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About EXTAVIA

Well-Established Safety and Tolerability Profile

  • 92% of patients randomized to interferon beta-1b completed the 2-year study in CIS3
  • The safety and tolerability data for EXTAVIA reflect exposure to interferon beta-1b across 4 placebo-controlled pivotal trials in MS1
Most Common Adverse Reactions 1 (at least 2% more than placebo)
Interferon beta-1b (n=1407) Placebo (n=965)
Blood and lymphatic system disorders
Lymphocyte count decreased (<1500/mm1)* 86% 66%
Absolute neutrophil count decreased (<1500/mm1)* 13% 5%
White blood cell count decreased (<3000/mm1)* 13% 4%
Lymphadenopathy 6% 3%
Nervous system disorders
Headache 50% 43%
Insomnia 21% 16%
Incoordination 17% 15%
Vascular disorders
Hypertension 6% 4%
Respiratory, thoracic, and mediastinal disorders
Dyspnea 6% 3%
Gastrointestinal disorders
Abdominal pain 16% 11%
Hepatobiliary disorders
Alanine aminotransferase increased (SGPT >5 times baseline)* 12% 4%
Aspartate aminotransferase increased(SGOT >5 times baseline)* 4% 1%
Skin and subcutaneous tissue disorders
Rash 21% 15%
Skin disorder 10% 8%
Musculoskeletal and connective tissue disorders
Hypertonia 40% 33%
Myalgia 23% 14%
Renal and urinary disorders
Urinary urgency 11% 8%
Reproductive system and breast disorders
Metrorrhagia 9% 7%
Impotence 8% 6%
General disorders and administration site conditions
Injection site reaction (various kinds)§ 78% 26%
Asthenia 53% 48%
Flu-like symptoms (complex)|| 57% 37%
Pain 42% 35%
Fever 31% 19%
Chills 21% 9%
Peripheral edema 12% 10%
Chest pain 9% 6%
Malaise 6% 3%
Injection site necrosis 4% 0%

*Laboratory abnormality.

Premenopausal women.

Men.

§ Injection site reaction (various kinds) comprises all adverse events occurring at the injection site (except injection site necrosis), ie, the following terms: injection site reaction, injection site hemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site pain, injection site edema, and injection site atrophy.

||Flu-like symptom complex denotes flu syndrome and/or a combination of at least two adverse reactions from fever, chills, myalgia, malaise, and sweating.

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References:
1. Extavia [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016. 2. Betaseron [Prescribing Information]. Montville, NJ: Bayer HealthCare Pharmaceuticals Inc; 2016. 3. 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. 4. Fingertip Formulary®. Analytics report. Extavia: Percentage of covered lives. Accessed October 2017.