IMPORTANT SAFETY
INFORMATION
ILARIS can cause serious side effects, including
increased risk of serious infections. ILARIS can lower the ability
of your immune system to fight infections. Your healthcare provider
should:
-
test you for tuberculosis (TB)
before you receive ILARIS
-
monitor you closely for symptoms
of TB during treatment with ILARIS
-
check you for symptoms of any
type of infection before, during, and after treatment with ILARIS
Tell your healthcare provider
right away if you have any symptoms of an infection such as fever,
sweats or chills, cough, flu-like symptoms, weight loss, shortness
of breath, blood in your phlegm, sores on your body, warm or painful
areas on your body, diarrhea or stomach pain, or feeling very tired.
Do not receive ILARIS if you
are allergic to canakinumab or any of the ingredients in ILARIS.
Before receiving ILARIS, tell
your healthcare provider about all your medical conditions,
including if you:
-
think you have or are being
treated for an active infection
-
have symptoms of infection
-
have a history of infections that
keep coming back
-
have a history of low white blood
cells
-
have or have had HIV, Hepatitis
B, or Hepatitis C
-
have recently received or are scheduled to receive any vaccinations
-
You should be brought up to date with all age required vaccines before starting treatment with ILARIS
-
You should not receive "live" vaccines while you are being treated with ILARIS and until your healthcare provider tells you that your immune system is no longer weakened
-
are pregnant or planning to
become pregnant. It is not known if ILARIS will harm your unborn
baby. Tell your healthcare provider right away if you become
pregnant while receiving ILARIS
-
received ILARIS while you were pregnant. It is important that
you tell your baby's healthcare provider before any vaccinations
are given to your baby within 4 to 12 months after you received
your last dose of ILARIS before giving birth
-
are breastfeeding or planning to
breastfeed. It is not known if ILARIS passes into your breast
milk. Talk to your healthcare provider about the best way to feed
your baby if you receive ILARIS
Tell your healthcare provider about all the
medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Especially tell your
healthcare provider if you take:
-
medicines that affect your immune
system
-
medicines called interleukin-1 (IL-1) blocking agents such as
Kineret® (anakinra) or Arcalyst®
(rilonacept)
-
medicines called tumor necrosis factor (TNF) inhibitors such as
Enbrel® (etanercept), Humira®
(adalimumab), Remicade® (infliximab), Simponi®
(golimumab), or Cimzia® (certolizumab pegol)
-
medicines that affect enzyme
metabolism
Ask your healthcare provider
for a list of these medicines if you are not sure.
ILARIS can cause serious side effects including:
-
serious infections
-
decreased ability of the body to fight infections
(immunosuppression). For people treated with medicines that cause
immunosuppression like ILARIS, the chances of getting cancer may
increase
-
allergic reactions. Allergic reactions can happen
while receiving ILARIS. Call your healthcare provider right away
if you have any of these symptoms of an allergic reaction:
difficulty breathing or swallowing, nausea, dizziness or feeling
faint, rash, itching or hives, palpitations (feels like your heart
is racing), or low blood pressure
-
risk of infection with live vaccines. You should
not get live vaccines if you are receiving ILARIS. Tell your
healthcare provider if you are scheduled to receive any vaccines
The most common side effects of ILARIS when used
for the treatment of CAPS include: cold symptoms, diarrhea, flu
(influenza), runny nose, headache, cough, body aches, nausea,
vomiting, and diarrhea (gastroenteritis), feeling like you are
spinning (vertigo), weight gain, injection-site reactions (such as
redness, swelling, warmth, or itching), and nausea.
The most common side effects of ILARIS when used
for the treatment of TRAPS, HIDS/MKD, and FMF include: cold
symptoms, upper respiratory tract infection, runny nose, sore
throat, nausea, vomiting, and diarrhea (gastroenteritis), and
injection-site reactions (such as redness, swelling, warmth, or
itching).
The most common side effects of ILARIS when used
for the treatment of Still's disease (AOSD and SJIA) include: cold
symptoms, upper respiratory tract infection, pneumonia, runny nose,
sore throat, urinary tract infection, nausea, vomiting, and diarrhea
(gastroenteritis), stomach pain, and injection-site reactions (such
as redness, swelling, warmth, or itching).
The most common side effects of ILARIS when used
for the treatment of gout flares include: cold symptoms, upper
respiratory tract infection, urinary tract infection, increased
levels of triglycerides in blood, and back pain.
Tell your healthcare provider
about any side effect that bothers you or does not go away.
What is Macrophage Activation Syndrome (MAS)?
MAS is a syndrome associated with
Still's disease and some other autoinflammatory diseases like
HIDS/MKD that can lead to death. Tell your healthcare provider right
away if your AOSD or SJIA symptoms get worse or if you have any of
these symptoms of an infection:
-
a fever lasting longer than 3
days
-
a cough that does not go away
-
redness in one part of your body
-
warm feeling or swelling of your
skin
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit or call 1-800-FDA-1088.1-800-FDA-1088.
Please see full Prescribing Information,
including Medication
Guide.
All trademarks and
registered trademarks are the property of their respective owners.
APPROVED USE
ILARIS® (canakinumab) is a prescription medicine
injected by your healthcare provider just below the skin
(subcutaneous) used to treat:
-
The following auto-inflammatory
Periodic Fever Syndromes
-
Cryopyrin-Associated Periodic
Syndromes (CAPS) in patients 4 years of age and older,
including:
-
Tumor Necrosis Factor Receptor
Associated Periodic Syndrome (TRAPS) in adult and pediatric
patients
-
Hyperimmunoglobulin D Syndrome
(HIDS) also known as Mevalonate Kinase Deficiency (MKD) in
adult and pediatric patients
-
Familial Mediterranean Fever
(FMF) in adult and pediatric patients
-
Still's disease including
Adult-Onset Still's Disease (AOSD) and Systemic Juvenile
Idiopathic Arthritis (SJIA) in children 2 years of age and older.
-
Gout flares in adults who:
-
are not able to receive or
tolerate treatment with nonsteroidal anti-inflammatory drugs
(NSAIDs) and colchicine
-
have not responded to treatment
with NSAIDs and colchicine
-
are not able to receive repeated treatment with steroids
It is not known if ILARIS is
safe and effective when used to treat SJIA in children under 2
years of age or when used to treat CAPS in children under 4 years
of age or when used to treat gout flares in children.