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AVONEX- interferon beta-1a kitAVONEX PEN- interferon beta-1a injection, solutionAVONEX- interferon beta-1a injection, powder, lyophilized, for solution


  1. Patient Information
  2. Do Not Take Avonex If You:
  3. Before Taking Avonex, Tell Your Healthcare Provider If You:
  4. How Should I Use Avonex?
  5. Avonex Can Cause Serious Side Effects Including:
  6. Active Ingredient:
  7. Vial With Freeze-dried (lyophilized) Powder:
  8. Single-use Prefilled Syringe:
  9. Single-use Prefilled Autoinjector Pen:
  10. Preparing The Avonex Pen:
  11. Supplies You Will Need To Give The Avonex Pen Injection:
  12. Preparing The Avonex Pen Injection:
  13. Step 14:
  14. Step 15:
  15. Step 16:
  16. Step 18:
  17. Preparing The Dose Of Avonex:
  18. Preparing The Avonex Injection:
  19. Giving The Avonex Injection:
  20. Preparing The Avonex Prefilled Syringe:
  21. Supplies You Will Need For The Avonex Injection:
  22. Using The Avonex Prefilled Syringe With The Avostartgrip Titration Kit:
  23. Attaching The Avostartgrip Device:
  24. Week 1 Injection:
  25. Week 2 Injection:
  26. Week 3 Injection:
  27. After The Avonex Injection:
  28. Preparing The Avonex Dose:
  29. Step 10:
  30. Step 11:
  31. Step 12:
  32. Step 13:
  33. Step 17:
  34. Step 18:
  35. Step 19:
  36. Step 20:
  37. Step 21:
  38. Manufactured By:
  39. Contents:
  40. Revised: 7/2019document Id:

Patient Information 

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

  1. Behavioral health problems including depression, suicidal thoughts or hallucinations.Some people taking AVONEX may develop mood or behavior problems including:
    • irritability (getting upset easily)
    • depression (feeling hopeless or feeling bad about yourself)
    • nervousness
    • anxiety
    • aggressive behavior
    • thoughts of hurting yourself or suicide
    • hearing or

      AVONEX is a form of a protein called beta interferon that occurs naturally in the body. AVONEX is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS),to include clinically isolated syndrome, relapsing -remitting disease, and active secondary progressive disease, in adults.

      It is not known if AVONEX is safe and effective in children.

Do Not Take Avonex If You: 

  • are allergic to interferon beta, albumin (human), or any of the ingredients in AVONEX.

Before Taking Avonex, Tell Your Healthcare Provider If You: 

  • are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior
  • have or had bleeding problems or blood clots
  • have or had low blood cell counts
  • have or had liver problems
  • have or had seizures (epilepsy)
  • have or had heart problems
  • have or had thyroid problems
  • have or had any kind of autoimmune disease (where the body's immune system attacks the body's own cells), such as psoriasis, systemic lupus erythematosus, or rheumatoid arthritis
  • drink alcohol
  • are pregnant or plan to become pregnant. It is not known if AVONEX will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with AVONEX.
  • are breastfeeding or plan to breastfeed. It is not known if AVONEX passes into your breast milk. You and your healthcare provider should decide if you will use AVONEX or breastfeed. You should not do both.

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

How Should I Use Avonex? 

  • Your healthcare provider should show you how to prepare and measure your dose of AVONEX and how to inject your AVONEX before you use AVONEX for the first time.
  • Your healthcare provider or nurse should watch the first AVONEX injection you give yourself.
  • AVONEX is given once a week by injection into the muscle (intramuscular injection).
  • Inject AVONEX exactly as your healthcare provider tells you.
  • Your healthcare provider will tell you how much AVONEX to inject and how often to inject AVONEX.Do notinject more than your healthcare provider tells you to.
  • If you miss a dose, you should take your next dose as soon as you remember. You should continue your regular schedule the following week.Do not take AVONEX 2 days in a row.
  • Do notchange your dose unless your healthcare provider tells you to.
  • Change (rotate) your injection site you choose with each injection. This will help decrease the chance that you will have an injection site reaction.
  • Do notinject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way.
  • AVONEX comes as a:
    • Vial with freeze-dried (lyophilized) powder
    • Prefilled syringe (can be used with the AVOSTARTGRIP titration kit)
    • Single-Use Prefilled Autoinjector Pen (AVONEX PEN)

Your healthcare provider will decide which one is best for you.

Avonex Can Cause Serious Side Effects Including: 

    • Store AVONEX in the refrigerator at 36 F to 46 F (2 C to 8 C).
    • Do notfreeze AVONEX.Do notuse AVONEX that has been frozen.
    • Do notstore AVONEX above 77 F (25 C).
    • Keep AVONEX away from light.
    • Do notuse AVONEX past the expiration date.
    • If you cannot refrigerate your AVONEX vials, you can store your AVONEX vials at 77 F (25 C) for up to 30 days. After mixing, the AVONEX solution should be used immediately, within 6 hours when stored refrigerated at 36 F to 46 F (2 C to 8 C).
    • If you cannot refrigerate your AVONEX PEN and AVONEX prefilled syringes, you can store your AVONEX PEN and AVONEX prefilled syringes up to 77 F (25 C) for up to 7 days.

    Keep AVONEX vials, prefilled syringes, pens and all other medicines out of the reach of children.

    General advice about the safe and effective use of AVONEX

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.Do notuse AVONEX for a condition for which it was not prescribed.Do notgive AVONEX to other people, even if they have the same symptoms that you have, it may harm them.

    This Medication Guide summarizes the most important information about AVONEX. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about AVONEX that is written for healthcare professionals.

Active Ingredient: 

interferon beta-1a

Vial With Freeze-dried (lyophilized) Powder: 

albumin (human), sodium chloride, dibasic sodium phosphate, and monobasic sodium phosphate.

Single-use Prefilled Syringe: 

sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride, polysorbate 20 in water for injection.

Single-use Prefilled Autoinjector Pen: 

sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride, polysorbate 20 in water for injection.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Preparing The Avonex Pen: 

  • Find a well lit, clean, flat work surface like a table and collect all the supplies you will need to give yourself or receive an injection.
  • Take 1 AVONEX PEN Administration Dose Pack out of the refrigerator about 30 minutes before you plan on injecting the AVONEX dose to allow it to reach room temperature.Do notuse external heat sources such as hot water to warm the AVONEX PEN.
  • Check the expiration date printed on the AVONEX PEN, AVONEX PEN Administration Dose Pack carton, and the outer carton.Do notuse the AVONEX PEN past the expiration date.
  • Wash your hands with soap and water.

Supplies You Will Need To Give The Avonex Pen Injection: 

  • 1 AVONEX Administration Dose Pack that contains:
    • 1 AVONEX PEN
    • a 25 gauge, 5/8 inch long sterile needle
    • 1 AVONEX PEN cover
  • 1 alcohol wipe
  • 1 gauze pad
  • 1 adhesive bandage
  • a puncture resistant container for disposal of used AVONEX PEN and needle

Identifying parts of the AVONEX PEN (SeeFigure A).

Single-Use Administration Dose Pack Contents AVONEX PEN, Supplied Needle and AVONEX PEN Cover

Figure

(Figure A)

Preparing The Avonex Pen Injection: 

Step 1:Hold the AVONEX PEN with the white tamper-evident cap (cap) pointing up (SeeFigure B).
  • Check that the cap is intact and has not been removed. If the cap has been removed or is not tightly attached,do notuse it, throw it away and get a new AVONEX PEN.



Figure (Figure B)
Step 2:With your other hand, grasp the cap and bend it at a 90 angle until the cap snaps off (SeeFigure C).
  • After the cap comes off, you will see the glass tip of the syringe.Do nottouch the glass tip of the syringe (SeeFigure D).


Figure (Figure C)

Figure (Figure D)
Step 3:Place the AVONEX PEN down on a flat work surface.
Step 4:Pull off the sterile foil from the needle cover (SeeFigure E).
  • Only use the needle that comes with your AVONEX PEN.


Figure (Figure E)
Step 5:Hold the AVONEX PEN with the glass syringe tip pointing up. Press the needle onto the AVONEX PEN glass syringe tip (SeeFigure F).

Figure (Figure F)
Step 6:Gently turn the needle clockwise until it is firmly attached (SeeFigure G).
  • If the needle is not firmly attached, it may leak, and you may not get your full dose of AVONEX.

Figure (Figure G)
  • Do notremove the plastic cover from the needle (SeeFigure H).


Figure (Figure H)
Step 7:Hold the body of the AVONEX PEN in 1 hand with the needle and needle cover pointing away from you and other people.Do notremove the plastic cover from the needle (SeeFigure I).

Figure (Figure I)
Step 8:Using your other hand, hold onto the injector shield (grooved area) tightly and quickly pull up on the injector shield until the injector shield covers the needle all the way.
  • The plastic needle cover will pop off after the injector shield has been fully extended (SeeFigure J).


Figure (Figure J)
  • When the injector shield is extended the right way, you will see a small blue rectangular area next to the oval medication display window (SeeFigure K).


Figure (Figure K)
Step 9:Check the oval medication display window and make sure the AVONEX is clear and colorless (SeeFigure L).
You might see air bubbles in the oval display window. This is normal and will not affect your dose.
  • Do notuse AVONEX PEN if the liquid is colored, cloudy, or contains any lumps or particles. Throw away the AVONEX PEN and get a new one, then repeat steps 1 to 9.

Figure (Figure L)

Step 14: 

Continue to firmly maintain pressure and push down on the AVONEX PEN against the injection site, then push down on the blue activation button with your thumb (SeeFigure S). Keep the AVONEX PEN pushed down against the injection site and slowly count to 10.
  • You will hear a click when the injection starts.If youdo nothear a click , your injection was not given the right way.
    • If this happens, make sure that the injector shield is extended, the safety lock is completely released, and that you are firmly maintaining pressure and pushing down against the injection site. Press the blue activation button with your thumb again. If you stilldo nothear a click , call Biogen Idec Inc. at 1-800-456-2255.

Figure (Figure S)


Figure

Step 15: 

After you count to 10, pull the AVONEX PEN straight out of the skin (SeeFigure T). Use the gauze pad to apply pressure to the injection site for a few seconds or rub gently in a circular motion.
  • If you see blood after you press the injection site for a few seconds, wipe it off with gauze and apply an adhesive bandage.

Figure (Figure T)

Step 16: 

Check the circular display window on the AVONEX PEN to make sure that it is yellow. This is to be sure that you have been given your full dose (SeeFigure U).
  • If you did not receive your full dose of AVONEX, throw away the AVONEX PEN and call your doctor.Do notre-use the AVONEX PEN.



Figure (Figure U)STEP 17: Do nothold the AVONEX PEN cover with your hands. Place the AVONEX PEN cover on a flat work surface.Line up the exposed needle with the hole of the AVONEX PEN cover, and insert directly into the opening (SeeFigure V).
Figure (Figure V)

Step 18: 

Firmly press the AVONEX PEN down until you hear a click to seal the needle (SeeFigure W). You may need to hold both hands around the AVONEX PEN body to snap the AVONEX PEN cover into place.
Figure (Figure W)

Preparing The Dose Of Avonex: 

  • Find a well lit, clean, flat work surface like a table and collect all the supplies you will need to give yourself or receive an injection.
  • Take 1 AVONEX Administration Dose Pack out of the refrigerator about 30 minutes before you plan on injecting the AVONEX dose to allow it to reach room temperature.Do notuse external heat sources such as hot water to warm the AVONEX prefilled syringe.
  • Check the expiration date printed on AVONEX prefilled syringe, AVONEX prefilled syringe Administration Dose Package carton, and the outer carton.Do notuse AVONEX prefilled syringe past the expiration date.
  • Wash your hands with soap and water.

Identifying parts of the AVONEX prefilled syringe (SeeFigure A):

Preparing The Avonex Injection: 

Step 1:Hold the AVONEX prefilled syringe with the cap pointing down and with the 0.5 mL mark at eye level (SeeFigure A).
  • Check the syringe:
    • The syringe should not have any cracks or damage.
    • Check that the cap is intact and has not been removed.
    • The amount of liquid in the syringe should be at or very close to the 0.5 mL mark.
    • AVONEX should look clear, colorless, and should not have any particles in it.
  • Do notuse the AVONEX prefilled syringe if:
    • the syringe is cracked or damaged
    • the solution is cloudy, colored, or has lumps or particles in it
    • the cap has been removed or is not tightly attached or
    • there is not enough liquid in the syringe

Do notuse that syringe. Get a new syringe. Contact MS ACTIVESOURCE at 1-800-456-2255.


Figure (Figure A)
Step 2:With 1 hand, hold the AVONEX prefilled syringe right under the cap and with the cap pointing up (SeeFigure B).
  • Make sure you are holding the AVONEX prefilled syringe by the ridged part, directly under the cap.


Figure (Figure B)
Step 3:With the other hand, grasp the cap and bend it at a 90 angle until the cap snaps off (SeeFigure CandFigure D).

Figure (Figure C)


Figure (Figure D)
Step 4:Open the sterile needle package and take out the covered needle. Hold the AVONEX prefilled syringe with the glass syringe tip pointing up. Press the needle on the AVONEX prefilled syringe glass tip (SeeFigure E).



Figure (Figure E)
Step 5:Gently turn the needle forward (clockwise) until it is tight and firmly attached (SeeFigure F).
  • If the needle is not firmly attached, it may leak and you may not get your full dose of AVONEX.
  • Do notremove the plastic cover from the needle.


Figure (Figure F)

Giving The Avonex Injection: 

  • Your healthcare provider should show you or a caregiver how to prepare and inject the dose of AVONEX before AVONEX prefilled syringe is used for the first time. Your healthcare provider or nurse should watch you inject the dose of AVONEX the first time AVONEX prefilled syringe is used.
  • Inject your AVONEX exactly as your healthcare provider has shown you.
  • AVONEX is injected into the muscle (intramuscularly).
  • AVONEX should be injected into the thigh or upper arm (SeeFigures GandH).
  • Change (rotate) your injection sites for each dose.Do notuse the same injection site for each injection.
  • Do notinject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way.
Step 6:Choose an injection site and wipe the skin with an alcohol wipe (SeeFigures GandH). Let the injection site dry before injecting the dose.
  • Do nottouch this area again before giving the injection.


Figure Figure
(Figure G) (Figure H)


Step 7:Pull the protective cover straight off the needle (SeeFigure I).Do nottwist the cover off.

Figure (Figure I)
Step 8:With 1 hand, stretch the skin out around the injection site. With the other hand, hold the syringe like a pencil. Use a quick dart-like motion and insert the needle at a 90 degree angle, through the skin and into the muscle (SeeFigure J). Once the needle is in, let go of the skin.

Figure (Figure J)

Step 9:Slowly push the plunger down until the syringe is empty (SeeFigure K).








Figure (Figure K)

Preparing The Avonex Prefilled Syringe: 

  • Find a well lit, clean, flat work surface like a table and collect all the supplies you will need to give yourself or receive an injection.
  • Take 1 AVONEX Administration Dose Pack out of the refrigerator about 30 minutes before you plan on injecting the AVONEX dose to allow it to reach room temperature.Do notuse external heat sources such as hot water to warm the AVONEX prefilled syringe.
  • Check the expiration date printed on the AVONEX prefilled syringe, AVONEX prefilled syringe Administration Dose Package carton, and the outer carton.Do notuse the AVONEX prefilled syringe past the expiration date.
  • Wash your hands with soap and water.

Supplies You Will Need For The Avonex Injection: 

  • 1 AVONEX Administration Dose Pack that contains:
    • 1 AVONEX prefilled syringe
    • 23 gauge, 1 inch long sterile needle
  • 1 alcohol wipe
  • 1 gauze pad
  • 1 adhesive bandage
  • a puncture resistant container for disposal of used syringes and needles

Identifying parts of the AVONEX prefilled syringe (SeeFigure A):

Using The Avonex Prefilled Syringe With The Avostartgrip Titration Kit: 

  • Your AVONEX dose may be titrated over 3 weeks by using AVONEX prefilled syringe with the AVOSTARTGRIP titration kit. The AVOSTARTGRIP is used for giving the week 1, 2, and 3 ( , , ) injections.
    • Week 1: dose (white device)
    • Week 2: dose (yellow device)
    • Week 3: dose (purple device)
    • Week 4: a full dose
  • The 3 AVOSTARTGRIP devices are for single-use only with the AVONEX prefilled syringe.Do notre-use the AVONEX prefilled syringe and AVOSTARTGRIP devices.
  • You must prepare the AVONEX prefilled syringe and needle before you put it into the AVOSTARTGRIP device.Follow steps 1 to 5 above to prepare the AVONEX prefilled syringe.

Identifying the parts of AVOSTARTGRIP titration kit (SeeFigure G):

Figure

(Figure G)

  • AVOSTARTGRIP has a collar on top of the device that will stop the syringe from injecting a full dose (SeeFigure H). The collar makes sure that you do not get the full dose of AVONEX.
Figure

(Figure H)

Attaching The Avostartgrip Device: 

Step 6:Choose the right AVOSTARTGRIP titration device for your weekly dose.

Week 1 Injection: 

Choose thewhitedevice to give dose (SeeFigure I).

Figure (Figure I)

Week 2 Injection: 

Choose theyellowdevice to give dose (SeeFigure J).
Figure (Figure J)

Week 3 Injection: 

Choose thepurpledevice to give dose (SeeFigure K).Figure (Figure K)Step 7:Put the right AVOSTARTGRIP device on a flat surface with the door open (SeeFigure L).

Figure (Figure L)Step 8:Line up the AVONEX prefilled syringe over the AVOSTARTGRIP device with the plunger pointing to the left and the needle pointing to the right (SeeFigure M).

Figure (Figure M)Step 9:Push the AVONEX prefilled syringe down into the AVOSTARTGRIP device until both ends snap into place (SeeFigure N).

Figure (Figure N)

After The Avonex Injection: 

Do notrecap the needle. Recapping the needle can lead to a needle stick injury.

  • Throw away the used AVONEX prefilled syringes, AVOSTARTGRIP devices, and needles in a sharps container or some type of hard plastic or metal container with a screw cap such as a detergent bottle or coffee can. Check with your healthcare provider about the right way to throw away the container. There may be local or state laws about how to throw away used AVONEX prefilled syringes, AVOSTARTGRIP devices, and needles.Do notthrow away used AVONEX prefilled syringes, AVOSTARTGRIP devices, and needles in household trash or recycling bins.
  • After 2 hours, check the injection site for redness, swelling or tenderness. If you have a skin reaction and it does not clear up in a few days, contact your healthcare provider.

General information about the safe and effective use of AVONEX

  • Always use a new AVONEX prefilled syringe, AVOSTARTGRIP device, and needle for each injection.Do notre-use your AVONEX prefilled syringe, AVOSTARTGRIP device, or needles.
  • Do notshare your AVONEX prefilled syringe, AVOSTARTGRIP device, or needles.
  • Keep the AVONEX prefilled syringe, AVOSTARTGRIP device, and needles out of the reach of children.
  • You can use the table below to keep track of your weekly injections.

Figure

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised 09/2016
Manufactured for:
Biogen Inc.
250 Binney Street
Cambridge, MA 02142 USA
2012-2016 Biogen. All rights reserved.
1-800-456-2255

I11073-05

Instructions for Use

AVONEX(a-vuh-necks)

(interferon beta-1a)

lyophilized powder for intramuscular injection

single-use vial

Read the Instructions for Use before you start using AVONEX and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Supplies you will need for the AVONEX injection (SeeFigure A):

  • 1 AVONEX Administration Dose Pack that contains:
    • 1 vial of AVONEX (white to off-white powder or cake)
    • 10 mL diluent vial (Sterile Water for Injection, USP)
    • a 3 mL syringe
    • 1 MICRO PIN(vial access pin)
    • 23 gauge, 1 inch long sterile needle
    • 2 alcohol wipes
    • 1 gauze pad
    • 1 adhesive bandage
  • a puncture resistant container for disposal of used syringes, needles, and MICRO PIN

Preparing The Avonex Dose: 

Step 1:Pull off the cap from the vial of AVONEX and the vial of diluent (SeeFigure B).


Figure (Figure B)
Step 2:Wipe the rubber stopper on each vial with an alcohol wipe (SeeFigure C).

Figure (Figure C)
Step 3:Open the sterile package and take out the MICRO PIN. Hold the syringe with the tip pointing up. Push the MICRO PIN down onto the top of the syringe. Turn the MICRO PIN counterclockwise until it is tight and firmly attached (SeeFigure D).
  • Do notover-tighten the MICRO PIN, it can make it hard to remove.



Figure (Figure D)
Step 4:Pull straight up on the MICRO PIN cover to remove it, and save the cover for later (SeeFigure E).Do nottwist the MICRO PIN cover when you are removing it.


Figure (Figure E)
Step 5:Pull down the syringe plunger until the rubber tip reaches the 1.1 mL mark (SeeFigure F).

Figure (Figure F)
Step 6:Push the MICRO PIN down through the center of the rubber stopper of the diluent vial (SeeFigure G).


Figure (Figure G)
Step 7:Push the plunger all the way in. This puts air into the diluent vial (SeeFigure H).

Figure (Figure H)
Step 8:Keep the MICRO PIN in the vial. Turn the diluent vial and syringe upside down and slowly pull the plunger down until the rubber tip reaches the 1.1 mL mark on the syringe (SeeFigure I).
  • If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top (SeeFigure J). If you still see air bubbles, slowly push the plunger up until the bubbles come out through the needle. Check to make sure there is still 1.1 mL of diluent in the syringe.


Figure (Figure I)



Figure (Figure J)
Step 9:Slowly pull the MICRO PIN out of the diluent vial's rubber stopper (SeeFigure K).

Figure (Figure K)

Step 10: 

Push the MICRO PIN through thecenterof the rubber stopper of the AVONEX vial (SeeFigure L).
  • If the rubber stopper of the AVONEX vial falls into the vial,do notuse the AVONEX. Throw away the AVONEX vial and get a new one, then repeat steps 1 to 10.



Figure (Figure L)

Step 11: 

Slowly push the plunger all the way in. This puts the diluent into the vial of AVONEX.Do notremove the syringe (SeeFigure M).
  • Do notaim the stream of diluent directly on the AVONEX powder or push the plunger down too fast. If you aim the stream of diluent directly on the AVONEX powder or push the plunger down too fast, the AVONEX may foam and make it hard to withdraw the AVONEX into the syringe.


Figure (Figure M)

Step 12: 

Gently swirl the AVONEX vial until the powder in the vial is dissolved (SeeFigure N).Do notshake the AVONEX vial.
  • Check the AVONEX vial to make sure that all of the AVONEX is dissolved.
  • AVONEX should look clear to slightly yellow in color after mixing and should not have any particles in it.Do notuse AVONEX if it looks cloudy, is colored any color other than slightly yellow, or has any lumps or particles in it.

Do notuse that vial. Get a new vial. Contact MS ACTIVESOURCE at 1-800-456-2255.

Figure (Figure N)

Step 13: 

Turn the AVONEX vial and syringe upside down and slowly pull the plunger down until the rubber tip reaches the 1 mL mark on the syringe (SeeFigure O).
  • If there are large bubbles in the syringe, slowly push the plunger all the way in to push the AVONEX solution back into the vial, then repeat Step 13.
  • If there are small air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top (SeeFigure P). If you still see air bubbles, slowly push the plunger up until the bubbles come out through the needle.



Figure (Figure O)

Figure (Figure P)

Step 17: 

Choose an injection site and wipe the skin with an alcohol wipe (SeeFigures UandV). Let the injection site dry before injecting the dose.
  • Do nottouch this area again before giving the injection.

Figure Figure
(Figure U) (Figure V)


Step 18: 

Pull the protective cover straight off the needle (SeeFigure W).Do nottwist the cover off.

Figure (Figure W)

Step 19: 

With 1 hand, stretch the skin out around the injection site. With the other hand, hold the syringe like a pencil. Use a quick dart-like motion and insert the needle at a 90 degree angle, through the skin and into the muscle (SeeFigure X). Once the needle is in, let go of the skin.


Figure (Figure X)

Step 20: 

Slowly push the plunger in until the syringe is empty (SeeFigure Y).




Figure (Figure Y)

Step 21: 

Pull the needle out of the skin (SeeFigure Z). Press down on the injection site with the gauze pad for a few seconds or rub gently in a circular motion.
  • If you see blood after you press the injection site for a few seconds, wipe it off with gauze and apply an adhesive bandage.


Figure (Figure Z)

Manufactured By: 

Biogen Inc.

Cambridge, MA 02142 USA

Biogen [1996-2015]. All rights reserved.

1-800-456-2255

MICRO PINis the trademark of B. Braun Medical Inc.

Revised: 08/2015

41612-02

Principal Display Panel - 30 mcg Carton Label

NDC 59627-003-01

Avonex Pen

(interferon beta-1a)

Injection

30 mcg/0.5 mL Single-Use Prefilled Autoinjector

For Intramuscular Injection

Once a Week

Avonex PenAdministration Dose Pack

ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.

Store refrigerated at 2-8 C (36-46 F).

Do not freeze or expose to high temperatures. Protect from light.

The recommended dosage of Avonexis 30 mcg injected intramuscularly
once weekly. See package insert for full prescribing information.

This Product Contains Dry Natural Rubber.

Rx only

Principal Display Panel - 30 mcg Carton Label

Principal Display Panel - 30 mcg Carton Label

NDC 59627-002-06

Avonex
(interferon beta-1a)
Injection

30 mcg/0.5 mL Single-Use Prefilled Syringe

For Intramuscular Injection

Once a Week

AvonexAdministration Dose Pack

ATTENTION PHARMACIST: Each patient is required
to receive the enclosed Medication Guide.

Store refrigerated at 2-8 C (36-46 F)

Do not freeze or expose to high temperatures.

Protect from light.

See package insert for dosage and administration.

This Product Contains Dry Natural Rubber.

Rx only

Principal Display Panel - 30 mcg Carton Label

Principal Display Panel - 30 mcg Carton Label

NDC 59627-111-03

Avonex
(interferon beta-1a)
Injection

30 mcg Single-Use Lyophilized Powder Vial

For Intramuscular Injection

Once a Week

Contents: 

4 AvonexAdministration Dose Packs

ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.

This Product Contains Dry Natural Rubber.

Rx only

Store refrigerated at 2-8 C (36-46 F).

Do not freeze or expose to high temperatures.

Protect from light.

See package insert for dosage and administration.

Principal Display Panel - Carton Label

Principal Display Panel - Tray Lid Label

Avonex(interferon beta-1a)

30 mcg/0.5 mL Single-Use Prefilled Syringe

For Intramuscular Injection

Store refrigerated at 2-8 C (36-46 F). Do not freeze or expose to high temperatures.

Protect from light. Contents: 1 single-use prefilled syringe of Avonexand 1, 23G, 1 1/4" needle. See package insert for dosage and administration. This Product Contains Dry Natural Rubber.ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.U.S. License# 1697

Biogen Inc., Cambridge, MA 02142 1-800-456-2255 Rx only 46043 -02

NDC 59627-002-07

Principal Display Panel - Tray Lid Label
AVONEX
interferon beta-1a kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59627-333
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59627-333-041 in 1 CARTON; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)08/29/2014
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 SYRINGE2 mL
Part 24 POUCH1.6 mL
Part 1 of 2
AVONEX PEN
interferon beta-1a injection, solution
Product Information
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
interferon beta-1a(UNII: XRO4566Q4R) (interferon beta-1a - UNII:XRO4566Q4R)interferon beta-1a30 ug in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
Sodium acetate(UNII: 4550K0SC9B)0.79 mg in 0.5 mL
Arginine hydrochloride(UNII: F7LTH1E20Y)15.8 mg in 0.5 mL
acetic acid(UNII: Q40Q9N063P)0.25 mg in 0.5 mL
polysorbate 20(UNII: 7T1F30V5YH)0.025 mg in 0.5 mL
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 BOX
10.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10362805/23/2003
Part 2 of 2
DUKAL ALCOHOL PREP
isopropyl alcohol swab
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL(UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)ISOPROPYL ALCOHOL0.70 mL in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 POUCH
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34405/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10362808/29/2014
AVONEX
interferon beta-1a kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59627-222
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59627-222-051 in 1 CARTON; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)08/29/2014
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 SYRINGE2 mL
Part 24 POUCH1.6 mL
Part 1 of 2
AVONEX
interferon beta-1a injection, solution
Product Information
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
interferon beta-1a(UNII: XRO4566Q4R) (interferon beta-1a - UNII:XRO4566Q4R)interferon beta-1a30 ug in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
Sodium acetate(UNII: 4550K0SC9B)0.79 mg in 0.5 mL
Arginine hydrochloride(UNII: F7LTH1E20Y)15.8 mg in 0.5 mL
acetic acid(UNII: Q40Q9N063P)0.25 mg in 0.5 mL
polysorbate 20(UNII: 7T1F30V5YH)0.025 mg in 0.5 mL
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 TRAY
10.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10362805/23/2003
Part 2 of 2
DUKAL ALCOHOL PREP
isopropyl alcohol swab
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL(UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)ISOPROPYL ALCOHOL0.70 mL in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 POUCH
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34405/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10362808/29/2014
AVONEX
interferon beta-1a kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59627-111
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59627-111-034 in 1 CARTON08/29/2014
1NDC:59627-111-041 in 1 TRAY; Type 1: Convenience Kit of Co-Package
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 VIAL, GLASS1 mL
Part 21 VIAL10 mL
Part 32 POUCH0.8 mL
Part 1 of 3
AVONEX
interferon beta-1a injection, powder, lyophilized, for solution
Product Information
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
interferon beta-1a(UNII: XRO4566Q4R) (interferon beta-1a - UNII:XRO4566Q4R)interferon beta-1a30 ug in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium acetate(UNII: 4550K0SC9B)1.58 mg in 1 mL
Arginine hydrochloride(UNII: F7LTH1E20Y)31.6 mg in 1 mL
acetic acid(UNII: Q40Q9N063P)0.5 mg in 1 mL
polysorbate 20(UNII: 7T1F30V5YH)
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 mL in 1 VIAL, GLASS; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10362805/17/1996
Part 2 of 3
STERILE WATER
water injection, solution
Product Information
Route of AdministrationINTRAMUSCULAR
Inactive Ingredients
Ingredient NameStrength
WATER(UNII: 059QF0KO0R)10 mL in 10 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01880109/15/2011
Part 3 of 3
DUKAL ALCOHOL PREP
isopropyl alcohol swab
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL(UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)ISOPROPYL ALCOHOL0.70 mL in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34405/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10362808/29/2014
AVONEX PEN
interferon beta-1a injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59627-003
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
interferon beta-1a(UNII: XRO4566Q4R) (interferon beta-1a - UNII:XRO4566Q4R)interferon beta-1a30 ug in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
Sodium acetate(UNII: 4550K0SC9B)0.79 mg in 0.5 mL
Arginine hydrochloride(UNII: F7LTH1E20Y)15.8 mg in 0.5 mL
acetic acid(UNII: Q40Q9N063P)0.25 mg in 0.5 mL
polysorbate 20(UNII: 7T1F30V5YH)0.025 mg in 0.5 mL
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59627-003-044 in 1 CARTON05/23/200306/30/2016
1NDC:59627-003-011 in 1 BOX
10.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10362805/23/200306/30/2016
AVONEX
interferon beta-1a injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59627-002
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
interferon beta-1a(UNII: XRO4566Q4R) (interferon beta-1a - UNII:XRO4566Q4R)interferon beta-1a30 ug in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
Sodium acetate(UNII: 4550K0SC9B)0.79 mg in 0.5 mL
Arginine hydrochloride(UNII: F7LTH1E20Y)15.8 mg in 0.5 mL
acetic acid(UNII: Q40Q9N063P)0.25 mg in 0.5 mL
polysorbate 20(UNII: 7T1F30V5YH)0.025 mg in 0.5 mL
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59627-002-054 in 1 CARTON05/23/200308/31/2016
1NDC:59627-002-071 in 1 TRAY
10.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10362805/23/200308/31/2016
AVONEX
interferon beta-1a injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59627-001
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
interferon beta-1a(UNII: XRO4566Q4R) (interferon beta-1a - UNII:XRO4566Q4R)interferon beta-1a30 ug in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium acetate(UNII: 4550K0SC9B)1.58 mg in 1 mL
Arginine hydrochloride(UNII: F7LTH1E20Y)31.6 mg in 1 mL
acetic acid(UNII: Q40Q9N063P)0.5 mg in 1 mL
polysorbate 20(UNII: 7T1F30V5YH)
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59627-001-034 in 1 CARTON05/17/199607/31/2016
1NDC:59627-001-041 in 1 TRAY
11 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10362805/17/199607/31/2016
Labeler -Biogen Inc. (009492211)
Establishment
NameAddressID/FEIBusiness Operations
Biogen (Denmark) Manufacturing ApS307258082LABEL(59627-333) , PACK(59627-333) , ANALYSIS(59627-111, 59627-333, 59627-222) , MANUFACTURE(59627-333)
Establishment
NameAddressID/FEIBusiness Operations
Biogen MA Inc.841087823API MANUFACTURE(59627-333, 59627-222) , ANALYSIS(59627-111, 59627-333, 59627-222)
Establishment
NameAddressID/FEIBusiness Operations
Cilag AG483237103MANUFACTURE(59627-333, 59627-222) , ANALYSIS(59627-333, 59627-222)
Establishment
NameAddressID/FEIBusiness Operations
Packaging Coordinators, LLC078525133LABEL(59627-333, 59627-222) , PACK(59627-333, 59627-222)
Establishment
NameAddressID/FEIBusiness Operations
Sharp Corporation143696495LABEL(59627-333, 59627-222) , PACK(59627-333, 59627-222)
Establishment
NameAddressID/FEIBusiness Operations
Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse)344217323MANUFACTURE(59627-333, 59627-222) , ANALYSIS(59627-333, 59627-222)
Establishment
NameAddressID/FEIBusiness Operations
Bioreliance Corporation147227730ANALYSIS(59627-333, 59627-222)
Establishment
NameAddressID/FEIBusiness Operations
Bioreliance Ltd.505004556ANALYSIS(59627-333, 59627-222)
Establishment
NameAddressID/FEIBusiness Operations
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)316126754ANALYSIS(59627-333, 59627-222)
Establishment
NameAddressID/FEIBusiness Operations
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)312670654ANALYSIS(59627-333, 59627-222)

Revised: 7/2019document Id: 

d6a4abc5-4603-4b3b-bf7a-87b63a7d06d9Set id: d70a39cc-de15-4c12-a1ec-8063b69ea0e1Version: 13Effective Time: 20190722Biogen Inc.



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