"The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
MS is a chronic, inflammatory, autoimmune disease of the central nervous system"...
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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
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 Dose1||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|
|1Dosed every other day, subcutaneously|
If a dose of Betaseron is missed, then it should be taken as soon as the patient remembers or is able to take it. The patient should not take Betaseron on two consecutive days. The next injection should be taken about 48 hours (two days) after that dose. If the patient accidentally takes more than their prescribed dose, or takes it on two consecutive days, they should be instructed to call their healthcare provider immediately.
Reconstitution of the Lyophilized Powder
- Prior to reconstitution, verify that the vial containing lyophilized Betaseron is not cracked or damaged. Do not use cracked or damaged vials.
- To reconstitute lyophilized Betaseron for injection, attach the pre-filled syringe containing the diluent (Sodium Chloride, 0.54% Solution) to the Betaseron vial using the vial adapter.
- Slowly inject 1.2 mL of diluent into the Betaseron vial.
- 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.
- 1 mL of reconstituted Betaseron solution contains 0.25 mg of interferon beta-1b.
- After reconstitution, if not used immediately, refrigerate the reconstituted Betaseron solution at 35°F to 46°F (2°C to 8°C) and use within three hours. Do not freeze.
Important Administration Instructions
- 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.
- Visually inspect the reconstituted Betaseron solution before use; discard if it contains particulate matter or is discolored.
- 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.
- Use safe disposal procedures for needles and syringes.
- Do not re-use needles or syringes.
- 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.
Storage And Handling
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:
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
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.
Manufactured by: Bayer HealthCare Pharmaceuticals Inc. Montville, NJ 07045. Revision Date: 06/2013
Last reviewed on RxList: 8/6/2013
This monograph has been modified to include the generic and brand name in many instances.
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