Betaseron (interferon beta-1b)


Betaseron (interferon beta-1b) is an injectable disease-modifying treatment for people diagnosed with MS, made by Bayer Healthcare Pharmaceuticals. Betaseron is indicated (approved for use) for the treatment of relapsing forms of MS to reduce frequency of exacerbations or relapses. Betaseron is also approved for delaying a second exacerbation in people who have been diagnosed with clinically isolated syndrome (CIS).

How does Betaseron work?

Betaseron is an interferon, a family of glycoproteins produced naturally in the body in response to viral infection or invasion of the body by another biologic agent. Betaseron is produced using a recombinant DNA technique that involves insertion of a human interferon beta gene in a bacterial strain. Bacterial fermentation is then used to manufacture the interferon.

The exact process by which Betaseron and other interferon beta drugs work to reduce exacerbations in MS is unknown. However, as interferons play an important role in controlling immune system activities, Betaseron may use its ability (as an interferon) to control the abnormal immune response that appears to be involved in MS. When Betaseron is given to a person, levels of an immune system protein called interleukin-10 (IL-10) are increased. IL-10 is an anti-inflammatory cytokine which helps to stop or inhibit inflammation.

How is Betaseron taken?

Betaseron is given as a subcutaneous (under the skin) injection every other day. The recommended dose of Betaseron is 0.25 mg. Betaseron injections should be taken about 48 hours (or two days) apart. To stay on schedule, it is best to take Betaseron at the same time every other day, for instance, in the evening before going to bed.

Your doctor may want to start you on a lower dose of Betaseron and titrate (work up gradually) to the recommended dose. This will involve starting Betaseron at 0.0625 mg every other day and increasing the dose gradually over a period of six weeks. If you miss an injection of Betaseron, take your next dose as soon as you remember and continue with the following dose 48 hours later. DO NOT take Betaseron on two consecutive (back to back) days. If you make this mistake, call your doctor immediately.

Always use a new, unopened syringe and vial of Betaseron for each injection. To decrease the chances of developing a skin reaction to the injection, always inject at a new site each time you take Betaseron. Never inject at a site where the skin is reddened, infected, sore, or damaged in any other way. Your doctor or another qualified medical personnel should train you in administering Betaseron before you inject the drug yourself.1


How should Betaseron be prepared and stored?

Betaseron comes as a powder and must be reconstituted (mixed with a diluent, or sterile saline) before injecting. To reconstitute Betaseron, use a vial adapter to attach a syringe prefilled with the appropriate solution to a vial containing powdered Betaseron. Once the vial is attached, inject the contents of the syringe into the vial and gently swirl the vial to completely dissolve the drug. Once the drug is dissolved, position the syringe so that the vial is on top and withdraw the appropriate dose of Betaseron. Then remove the vial from the vial adapter. For complete instructions on preparing Betaseron, see the patient instructions provided by the manufacturer.

Before reconstituting Betaseron, make sure that the syringe containing diluent is at room temperature (59ºF to 86ºF). Betaseron may be refrigerated if not used immediately after it is reconstituted, as long as it is used within 3 hours of being reconstituted.


Are there people who should not take Betaseron?

Betaseron should not be taken by persons who have had an allergic reaction to an interferon beta medication, such as itching, hives, difficulty breathing (dyspnea), and flushing, or a history of hypersensitivity to albumin.

If you have had problems with depression, liver disease, thyroid gland problems, blood problems (such as bleeding, easy bruising, anemia, or low white blood cell counts), epilepsy, heart problems, or are planning to become pregnant, you should talk to your doctor before starting Betaseron. Betaseron can cause serious side effects related to each of the conditions previously mentioned. Tell your doctor about all medications and supplements you are taking, including vitamins and herbal preparations, before starting Betaseron.

You should avoid becoming pregnant while taking Betaseron, as it may cause miscarriage. If you should become pregnant while taking Betaseron, stop taking the drug immediately and talk with your doctor. Talk with your doctor about whether you should breast feed while taking Betaseron, as it is not known whether Betaseron is passed through breast milk or if it can harm your baby.


What evidence do we have that Betaseron works?

Betaseron was compared with placebo in three clinical trials, involving over 1,000 subjects, to determine how well it could change the course of MS in people with relapsing forms of the disease. These studies found that people with MS who received Betaseron had fewer relapses or exacerbations, fewer active brain lesions, and a smaller volume of lesions as shown on MRI than people who received placebo.

In a fourth study, people diagnosed with clinically isolated syndrome (CIS) and had MS-like brain lesions who took Betaseron experienced a delay in the time it took to have a second exacerbation, leading to diagnosis of MS.


Is there a generic alternative to Betaseron?

There is no generic alternative to Betaseron. However, the drug Extavia (interferon beta-1b), a subcutaneous injectable medication given every other day made by Novartis, contains the same active ingredient as Betaseron. In fact, Betaseron and Extavia are made on the same manufacturing line and receive different labels.