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BETASERON- interferon beta-1b kit


  1. Betaseron Can Cause Serious Side Effects, Including:
  2. What Is Betaseron?
  3. Who Should Not Take Betaseron?
  4. Before You Take Betaseron, Tell Your Healthcare Provider If You:
  5. Betaseron May Cause Serious Side Effects. Call Your Healthcare Provider Right Away If You Have Any Of The Serious Side Effects Of Betaseron Including:
  6. What Are The Ingredients In Betaseron?
  7. 1 Single-use Carton Containing:
  8. Manufactured For:
  9. Contains:
  10. Revised: 8/2019document Id:
  11. Patient Information

Betaseron Can Cause Serious Side Effects, Including: 

liver problems including liver failure.Symptoms of liver problems may include:
yellowing of your eyes
feeling very tired
itchy skin
flu-like symptoms
nausea or vomiting
bruising easily or bleeding problems
Your healthcare provider will do blood tests to check for these problems while you take BETASERON.
serious allergic reactions.Serious allergic reactions can happen quickly and may happen after your first dose of BETASERON or after you have taken BETASERON many times. Symptoms may include difficulty breathing or swallowing, swelling of the mouth or tongue, rash, itching, or skin bumps.
depression or suicidal thoughts.Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
thoughts about suicide or dying
new or worse anxiety
acting aggressive, being angry, or violent
hallucinations
new or worse depression
trouble sleeping (insomnia)
acting on dangerous impulses
other unusual changes in behavior or mood

What Is Betaseron? 

BETASERON is a prescription medicine used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BETASERON is similar to certain interferon proteins that are produced in the body.

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

Who Should Not Take Betaseron? 

Do not take BETASERON if youare allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol.

Before You Take Betaseron, Tell Your Healthcare Provider If You: 

have or have had depression (sinking feeling or sadness), anxiety (feeling uneasy, nervous, or fearful for no reason) or trouble sleeping
have or have had liver problems
have or have had blood problems such as bleeding or bruising easily, low red blood cells (anemia) or low white blood cells
have or have had seizures
have or have had heart problems
are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed. It is not known if BETASERON passes into your breast milk.

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

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Betaseron May Cause Serious Side Effects. Call Your Healthcare Provider Right Away If You Have Any Of The Serious Side Effects Of Betaseron Including: 

Before mixing, store BETASERON at room temperature between 68 F to 77 F (20 C to 25 C).
Before mixing, BETASERON may be stored for up to 3 months between 59 F to 86 F (15 C to 30 C).
After mixing, you can refrigerate BETASERON for up to 3 hours before using. Your BETASERON must be used within 3 hours of mixing even if refrigerated.
Do not freeze.

Keep BETASERON and all medicines out of the reach of children.

General information about the safe and effective use of BETASERON.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BETASERON for a condition for which it was not prescribed. Do not give BETASERON 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 BETASERON. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about BETASERON that is written for health professionals.

For more information, go towww.BETASERON.comor call BETAPLUS, the BETASERON patient support program, at 1-800-788-1467.

What Are The Ingredients In Betaseron? 

Active ingredient: interferon beta-1b

Inactive ingredients: albumin (human), mannitol

Diluent contains sodium chloride solution.

This Medication Guide has been approved by the U.S. Food and Drug Administration 8/2019

Instructions for Use

BETASERON
(bay-ta-seer-on)

interferon beta-1b
(in-ter-feer-on beta-one-be)

Read the Instructions for Use that come with your BETASERON before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. Before you use BETASERON for the first time, make sure your healthcare provider shows you the right way to use it.

Supplies needed for your BETASERON Injection (See Figure A).

1 Single-use Carton Containing: 

A vial of BETASERON
A pre-filled diluent syringe
A vial adapter with a 30-gauge needle attached (in the blister pack)
2 alcohol prep pads
Figure A

Step 1: Preparing for Your BETASERON Injection

Place the supplies you will need on a clean, flat surface in a well-lit area.
Check the expiration date on the single-use carton to make sure that it has not expired. Do not use it if the medication has expired.
Wash your hands thoroughly with soap and water.
Open the single-use carton and take out all the contents. Make sure the blister pack containing the vial adapter is sealed. Check to make sure the plastic cap on the pre-filled diluent syringe is firmly attached.
Remove the tray from the single-use carton and place it on a flat surface.
Place the BETASERON vial in the well (vial holder) and place the pre-filled diluent syringe in the U-shaped trough(See Figure B).
Figure B

Step 2: Mixing BETASERON

Remove the BETASERON vial from the well (vial holder) and take the cap off the vial.
Place the vial back into the well (vial holder).
Use an alcohol prep pad to clean the top of the vial. Move the alcohol prep pad in 1 direction. Leave the alcohol prep pad on top of the vial.
Peel the label off the blister pack with the vial adapter in it. The vial adapter is sterile. Do not remove or touch the vial adapter.
Remove the alcohol prep pad from the top of the BETASERON vial. Pick up the vial adapter in the blister pack. Turn over the blister pack keeping the vial adapter inside. Put the adapter on top of the BETASERON vial. Push down on the adapter until it pierces the rubber top of the BETASERON vial and snaps in place(See Figure C). Remove the blister packaging from the vial adapter.
Figure C
Twist the plastic cap from the pre-filled diluent syringe. Throw away the plastic cap.(See Figure D).
Figure D
Keep the vial adapter attached to the vial and remove the vial from the well (vial holder). Be careful not to pull the vial adapter off the top of the vial.
Connect the pre-filled diluent syringe to the vial adapter by turning clockwise until resistance is felt and the attachment is secure. This forms the syringe assembly(See Figure E).
Figure E
Slowly push the plunger of the pre-filled diluent syringe all the way in. This will transfer all of the liquid from the syringe into the BETASERON vial(See Figure F). The plunger may return to its original position after you release it.
Figure F
Gently swirl the vial to completely dissolve the white powder of BETASERON.Do not shake.Shaking and even gentle mixing can cause foaming of the medicine. If there is foam, let the vial sit until the foam settles before using it.
After the powder dissolves, look closely at the solution in the vial. Do not use the solution if it is cloudy or contains particles. It should be clear and colorless.
Do not use cracked or damaged BETASERON vials. If your vial is cracked or damaged, get a new single-use carton containing a BETASERON vial, pre-filled diluent syringe, vial adapter and 2 alcohol prep pads. Repeat the steps to prepare your BETASERON dose.
Contact BETAPLUS, the BETASERON patient support program, at 1-800-788-1467 to obtain a replacement product.

Step 3: Preparing the Injection

You have completed the steps to prepare your BETASERON and are ready for the injection. The injection should be given immediately after mixing and allowing any foam in the solution to settle. If you must wait to give yourself the injection, you may refrigerate the solution and use within 3 hours of mixing your BETASERON.Do not freeze.

Push the plunger in and hold it there; then turn the syringe assembly so that the syringe is horizontal and the vial is on top.
Slowly pull the plunger back to withdraw all the liquid from the BETASERON vial into the syringe(See Figure G).
Figure G
NOTE: The syringe barrel is marked with numbers from 0.25 mL to 1 mL(See Figure H). If the solution in the vial cannot be drawn up to the 1 mL mark, discard the vial and syringe and start over with a new single-use carton containing a BETASERON vial, pre-filled diluent syringe, vial adapter and alcohol prep pads.
Turn the syringe assembly so that the needle end is pointing up. Remove any air bubbles by tapping the outside of the syringe with your fingers. Slowly push the plunger to the 1 mL mark on the syringe or to the mark that matches the amount of BETASERON prescribed by your healthcare provider(See Figure H).If too much solution is pushed into the vial, repeat Step 3.
Figure H
Turn the syringe assembly so that the vial is at the bottom. Remove the vial adapter and the vial from the syringe by twisting the vial adapter. This will remove the vial adapter and the vial from the syringe, but will leave the needle on the syringe(See Figure I).
Figure I

Step 4: Choosing an Injection Site

BETASERON (interferon beta-1b) is injected under the skin and into the fat layer between the skin and the muscles (subcutaneous tissue). The best areas for injection are where the skin is loose and soft and away from the joints, nerves, and bones.Do notuse the area near your navel or waistline. If you are very thin, use only the thigh or outer surface of the arm for injection.
Choose a different site each time you give yourself an injection.Figure Jshows different areas for giving injections. Do notinject in the same area for 2 injections in a row. Keep a record of your injections to help make sure you change (rotate) your injection sites. You should decide where you will inject BETASERON before you prepare your medicine for injection. If there are any sites that are difficult for you to reach, you can ask someone who has been trained to give the injection to help you.
Figure J
Do notinject BETASERON in a site where the skin is red, bruised, infected, or scabbed, has broken open, or has lumps, bumps, or pain. Tell your healthcare provider if you find skin conditions like the ones mentioned here or any other unusual-looking areas where you have been given injections.
Step 5: Injecting BETASERON
Using a circular motion, clean the injection site with an alcohol prep pad, starting at the injection site and moving outward. Let the skin area air dry.
Remove the cap from the needle. Hold the syringe like a pencil or dart in 1 hand.
Gently pinch the skin around the site with the thumb and forefinger of the other hand(See Figure K).Insert the needle straight up and down into your skin at a 90 angle with a quick, dart-like motion.
Figure K
Slowly push the plunger all the way in until the syringe is empty(See Figure L).
Figure L
Remove the needle from the skin. Place a dry cotton ball or gauze pad over the injection site. Gently massage the injection site for a few moments with the dry cotton ball or gauze pad. Throw away the syringe in your puncture-proof disposal container.
Optional Use of BETACONNECT Autoinjector:
You may also give BETASERON by using the BETACONNECT autoinjector. You should get help with training on the use of the BETACONNECT autoinjector from a healthcare provider before using it for the first time. The BETACONNECT autoinjector should only be used with the syringes that come in the BETASERON packaging. See the Instructions for Use that come with the BETACONNECT autoinjector. For more information, call BETAPLUS, the BETASERON patient support program, at 1-800-788-1467.
Step 6: Disposing of used syringes, needles, and vials
To prevent needle-stick injury and spread of infection, do not try to re-cap the needle.
Place used needles, syringes, and vials in a closeable, puncture-resistant container. You may use a sharps container (such as a red biohazard container), hard plastic container (such as a detergent bottle), or metal container (such as an empty coffee can). Do not use glass or clear plastic containers. Ask your healthcare provider for instructions on the right way to throw away (dispose of) the container. There may be state and local laws about how you should throw away used needles and syringes.
Do not throw used needles, syringes, or vials in your household trash or recycle.
Throw away any unused medicine. Do not save any unused BETASERON for a future dose.
Keep the disposal container, needles, syringes, and vials of BETASERON out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. 09/15

Manufactured For: 

Bayer HealthCare Pharmaceuticals Inc.
Whippany, NJ 07981

Manufactured in Germany

U.S. License No. 1778

1993 Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

NDC 50419-524-01 Rx only

BETASERON
(interferon beta-1b)

For injection

0.3 mg per vial

For subcutaneous injection

No U.S. standard of potency

Single use carton

Contains: 

1 single-use vial for reconstitution
1 pre-filled single-use sodium chloride 0.54% solution diluent syringe
1 vial adapter with a 30 gauge needle attached
2 alcohol prep pads
Figure Betaseron Single-Use PDP
BETASERON
interferon beta-1b kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50419-524
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50419-524-3514 in 1 BOX08/11/2009
1NDC:50419-524-011 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2NDC:50419-524-055 in 1 BOX08/11/2009
2NDC:50419-524-011 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
3NDC:50419-524-091 in 1 BOX08/11/2009
3NDC:50419-524-011 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
4NDC:50419-524-8114 in 1 BOX09/01/2016
4NDC:50419-524-011 in 1 CARTON; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 VIAL, SINGLE-USE1 mL
Part 21 SYRINGE1.2 mL
Part 1 of 2
BETASERON
interferon beta-1b injection, powder, lyophilized, for solution
Product Information
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
INTERFERON BETA-1B(UNII: TTD90R31WZ) (INTERFERON BETA-1B - UNII:TTD90R31WZ)INTERFERON BETA-1B0.25 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALBUMIN HUMAN(UNII: ZIF514RVZR)15 mg in 1 mL
MANNITOL(UNII: 3OWL53L36A)15 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10347107/09/2009
Part 2 of 2
DILUENT
sodium chloride solution, concentrate
Product Information
Route of AdministrationSUBCUTANEOUS
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE(UNII: 451W47IQ8X)5.4 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.2 mL in 1 SYRINGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10347107/09/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10347107/09/2009
Labeler -Bayer HealthCare Pharmaceuticals Inc. (005436809)
Establishment
NameAddressID/FEIBusiness Operations
Boehringer Ingelheim Pharma GmbH and Co. KG340700520MANUFACTURE(50419-524)
Establishment
NameAddressID/FEIBusiness Operations
Quality Packaging Specialists International LLC080629831RELABEL(50419-524)
Establishment
NameAddressID/FEIBusiness Operations
Bayer AG315097875ANALYSIS(50419-524) , API MANUFACTURE(50419-524) , LABEL(50419-524) , MANUFACTURE(50419-524) , PACK(50419-524) , STERILIZE(50419-524)

Revised: 8/2019document Id: 

42a9c350-59ec-492e-80f9-6efd36c9fee8Set id: 66311f74-0472-4fa3-848a-06002ca0def5Version: 15Effective Time: 20190816Bayer HealthCare Pharmaceuticals Inc.

Patient Information 

See FDA-approved patient labeling (Medication Guide and Instructions for Use).

Instruct patients to carefully read the supplied BETASERON Medication Guide and caution patients not to change the BETASERON dose or schedule of administration without medical consultation.

Instruction on Self-Injection Technique and Procedures

Provide appropriate instruction for reconstitution of BETASERON and methods of self-injection, including careful review of the BETASERON Medication Guide. Instruct patients in the use of aseptic technique when administering BETASERON.

Tell patients not to re-use needles or syringes and instruct patients on safe disposal procedures. Advise patients of the importance of rotating areas of injection with each dose, to minimize the likelihood of severe injection site reactions, including necrosis or localized infection[see Medication Guide].

Hepatic Injury

Advise patients that severe hepatic injury, including hepatic failure, has been reported during the use of BETASERON.

Inform patients of symptoms of hepatic dysfunction, and instruct patients to report them immediately to their healthcare provider[see Warnings and Precautions (5.1)].

Anaphylaxis and Other Allergic Reactions

Advise patients of the symptoms of allergic reactions and anaphylaxis, and instruct patients to seek immediate medical attention if these symptoms occur[see Warnings and Precautions (5.2)].

Depression and Suicide

Advise patients that depression and suicidal ideation have been reported during the use of BETASERON. Inform patients of the symptoms of depression or suicidal ideation, and instruct patients to report them immediately to their healthcare provider[see Warnings and Precautions (5.3)].

Congestive Heart Failure

Advise patients that worsening of pre-existing congestive heart failure have been reported in patients using BETASERON.

Advise patients of symptoms of worsening cardiac condition, and instruct patients to report them immediately to their healthcare provider[see Warnings and Precautions (5.4)].

Injection Site Necrosis and Reactions

Advise patients that injection site reactions occur in most patients treated with BETASERON, and that injection site necrosis may occur at one or multiple sites. Instruct patients to promptly report any break in the skin, which may be associated with blue-black discoloration, swelling, or drainage of fluid from the injection site, prior to continuing their BETASERON therapy[see Warnings and Precautions (5.5)].

Flu-like Symptom Complex

Inform patients that flu-like symptoms are common following initiation of therapy with BETASERON, and that concurrent use of analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms associated with BETASERON use[see Warnings and Precautions (5.8)andDosage and Administration (2.4)].

Seizures

Instruct patients to report seizures immediately to their healthcare provider[see Warnings and Precautions (5.9)].

Pregnancy

Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant[see Use in Specific Populations (8.1)].



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