What is Familial Mediterranean Fever (FMF)?
FMF is an inherited, rare, and serious condition belonging to a group of diseases called Periodic Fever Syndromes. Like other types of Periodic Fevers, FMF is an autoinflammatory condition that can cause attacks, or flares, which can result in symptoms such as fever, stomach pain, rash, chest pain, and muscle/joint pain.
What causes FMF?
FMF is a genetic disease caused by an inherited mutation of the MEFV gene, which causes an overactivation of a protein called cryopyrin. This leads to an overproduction of interleukin-1 beta (IL-1β), 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 FMF.
How long will my child have FMF?
There is no cure for FMF, but with continuous treatment, children with FMF may experience symptom improvement.
What are Periodic Fever Syndromes?
Periodic Fever Syndromes are a group of rare, autoinflammatory diseases that are characterized by symptoms including recurrent fevers, rash, pain, and joint inflammation. Periodic Fevers are typically inherited from other family members, but can occur on their own. Both children and adults can be affected by Periodic Fevers, though symptoms usually begin during childhood.
Is FMF contagious?
FMF is not contagious. It's an inherited disease, which means that it can be passed down from other family members, although the disease can occur on its own. Certain factors are thought to trigger FMF flares, including stress, immunizations, and intense physical activity.
What will happen to my child with FMF?
FMF can vary from child to child. In some patients, untreated FMF can lead to a buildup of protein in the kidneys, which can lead to kidney damage and/or failure. So you should keep track of your child's FMF symptoms, and be sure to know about possible disease triggers. Learn about Managing FMF.
What is ILARIS?
ILARIS® is a prescription medication that is FDA approved to treat FMF. ILARIS works by attaching to and blocking interleukin-1 beta (IL-1β), a type of cytokine responsible for inflammation. ILARIS is given once a month as a subcutaneous injection right below the skin.
How can ILARIS help with FMF?
ILARIS helps provide fast and sustained relief. Of 31 study participants with FMF, 61.3% of FMF patients had minimal to no disease activity at Day 15 through Week 16 of the study. Study participants were assessed and given a single Physician's Global Assessment (PGA) score based on several signs and symptoms, including chest pain, abdominal pain, arthralgia/arthritis (painful and/or swollen joints), and skin rash.
Is ILARIS given intravenously?
ILARIS is not given as an intravenous infusion (infused inside a vein over a period of time). Instead, it is given as a subcutaneous (right under the skin) injection, or shot, once a month by a doctor or nurse. A home health nurse can be sent to your home to administer ILARIS to your child. If you are eligible, this service and other ILARIS support opportunities may be available for your child.
How often will my child receive ILARIS?
ILARIS is given as a once-monthly injection. A home health nurse can be sent to your home to administer ILARIS to your child. If you are eligible, this service and other ILARIS support opportunities may be available for your child.
Is support available to help us pay for ILARIS?
We're committed to helping you get access to ILARIS. Our representatives work with you and your child's doctor to help you get started, including:
Contacting your insurance company
Verifying insurance benefits and investigation of coverage
Addressing coverage issues
Assisting with prior authorization and appeals, if needed
Providing co-pay* assistance for eligible patients with commercial insurance
Providing information about alternative assistance options for uninsured patients
*Limitations apply. Please contact the ILARIS Support Program at 866-972-8315 for more information.
Who can I speak to if I have more questions about ILARIS?
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 your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving ILARIS.
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 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)
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 SJIA and some other auto-inflammatory diseases like HIDS/MKD that can lead to death. Tell your healthcare provider right away if your 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
ILARIS® (canakinumab) is a prescription medicine injected by your healthcare provider just below the skin (subcutaneous) used to treat adults and pediatric patients with the following Periodic Fever Syndromes
Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS)
Hyperimmunoglobulin D Syndrome (HIDS) also known as Mevalonate Kinase Deficiency (MKD)
Familial Mediterranean Fever (FMF)
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