Rebif 44 Micrograms Solution for Injection

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. …

Tome assim que lembrar, a menos que esteja quase na hora da próxima dose. Nesse caso, pule a dose esquecida. Nunca tome duas doses de uma vez para compensar. Confira a bula, pois alguns medicamentos são diferentes.