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Multiple Sclerosis - MS LifeLines

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Rebiject II

Rebiject II is the latest generation of Rebiject autoinjector designed for use with Rebif® (interferon beta-1a ). Rebiject II may make your injections easier and more convenient than a manual injection. Rebiject II is for use only with Rebif pre-measured, pre-filled glass syringes and is available exclusively for Rebif users. This device is only for you and should not be shared. Rebiject II is available free of charge through the MS LifeLines® Support Program toll free at 1-877-447-3243, Monday through Friday, 8 AM to 10 PM ET.

Caution: Federal Law (U.S.) restricts this device for sale by or on the order of a physician.

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How to use Rebiject II

  1. Check that the gray Needle Cap Remover is completely attached to the end of the Needle Depth Adjuster.
  2. Hold the Syringe Housing firmly on a flat surface. Align the dark yellow round end of the Device Plunger to the gray Needle Cap Remover. Push the Injector Body down to move the Release Mechanism inside the Injector Body until it will go no further and a click is heard. Remove Syringe Housing from Injector Body.
  3. The Rebiject II autoinjector is preset to administer the injection approximately 10 mm (3/8 inch) into the skin when the setting reads [>>>]. See Maintenance and Troubleshooting information to decrease the depth setting if directed by your doctor, nurse, or other healthcare provider.
  4. Prepare your Rebif® (interferon beta-1a) dose as directed by your doctor, nurse, or other healthcare provider. Do not remove the needle cap or syringe plunger.
  5. Insert the Rebif syringe needle cap end first into the Syringe Housing. With gentle pressure, push the syringe down into the Syringe Housing until a click is heard, locking the syringe in the Syringe Housing.
  6. Screw the Syringe Housing containing the syringe and the Injector Body together.
  7. Pull the Needle Cap Remover from Syringe Housing to remove the needle cap from the syringe. Dispose of the needle cap.
  8. Prepare the injection site according to the instructions in the Rebif Medication Guide that accompanies the drug or as directed by your doctor, nurse, or healthcare provider. Place the Rebiject II autoinjector against your skin so that you can see the Indicator Window. Apply slight pressure so the Injector Body moves downwards, toward the Syringe Housing. This releases the safety lock so that the Release Button can be pressed.
  9. Press the Release Button and continue to hold the Rebiject II autoinjector in place on your skin for at least 10 seconds. The syringe contents are injected automatically.
  10. View Indicator Window. When the injection has been completed, a series of black lines is visible against the yellow background in the window and their movement is stopped.
  11. Withdraw the Rebiject II autoinjector from the skin. Clean the skin according to the instructions in the Rebif Medication Guide that accompanies the drug or as directed by your doctor, nurse, or other healthcare provider.
  12. Unscrew the Syringe Housing from the Injector Body. Remove the syringe from the Syringe Housing and dispose of the empty needle and syringe properly in a biohazard* container.
  13. Reattach the Needle Cap Remover and the Needle Depth Adjuster and store the device in its case.

IMPORTANT

Contact your doctor, nurse, other healthcare provider, or call MS LifeLines toll free at 1-877-447-3243, Monday through Friday, 8 AM to 10 PM ET, if:

  • You are unsure about any of these steps.
  • Rebiject II autoinjector is not working properly.
  • You cannot perform the injection using Rebiject II.

Maintenance and Troubleshooting

  • Contact your doctor, nurse, or other healthcare provider for further instruction if you received less than the prescribed dose using the Rebiject II autoinjector, or otherwise experience difficulties with the use of the Rebiject II autoinjector.
  • The depth of needle insertion into the skin can be decreased by turning the green end of the device counterclockwise. Scale readings (>, >>, >>>) are visible and correspond to a depth of setting range from approximately 6 mm to 10 mm (3/8 inch or less). Your doctor, nurse, or other healthcare provider will provide instructions if a change in depth setting is needed.
  • The Rebiject II autoinjector may be cleaned by wiping with a damp cloth if needed. Do not use soap. The Rebiject II autoinjector should not be placed in boiling water, microwaved, or autoclaved.
  • Never store a loaded Rebiject II autoinjector.
  • In the unlikely event of a failure of the Rebiject II autoinjector, please contact MS LifeLines toll free at 1-877-447-3243, Monday through Friday, 8 AM to 10 PM ET, for a replacement.

Replacement

Every effort has been made to ensure that the Rebiject II will function correctly for at least two years. After two 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, Monday through Friday, 8 AM to 10 PM ET.

Warnings

  • Do not inject yourself using Rebiject II autoinjector until you have had proper training by a doctor, nurse, or other healthcare provider.
  • Rebiject II must be used according to its instructions. Read the instructions that came with your Rebiject II thoroughly and save them. You may want to refer to them again.
  • Rebiject II must only be used with Rebif® (interferon beta-1a) and no other brand of interferon or medication.
  • Do not share Rebiject II with anyone since doing so may result in infection, including the transmission of infectious blood-borne diseases. Adhere to strict safety and antiseptic precautions at all times.

Safety Precautions

  • Only use Rebiject II with Rebif pre-filled glass syringes with fixed needles and removable plungers that have been prescribed to you.
  • 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.
  • Always keep Rebiject II autoinjector and Rebif out of the reach of children.

For more information about the Rebiject II autoinjector, call MS LifeLines toll free at 1-877-447-3243, Monday through Friday, 8 AM to 10 PM ET. For complete instructions on the use of the Rebiject II autoinjector, please refer to the instructions that came with your Rebiject II.

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

Brought to you by EMD Serono, Inc. and Pfizer Inc, the co-marketers of Rebif® (interferon beta-1a) in the US EMD SeronoPfizer

Prescribing Information - Medication Guide

This information is intended only for residents of the United States.

Indication

Rebif is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS. Rebif is not approved for treatment of chronic progressive MS. Rebif is available in 22 mcg and 44 mcg prefilled, preassembled syringes and a titration pack by prescription only.

Important Safety Information

Before beginning treatment, patients should discuss with their doctor the potential benefits and risks associated with Rebif. Let your doctor know if you have a history of depression, seizures, liver disease, thyroid problems, or blood cell count or bleeding problems, or if you have had previous allergic reactions to medications. Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Rebif and other medicines may affect each other causing serious side effects. Talk to your doctor before you take any new medicines. Rebif is not recommended for women who are or plan to become pregnant.

Potential serious side effects of Rebif include depression and risk of suicide, liver problems, risk to pregnancy, injection-site problems, and severe allergic reactions. Allergic reactions are rare and may be associated with difficulty in breathing and loss of consciousness, which require immediate medical attention.

The most common side effects with Rebif are injection-site reactions, flu-like symptoms (fever, chills, muscle aches, tiredness), depression, abdominal pain, increased liver enzymes, and blood cell count decreases. Let your doctor know if you have any of these symptoms or feel sad, tired, hot or cold, or experience hives, rashes, bruising, yellowing of the skin, or a change in body weight (gain or loss).

Compared with Avonex, side effects were generally similar despite the higher, more frequent dosing of Rebif. Differences included people taking Avonex had more flulike symptoms than those taking Rebif. People taking Rebif had a greater number of injection-site reactions, elevated liver enzymes, and decreased white blood cell counts; these events also occurred more frequently with Rebif posttransition versus prior use of Avonex.

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

This information is not intended to replace discussions with your doctor. For additional information about Rebif, please consult the Prescribing Information and Medication Guide and talk to your doctor. You can also visit www.mslifelines.com or call toll-free 1-877-44-REBIF (1-877-447-3243). Rebif is available by prescription only.

MS LifeLines is an educational support service for people living with MS and their families. MS LifeLines and MS LifeLines Ambassadors are sponsored by EMD Serono, Inc. and Pfizer Inc.

Rebif, Rebiject II and MS LifeLines are registered trademarks and the Rebif logo is a trademark of EMD Serono, Inc. or its affiliates.

MS in Balance Your Life in Full is a service mark of EMD Serono, Inc. or its affiliates.

Copyright 2010 EMD Serono, Inc. All rights reserved.