For Patients and Caregivers
For US Residents Only
For Patients and Caregivers
For US Residents Only
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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.
You should 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
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:
Familial Cold Autoinflammatory Syndrome (FCAS)
Muckle-Wells Syndrome (MWS)
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.
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.
have or have had HIV, Hepatitis B, or Hepatitis C
are scheduled to receive any immunizations (vaccines). You should not get live vaccines if you are receiving ILARIS
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 canakinumab while you were pregnant. It is important that you tell your baby's healthcare provider before any vaccinations are given to your baby within 4-12 months after you received your last dose of canakinumab 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 the 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: 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).
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 auto-inflammatory 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 www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.
Please see full Prescribing Information, including Medication Guide.
ILARIS is a registered trademark of Novartis AG.
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:
Familial Cold Autoinflammatory Syndrome (FCAS)
Muckle-Wells Syndrome (MWS)
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.
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.
