Interferon beta-

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 )

• For subcutaneous use only • 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. • Reconstitute lyophilized powder with supplied diluent 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
• 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. …

For injection: 0.3 mg lyophilized powder in a single-dose vial for reconstitution. For injection: 0.3 mg of lyophilized powder in a single-dose vial for reconstitution ( 3 )

• Safety and efficacy
• In pediatric patients have not been established

Clinical studies of BETASERON did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

• See FDA-approved patient labeling (Medication Guide and Instructions for Use)
• Instruct patients to carefully read the supplied BETASERON Medication Guide and caution patients not to change the BETASERON dose or schedule of administration without medical consultation
• Instruction on Self-Injection Technique and Procedures Provide appropriate instruction for reconstitution of BETASERON and methods of self-injection, including careful review of the BETASERON Medication Guide
• Instruct patients in the use of aseptic technique when administering BETASERON
• Tell patients not to re-use needles or syringes and instruct patients on safe disposal procedures. …

• BETASERON is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), or any other component of the formulation
• History of hypersensitivity to natural or recombinant interferon beta, albumin or mannitol

• Hepatic Injury: Monitor liver function tests and signs and symptoms of hepatic injury; consider discontinuing BETASERON if serious hepatic injury occurs. ( 5.1 , 5.11 ) • Anaphylaxis and Other Allergic Reactions: Discontinue if anaphylaxis occurs. ( 5.2 ) • Depression and Suicide: Advise patients to immediately report any symptom of depression and/or suicidal ideation; consider discontinuation of BETASERON if depression occurs. ( 5.3 ) • Congestive Heart Failure (CHF): Monitor patients with CHF for worsening of cardiac symptoms; consider discontinuation of BETASERON if worsening of CHF occurs. …

The following serious adverse reactions are discussed in more details in other sections of labeling: • Hepatic Injury [see Warnings and Precautions ( 5.1 )] • Anaphylaxis and Other Allergic Reactions [see Warnings and Precautions ( 5.2 )] • Depression and Suicide [see Warnings and Precautions ( 5.3 )] • Congestive Heart Failure [see Warnings and Precautions ( 5.4 )] • Injection Site Reactions Including Necrosis [see Warnings and Precautions ( 5.5 )] • Leukopenia [see Warnings and Precautions ( 5.6 )] • Thrombotic Microangiopathy [see Warnings and Precautions ( 5.7 )] • Pulmonary Arterial Hypertension [see Warnings and Precautions ( 5.8 )] • Flu-like Symptom Complex [see Warnings and Precauti …

8.1 Pregnancy Risk Summary Although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.