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Betaseron (Interferon Beta-1B) - Summary



BetaseronĀ® (interferon beta-lb) is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques. Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon betaser17. The native gene was obtained from human fibroblasts and altered in a way that substitutes serine for the cysteine residue found at position 17. Interferon beta-1b has 165 amino acids and an approximate molecular weight of 18,500 daltons. It does not include the carbohydrate side chains found in the natural material. The specific activity of Betaseron is approximately 32 million international units (IU)/mg interferon beta-lb. Each vial contains 0.3 mg of interferon beta-lb. The unit measurement is derived by comparing the antiviral activity of the product to the World Health Organization (WHO) reference standard of recombinant human interferon beta. Mannitol, USP and Albumin (Human), USP (15 mg each/vial) are added as stabilizers. Lyophilized Betaseron is a sterile, white to off-white powder, for subcutaneous injection after reconstitution with the diluent supplied (Sodium Chloride, 0.54% Solution). Albumin (Human) USP and Mannitol, USP (15 mg each/vial) are added as stabilizers.

BetaseronĀ® (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

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Published Studies Related to Betaseron (Interferon Beta-1B)

Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. [2014]
(persistent black holes (PBHs))... CONCLUSIONS: Although the rate of lesions that converted to PBH showed no

Cognitive dysfunction in patients with multiple sclerosis treated with different types of interferon beta: a randomized clinical trial. [2014]
function in MS... CONCLUSIONS: Different types of DMTs may improve some aspects of cognitive

Interferon beta for secondary progressive multiple sclerosis. [2012]
CONCLUSIONS: Well designed RCTs, evaluating a high number of patients

Interferon beta-1b-neutralizing antibodies 5 years after clinically isolated syndrome. [2011.08.30]
OBJECTIVE: To determine the frequency and consequences of neutralizing antibodies (NAbs) in patients with a first event suggestive of multiple sclerosis (MS) treated with interferon beta-1b (IFNbeta-1b)... CONCLUSIONS: Although NAb positivity was associated with increased brain MRI activity, no discernible effects on clinical outcomes were found. This finding may reflect the greater power of MRI compared with clinical outcomes to detect the treatment effects of IFNbeta-1b and may also result from temporal changes in NAb titers and biology.

Interferon beta-1b and glatiramer acetate effects on permanent black hole evolution. [2011.04.05]
OBJECTIVE: To compare interferon beta-1b (IFNbeta-1b) and glatiramer acetate (GA) on new lesion (NL) (gadolinium-enhancing, new T2) evolution into permanent black holes (PBH)--a marker of irreversible tissue damage--in patients with relapsing-remitting multiple sclerosis (RRMS)... CONCLUSION: IFNbeta-1b affected PBH development to a similar or better extent than GA. IFNbeta-1b favorably influences an MRI outcome indicative of permanent tissue destruction in the brains of patients with multiple sclerosis. Classification of evidence: This study provides Class III evidence that IFNbeta-1b is associated with a reduction in MRI PBH formation and evolution compared with GA between years 1 and 2 of treatment.

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Clinical Trials Related to Betaseron (Interferon Beta-1B)

Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI [Active, not recruiting]

Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis [Completed]
The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.

BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose [Completed]
The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.

BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up Study [Completed]
This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study). Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.

BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients [Completed]
The purpose of this study is to determine

- whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe,

tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms

- whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more

efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg

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Reports of Suspected Betaseron (Interferon Beta-1B) Side Effects

Injection Site Pain (146)Influenza Like Illness (124)Injection Site Erythema (115)Depression (110)Pyrexia (103)Pain (98)Fatigue (96)Headache (90)Multiple Sclerosis Relapse (83)Chills (74)more >>


Based on a total of 1 ratings/reviews, Betaseron has an overall score of 8. The effectiveness score is 10 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.

Betaseron review by 43 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   multiple sclerosis
Dosage & duration:   0.3mg taken every other night for the period of 4 years and will continue thru life
Other conditions:   DM II, hypertension, splenomegaly, metabolic syndrome, gerd, ibs,edema of lower extremities, seizure
Other drugs taken:   glucophage, omeprazole,paxil, clonazepam,benicar, atenolol,flovent, albuterol, topamax, tretinoin
Reported Results
Benefits:   Storage of a drug may not seem important, but betaseron does not have to be refridgerated, which makes it highly portable. But the main benefit is that the lesions that I was originally diagnosed with DID NOT WORSEN over time. In addition, I have had NO new lesions since beginning betaseron. So this has helped to slow the progress (secondary progressive relapse/remit) and I believe decreased the amount of relapses with residual. Which, if you have ms this is what you aim for.
Side effects:   I do, for some unknown reason, still have side effects from the betaseron. They don't happen every injection, and there is no pattern. I will have a fever and/or chills, and I hurt all over. It feels sometimes like even my hair hurts:) And my injection sites do have a tendency to form large red circles, but they are NOT infections, just a side effect. And for some reason the injections on my legs hurt the worst.
Comments:   I guess the treatment details are how I take it. The injections are deep subcutaneous. Because the drug is very hard on tissue, you can't inject into the same area. Upper arms are divided into 6 imaginary sections, abdomen 6 areas, legs 6 areas, and buttocks 6. So inject into first arm area on one arm, then next injection opposite arm, then abdomen, legs, and buttocks. Then you must start over in the first arm, but a different section and then work your way down again. This keeps tissue necrosis from occuring. The injections are every other night, and come in a pre-measured syringe the must be mixed SLOWLY with the powder immediately before injection. MAKE SURE to NOT agitate the sol'n, as it will foam, then you can't get it in the syringe, and then it's useless.

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Page last updated: 2015-08-10

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