16

Figure 2: Onset of Second Exacerbation by Time in Patients with Isolated Demyelinating Event

with Typical MS Lesions on Brain MRI in Study 4*

*Kaplan-Meier Methodology

In Study 4, patients treated with BETASERON demonstrated a lower number of newly active lesions during the course of

the study. A significant difference between BETASERON and placebo was not seen in the absolute change in T2 lesion

volume during the course of the study.

Safety and efficacy of treatment with BETASERON beyond three years are not known.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

BETASERON is supplied as a lyophilized powder in a clear glass, single-use vial (3 mL capacity). Each carton contains

5 single-use cartons (NDC 50419-524-05) or 14 single-use cartons (NDC 50419-524-35).

Each single-use carton contains:

A single-use vial containing 0.3 mg BETASERON (interferon beta-1b)

A pre-filled single-use syringe containing 1.2 mL diluent (Sodium Chloride, 0.54% solution)

A vial adapter with a 30-gauge needle attached

2 alcohol prep pads

The optional BETACONNECT autoinjector is not supplied with BETASERON, but is available for patients with a

prescription for BETASERON by calling the BETAPLUS patient support program toll-free number at 1-800-788-1467.

16.2 Stability and Storage

BETASERON and the diluent are for single-use only. Discard unused portions. The reconstituted product contains no

preservative. Store BETASERON vials at room temperature 68°F to 77°F (20°C to 25°C). Excursions of 59°F to 86°F