17
(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.
17 PATIENT COUNSELING INFORMATION
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.
Advise patients of the
importance of rotating areas of injection with each dose, to minimize the likelihood of severe injection site reactions,
including necrosis or localized infection
[see Medication Guide]
.
Hepatic Injury
Advise patients that severe hepatic injury, including hepatic failure, has been reported during the use of BETASERON.
Inform patients of symptoms of hepatic dysfunction, and instruct patients to report them immediately to their healthcare
provider
[see Warnings and Precautions (
5.1
)]
.
Anaphylaxis and Other Allergic Reactions
Advise patients of the symptoms of allergic reactions and anaphylaxis, and instruct patients to seek immediate medical
attention if these symptoms occur
[see Warnings and Precautions (
5.2
)]
.
Depression and Suicide
Advise patients that depression and suicidal ideation have been reported during the use of BETASERON. Inform patients
of the symptoms of depression or suicidal ideation, and instruct patients to report them immediately to their healthcare
provider
[see Warnings and Precautions (
5.3
)]
.
Congestive Heart Failure
Advise patients that worsening of pre-existing congestive heart failure have been reported in patients using
BETASERON.
Advise patients of symptoms of worsening cardiac condition, and instruct patients to report them immediately to their
healthcare provider
[see Warnings and Precautions (
5.4
)]
.
Injection Site Necrosis and Reactions
Advise patients that injection site reactions occur in most patients treated with BETASERON, and that injection site
necrosis may occur at one or multiple sites. Instruct patients to promptly report any break in the skin, which may be
associated with blue-black discoloration, swelling, or drainage of fluid from the injection site, prior to continuing their
BETASERON therapy
[see Warnings and Precautions (
5.5
)]
.