KOVALTRY TM and you

A GUIDE TO TREATMENT FOR HEMOPHILIA A

Welcome to KovaltryTM 3

Why have I been prescribed KovaltryTM? 4

What is KovaltryTM? 5

Who should not take KovaltryTM? 6

What is the usual dose of KovaltryTM? 7

What available vial sizes does KovaltryTM come in? 10

What if I miss a dose or overdose? 11

How should I store KovaltryTM? 12

What are some of the side effects associated with KovaltryTM? 13

Is there other important safety information I should know about? 16

Notes 17

Contact details 18

The KovaltryTM resource centre 19

Table of contents

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WELCOME TO KOVALTRYTM

You or someone you care for has been prescribed KovaltryTM to help manage hemophilia A.

This booklet was designed to help you learn more about KovaltryTM and better understand this treatment. It is meant to be a helpful guide that complements the information provided by your healthcare professional.

Inside this booklet, you will find: A general overview of KovaltryTM

Dosing information and available vial sizes

Instructions on how to properly store KovaltryTM

A list of possible side effects and other safety information

Helpful resources

There is also a notes section at the end to help you keep track of information from your healthcare professional or any questions you may have about your treatment.

Remember that your healthcare professional is your best source of information should you have any questions about hemophilia A and your treatment with KovaltryTM

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Your doctor has prescribed KovaltryTM to help manage your hemophilia A.

KovaltryTM is used to treat and prevent bleeding in people with hemophilia A.

It is also used as a prevention treatment in children with hemophilia A to reduce the occurrence of spontaneous bleeding episodes.

KovaltryTM does not contain von Willebrand factor and should therefore not be used in von Willebrand’s disease.

WHY HAVE I BEEN PRESCRIBED KOVALTRY™?

Hemophilia A, also called congenital Factor VIII deficiency, is a condition where the blood clotting protein Factor VIII is lacking or not enough of it is produced.

Hemophilia A is a genetic disorder, meaning it is passed down from parents to children. However, about one third of cases are caused by a spontaneous mutation (a change in a gene).

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WHAT IS KOVALTRY™?

KovaltryTM (Antihemophilic Factor [Recombinant]) is a clotting Factor VIII that has been developed in the laboratory and is very similar to the Factor VIII that occurs naturally in human blood.

People with hemophilia A do not have enough natural Factor VIII in their blood. KovaltryTM gives them additional Factor VIII to help prevent and/or control bleeding.

KovaltryTM is an intravenous medication, meaning it is given directly into the blood through an injection in a vein.

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Do not use KovaltryTM if:

You are allergic (hypersensitive) to octocog alfa or to any of the other ingredients in KovaltryTM*

You have had allergic reactions to mouse or hamster protein

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take KovaltryTM.

Tell your healthcare professional about:

Any health conditions or problems you may have, including if you are allergic to mouse or hamster protein

Whether you have been told you have heart disease or are at risk for heart disease

All the medicines you take or have recently taken (this includes any prescription or non-prescription drugs, vitamins, minerals, natural supplements or alternative medicines)

There are no known interactions with KovaltryTM and other medications. However, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

WHO SHOULD NOT TAKE KOVALTRY™?

* Non-medicinal ingredients: Calcium chloride, Histidine, Glycine, Polysorbate 80, Sodium chloride, Sucrose.

WHAT IS THE USUAL DOSE OF KOVALTRY™?

Your doctor should always adjust your dose and how often you use KovaltryTM based on your individual needs. Larger amounts than those calculated may be required under certain circumstances, especially for the initial dose.

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Treatment of bleeding Your doctor will calculate how much KovaltryTM to use and how frequently you should use it to get the necessary level of Factor VIII activity in your blood.

Many factors affect your dose of KovaltryTM and how often you should use it. These include:

Your weight

The severity of your hemophilia

Where the bleed is and how serious it is

Whether you have inhibitors and how high the inhibitor titer is

The level of Factor VIII that is needed

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In some cases, especially for younger patients, shorter dose intervals or higher doses may be necessary.

Prevention of bleeding (prophylaxis) Your doctor will let you know how much KovaltryTM to use.

IU=international units.

For an adult or adolescent (>12 years of age)

of KovaltryTM for every kilogram of body weight,

weeklygiven --

The usual dose for prevention of bleeding is:

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Duration of treatmentYour doctor will tell you how often and at what intervals KovaltryTM is to be used. Replacement therapy with KovaltryTM is usually a life-time treatment.

For children (≤12 years of age)

The recommended dose for routine prophylaxis is:

of KovaltryTM for every kilogram of body weight,

according to individual requirements

weekly orweekly,given -- --

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WHAT AVAILABLE VIAL SIZES DOES KOVALTRY™ COME IN?

KovaltryTM is a powder that must be reconstituted before it is administered intravenously.

KovaltryTM comes in the following vial sizes:

250 IU, 500 IU and 1,000 IU vials (with 2.5 mL of sterile water for injection)

2,000 IU and 3,000 IU vials (with 5.0 mL of sterile water for injection)

Vial Adapter and other supplies

1,000 IU2,000 IU500 IU

3,000 IU250 IU

Each carton of KovaltryTM contains a single-use vial with powder and a prefilled syringe containing sterile water for injection (diluent).

A sterile administration set is also provided, including a Vial Adapter.

Prefilled syringe Vial Adapter Single-use vial

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WHAT IF I MISS A DOSE OR OVERDOSE?

Missed dose

If you miss a dose of KovaltryTM, proceed with your next dose immediately and continue at regular intervals, as advised by your doctor. Do not take a double dose to make up for a forgotten one.

Do not stop using KovaltryTM without consulting your doctor.

Overdose

No symptoms of overdose with recombinant coagulation Factor VIII have been reported.

If you think you have taken too much KovaltryTM, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately – even if there are no symptoms

2 – 8°C 25°CUP TO

12 MONTHSFOR

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KovaltryTM should be stored in a refrigerator, between 2°C to 8°C. Do not freeze. Keep the vial and the prefilled syringe in the outer carton in order to protect them from light.

You may store KovaltryTM when kept in its outer carton at room temperature (up to 25°C) for a single period of up to 12 months. Once the product is removed from refrigeration, it cannot be returned.

The reconstituted solution should be used immediately (within 3 hours). KovaltryTM is for single use only and any unused solution must be discarded.

Keep KovaltryTM out of reach and sight of children.

HOW SHOULD I STORE KOVALTRY™?

Do not use KovaltryTM after the expiry date stated on the labels and cartons or if you notice any particles or the solution is cloudy

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WHAT ARE SOME OF THE SIDE EFFECTS ASSOCIATED WITH KOVALTRY™?

Possible side effects May affect more than 1% of people and less than 10%

Enlarged lymph nodes

Heart palpitations

Rapid heartbeat

Stomach pain

Stomach discomfort

Indigestion

Fever

Chest discomfort

Local reactions where you injected the medication

Headache

Dizziness

Trouble falling asleep

Rash/itchy rash, allergic dermatitis, itching

If you experience any side effects not listed here, contact your healthcare professional

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WHAT ARE SOME OF THE SIDE EFFECTS ASSOCIATED WITH KOVALTRY™?

Please refer to the Patient Medication Information leaflet included in your KovaltryTM product package for more information on possible side effects

Uncommon side effects May affect between 0.1% and up to 1% of people

Hypersensitivity reactions, including a severe sudden allergic reaction or anaphylactic shock (e.g., tightness of the chest/general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing)

Dysgeusia (odd taste)

Flushing (redness of the face)

Urticaria (swelling)

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Serious side effects and what to doA lack of effect (your medication not working) is a possible and serious side effect associated with KovaltryTM. Should this happen, contact your healthcare professional.

If you experience tightness in the chest or a general feeling of being unwell, hives, dizziness and nausea or feel faint upon standing, you may be experiencing a rare severe sudden allergic reaction (a so-called anaphylactic reaction) to KovaltryTM. If these uncommon but serious hypersensitivity reactions occur, stop taking KovaltryTM and seek immediate medical attention.

WHAT ARE SOME OF THE SIDE EFFECTS ASSOCIATED WITH KOVALTRY™?

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

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Factor VIII inhibitors are antibodies in the blood, which block the Factor VIII you are using and make it less effective to prevent and control bleeding

IS THERE OTHER IMPORTANT SAFETY INFORMATION I SHOULD KNOW ABOUT?

Checking Factor VIII levels

Your doctor may carry out tests to ensure that your current dose of KovaltryTM provides adequate Factor VIII levels.

If your bleeding is not being controlled with your usual dose of KovaltryTM, consult your doctor immediately. You may have developed Factor VIII inhibitors and your doctor may carry out tests to confirm this.

If you have previously developed a Factor VIII inhibitor and you switch Factor VIII products, you may be at risk of your inhibitor coming back.

Surgical device

When frequent injections are required, your healthcare professional may suggest that you have a device surgically placed under the skin to facilitate access to the bloodstream.

This device may result in an infection. Be sure to inform your healthcare provider if you have a catheter-related infection.

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Use this space to keep track of notes regarding your treatment or any questions you may have for your healthcare provider.

NOTES

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NOTES

CONTACT DETAILSHealthcare provider name: __________________________________

__________________________________________________________

Clinic name: _____________________________________________________

Address: ______________________________________________________

__________________________________________________________

Phone: ________________________ Fax: _________________________

Email: ____________________________________________________

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THE KOVALTRY™ ONLINE RESOURCE CENTRE

Kovaltry.ca is an online resource centre available for anyone who has been prescribed KovaltryTM and their caregivers who are looking for more information on KovaltryTM.

Median ABR (n=18) (IQR=0.0; 8.0)

Median ABR (n=44) (IQR=0.5; 5.0)

Median dose: 35.0 IU/kg

(range: 21-42 IU/kg)

Median dose: 31.1 IU/kg

(range: 24-43 IU/kg)

3x/weekprophylaxis

2x/weekprophylaxis

1 2Median ABR

(n=18) (IQR=0.0; 8.0)Median ABR

(n=44) (IQR=0.5; 5.0)

Median dose: 35.0 IU/kg

(range: 21-42 IU/kg)

Median dose: 31.1 IU/kg

(range: 24-43 IU/kg)

3x/weekprophylaxis

2x/weekprophylaxis

1 2GETTING TO KOVALTRY.CA IS EASY

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Bayer Inc., 2920 Matheson Blvd. E., Mississauga, Ontario L4W 5R6® TM see www.bayer.ca/tm-mc© 2016, Bayer Inc.

KVL111-0516E L.CA.MKT.03.2016.1441

Want more information on KOVALTRY TM? Please refer to the package insert included with Kovaltry TM.You can also speak with your healthcare professional or contact Bayer Medical Information at 1-800-265-7382 (7:30 am to 7:30 pm EST).