Extavia® (Interferon Beta 1b) Multiple Sclerosis (MS) Injectable Disease Modifying Therapy

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Extavia® (Interferon Beta 1b)

Overview:

EXTAVIA is one of several MS treatments called interferons that are known as disease-modifying therapies.

Interferon beta-1b is the active ingredient in EXTAVIA and is based on a protein that’s found naturally in the human body.

Interferons (IFNs) are a family of naturally occurring proteins, produced by eukaryotic cells in response to viral infection and other biologic agents. Three major groups of interferons have been distinguished: alpha, beta, and gamma. Interferons alpha and beta comprise the Type I interferons and interferon gamma is a Type II interferon. Type I interferons have considerably overlapping but also distinct biologic activities. The bioactivities of IFNs are mediated by their interactions with specific receptors found on the surfaces of human cells. Differences in bioactivites induced by IFNs likely reflect divergences in the signal transduction process induced by IFN-receptor binding.

The mechanism of action of Interferon beta-1b in patients with multiple sclerosis is unknown. Interferon beta-1b receptor binding induces the expression of proteins that are responsible for the pleiotropic bioactivities of Interferon beta-1b. A number of these proteins (including neopterin, β2-microglobulin, MxA protein, and IL-10) have been measured in blood fractions from Betaseron-treated patients and Betaseron-treated healthy volunteers. Immunomodulatory effects of Interferon beta-1b include the enhancement of suppressor T cell activity, reduction of pro-inflammatory cytokine production, down-regulation of antigen presentation, and inhibition of lymphocyte trafficking into the central nervous system. It is not known if these effects play an important role in the observed clinical activity of Betaseron in multiple sclerosis (MS).

EXTAVIA is a prescription medicine used to reduce the number of relapses in people with relapsing forms of multiple sclerosis (MS). This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with MS. EXTAVIA will not cure MS but may decrease the number of flare-ups of the disease.

Although EXTAVIA is proven effective, the exact mechanism of action is unknown.

Extavia is essentially the same medication as Betaseron.

FDA approval on August 14th, 2009.

Dosing:

EXTAVIA is injected under the skin every other day using the EXTAVIA Auto-Injector II or by manual injection.

The recommended dose of EXTAVIA is 0.25 mg every other day. Your doctor may start you on a smaller dose of 0.0625 mg and increase your dosage gradually over a 6-week period to 0.25 mg.

Side Effects:

The most common side effects with EXTAVIA (at least 2% more than placebo) were:

  • Injection site reaction
  • Flu-like symptom complex
  • Excessive fatigue
  • Headache
  • Pain
  • Increased muscle tone
  • Fever
  • Muscle pain
  • Rash
  • Chills
  • Trouble sleeping
  • Incoordination
  • Abdominal pain
  • Decreased white blood cells
  • Tissue swelling
  • Urinary urgency
  • Skin disorder
  • Chest pain
  • Vaginal bleeding
  • Impotence
  • High blood pressure
  • Malaise
  • Enlarged lymph nodes
  • Shortness of breath
  • Increased liver enzymes
  • Injection site necrosis

Efficacy Results:

  % of patients exacerbation free at end of 2 years
Placebo Extavia ® Extavia ®
0.05mg 0.25mg
16% 18% 25%

Note: Patients on the study who required more than three 28-day courses of corticosteroids were removed from the study

Number of exacerbations in Subset (people who completed full 2 years) completing 2 years of Betaseron

No. of Exacerbations Placebo Extavia ® Extavia ®
0.05mg 0.25mg
0 20% 22% 29%
1 32% 31% 39%
2 20% 28% 17%
3 15% 15% 14%
4 15% 7% 9%
≥5 21% 16% 8%

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. We apply our expertise in science and innovation to society’s biggest health challenges. Responsibility is a core part of our business strategy.

Website: www.extavia.com


Extavia Patient Information:
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