Rx Item-Extavia 0.3Mg Kit 15 By Novartis

EXTAVIA- interferon beta-1b
Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 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
1 Dosed every other day, subcutaneously
EXTAVIA

Dose1

Percentage ofrecommended 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

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.

2.2 Reconstitution of the Lyophilized Powder
(a) Prior to reconstitution, verify that the vial containing lyophilized EXTAVIA is not cracked or damaged. Do not use cracked or damaged vials.

(b) 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.

(c) Slowly inject 1.2 mL of diluent into the EXTAVIA 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 EXTAVIA solution contains 0.25 mg of interferon beta-1b.

(f) 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.

RX ITEM-Extavia 0.3Mg Kit 15 By Novartis
NDC 00078-0569-12 UPC/GTIN No.3-00780-56912-5 Mfg.Part No.56912

Extavia 0.3Mg Kit 15 By Novartis
BRAND: EXTAVIA NDC: 00078-0569-12,78056912 UPC: 3-00780-56912-5,300780569125 Novartis Pharma Corp

INTERFERON BETA-1B SUB-Q
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