Consumer Information for: OCTOSTIM SPRAY

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Octostim® Injection and Octostim® Spray are used to treat bleeding disorders called hemophilia A and von Willebrand’s disease.

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

What it does

Octostim® Injection and Octostim® Spray contain 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?

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® Injection) by your doctor into one of the veins to stimulate a release of more of your own clotting factor to stop the bleeding. Occasionally, desmopressin is given as a nasal medication (Octostim® Spray).

Moderate to severe hemophilia A or hemophila 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. Test 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® Spray should not be used in infants younger than 11 months.

There are people who should not take Octostim® Injection and Octostim® Spray. 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 Spray or Injection.

What the medicinal ingredient is

Octostim® Injection and Octostim® Spray contains an active drug called desmopressin acetate.

What the non-medicinal ingredients are

The nonmedicinal ingredients of Octostim® Spray are: benzalkonium chloride solution, citric acid monohydrate, disodium phosphate dihydrate, purified water and sodium chloride,

The nonmedicinal ingredients of Octostim® Injection are: hydrochloric acid, purified water and sodium chloride

What dosage form it comes in

Octostim® Spray is filled in a 2.5 mL glass bottle with a pre-compression pump and protective cap. The spray pump is designed to give 100 ug (0.1 mL or 150 μg desmopressin acetate) per actuation.

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® Injection and Octostim® Spray, 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.

Due to the presence of benzalkonium chloride OCTOSTIM Nasal spray may cause bronchospasm.

Interactions with this medication

Drugs that may interact with Octostim® Injection and Octostim® Spray 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 take Octostim® Spray

  1. Gently blow your nose. If you can’t clear your nasal passage, inform your doctor.

  2. Remove the protective cap from the bottle.

  3. The very first time the spray is used, prime the pump by pressing downwards on the white collar using your index and middle fingers while supporting the base of the bottle with your thumb (see Figure # 1). Press down at least 5 times until an even spray appears. The spray is now ready for use.
  4. In a standing or sitting position, hold the bottle in a way which places the dip tube in the position indicated by the arrow (see Figure # 2). Tilt your head backward slightly and carefully insert the nasal applicator into one nostril (see Figure # 3).
  5. For each spray your physician has instructed you to take, press firmly downwards once on the white collar using your index and middle fingers while supporting the base of the bottle with your thumb. Hold your breath as you administer the dose.

  6. If more than 1 spray is prescribed by your physician, repeat steps 4 and 5 above for the other nostril.

Replace the protective cap on the bottle.

If the spray has not been used during the last 48 hours, it is necessary to prime it again. Press downwards on the white collar a couple of times until an even spray appears before placing the nasal applicator in the nostril.

IMPORTANT: The end of the tube inside the bottle must always be submerged in the liquid when administering the spray. Always keep the bottle upright and store in an upright position.

How many sprays should I take?

Take the medication only as directed by your doctor.

Usual Dose

Follow your doctor’s direction on how much medicine you should take. The usual dose taken by nasal inhalation is one spray per nostril, to provide a total dose of 300 μg. In patients weighing less than 50 kg, 150 μg is administered as a single spray to provide the expected effect on Factor 8 coagulant activity, Factory 8 ristocetin cofactor activity and skin bleeding time.

If Octostim® spray is used before an operation; it is administered 2 hours prior to the scheduled procedure.

How to administer Octostim Injection

Octostim® injection is administered by subcutaneous injection or by slow intravenous infusion over 20 to 30 minutes to provide a dose of 0.3 μg/kg. Octostim® Injection 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 μg. If Octostim® Injection 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.

Call your doctor or poison control center, or go to an emergency room.
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, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and call your doctor or pharmacist
Rare
hyponatremia (low blood sodium level)   T T

This is not a complete list of side effects. For any unexpected effects while taking Octostim, contact your doctor or pharmacist.
How to store

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

Octostim® Spray should be stored in upright position at 15-25ºC. Do not freeze.

Reporting side effects

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at : 1- 866-234-2345
Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789 or,
  • Mail to: Canada Vigilance Program
    Health Canada
    Postal Locator 1908C
    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of the side effect, please contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full Product Monograph, prepared for health professionals, can be found by contacting the sponsor, Ferring Inc., at: 1-866-384-1314.

This leaflet was prepared by Ferring Inc.

Last revised: April 12, 2018

Date modified: