infusion of clotting factor derived from human blood or from genetically engineered products called recombinant clotting factors.

What is von Willebrand’s disease?

Von Willebrand’s disease is a bleeding disorder caused by a defect or deficiency of a blood clotting protein, called von Willebrand factor. Von Willebrand factor is a protein critical to the initial stages of blood clotting. This glue-like protein, produced by the cells that line the blood vessels’ walls, interacts with blood cells called platelets to form a plug which prevents the blood from flowing at the site of injury. People with von Willebrand’s disease are unable to make this plug because they do not have enough von Willebrand factor or their factor is missing or does not work well.

The von Willebrand factor usually carries another blood-clotting protein called Factor 8. If you have von Willebrand’s disease, the two proteins may not attach properly to each other and your blood will not clot as well as it should.

There are three types of von Willebrand’s disease:

Type I: A shortage of von Willebrand factor (mild). This type of von Willebrand’s disease can result in mild to moderate bleeding episodes, depending on how much von Willebrand factor is missing. About 70% to 80% of all cases of von Willebrand’s disease are type I. Some people with type I disease do not need treatment and may not be aware that they have a blood disorder.

Type 2: A flawed von Willebrand factor (usually mild). Although the body produces normal amounts of the von Willebrand factor, it doesn’t work properly. Type 2 is further classified (2a or 2b) depending on the type of flaw.

Type 3: A complete lack of von Willebrand factor (more severe). Type 3 von Willebrand’s disease is very rare. When the body does not produce von Willebrand factor, the cells (platelets) needed to form a clot do not work properly and clotting Factor VIII levels are low, both of which can lead to severe bleeding. People with type 3 disease are in more danger of anemia and excessive bleeding after an accident or during surgery.

What causes von Willebrand’s disease?

Von Willebrand’s disease is usually passed down through families. It is the most common bleeding disorder present at birth (congenital), but most cases are mild. About 1% of people inherit this disease. If one parent has von Willebrand’s disease, a child has a 50% chance of having the condition. Men and women are equally likely to have von Willebrand’s disease.

What are the symptoms?

Most cases of von Willebrand’s disease are mild. Some people with type I von Willebrand’s disease have no more bleeding than members of the general population. Mild von Willebrand’s disease may not be noticed until you have excessive bleeding after an injury, dental procedure, or surgery. Severe cases (Type 3) are often recognized early in childhood because of unusual and heavy bleeding.

Excessive bleeding is the main symptom of von Willebrand’s disease. The severity of the condition varies from person to person, even within the same family. Over half of all women with von Willebrand’s disease have very heavy menstrual bleeding. Other symptoms include frequent nosebleeds and heavy bleeding after injury or surgery.

Von Willebrand’s disease causes symptoms similar to the bleeding disorder hemophilia, but usually less severe.

How is von Willebrand’s disease diagnosed?

Von Willebrand’s disease can be hard to diagnose. If you have symptoms that suggest a blood clotting disorder, your doctor will ask about your medical history, especially about episodes of excessive bleeding. Tests that can help with the diagnosis include:

• Blood tests that measure bleeding time, von Willebrand factor activity test, or von Willebrand factor antigen
• Genetic testing that shows a defect in your von Willebrand factor.

How is von Willebrand’s disease treated?

If you have von Willebrand’s disease, you will need to prevent and treat bleeding episodes throughout your life. The course of von Willebrand’s disease is difficult to predict because it may stay at the same level of activity or get better or worse as you get older.

When it should not be used:

OCTOSTIM should not be used in infants younger than three months in the treatment of hemophilia A or von Willebrand’s disease.

There are people who should not take OCTOSTIM ^®. Tell your doctor or pharmacist if you have:

• Hemophilia B
• Hyponatremia (low blood sodium levels)
• Syndrome of Inappropriate ADH secretion (SIADH)
• Any heart, liver or kidney problems
• Bleeding problems such as Type II B or platelet-type (pseudo) von Willebrand’s disease
• An allergy to desmopressin acetate or any of the other ingredients in OCTOSTIM^® (see What the nonmedicinal ingredients are)

Patients who are hypersensitive to this drug or any non-medicinal ingredient in the formulation (see the section What the nonmedicinal ingredients are) should not take OCTOSTIM^®.

What the medicinal ingredient is:

OCTOSTIM ^® contains an active drug called desmopressin acetate.

What the nonmedicinal ingredients are:

The nonmedicinal ingredients of OCTOSTIM ^® are: hydrochloric acid, purified water and sodium chloride

What dosage forms it comes in:

OCTOSTIM ^® Injection is contained in a clear glass ampoule with a red identification ring and a blue dot indicating the cut area.

WARNINGS AND PRECAUTIONS

Before you use OCTOSTIM ^®, talk to your doctor or pharmacist if you are:

• Breast-feeding

• Pregnant or think you might be pregnant

And/or if you have:

• Hyponatremia (low blood sodium level)
• Heart problems
• Liver disease

• Kidney problems

  • Bleeding problems such as Type II B or platelet-type (pseudo) von Willebrand’s disease
  • Any allergies to desmopressin acetate or any of the ingredients listed in “What the nonmedicinal ingredients are”

Before you commence treatment with this medicine, you should receive appropriate advice concerning fluid intake from your doctor. Excessive fluid intake may lead to a build up of water in the body resulting in water intoxication and hyponatremia.

Treatment with desmopressin should be stopped or carefully adjusted if any new illnesses arise that are associated with fluid and/or electrolyte imbalance (such as infections, fever, stomach flu). The fluid and electrolyte balance should be carefully monitored, especially in situations with excessive bleeding.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with OCTOSTIM ^® include:

• Tricyclic antidepressants (amitriptyline, nortriptyline)
• Chlorpromazine
• Carbamazepine
• Urea
• Fludrocortisone
• Clofibrate
• Chlorpropamide
• Lithium
• Norepinephrine
• Indomethacin
• Heparin

• Alcohol

• NSAIDs (i.e.; ibuprofen)
• Opioids
• SSRI’s (e.g. paroxetine, citalopram, fluvoxamine)
• Sulfonylureas (e.g. glyburide, glipizide, tolbutamide)

If you are taking any of these drugs, please talk to your doctor or pharmacist before taking OCTOSTIM ^®

PROPER USE OF THIS MEDICATION

How to administer OCTOSTIM Injection

OCTOSTIM ^® is administered by subcutaneous injection or by slow intravenous infusion over 20 to 30 minutes to provide a dose of 0.3 mcg /kg.

OCTOSTIM ^® should be diluted with sterile saline (diluent) before infusion.

Dilution for Infusion

OCTOSTIM ^® Injection should be diluted with sterile physiological saline and infused 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.

Maximum Dose

The maximum intravenous dose is 20 mcg. If OCTOSTIM ^® is used pre-operatively, it is administered 30 minutes prior to the scheduled procedure. The peak effect is obtained one hour after administration. Response is immediate for bleeding time reduction.

Overdose

If you took too much of the medication, you should immediately contact your doctor and/or the emergency room of the nearest hospital. Symptoms of overdose may include headache, nausea, vomiting, abdominal cramps, facial flushing, and weight gain due to water retention and, in severe cases, convulsions.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

As with all medicines, side effects may be experienced. The frequency varies with the dosage and the route of administration. These may include headache, nausea and mild abdominal cramps, low blood pressure, facial flushing, dizziness and fatigue. Tell your doctor about any side effects you experience.

Excessive fluid intake may lead to a build up of water which dilutes the salt in the body in severe cases. This can become a serious problem and may lead to convulsions. Early symptoms may include an unusually bad or prolonged headache, confusion, unexplained weight gain, nausea and vomiting, abdominal pain, faintness, muscle cramps/spasms, tiredness, dizziness, swelling of hands/feet and in severe cases, coma. If you experience one or more of these symptoms, you should stop taking the medicine. Tell your doctor immediately or go to the nearest emergency hospital.

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

This is not a complete list of side effects. For any unexpected effects while taking OCTOSTIM^®, contact your doctor or pharmacist.

HOW TO STORE IT

OCTOSTIM ^® should be stored in the refrigerator at 2° – 8°C but do not freeze.

Keep out of reach and sight of children.

REPORTING SIDE EFFECTS

MORE INFORMATION

If you want more information about OCTOSTIM:

•Talk to your healthcare professional

•Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website:

(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drugproduct-database.html); Ferring.ca, or by calling 1-866-384-1314

Last revised: March 17, 2021