Frequently
Asked Questions
What is BETASERON®?
BETASERON® 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 BETASERON is safe and effective in children.
Who should not take BETASERON?
Do not take BETASERON if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol. See Medication Guide for a complete list of ingredients in BETASERON.
How should I store BETASERON?
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.
What are the ingredients in BETASERON?
Active ingredient: interferon beta-1b
Inactive ingredients: albumin (human), mannitol
Diluent contains sodium chloride solution
Do I need to disinfect the vial after taking off the cap?
Use an alcohol prep pad to clean the top of the vial. Move the alcohol prep pad in one direction. Leave the alcohol prep pad on top of the vial. Wipe in one direction only—NOT back and forth—so you don’t spread germs.
How do I best connect the syringe to the vial adapter?
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. Taking care not to overtighten, turn the syringe clockwise, no more than 3 turns, until the 2 pieces are securely connected. It doesn’t take much force.
How do I avoid bubbles and foam when diluting the medication?
Never shake the vial; it doesn’t speed up the mixing, and it can cause foam to form. If there is foam, let the vial sit until the foam settles before using it.
Hold the assembled syringe with the vial on the bottom and tilt the vial just slightly to the side. This will help prevent bubbles from forming.
What do I do with my used syringes?
Put your used BETASERON syringe and needle in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) your used syringes and needles in your household trash. When the container is full, ask your pharmacist or healthcare provider how to dispose of it.
Review injection steps
IMPORTANT SAFETY INFORMATION (CONT'D)
BETASERON can cause serious side effects, including:
Liver Problems Including Liver Failure. Symptoms of liver problems may include yellowing of your eyes, itchy skin, feeling very tired, 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.
How do I turn on the BETACONNECT™ autoinjector?
First, make sure the BETACONNECT autoinjector is fully charged. Then firmly press the on/off button for more than 2 seconds.
My BETACONNECT autoinjector turns off automatically. What should I do?
BETACONNECT autoinjector will automatically turn off after 20 minutes of inactivity. Press the on/off button to turn on.
BETACONNECT autoinjector will power off if the battery level is too low. Recharge your BETACONNECT autoinjector if the battery indicator flashes orange when you turn your device on.
Can I use the BETACONNECT autoinjector while it’s being charged?
The BETACONNECT autoinjector will not operate while it is being charged. Fully charge the BETACONNECT autoinjector and remove the charger before use.
I’m unable to open the lid.
The lid cannot be opened during the injection process. Wait until the injection process is completed.
If the lid or the blue lid release button does not function, ask your healthcare provider for a replacement.
I can’t inject by activating the safety release.
If the safety release does not function, ask your healthcare provider for a replacement.
It is not possible to charge the BETACONNECT autoinjector.
You might be using the wrong micro-USB cable or charger. Make sure you use the charger and cables that come with your BETACONNECT autoinjector.
The micro-USB connection could be worn out. Ask your healthcare provider for a replacement.
I can’t insert the syringe into the BETACONNECT autoinjector.
The wrong syringe type is being used. Use only the syringes that come with your BETASERON.
The syringe might not be placed into the insertion area correctly. Make sure that the syringe is lined up with the syringe outline in the insertion area.
The syringe could be prepared incorrectly. Refer to the instructions in the BETASERON Medication Guide, and prepare a new syringe if necessary.
The plunger is pulled past the "1-mL" mark.
The green light on the on/off button does not stop blinking after the BETACONNECT autoinjector was turned on.
The self-test is not completed. Make sure the safety release in the front of the BETACONNECT autoinjector is not pressed. Open the lid and close the lid. Make sure the lid is fully closed. Make sure no buttons are pressed down. Hold the on/off button to shut down BETACONNECT autoinjector, and turn it on again.
If the problem is not solved, contact your healthcare provider. Have your healthcare provider or specialty pharmacy call Bayer Medical Information at 1-888-84BAYER.
A red blinking light is showing on the BETACONNECT autoinjector.
The injection procedure could have been interrupted. If the injection was interrupted, check to see that the entire dose was injected. If it was not, talk with your healthcare provider.
BETACONNECT™ could be detecting a malfunction. Hold the on/off button down to shut down BETACONNECT autoinjector and turn it on again. If the red blinking light is still there, talk with your healthcare provider. Have your doctor or your specialty pharmacy call Bayer Medical Information at 1-888-84BAYER.
An orange light is shown on the BETACONNECT autoinjector during charging.
The temperature is too low or too high for charging. The BETACONNECT autoinjector can be recharged at a temperature from 50°F to 95°F (10°C to 35°C).
More about BETACONNECT
IMPORTANT SAFETY INFORMATION (CONT'D)
BETASERON can cause serious side effects, including:
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.
Overview
Where can I download BETA track, and does it cost anything?
You can download BETA track onto your smartphone, tablet, or computer. To download BETA track onto your mobile device, install the app from the Apple® App Store® or Google Play™ Store. BETA track is free to use.
Do I have to be a BETASERON patient to use BETA track?
Yes, BETA track is intended for BETASERON patients only. Ask your doctor if BETASERON is right for you.
Do I need an Internet connection to use BETA track?
No. You don't need an Internet connection to use BETA track. You can also access the app through your data plan.
Setup
Do I need to register to use BETA track?
No. You will not need to set up an account when you first launch BETA track on your smartphone, tablet, or computer.
Is my personal and medical information secure?
Yes. Your personal and medical data is secured with safeguards in place, as described in the Privacy Statement.
Tracking
Why should I share my injection data via text, email, or printed PDF?
When you share your injection data with your healthcare team, it will help facilitate your discussion by providing information on your treatment journey.
Why does my “suggested next injection site” function not include all of the injection sites?
Confirm that you have not disabled any of the injection sites on the SETTINGS screen. If you have done so, the site’s suggestion function will automatically skip any injection site that you deselected.
Can I print my recorded injection history from BETA track?
You can print your recorded injection history using the print feature in your browser on your computer. This list of recorded injections has been formatted specifically for printing. Additionally, from the RECORDED INJECTIONS in the MENU, you can export your injection history into a PDF document or a CSV file, which can be printed or shared further.
When recording my injections, what do the 3 colors represent?
BETA track uses 3 colors to represent injection activity. Green indicates a recorded injection. Red indicates an injection not recorded. Blue indicates a scheduled injection.
Troubleshooting
Can I install BETA track on more than one tablet device or mobile device?
Yes. You can install BETA track on any number of tablets or mobile devices, as long as they are supported platforms.
My computer or mobile device was lost or stolen. Can I still access my recorded injection history?
Yes. Since your recorded injection history and other information is stored in the cloud, you can install BETA track on your new device and log in to access your information.
My computer or mobile device was upgraded. Will be data be transferred onto my new device?
If you are using BETA track for iPhone, iPod touch, or iPad, your data can be transferred onto your new device if you have backed up your device by syncing with iTunes or iCloud, and you did not delete the app from your device. It is very important that you sync your device regularly for this reason. If you are using BETA track for Android, you data is stored using the storage option you've selected on your Android device.
How do I uninstall BETA track?
To uninstall BETA track, follow the same process that you would use to remove other software or apps from your computer/mobile device. Note that uninstalling BETA track does not delete your BETA track data if you have synced it to your iCloud or Android device. You can access data by reinstalling BETA track or using it on a different device.
How do I delete by BETA track account?
To delete your BETA track app, permanently delete it like other software or apps on your computer/mobile device. There are no specific actions needed since your data only lives on your device or where you chose to store it. Bayer does not store any data.
I am still having problems using BETA track. What should I do?
If the program is not responding, you may try to restart the application or reboot your computer/mobile device.
More about BETA track
IMPORTANT SAFETY INFORMATION (CONT'D)
BETASERON can cause serious side effects, including:
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 depression (sinking feeling or sadness), new or worse anxiety (feeling uneasy, nervous or fearful for no reason), trouble sleeping (insomnia), acting aggressive, being angry, or violent, acting on dangerous impulses, hallucinations, other unusual changes in behavior or mood.
Be prepared for your next doctor visit
To Report Product Complaints:
Please have your healthcare provider or specialty pharmacy contact Bayer Medical Information at 1-888-84BAYER
Don't have time to talk now?
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INDICATIONS
BETASERON® (interferon beta-1b) 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.
IMPORTANT SAFETY INFORMATION
Do not take BETASERON (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol.
BETASERON can cause serious side effects, including:
Liver Problems Including Liver Failure. Symptoms of liver problems may include yellowing of your eyes, itchy skin, feeling very tired, 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 depression (sinking feeling or sadness), new or worse anxiety (feeling uneasy, nervous or fearful for no reason), trouble sleeping (insomnia), acting aggressive, being angry, or violent, acting on dangerous impulses, hallucinations, other unusual changes in behavior or mood.
Other possible serious side effects with BETASERON include:
Heart Problems. BETASERON may worsen heart problems including congestive heart failure. Symptoms of heart problems may include swollen ankles, shortness of breath, decreased ability to exercise, fast heartbeat, tightness in chest, increased need to urinate at night, not being able to lay flat in bed.
Injection Site Problems. Serious skin reactions can happen in some people including areas of severe damage to skin and the tissue below the skin (necrosis). These reactions can happen anywhere you inject BETASERON. Symptoms of injection site problems may include swelling, redness, or pain at the injection site, fluid drainage from the injection site, and breaks in your skin or blue-black skin discoloration. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider.
Pulmonary Arterial Hypertension. Pulmonary arterial hypertension can occur with interferon beta products, including BETASERON. Symptoms may include new or increasing fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms.
Flu-like Symptoms. BETASERON can cause flu-like symptoms including fever, chills, tiredness, sweating, muscle aches when you first start to use it. These symptoms may decrease over time. Taking medicines for fever and pain relief on the days you are using BETASERON may help decrease these symptoms.
Seizures. Some people have had seizures while taking BETASERON, including people who have never had seizures before. It is not known if the seizures were related to MS, to BETASERON, or to a combination of both. If you have a seizure after taking BETASERON call your healthcare provider right away.
Blood Problems. You may have a drop in the levels of infection-fighting white blood cells, red blood cells, or cells that help you form blood clots. If drops in levels are severe, they can lessen your ability to fight infections, make you feel tired or sluggish or cause you to bruise or bleed easily.
Pregnancy:
Tell your doctor if you are pregnant or plan to become pregnant.
Most Common Side Effects:
The most common side effects of BETASERON include low white blood cell count, increases in your liver enzymes, headache, increase in your muscle tension, pain, rash, problems sleeping, stomach pain, weakness. These are not all the possible side effects of BETASERON.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Tell your healthcare provider about all the medicines you take and your medical conditions.
Please see the Full Prescribing Information and BETACONNECT™ Instructions for Use for additional information, and talk to your healthcare provider.
IMPORTANT SAFETY INFORMATION
Contraindications. BETASERON (interferon beta-1b) is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), mannitol, or any other component of the formulation.
Hepatic Injury. Severe hepatic injury including cases of hepatic failure has been rarely reported in patients taking BETASERON. In some cases, these events have occurred in the presence of other drugs or comorbid medical conditions that have been associated with hepatic injury. Consider the potential risk of BETASERON used in combination with known hepatotoxic drugs or other products (e.g., alcohol) prior to BETASERON administration, or when adding new agents to the regimen of patients already on BETASERON. Monitor patients for signs and symptoms of hepatic injury. Consider discontinuing BETASERON if serum transaminase levels significantly increase, or if they are associated with clinical symptoms such as jaundice.
Asymptomatic elevation of serum transaminases is common in patients treated with BETASERON. In controlled clinical trials, elevations of SGPT to greater than five times baseline value were reported in 12% of patients receiving BETASERON (compared to 4% on placebo), and increases of SGOT to greater than five times baseline value were reported in 4% of patients receiving BETASERON (compared to 1% on placebo), leading to dose-reduction or discontinuation of treatment in some patients. Monitor liver function tests.
Anaphylaxis and Other Allergic-Reactions. Anaphylaxis has been reported as a rare complication of BETASERON use. Other allergic reactions have included dyspnea, bronchospasm, tongue edema, skin rash and urticaria.
Discontinue BETASERON if anaphylaxis occurs.
Depression and Suicide. Depression and suicide have been reported to occur with increased frequency in patients receiving interferon compounds, including BETASERON. Patients treated with BETASERON should be advised to report immediately any symptoms of depression and/or suicidal ideation. Consider discontinuation of BETASERON if depression occurs.
Congestive Heart Failure. Monitor patients with pre-existing congestive heart failure (CHF) for worsening of their cardiac condition during initiation of and continued treatment with BETASERON. Cases of CHF, cardiomyopathy, and cardiomyopathy with CHF have been reported in patients without known predisposition to these events, and without other known etiologies being established. In some cases, these events have been temporally related to the administration of BETASERON. Recurrence upon rechallenge was observed in some patients. Consider discontinuation of BETASERON if worsening of CHF occurs with no other etiology.
Injection Site Necrosis and Reactions. Injection site reactions occurred in 78% of BETASERON patients receiving BETASERON (compared to 26% on placebo) in controlled clinical trials with injection site necrosis reported in 4% of BETASERON patients (compared to 0% on placebo). For patients who continue BETASERON after injection site necrosis has occurred, BETASERON should not be administered into the affected area until it is fully healed. If multiple lesions occur, therapy should be discontinued until healing occurs. Patients should be advised of the importance of the use of aseptic technique and rotating injection sites.
Leukopenia. Leukopenia has been reported in 18% of patients receiving BETASERON (compared to 6% on placebo) in controlled clinical trials leading to a reduction in dose in some patients. Monitoring of complete blood and differential white blood cell counts is recommended. Patients with myelosuppression may require more intensive monitoring.
Thrombotic Microangiopathy. Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported several weeks to years after starting interferon beta products. Discontinue BETASERON if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.
Flu-like Symptom Complex. Flu-like symptom complex for patients on BETASERON was 57% (versus 37% on placebo) in controlled clinical trials. Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms.
Seizures. Seizures have been temporally associated with the use of beta interferons.
Drug-induced Lupus Erythematosus. Drug-induced lupus erythematosus has been reported with interferon beta products, including BETASERON. Signs and symptoms of drug-induced lupus reported in BETASERON-treated patients have included rash, serositis, polyarthritis, nephritis, and Raynaud's phenomenon. Cases have occurred with positive serologic testing (positive anti-nuclear and/or anti-double-stranded DNA antibody testing). If patients develop new signs and symptoms of this syndrome, BETASERON therapy should be stopped.
Monitoring for Laboratory Abnormalities. In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts and blood chemistries including liver function tests are recommended at one, three and six months after introduction of BETASERON therapy, and periodically thereafter in the absence of clinical symptoms.
Most Common Adverse Reactions. The most commonly reported adverse reactions (at least 5% more frequent on BETASERON than on placebo) in controlled clinical trials were injection site reaction (78% vs 26% for placebo), lymphopenia (86% vs 66%), flu-like symptoms (57% vs 37%), myalgia (23% vs 14%), leukopenia (13% vs 4%), neutropenia (13% vs 5%), increased liver enzymes (SGPT to greater than five times baseline value [12% vs 4%], SGOT to greater than five times baseline value [4% vs 1%]), headache (50% vs 43%), hypertonia (40% vs 33%), pain (42% vs 35%), rash (21% vs 15%), insomnia (21% vs 16%), abdominal pain (16% vs 11%), and asthenia (53% vs 48%).
Please see the Full Prescribing Information and BETACONNECT™ Instructions for Use for additional information, and talk to your healthcare provider.
