Rebif® (interferon beta‐1a) Injection Options

Which injection option is right for you?

Rebif^® (interferon beta-1a) is administered subcutaneously, which means that you inject Rebif under the skin. There are 3 options available for injecting Rebif: the Rebif prefilled syringe, the Rebiject II^® autoinjector, and Rebif^® Rebidose^® (interferon beta-1a) autoinjector. There are 2 dosing options: 22 mcg and 44 mcg.

There is also an 8.8-mcg dose available as part of the Rebif Titration Pack. Titration means starting at a lower dosage and gradually building up to the full dosage. Your healthcare provider may offer this to help you adjust to Rebif if you are just starting Rebif therapy.

Rebif may cause redness, pain, or swelling at the place where an injection was given. Some patients have developed skin infections or areas of severe skin damage (necrosis) requiring treatment by a doctor. If one of your injection sites becomes swollen and painful or the area looks infected, call your doctor right away. For more information, please see Medication Guide.

Rebif prefilled syringe

Rebif comes ready to use in premeasured, prefilled syringes that already contain medicine and do not require needle assembly. What this means is that you don’t have to worry about mixing any solutions before injection. No twisting, turning, pulling, or adjusting of the syringe is necessary before injecting. The Rebif prefilled syringe can also be used with the Rebiject II^®autoinjector. You should use the Rebif prefilled syringe only after you have received proper training from a healthcare professional. An MS LifeLines Nurse may be able to provide injection training for you in the comfort of your home.

Learn more about how to use the prefilled syringe, including video instructions, below.

Relapsing MS Treatment Injection Video

HOW TO USE THE REBIF PREFILLED SYRINGE

Pinch the skin around the cleaned injection site to lift it up a bit, and hold the syringe like a pencil or dart.
While still pinching the skin, use a quick, firm motion to insert the needle straight under the skin at about a 90° angle.
With the needle inserted, stop pinching the skin and gently, steadily push the plunger all the way down.
Remove the needle and apply gentle pressure to the injection site with a dry cotton ball or sterile gauze. Applying a cold compress or ice pack to the injection site after injection may help reduce local skin reactions.
Discard the empty syringe and cap in the syringe disposal container,* and keep a record of the date and injection site in your treatment journal.
Check recent injection sites for redness, swelling, or tenderness. Contact your healthcare professional about any skin reaction. You can also contact an MS LifeLines^® Nurse Support Specialist, who can give you tips that may help manage these reactions.

For more information about the Rebif prefilled syringe, call MS LifeLines, toll-free, at 1-877-447-3243. For complete instructions on the use of the Rebif prefilled syringe, please refer to the Medication Guide.

* Regulations for needle disposal vary. Consult your physician or pharmacist for the regulations in your area.

Rebiject II® autoinjector

The Rebiject II autoinjector works with the Rebif prefilled syringe and is designed to automate the injection process. It is for use only with Rebif preassembled, prefilled glass syringes and is available exclusively for Rebif users. With the assembled Rebiject II, the needle remains hidden both before and after injecting and while loading. It gives you the ability to adjust how deeply the needle will go under your skin. Rebiject II is available free of charge.

You should only use the Rebiject II autoinjector after you have received proper training from a healthcare professional. An MS LifeLines Nurse may be able to provide injection training for you in the comfort of your home. Call 1-877-447-3243 to learn more.

You can learn more here about how Rebiject II works and how to use it.

HOW TO USE REBIJECT II

Check that the gray needle-cap remover is completely attached to the end of the needle-depth adjuster.
Prepare the injector plunger.
Hold the syringe housing on a flat, hard surface.Align the dark yellow, round end of the device plunger to the gray needle-cap remover. Push the injector body down until it can go no farther and you hear a "click." The injector plunger is now set. Do not remove the gray needle-cap remover or the syringe plunger.

Note: The Rebiject II is pre-set to administer an injection 10 mm (3/8 inch) under the skin when the setting reads [>>>]. If your healthcare provider directs you to change the depth setting, follow the instructions in the Maintenance and Troubleshooting Guide section of the Instructions for Use, which is provided with your Rebiject II autoinjector.
Insert the Rebif syringe into the syringe housing.
- Hold the syringe housing firmly on a flat surface.
- Insert the Rebif syringe, needle-cap end first, into the syringe housing. Be sure to keep the needle-cap on the syringe.
- Using gentle pressure, guide the syringe into the syringe housing until 1 to 3 "clicks" are heard.
- The syringe is now locked in the housing.
Screw the syringe housing and injector body together.
Pull the needle-cap remover from the syringe housing.
Dispose of the needle-cap, but keep the needle-cap remover for subsequent injections.
Prepare and perform the injection.
- Choose your injection site as directed by your healthcare provider. Refer to the Medication Guide for injection-site selection and additional tips.
- Prepare your injection site as directed by your healthcare provider.
- Place the Rebiject II lightly against your skin so that you can see the indicator window.
- Apply light pressure so that the injector body moves downward toward the syringe housing. This releases the safety lock so that the release button can be pressed.
Inject Rebif medication.
Press the injector release button and continue to hold the Rebiject II in place on your skin for at least 10 seconds. The contents will be automatically injected.
Check the indicator window.
You will see a series of black lines moving against a yellow background. Once the injection is complete, the lines will stop moving.
Lift the Rebiject II from the skin and apply gentle pressure to the injection site with a dry cotton ball or sterile gauze.
Applying a cold compress or ice pack to the injection site after injection may help reduce local skin reactions.
Disassemble the Rebiject II.
- Unscrew the syringe housing from the injector body.
- The syringe needle will now be exposed. Be careful when handling.
- Remove the syringe from the syringe housing.
- Dispose of the empty needle and syringe properly in the syringe disposal container.*

_{*Regulations for disposal vary. Consult your doctor or pharmacist for regulations in your area.}
Reattach the needle-cap remover and the needle-depth adjuster, and store the Rebiject II in its case.
Remember to clean your Rebiject II prior to storing. The Rebiject II may be cleaned by wiping with a damp cloth if needed. Do not use soap or place in boiling water, a microwave, or an autoclave.
Keep a record of the date and injection site in your treatment journal.
Check recent injection sites for redness, swelling, or tenderness. Contact your healthcare provider about any skin reaction that does not clear up in a few days. You can also contact an MS LifeLines Nurse Support Specialist, who can give you tips that may help manage these reactions.

IF YOU NEED HELP

Contact your doctor, nurse, or other healthcare professional, or call MS LifeLines^®, toll-free, at 1-877-447-3243, Monday through Friday, 8 AM to 8 PM ET, and Saturday, 9 AM to 5 PM ET, if:

You are unsure about any of these steps
The Rebiject II^® prefilled autoinjector is not working properly
You cannot perform the injection using the Rebiject II

A live representative answers every call, day or night.

REPLACEMENT

Every effort has been made to ensure that the Rebiject II^® will function correctly for at least 2 years. After 2 years of operation, your Rebiject II should be replaced. A new Rebiject II can be obtained by calling MS LifeLines^®, toll-free, at 1-877-447-3243.

WARNINGS AND SAFETY PRECAUTIONS

Do not inject yourself using the Rebiject II^® autoinjector until you have been properly trained by a doctor, nurse, or other healthcare provider.
The Rebiject II autoinjector must only be used with your prescribed prefilled glass syringes of Rebif and should not be used with any other brand of interferon or medication.
Do not share the Rebiject II autoinjector with anyone. Doing so may result in injury and/or the transmission of infectious blood-borne diseases. Adhere to strict safety and antiseptic precautions at all times.
Always keep the Rebiject II autoinjector and Rebif out of the reach of children.
Do not operate or store the Rebiject II autoinjector with an empty syringe.
Do not point the Rebiject II autoinjector at yourself or others when loading the syringe or at any other time.

For more information about the Rebiject II autoinjector, call MS LifeLines, toll-free, at 1-877-447-3243. For complete instructions on the use of the Rebiject II autoinjector, please refer to the instructions that came with it.

Rebif® Rebidose® (interferon beta-1a)

Rebif Rebidose is a prefilled, preassembled single-use autoinjector.

No assembly required
Portable, goes where you go
Covered needle before and after the injection

In this section, you can learn more about Rebif Rebidose and what people said in a user trial.

You should only use Rebif Rebidose after you have been given proper instructions by a healthcare professional. An MS LifeLines^® Nurse may be able to teach you how to inject in the comfort of your home.

Speak to your doctor to see if Rebif or Rebif Rebidose is the right option for you.

OVERVIEW

Meet Rebif Rebidose

Watch this video to learn about one way to take Rebif.

WHAT PEOPLE SAID IN A USER TRIAL
In a short-term, open-label user trial*:

Do not try to give yourself injections at home until you understand, and are comfortable with, how to prepare your dose and give the injections.

^*In this user trial, Rebif Rebidose was evaluated for 12 weeks by 109 patients with relapsing MS who had previously taken Rebif using the prefilled syringes or the reusable Rebiject II autoinjector.

^†See storage and disposal information below.

^‡ Rebif should be refrigerated (between 36°F and 46°F). Do not freeze. If refrigeration is not available, Rebif Rebidose can be stored at room temperature for up to 30 days away from heat and light.

HOW TO USE REBIF REBIDOSE

Remember to always use the injection technique advised by your healthcare provider.

If at any time you have questions or concerns, please contact your healthcare provider or call MS LifeLines^® at 1-877-447-3243.

For complete injection instructions, please refer to the Instructions for Use.

IF YOU NEED HELP

Contact your doctor, nurse, or other healthcare professional, or call MS LifeLines, toll-free, at 1-877-447-3243, Monday through Friday, 8 AM to 8 PM ET, and Saturday, 9 AM to 5 PM ET, if:

You are unsure about how to use the Rebif Rebidose autoinjector
Rebif Rebidose is not working properly
You need help with injection training

A live representative answers every call, day or night.

WARNINGS AND SAFETY PRECAUTIONS

Do not share Rebif Rebidose with anyone. This may result in injury and/or transmission of infectious blood-borne diseases. Adhere to strict safety and antiseptic precautions at all times.
Always keep Rebif Rebidose and Rebif out of the reach of children.
Do not point the Rebif Rebidose at yourself or others at any time.
Do not heat or microwave the medication.

In the unlikely event of failure of your Rebif Rebidose, please contact MS LifeLines at 1-877-447-3243. They will help you obtain a replacement.

For more information about the Rebif Rebidose autoinjector, call MS LifeLines, toll-free, at 1-877-447-3243 Monday through Friday, 8 AM to 8 PM ET, and Saturday, 9 AM to 5 PM ET. For complete instructions on the use of the Rebif Rebidose autoinjector, please refer to the Instructions for Use.

Storage and disposal

Storing Rebif

Rebif should be refrigerated between 36°F and 46°F (2°C and 8°C). Do not freeze. If a refrigerator is not available, Rebif may be stored between 36°F and 77°F (2°C and 25°C) for up to 30 days and away from heat and light.

Disposing of Rebif after use

Dispose of properly
Put your used Rebif injectors in an FDA-cleared sharps disposal container right away after use. Do not throw them away (dispose of) in your household trash.
Use appropriate containers
If you do not have an FDA-cleared sharps disposal container, you may use a properly labeled household container that is made of heavy-duty plastic and can be closed with a tight-fitting, puncture-resistant lid. It should be upright and stable during use, leak resistant, and properly labeled to warn of hazardous waste inside the container.
Follow community guidelines
When your sharps disposal container is almost full, you will need to follow your community guidelines for the correct way to dispose of it. For more information about safe sharps disposal, go to the FDA’s website at:
www.fda.gov/safesharpsdisposal.
Don’t dispose of Rebif in household trash

DISPOSAL PROGRAM

EMD Serono, Inc. is proud to partner with Sharps Compliance. Call MS LifeLines^® at
1-877-447-3243 and ask about the Rebif^® Rebidose^®sharps disposal program.

Call MS LifeLines at 1-877-447-3243 →

The people in these photos are not actual Rebif patients.

Next: Treatment routine →

IMPORTANT SAFETY INFORMATION

Before beginning treatment, you should discuss the potential benefits and risks associated with Rebif with your healthcare provider.

Rebif can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking Rebif.

Behavioral health problems including depression and suicidal thoughts. You may have mood problems including depression (feeling hopeless or feeling bad about yourself), and thoughts of hurting yourself or suicide
Liver problems or worsening of liver problems including liver failure. Symptoms may include nausea, loss of appetite, tiredness, dark colored urine and pale stools, yellowing of your skin or the white part of your eye, bleeding more easily than normal, confusion, and sleepiness. During your treatment with Rebif you will need to see your healthcare provider regularly and have regular blood tests to check for side effects
Serious allergic and skin reactions. Symptoms may include itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, anxiousness, feeling faint, skin rash, hives, sores in your mouth, or skin blisters and peels
Injection site problems. Symptoms at the injection site may include redness, pain, swelling, color changes (blue or black), and drainage of fluid
Blood problems. Rebif can affect your bone marrow and cause low red and white blood cell and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising. Your healthcare provider may ask you to have regular blood tests to check for blood problems
Seizures. Some people have had seizures while taking Rebif

Rebif will not cure your MS but may decrease the number of flare-ups of the disease and slow the occurrence of some of the physical disability that is common in people with MS.

Do not take Rebif if you are allergic to interferon beta, human albumin, or any of the ingredients in Rebif.

Before you take Rebif, tell your healthcare provider if you have or have had any of the following conditions:

mental illness, including depression and suicidal behavior
liver problems, bleeding problems or blood clots, low blood cell counts, seizures (epilepsy), or thyroid problems
you drink alcohol
you are pregnant or plan to become pregnant. It is not known if Rebif will harm your unborn baby
you are breastfeeding or plan to breastfeed. Rebif may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take Rebif

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

The most common side effects of Rebif include:

flu-like symptoms. You may have flu-like symptoms when you first start taking Rebif. You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers. For many people, these symptoms lessen or go away over time. Symptoms may include muscle aches, fever, tiredness, and chills
stomach pain
change in liver blood tests

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Rebif. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION

Before beginning treatment, you should discuss the potential benefits and risks associated with Rebif with your healthcare provider.

Rebif can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking Rebif.

Behavioral health problems including depression and suicidal thoughts. You may have mood problems including depression (feeling hopeless or feeling bad about yourself), and thoughts of hurting yourself or suicide
Liver problems or worsening of liver problems including liver failure. Symptoms may include nausea, loss of appetite, tiredness, dark colored urine and pale stools, yellowing of your skin or the white part of your eye, bleeding more easily than normal, confusion, and sleepiness. During your treatment with Rebif you will need to see your healthcare provider regularly and have regular blood tests to check for side effects
Serious allergic and skin reactions. Symptoms may include itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, anxiousness, feeling faint, skin rash, hives, sores in your mouth, or skin blisters and peels
Injection site problems. Symptoms at the injection site may include redness, pain, swelling, color changes (blue or black), and drainage of fluid
Blood problems. Rebif can affect your bone marrow and cause low red and white blood cell and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising. Your healthcare provider may ask you to have regular blood tests to check for blood problems
Seizures. Some people have had seizures while taking Rebif

Rebif will not cure your MS but may decrease the number of flare-ups of the disease and slow the occurrence of some of the physical disability that is common in people with MS.

Do not take Rebif if you are allergic to interferon beta, human albumin, or any of the ingredients in Rebif.

Before you take Rebif, tell your healthcare provider if you have or have had any of the following conditions:

mental illness, including depression and suicidal behavior
liver problems, bleeding problems or blood clots, low blood cell counts, seizures (epilepsy), or thyroid problems
you drink alcohol
you are pregnant or plan to become pregnant. It is not known if Rebif will harm your unborn baby
you are breastfeeding or plan to breastfeed. Rebif may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take Rebif

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

The most common side effects of Rebif include:

flu-like symptoms. You may have flu-like symptoms when you first start taking Rebif. You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers. For many people, these symptoms lessen or go away over time. Symptoms may include muscle aches, fever, tiredness, and chills
stomach pain
change in liver blood tests

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Rebif. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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3 INJECTION OPTIONS

Which injection option is right for you?

Rebif prefilled syringe

Relapsing MS Treatment Injection Video

HOW TO USE THE REBIF PREFILLED SYRINGE

* Regulations for needle disposal vary. Consult your physician or pharmacist for the regulations in your area.

Rebiject II® autoinjector

HOW TO USE REBIJECT II

Rebif® Rebidose® (interferon beta-1a)

Rebif® Rebidose® (interferon beta-1a)

OVERVIEW

Meet Rebif Rebidose

WHAT PEOPLE SAID IN A USER TRIALIn a short-term, open-label user trial*:

* In this user trial, Rebif Rebidose was evaluated for 12 weeks by 109 patients with relapsing MS who had previously taken Rebif using the prefilled syringes or the reusable Rebiject II autoinjector.

† See storage and disposal information below.

‡ Rebif should be refrigerated (between 36°F and 46°F). Do not freeze. If refrigeration is not available, Rebif Rebidose can be stored at room temperature for up to 30 days away from heat and light.

Storage and disposal

DISPOSAL PROGRAM

The people in these photos are not actual Rebif patients.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

WHAT PEOPLE SAID IN A USER TRIAL
In a short-term, open-label user trial*:

^*In this user trial, Rebif Rebidose was evaluated for 12 weeks by 109 patients with relapsing MS who had previously taken Rebif using the prefilled syringes or the reusable Rebiject II autoinjector.

^†See storage and disposal information below.

^‡ Rebif should be refrigerated (between 36°F and 46°F). Do not freeze. If refrigeration is not available, Rebif Rebidose can be stored at room temperature for up to 30 days away from heat and light.