"The US Food and Drug Administration (FDA) is warning that a case of definite multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking fingolimod (Gilenya, Novartis) for relapsing forms of mult"...
EXTAVIA (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
|EXTAVIA 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|
If a dose of EXTAVIA is missed, then it should be taken as soon as the patient remembers or is able to take it. The patient should not take EXTAVIA 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 EXTAVIA is not cracked or damaged. Do not use cracked or damaged vials.
- To reconstitute lyophilized EXTAVIA for injection, attach the pre-filled syringe containing the diluent (Sodium Chloride, 0.54% Solution) to the EXTAVIA vial using the vial adapter.
- The removable rubber cap of the diluent (Sodium Chloride, 0.54% Solution) pre-filled syringe contains natural rubber latex, which may cause allergic reactions and should not be handled by latex-sensitive individuals.
- Slowly inject 1.2 mL of diluent into the EXTAVIA 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 EXTAVIA solution contains 0.25 mg of interferon beta-1b.
- After reconstitution, if not used immediately, refrigerate the reconstituted EXTAVIA 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 EXTAVIA injection under the supervision of an appropriately qualified healthcare professional. If patients or caregivers are to administer EXTAVIA, train them in the proper subcutaneous injection technique and assess their ability to inject subcutaneously to ensure the proper administration of EXTAVIA.
- Visually inspect the reconstituted EXTAVIA 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 EXTAVIA solution. Remove the vial from the vial adapter before injecting EXTAVIA.
- 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 EXTAVIA 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
EXTAVIA is supplied as a lyophilized powder in a clear glass, single-use vial (3 mL capacity). Each carton contains 15 blister units: NDC 0078-0569-12.
Each blister unit contains:
A single-use vial containing
0.3 mg EXTAVIA (interferon beta-1b)
A pre-filled single-use syringe containing 1.2 mL diluent (Sodium Chloride, 0.54% solution). The rubber cap of the pre-filled syringe contains natural rubber latex.
A vial adapter with a 27-gauge needle attached
2 alcohol prep pads
Stability And Storage
EXTAVIA and the diluent are for single-use only. Discard unused portions. The reconstituted product contains no preservative. Store EXTAVIA 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.
Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised: May 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/20/2016
Additional Extavia Information
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