What is REBINYN® used for?

REBINYN® is used to prevent and treat bleeds in people with Hemophilia B (also called congenital factor IX deficiency).

Factor IX

When you have hemophilia B, the factor IX in your body is missing or does not work properly. Factor IX is a protein naturally found in the blood that helps stop bleeding.

How does REBINYN® work?

REBINYN® replaces this faulty or missing factor IX and helps blood to form clots at the site of bleeding. When you experience a bleed, REBINYN® is activated in the blood to form the naturally found factor IX.

Usual dose for treatment of bleeding

The usual dose of REBINYN® for treating a bleed is 40 IU per kg of body weight, but depending on the location and the severity of the bleed, you may need a higher dose (80 IU per kg) or one or more extra injections. You should discuss with your healthcare professional the dose and number of injections you require.

Nervous about infusions?

You don’t need to figure it out alone. The Novo Nordisk® Home Infusion Program offers you access to a trained nurse to assist you with infusion training. To enroll in the Novo Nordisk® Home Infusion Program, please speak to your prescribing healthcare professional.

Important safety information

Who is the medication for?

REBINYN® is used to treat bleeding in adults, adolescents and children with hemophilia B (also called congenital factor IX deficiency).

Who should not use REBINYN®?

Do not use REBINYN® if you are allergic to the medicinal ingredient, or to any ingredient in the formulation (including hamster protein) or component of the container.

What side effects can occur with REBINYN®?

The following side effects have been observed with REBINYN®:

Common side effects that may affect up to 1 in 10 people include itching (pruritus) and skin reactions at the site of injection.

Uncommon side effects that may affect up to 1 in 100 people include allergic reactions (hypersensitivity).

Side effects with unknown frequency (it is not known how often these happen) include anaphylactic reactions and activity-neutralizing antibodies (inhibitors). Inhibitors (activity-neutralizing antibodies) have occurred in connection with severe and sudden allergic reaction (e.g. anaphylactic reaction). Allergic reactions or anaphylactic reaction are a serious side effect and can include the following symptoms or effects: difficulty in swallowing or breathing; shortness of breath or wheezing; chest tightness; redness and/or swelling of the lips, tongue, face or hands; rash, hives, wheals or generalized itching; having pale and cold skin, fast heartbeat, and/or dizziness (low blood pressure). If you have a reaction, stop taking the drug and get immediate medical help and talk to your healthcare professional about the reaction in all cases.

These are not all the possible side effects you may feel when taking REBINYN®.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How do I report side effects?

You can report serious and unexpected side effects and adverse events to Novo Nordisk Canada Inc. Drug Safety at 1-800-465-4334 (toll-free).

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report to Health Canada:

- Online at MedEffect;

- By calling 1-866-234-2345 (toll-free);

- By completing a Patient Side Effect Reporting Form and sending it by:

Fax to 1-866-678-6789 (toll-free), or

Mail to: Canada Vigilance Program, Health Canada, Postal Locator 0701E, Ottawa, ON K1A 0K9

Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Are there any other warnings I should know about?

Other warnings you should know about include:

Allergic reactions and development of inhibitors There is a rare risk that you may experience a sudden and severe allergic reaction (e.g. anaphylactic reaction) to REBINYN®. Stop the injection and contact your healthcare professional or an emergency unit immediately if you experience early signs of an allergic reaction.

Your healthcare professional may need to treat you promptly for these reactions. Your healthcare professional may also do a blood test to check if you have developed factor IX inhibitors (activity-neutralizing antibodies) against your medicine, as inhibitors may develop together with allergic reactions. If you have such antibodies, you may be at an increased risk of sudden and severe allergic reactions (e.g. anaphylactic reaction) during future treatment with factor IX.

Because of the risk of allergic reactions with factor IX, your first injections with REBINYN® should be given in a medical clinic or in the presence of healthcare professionals where proper medical care for allergic reactions can be provided.

Talk to your healthcare professional immediately if bleeding does not stop as expected, or if you experience a significant increase in your usage of REBINYN® in order to stop a bleed. Your healthcare professional will do a blood test to check if you have developed inhibitors (activity-neutralizing antibodies) against REBINYN®. The risk for developing inhibitors is highest if you have not been treated with factor IX medicines before (i.e. for small children).

Blood clots Inform your healthcare professional if any of the following apply to you, as there is an increased risk of blood clots during treatment with REBINYN®:

- You have recently had surgery.

- You suffer from other serious illness (e.g. liver, heart disease, or cancer).

Kidney disorder (nephrotic syndrome) There is a rare risk of developing a specific kidney disorder called “nephrotic syndrome” following high doses of factor IX in hemophilia B patients with factor IX inhibitors and a history of allergic reactions.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take REBINYN®. Talk about any health conditions or problems you may have, including if you:

- Are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription or herbal medicines.

- Are pregnant or breast-feeding, or if you think that you may be pregnant or are planning to have a baby.