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Extavia^® Overview

EXTAVIA, a Disease-Modifying Therapy for People With Relapsing Forms of MS

EXTAVIA is a disease-modifying therapy (DMT) for people with relapsing forms of multiple sclerosis (MS). EXTAVIA is interferon beta-1b — the exact same molecule as Betaseron^® (interferon beta-1b). EXTAVIA 0.25 mg was approved by the FDA based on the same registration trials as Betaseron 0.25 mg.^1,2

Extavia History

EXTAVIA Dosing and Administration

The recommended dose of EXTAVIA in patients with relapsing-remitting MS (RRMS) is 0.25 mg injected subcutaneously every other day.¹ Read more about EXTAVIA dosing and administration.

Well-Established Safety and Tolerability Profile

Safety and tolerability data reflect exposure to interferon beta-1b in 4 placebo-controlled trials of 1407 patients with MS, including 1261 patients exposed for greater than 1 year.¹ Read more about safety and tolerability.

Efficacy From CIS Through RRMS

EXTAVIA has proven efficacy in delaying the second exacerbation in clinically isolated syndrome (CIS) and is effective in reducing annualized exacerbation rate in RRMS^1,3

EXTAVIA Patient Support Program

The EXTAVIA Patient Support Program is free and comprehensive, providing the services, information, and tools your patients need to help manage their EXTAVIA treatment. The program can even assist patients in identifying resources that can help pay for their EXTAVIA treatment.

Coverage Information

EXTAVIA has been granted preferential formulary access^* over Betaseron^® for your Medicare Part D patients covered by UAFC/MemberHealth.⁴

Visit the Formulary Tool, where you can search coverage for EXTAVIA by state and health plan.

*Avonex^® (interferon beta-1a) and Copaxone^® (glatiramer acetate) are preferred Tier 2 agents; EXTAVIA has been granted Tier 3 access versus Betaseron. All existing Betaseron patients will now be required to try a preferred agent like EXTAVIA, Avonex, or Copaxone first. Patients new to therapy will be required to try Avonex or Copaxone prior to EXTAVIA, Rebif^® (interferon beta-1a), or Betaseron. Inclusion on formulary or formulary status does not imply superior clinical efficacy or safety.

EXTAVIA is a registered trademark of Novartis AG.
Betaseron is a registered trademark of Bayer HealthCare Pharmaceuticals.
Rebif is a registered trademark of EMD Serono, Inc.
Avonex is a registered trademark of Biogen Idec.
Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.

Extavia [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2009.
Betaseron [package insert]. Montville, NJ: Bayer HealthCare Pharmaceuticals Inc; 2008.
Kappos L, Polman CH, Freedman MS, et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology. 2006;67:1242-1249.
MemberHealth website. http://2010.mhrx.com/about-memberhealth.aspx. Accessed on 6/15/2010.

Indication and Important Safety Information

Indication

EXTAVIA (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.

Important Safety Information

EXTAVIA is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin (human), USP, or any other component of the formulation.

EXTAVIA should be used with caution in patients with depression. Depression and suicide have been reported to occur with increased frequency in patients receiving interferon compounds, including EXTAVIA. Patients treated with EXTAVIA should be advised to immediately report any symptoms of depression and/or suicidal ideation. Consider discontinuation of EXTAVIA if depression occurs.

Injection site necrosis has been reported in 4% of patients in controlled clinical trials. Injection site reactions occurred in 78% of patients receiving EXTAVIA. Patients should be advised of the importance of rotating injection sites and the use of aseptic self-injection techniques.

Anaphylaxis has been reported as a rare complication of EXTAVIA use.

The rate of flu-like symptom complex was approximately 57%. The incidence decreased over time, with only 10% of patients reporting flu-like symptom complex at the end of the studies. Concurrent use of analgesics and/or antipyretics may help ameliorate flu-like symptoms on treatment days. Leukopenia was reported in 18% of patients. Hepatic enzyme elevations of SGPT to greater than five times baseline value were reported in 12% of patients and increases of SGOT to greater than five times baseline value were reported in 4% of patients leading to dose reduction or discontinuation of EXTAVIA in some patients. Monitoring of certain lab tests is recommended following initiation of EXTAVIA therapy, including complete blood count and liver function tests. In patients with a history of thyroid dysfunction, thyroid function tests are recommended every six months.

EXTAVIA should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

The most common adverse reactions (at least 2% more than placebo) with EXTAVIA were: lymphopenia (66% vs 86%), neutropenia (5% vs 13%), leukopenia (4% vs 13%), lymphadenopathy (3% vs 6%), headache (43% vs 50%), insomnia (16% vs 21%), incoordination (15% vs 17%), hypertension (4% vs 6%), dyspnea (3% vs 6%), abdominal pain (11% vs 16%), increased liver enzymes (up to 4% vs up to 12%), rash (15% vs 21%), skin disorder (8% vs 10%), hypertonia (33% vs 40%), myalgia (14% vs 23%), urinary urgency (8% vs 11%), metrorrhagia (7% vs 9%), impotence (6% vs 8%), injection site reaction (26% vs 78%), asthenia (48% vs 53%), flu-like symptom complex (37% vs 57%), pain (35% vs 42%), fever (19% vs 31%), chills (9% vs 21%), peripheral edema (10% vs 12%), chest pain (6% vs 9%), malaise (3% vs 6%), and injection site necrosis (0% vs 4%).

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Extavia® Overview