Indication
AVONEX® (interferon beta-1a) is approved by FDA
to treat relapsing forms of multiple sclerosis (MS)
to decrease the number of flare-ups and slow the
occurrence of some of the physical disability that is
common in people with MS. AVONEX is approved for
use in people who have experienced a first attack and
have lesions consistent with MS on their MRI.
Important Safety Information
Before beginning treatment, you should discuss with
your healthcare provider the potential benefits and risks
associated with AVONEX.
AVONEX can cause serious side effects. Tell your
healthcare provider right away if you have any of the
symptoms listed below while taking AVONEX.
1. Behavioral health problems including
depression, suicidal thoughts or
hallucinations. Some people taking AVONEX
may develop mood or behavior problems including
irritability (getting upset easily), depression (feeling
hopeless or feeling bad about yourself), nervousness,
anxiety, aggressive behavior, thoughts of hurting
yourself or suicide, and hearing or seeing things that
others do not hear or see (hallucinations).
2. Liver problems, or worsening of liver
problems including liver failure and death.
Symptoms may include nausea, loss of appetite,
tiredness, dark colored urine and pale stools,
yellowing of your skin or the white part of your eye,
bleeding more easily than normal, confusion, and
sleepiness. During your treatment with AVONEX you
will need to see your healthcare provider regularly
and have regular blood tests to check for side effects.
3. Serious allergic reactions and skin reactions.
Symptoms may include itching, swelling of the
face, eyes, lips, tongue or throat, trouble breathing,
anxiousness, feeling faint, and skin rash, hives, sores
in your mouth, or your skin blisters and peels.
AVONEX will not cure your MS but may decrease
the number of flare-ups of the disease and slow the
occurrence of some of the physical disability that is
common in people with MS. MS is a life-long disease that
affects your nervous system by destroying the protective
covering (myelin) that surrounds your nerve fibers.
The way AVONEX works in MS is not known. It is not
known if AVONEX is safe and effective in children.
Do not take AVONEX if you are allergic to
interferon beta, albumin (human), or any of the
ingredients in AVONEX.
Before taking AVONEX, tell your healthcare
provider if you:
• are being treated for a mental illness, or had treatment
in the past for any mental illness, including depression
and suicidal behavior
• have or had bleeding problems or blood clots, have or
had low blood cell counts, have or had liver problems,
have or had seizures (epilepsy), have or had heart
problems, have or had thyroid problems, have or had any
kind of autoimmune disease (where the body’s immune
system attacks the body’s own cells), such as psoriasis,
systemic lupus erythematosus, or rheumatoid arthritis
• drink alcohol
• are pregnant or plan to become pregnant. It is not
known if AVONEX will harm your unborn baby. Tell
your healthcare provider if you become pregnant
during your treatment with AVONEX.
• are breastfeeding or plan to breastfeed. It is not
known if AVONEX passes into your breast milk. You
and your healthcare provider should decide if you will
use AVONEX or breastfeed. You should not do both.
Tell your healthcare provider about all
the medicines you take, including prescription
and non-prescription medicines, vitamins, and
herbal supplements.
(Continued on the following pages.)
For additional important safety information, please see the following pages and the brief summary of the
Medication Guide. This information is not intended to replace discussions with your healthcare provider.
