Cryopyrin-Associated Periodic Syndromes (CAPS) are a group of rare and genetic diseases that include Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS). CAPS are chronic diseases that belong to a larger group of diseases known as Periodic Fever Syndromes.
Children can develop CAPS at any point throughout childhood, but FCAS symptoms typically appear during infancy or early childhood, while MWS tends to appear during early adolescence.
It is estimated that only about 1 in 1 million people in the United States have CAPS. But because the symptoms of CAPS can appear similar to those of other conditions, some experts believe that there are people living with CAPS who have either been overlooked or misdiagnosed.
CAPS are genetic diseases that are generally passed on from other family members. CAPS are caused by an inherited mutated gene, called the NLRP3 gene (or the CIAS1 gene). In some cases, however, the genetic mutation responsible for CAPS may occur spontaneously at birth.
A mutated NLRP3 gene causes overactivation of a protein called cryopyrin, which then causes the uncontrolled production of interleukin-1 beta (IL-1β). IL-1β is a protein that is part of the body's immune system. Too much IL-1β in the body can lead to inflammation and other symptoms of CAPS.
Because CAPS are a genetic condition, you may want to talk about CAPS with your family. The Your Family and CAPS Brochure can provide information to help you start the conversation.
Muckle-Wells Syndrome (MWS) is considered to be more severe than Familial Cold Autoinflammatory Syndrome (FCAS). MWS symptoms are thought to be more frequent, more severe, and longer lasting than FCAS symptoms.
If you have questions about CAPS and about how ILARIS® can help, ask your doctor or call 866-972-8315.
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.
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 an unborn baby. Patients who become pregnant while receiving ILARIS should tell their healthcare provider right away.
are breastfeeding or planning to breastfeed. It is not known if ILARIS passes into your breast milk. You and your healthcare provider should decide if you will receive ILARIS or breastfeed.
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 if you are not sure.
ILARIS can cause serious side effects including:
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: rash, itching and hives, difficulty breathing or swallowing, dizziness, or feeling faint.
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.
Tell your healthcare provider about any side effect that bothers you or does not go away.
ILARIS® (canakinumab) is a prescription medicine injected by your healthcare provider just below the skin (subcutaneous) used to treat adults and children aged 4 years and older who have auto-inflammatory diseases called Cryopyrin-Associated Periodic Syndromes (CAPS), including:
Familial Cold Autoinflammatory Syndrome (FCAS)
Muckle-Wells Syndrome (MWS)
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