"The European Medicines Agency (EMA) today issued updated recommendations on ways to minimize the risk for progressive multifocal leukoencephalopathy with dimethyl fumarate (Tecfidera, Biogen).
To date, three cases of PML have"...
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 sixweek 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|
|1 Dosed 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
- BETASERON is intended for use under the guidance and
supervision of a physician. If patients or caregivers are to administer
BETASERON, train them in the proper technique for self-administering subcutaneous injections using
the prefilled syringe or the optional injection device. The BETACONNECT autoinjector
has three adjustable injection depth settings; the healthcare provider should
determine the proper depth setting and injection technique. Use only the
syringes in the BETASERON packaging with the BETACONNECT autoinjector.
The initial BETASERON injection should be performed under the supervision of an appropriately qualified healthcare provider. Users should demonstrate competency in all aspects of the BETASERON injection prior to independent use. If a patient is to self-administer BETASERON, the physical and cognitive ability of that patient to self -administer and properly dispose of syringes should be assessed. Patients with severe neurological deficits should not self-administer injections without assistance from a trained caregiver.
Appropriate instruction for self-injection or injection by another person should be provided to the patient or their caregiver, including careful review of the BETASERON Medication Guide, the prefilled syringe Instructions for Use, and the BETACONNECT autoinjector Instructions for Use that accompanies the product.
- 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 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
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.
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 for: Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. Revised: Dec 2015.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/3/2016
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