Betaseron

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION • For subcutaneous use only ( 2.1 ) • The recommended dose is 0.25 mg every other day. Generally, start at 0.0625 mg (0.25 mL) every other day, and increase over a six-week period to 0.25 mg (1 mL) every other day. ( 2.1 ) • Reconstitute lyophilized powder with supplied diluent ( 2.2 ) 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 BETASERON Dose Dosed every other day, subcutaneously 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 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. 2.2 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 pre-filled 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 35°F to 46°F (2°C to 8°C) and use within three hours. Do not freeze . 2.3 Important Administration Instructions (a) 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. (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 [see Warnings and Precautions (5.5)] . 2.4 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