Betaseron

 

BETASERON®

 

[INTERFERON BETA-1b]

 
Betaseron® belongs to a class of drugs known as immunomodulators. Betaseron® is a synthetic form of human protein called interferon beta, made by Bayer Healthcare Pharmaceuticals Inc. Interferon is a type of immune-response protein that has antiviral activities and helps to mediate your body’s immune system. Betaseron

Betaseron® is currently FDA-approved for treating relapsing forms of multiple sclerosis (MS). Clinical studies show that Betaseron® reduces signs and symptoms of MS by decreasing the frequency of flare-ups and slowing progression of MS symptoms.

Betaseron® is given as a subcutaneous injection. Betaseron® requires a valid prescription from your prescriber. Ocean Breeze Healthcare can provide Betaseron® as well as most of the supplies you would need to administer the drug.

What form is Betaseron® currently available?

Betaseron® is currently available as a single-use vial.

The single-use vial is formulated as dry powder that needs to be mixed with 1.2 mL of the liquid mixing solution (diluent) for subcutaneous injection. Each vial of reconstituted solution contains 0.3mg/1.0ml dose of interferon beta-1b.

What are some potential side effects of Betaseron®?

Common side effects with Betaseron® include, but are not limited to, injection site reactions such as rash, redness or bruising. Other possible side effects are flu-like symptoms, headache, lymphopenia, and muscle weakness. More serious, but rare adverse effects include anxiety, depression, seizures and liver, blood, thyroid or heart problems.

If you are experiencing any unwanted side effect(s) or have any specific questions or concerns regarding a side effect, contact your doctor or pharmacist. You may also report the side effect(s) to the FDA at www.fda.gov/medwatch, or call 1-800-FDA-1088.

Who should NOT use Betaseron®?

Betaseron® should be avoided if you have a history of allergy and/or hypersensitivity to interferon beta, human albumin, mannitol, or to any other component of the formulation.

Speak to your doctor or pharmacist if you are pregnant, nursing, or have a history of seizures.

How do you administer Betaseron®?

Betaseron® must be injected under the skin, as a subcutaneous (SQ) injection. Each Betaseron® vial is for one-time administration only.

Before Betaseron® is ready for subcutaneous injection, the dry powder vial must to be mixed with the sterile diluent syringe to form a solution. Use the MixJet® adapter, provided in the drug package, for reconstitution. Gently swirl the vial to completely dissolve the white cake of Betaseron®. DO NOT SHAKE. The reconstituted solution should be clear, colorless and free of particles. Otherwise, contact your doctor or pharmacist.

Once the vial is mixed (reconstituted), pull the plunger back to withdraw the content from the vial, then removed the attached MixJet® adapter and vial from the syringe before subcutaneous injection. See Betaseron® Injection Training Guide for details.

Extavia

Bayer Healthcare Pharmaceuticals Inc., also has an injection device, called BetaJect® Lite, as an alternative to regular manual syringe injection. Prime the BetaJect® Lite device for use. Then, insert the reconstituted drug syringe into the syringe holder and attached the injector body. Once ready, press the release button on the BetaJect® Lite to automatically inject the syringe content into the skin. See Betaseron® Injection Training Guide for details.

How do you store Betaseron®?

Betaseron® should be stored in room temperature (up to 77° Fahrenheit) prior to reconstitution for up to 3 months. DO NOT FREEZE. Protect from light.

After reconstitution, Betaseron® should be used immediately or may be refrigerated for up to 3 hours.

How long does Betaseron® last?

Before opening, Betaseron® is stable for 3 months if stored under the required storage conditions. Once the vial is mixed, it is stable for up to 3 hours under refrigeration. Each Betaseron® vial is intended for one-time use only; discard any unused drug after each dose.

Commonly Asked Questions

Q:Does Betaseron® cure multiple sclerosis (MS)?
A:No, Betaseron® is not a cure for MS. It simply relieves the symptoms associated with MS and may potentially         slow the progression of MS.
 
Q:How do I use the Betaseron® with the BetaJect® Lite injection device?
A:First prime the BetaJect® Lite device, then insert the reconstituted Betaseron® syringe into the device for         subcutaneous injection. For detailed instructions, please refer to Betaseron® Injection Training Guide.
 
Q:Are there any preservatives in Betaseron®?
A:No, Betaseron® does not contain any preservatives.
 
Q:How often do I take Betaseron®?
A:You should inject Betaseron® at the exact dose as prescribed by your doctor. In general, Betaseron® is taken         every other day. Do not take Betaseron® two days in a row on consecutive days.

Manufacturer Website

http://www.betaseron.com/

Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for diagnosing or treating a health problem or disease, or prescribing any medication. You should read carefully all product packaging. If you have or suspect that you have a medical problem, promptly contact your health care provider.

 

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