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Betaseron (Interferon Beta-1B) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Betaseron® (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.

DOSAGE AND ADMINISTRATION

Dosing Information

The recommended starting dose is 0.0625 mg (0.25 mL) subcutaneously every other day, with dose increases over a six week period to the recommended dose of 0.25 mg (1 mL) every other day (see Table 1).

Table 1 Schedule for Dose Titration

Betaseron

Dose 1

Percentage of

recommended dose

Volume

Weeks 1-2

0.0625 mg

25%

0.25 mL

Weeks 3-4

0.125 mg

50%

0.5 mL

Weeks 5-6

0.1875 mg

75%

0.75 mL

Week 7 and thereafter

0.25 mg

100%

1 mL

1 Dosed every other day, subcutaneously

Reconstitution of the Lyophilized Powder

(a) Prior to reconstitution, verify that the vial containing lyophilized Betaseron is not cracked or damaged. Do not use cracked or damaged vials.

(b) To reconstitute lyophilized Betaseron for injection, attach the prefilled syringe containing the diluent (Sodium Chloride, 0.54% Solution) to the Betaseron vial using the vial adapter.

(c) Slowly inject 1.2 mL of diluent into the Betaseron vial.

(d) Gently swirl the vial to dissolve the lyophilized powder completely; do not shake. Foaming may occur during reconstitution or if the vial is swirled or shaken too vigorously. If foaming occurs, allow the vial to sit undisturbed until the foam settles.

(e) 1 mL of reconstituted Betaseron solution contains 0.25 mg of interferon beta-1b.

(f) After reconstitution, if not used immediately, refrigerate the reconstituted Betaseron solution at 2 to 8°C (35 to 46°F) and use within three hours. Do not freeze.

Important Administration Instructions

(a) Perform the first Betaseron injection under the supervision of an appropriately qualified healthcare professional. If patients or caregivers are to administer Betaseron, train them in the proper subcutaneous injection technique and assess their ability to inject subcutaneously to ensure the proper administration of Betaseron.

(b) Visually inspect the reconstituted Betaseron solution before use; discard if it contains particulate matter or is discolored.

(c) Keeping the syringe and vial adapter in place, turn the assembly over so that the vial is on top. Withdraw the appropriate dose of Betaseron solution. Remove the vial from the vial adapter before injecting Betaseron.

(d) Use safe disposal procedures for needles and syringes.

(e) Do not re-use needles or syringes.

(f) Advise patients and caregivers to rotate sites for subcutaneous injections to minimize the likelihood of severe injection site reactions, including necrosis or localized infection.

Premedication for Flu-like Symptoms

Concurrent use of analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms associated with Betaseron use [see Warnings and Precautions].

DOSAGE FORMS AND STRENGTHS

For injection: 0.3 mg lyophilized powder in a single use vial for reconstitution.

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Betaseron is supplied as a lyophilized powder in a clear glass, single-use vial (3 mL capacity). Each carton contains 14 blister units: NDC # 50419-523-35

Each blister unit contains:

Single-use vial containing 0.3 mg Betaseron (interferon beta-1b)

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

2 alcohol prep pads

Vial adapter attached to a 30 gauge needle

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 (15°C to 30°C) are permitted for up to 3 months. After reconstitution, if not used immediately, refrigerate the reconstituted solution and use within three hours. Do not freeze.

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