TOOLS AND RESOURCES
Download the following tools and resources for detailed information about ARCALYST and how to use it:
ARCALYST Brochure
This guide provides information about recurrent pericarditis, how ARCALYST works and how to administer it, and support we offer to people being treated with ARCALYST.
Doctor discussion guide
Getting the care you need often starts with being your own best advocate. This guide can help you plan for your next visit with space to record your medical history and suggested topics and questions to discuss with your healthcare provider.
ARCALYST step-by-step injection manual
In addition to what you have learned from your healthcare provider or ARCALYST Clinical Educator, this guide will give you step-by-step instructions for preparing and injecting ARCALYST. If you would prefer to watch a video you can also view the ARCALYST Injection Video.
ARCALYST step-by-step injection video
In addition to what you have learned from your healthcare provider or ARCALYST Clinical Educator, this video will give your step-by-step instructions for preparing and injecting ARCALYST. If you would prefer a printable version you can also download or print the ARCALYST Injection Manual.
Injection Tracker Manual
Getting the most out of your treatment with ARCALYST means taking it exactly as your doctor prescribes. Use this manual to keep track of your injection sites and keep a record of your weekly injections.
Kiniksa OneConnect™ Patient Support Program Brochure
See how Kiniksa OneConnect™ provides personalized support for getting started on ARCALYST, including insurance, delivery, financial assistance, and injection training.
Kiniksa OneConnect™ Patient Support Process Video
Watch how Kiniksa OneConnect™ may help with insurance coverage, eligible cost-saving options, refills, injection training, and ongoing support.
Traveling with Medications
Review tips for traveling with ARCALYST, including how to store, pack, and fly with your medication.
Creating a Treatment Routine
Get tips to help plan and track your ARCALYST treatment.
Medication Storage and Handling
Review important information about storing and handling ARCALYST safely before and after treatment.
Tips for ongoing success
Everybody's journey with recurrent pericarditis and ARCALYST is different. However, here are some tips for success that people with recurrent pericarditis and their doctors have shared:
Frequently asked questions
These FAQs are here to provide valuable information about ARCALYST and recurrent pericarditis.
Be sure to discuss your treatment options with your doctor and to contact the Kiniksa OneConnect™ program at 1-833-KINIKSA (1-833-546-4572) for additional information and support.
ARCALYST is an interleukin-1 (IL-1) blocker and prescription medication indicated for:
- Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older
- Maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more
- Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older
It is not known if ARCALYST is safe and effective in children under 12 years of age. It is not known if ARCALYST is safe and effective in children with DIRA weighing less than 22 pounds (10 kg).
To find a doctor who may be able to treat your recurrent pericarditis, a great place to start is with your insurance provider. Visit their website to view the doctors in your network. In many circumstances, insurance plans will not only list doctors and their specialties, but also list the conditions they treat. Additionally, there are patient advocacy groups such as the Pericarditis Alliance, Myocarditis Foundation, and American Heart Association that may provide support and resources.
Before starting treatment with ARCALYST, tell your healthcare provider if you:
- Think you have an infection
- Are being treated for an infection
- Have signs of an infection, such as fever, cough, or flu-like symptoms
- Have any open sores on your body
- Have a history of infections that keep coming back
- Have asthma. People with asthma may have an increased risk of infection
- Have diabetes or an immune system problem. People with these problems have a higher chance for infections
- Have tuberculosis (TB), or if you have been in close contact with someone who has had tuberculosis
- Have or have had HIV, hepatitis B, or hepatitis C
- Take other medicines that affect your immune system
Before you begin treatment with ARCALYST, talk with your healthcare provider about your vaccine history. Ask your healthcare provider whether you should receive any vaccines, including the pneumonia vaccine and flu vaccine, before you begin treatment with ARCALYST.
ARCALYST can affect your immune system. ARCALYST can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death, have happened in people taking ARCALYST. Taking ARCALYST can make you more likely to get infections, including life-threatening serious infections, or may make any infection that you have worse.
You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection).
After starting ARCALYST, if you get an infection, any sign of an infection, including a fever, cough, flu-like symptoms, or have any open sores on your body, call the healthcare provider right away. Treatment with ARCALYST should be stopped if you get a serious infection.
You should not take medicines that block tumor necrosis factor (TNF), such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab), while you are taking ARCALYST. You should also not take other medicines that block interleukin-1 (IL-1), such as Kineret® (anakinra), while taking ARCALYST. Taking ARCALYST with any of these medicines may increase your risk of getting a serious infection.
Before starting treatment with ARCALYST, tell the healthcare provider if you or your child:
- Think you have an infection
- Are being treated for an infection
- Have signs of an infection, such as fever, cough, or flu-like symptoms
- Have any open sores on your body
- Have a history of infections that keep coming back
- Have asthma. People with asthma may have an increased risk of infection
- Have diabetes or an immune system problem. People with these problems have a higher chance for infections
- Have tuberculosis (TB), or if you have been in close contact with someone who has had tuberculosis
- Have or have had HIV, hepatitis B, or hepatitis C
- Take other medicines that affect your immune system
Before you begin treatment with ARCALYST, talk with the healthcare provider about your vaccine history. Ask the healthcare provider whether you should receive any vaccines, including the pneumonia vaccine and flu vaccine, before you begin treatment with ARCALYST.
See Prescribing Information for additional safety information for ARCALYST.
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 other medicines that affect your immune system, such as medicines that block tumor necrosis factor, interleukin-1, or corticosteroids.
You should not take medicines that block tumor necrosis factor (TNF), such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab), while you are taking ARCALYST. You should also not take other medicines that block interleukin-1 (IL-1), such as Kineret® (anakinra), while taking ARCALYST. Taking ARCALYST with any of these medicines may increase your risk of getting a serious infection.
For patients taking CYP450 substrates, such as warfarin, the dose of these types of medications may need to be adjusted upon initiation of ARCALYST.
You should not receive live vaccines if you take ARCALYST.
ARCALYST can cause serious side effects, including:
- Serious Infections. ARCALYST can affect your immune system. ARCALYST can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death, have happened in people taking ARCALYST. Taking ARCALYST can make you more likely to get infections, including life-threatening serious infections, or may make any infection that you have worse.
- Risk of Cancer. Medicines that affect the immune system may increase the risk of getting cancer.
- Allergic Reaction. Stop taking or giving ARCALYST and call the healthcare provider or get emergency care right away if you get any of the following symptoms of an allergic reaction while taking ARCALYST:
- Rash
- Swollen face
- Trouble breathing
- Changes in your blood cholesterol and triglycerides (lipids). Your healthcare provider will do blood tests to check for these changes.
Common side effects:
- In people with CAPS and RP, the most common side effects of ARCALYST include:
- Injection-site reactions including: pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site.
- Upper respiratory tract infections
- Joint and muscle aches in RP
- In people with DIRA, the most common side effects of ARCALYST include:
- Upper respiratory tract infections
- Rash
- Ear infection
- Sore throat
- Runny nose
These are not all the possible side effects of ARCALYST. Tell your healthcare provider if you have any side effect that bothers you or does not go away. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you are pregnant or plan to become pregnant:
- It is not known if ARCALYST will harm your unborn child. Tell your healthcare provider right away if you become pregnant while taking ARCALYST
- If you are breastfeeding or plan to breastfeed. It is not known if ARCALYST passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ARCALYST
The Kiniksa OneConnect™ program is made up of a team of dedicated Patient Access Leads who provide personalized one-on-one support at each step of your treatment journey with ARCALYST. You can find services to help you with starting treatment, financial assistance, and treatment support. You can contact a Kiniksa OneConnect™ team member at 1-833-KINIKSA (1-833-546-4572) ) Monday-Friday (8 AM - 8 PM ET).
Your Kiniksa OneConnect™ Patient Access Lead will help you coordinate the delivery of your medication and supplies.
ARCALYST Clinical Educators are qualified personnel who can assist you with virtual or in-person training to help you better understand the self-injection process.
Every patient is different, so the amount of time each patient is on ARCALYST may vary.
Some patients may need treatment with ARCALYST for longer durations than others as the disease may still be present. Please talk to your healthcare provider to determine how long you should be on ARCALYST. Kiniksa is unable to provide individual recommendations for treatment duration with ARCALYST.
Take ARCALYST exactly as prescribed by your healthcare provider.
ARCALYST is given by injection under the skin (subcutaneous injection) once weekly. The Kiniksa OneConnect program can work with you to set up one-one injection training sessions with an ARCALYST Clinical Educator, so you are familiar with the administration process. Do not try to give yourself ARCALYST injections until you are sure that you understand how to prepare and inject your dose. Call your healthcare provider, pharmacist, or your Kiniksa OneConnect™ Patient Access Lead at 1-833-KINIKSA (1-833-546-4572) if you have any questions.
Other resources include the Step-by-Step Injection video, the Step-by-Step Injection Manual, and the ARCALYST Instructions for Use.
ARCALYST is a once-weekly, self-administered medication given by subcutaneous injection (under the skin).
Keep ARCALYST in the carton it comes in to protect it from light. Store ARCALYST in the refrigerator between 36° F and 46° F (2° C and 8° C). Refrigerated ARCALYST can be used until the expiration date printed on the vial and carton. ARCALYST may be kept at room temperature after mixing with sterile water for injection and should be used within 3 hours of mixing.
Keep ARCALYST away from light, and keep ARCALYST, injection supplies, and all other medicines out of the reach of children.
If you miss a dose, you should speak with your healthcare provider. For more information, please see the full Prescribing Information.
It is normal for the powder in the ARCALYST vial to appear as a solid clump or disc. If this is observed, continue following the steps related to the reconstitution of ARCALYST as outlined in the Instructions for Use. You may need to shake the vial back and forth for an extended period of time (repeat step 25 in the Instructions for Use) until the powder has completely dissolved and the solution is clear.
Call your healthcare provider, pharmacist, or your Kiniksa OneConnect™ Patient Access Lead at 1-833-KINIKSA (1-833-546-4572) if you have any questions.
ARCALYST should be stored in the refrigerator between 36° F and 46° F (2° C and 8° C) until it is time to prepare the product for your dose.
If you receive your ARCALYST and the product feels warm to the touch or the temperature monitor inside the shipping container has been activated, please contact your Patient Access Lead who can provide guidance on the use of the product.
Talk to your healthcare provider if you experience any side effects that bother you or that do not go away. Please report side effects by contacting Kiniksa Pharmaceuticals toll-free at 1-833-546-4572, Option 4, or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
If you believe you are experiencing a medical emergency, please call 911.
- Active ingredient: rilonacept
- Inactive ingredients: glycine, histidine, L-arginine, polyethylene glycol 3350, and sucrose
Connect with advocacy and support groups
For information about recurrent pericarditis, please see these organizations. The organizations listed here support various conditions, including recurrent pericarditis.
While Kiniksa may provide funding to one or more of these institutions, Kiniksa neither endorses nor is responsible for the content of any of these listed websites or the services provided by these organizations.
The Pericarditis Alliance is dedicated to the management and treatment of pericardial disease through research, education, and support for patients and healthcare providers.
The Myocarditis Foundation provides resources for patients, their families, healthcare professionals, and researchers about myocarditis and pericarditis.
NORD is a patient advocacy organization dedicated to individuals with rare diseases and the organizations that serve them.
Glossary of Terms
A
A
Active flare
The time when a person is actively experiencing the signs and symptoms of first episode or recurrent pericarditis, including chest pain that feels worse when breathing in or lying down.
Autoinflammation
"Auto" means both self and automatic. "Inflammation" is the painful swelling that happens as the body’s natural response to injury or infection. Combining these words, "autoinflammation" occurs when inflammation happens automatically or continuously because of a process within the body (not an external cause such as a virus or injury).
C
C
C-reactive protein (CRP)
This is a protein made by your liver in response to inflammation. The CRP blood test is used to help support a diagnosis of first episode or recurrent pericarditis.
Cardiac tamponade
A risk of first episode or recurrent pericarditis defined as a fluid-filled pericardium that affects the proper function of the heart. When pericardial effusion worsens (too much fluid builds up or it builds up too quickly), people can experience cardiac tamponade. This can be serious and life-threatening.
Cardiologist
A doctor who specializes in the management of heart diseases such as first episode or recurrent pericarditis.
Chronic pericarditis
A pericarditis episode that lasts for more than 3 months.
Constrictive (or restrictive) pericarditis
A rare risk of pericarditis or recurrent pericarditis, when the swelling (inflammation) causes the pericardial sac to become scarred and stiff, limiting the heart’s pumping action. This can occur during the first pericarditis episode or after recurrent (repeat) pericarditis episodes.
D
D
Diagnostic test
A medical examination that provides the information healthcare providers need to make a clinical decision, or diagnosis.
Dressler Syndrome
A cause of pericarditis defined as an immune system response to injury to the pericardium after heart attack, surgery, or traumatic injury.
E
E
Echocardiogram
An imaging test of the heart that uses sound waves to produce an image that shows how well your heart is working. It will also show if there is extra fluid in the pericardium.
Electrocardiogram (EKG/ECG)
A common test where electrodes are placed on the chest to check the rhythm of your heart. It can detect specific rhythm changes that can occur during first episode or recurrent pericarditis. This test also helps to rule out cardiovascular conditions such as a heart attack.
Erythrocyte sedimentation rate (ESR or "SED rate")
A blood test that uses certain red blood cells (erythrocytes) to measure inflammation in the body.
F
F
FDA
The US Food and Drug Administration (FDA) is a federal agency that, among other things, is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The FDA reviews the results of clinical trials and approves different medicines for different conditions.
FDA-approved treatment
A product that has been evaluated for safety and efficacy and has been approved by the US Food and Drug Administration (FDA) to treat a condition or disease.
First (or "one-time") episode of pericarditis
A single flare of pericarditis that goes away completely on its own or after treatment. Average duration is 4 to 6 weeks. Also referred to as "first episode of acute pericarditis".
First episode of acute pericarditis
A single flare of pericarditis that goes away completely on its own or
after treatment. Average duration is 4 to 6 weeks. Also referred to as
a “first episode” or “one-time episode” of pericarditis.
H
H
Heart palpitations
A possible sign of first episode or recurrent pericarditis defined by a sensation that the heart is racing or skipping a beat.
I
I
Idiopathic pericarditis
Pericarditis with no known cause.
Important Safety Information (ISI)
Safety information that is important for a patient or healthcare provider to be aware of regarding a prescription medication or device. This information balances the potential benefits of the treatment with potential risks and side effects.
L
L
Loading dose
A higher dose of a drug that may be given at the beginning of treatment before dropping down to a lower "maintenance dose." A loading dose helps a drug reach an effective level in the body more rapidly.
M
M
Magnetic Resonance Imaging (MRI)
An imaging test of the heart that uses magnetic waves to take in- depth pictures of your heart and reveal if there is swelling or inflammation in the pericardium.
Maintenance dose
The dose of a drug given at prescribed, regular intervals to sustain an effective level of drug in the body.
Myocarditis
A different type of inflammation than first episode or recurrent pericarditis. Myocarditis is defined as inflammation of the myocardium (the main heart muscle), whereas pericarditis or recurrent pericarditis is inflammation of the pericardium (the outside layer, or sac) of the heart.
N
N
NSAIDs (pronounced: en-saids)
A class of medications used to treat mild to moderate pain, fever, and inflammation. The acronym stands for nonsteroidal anti- inflammatory drugs.
- Nonsteroidal means it is not a steroid (also called a corticosteroid)
- Anti-inflammatory means it reduces the swelling and inflammation to relieve pain
P
P
Pericardial effusion
A risk of first episode or recurrent pericarditis defined as an abnormal level of fluid in the sac surrounding the heart.
Pericardial rub
A distinct sound that happens when the inflamed layers of the pericardium rub together.
Pericardial window
A procedure in which a small part of the pericardium is removed so it can be drained of extra fluid.
Pericardiectomy
A surgical procedure during which the pericardium is partially or completely removed.
Pericardiocentesis
A medical procedure during which fluid is removed from the pericardium with a needle or tube.
Pericarditis
Inflammation (swelling and irritation) of the pericardium. There are different types of pericarditis defined by the severity of symptoms and how long each episode lasts.
Pericardium
The protective sac that wraps around your heart. It contains 2 layers with fluid in between.
Prescribing Information (PI)
The primary tool of the US Food and Drug Administration (FDA) for communicating the essential scientific information needed to inform prescribing physicians and patients about the safe and effective use of a prescription drug.
R
R
Recurrent pericarditis
Recurrent pericarditis is when a pericarditis flare happens again more than 4 weeks after the first one.
Rheumatologist
A doctor who specializes in the treatment of autoimmune conditions, such as lupus and rheumatoid arthritis, and may have a special understanding of autoinflammation.
S
S
Sharp chest pain
Stabbing or piercing pain behind the breastbone or in the left side of your chest. This may be a common symptom of recurrent pericarditis. In pericarditis or recurrent pericarditis, the sharp chest pain can become worse when breathing in or lying down.
Sharps container
"Sharps" is a term for objects with sharp points or edges that can puncture skin, such as needles, syringes, auto injectors, and infusion sets. Sharps containers are used to safety dispose of sharp medical supplies. These containers are made from rigid puncture-resistant plastic or metal. The bottom and sides are leak resistant, and the lid is tight fitting and puncture resistant with an opening that is big enough for a needle (or other sharps), but not big enough for a hand to enter.
Steroid tapering (also known as steroid weaning)
The process of gradually reducing the dose of a steroid over time until the medication is completely discontinued.
T
T
Taper/tapering
In medicine, tapering is the practice of gradually lowering the dosage of a medication over time. Generally, tapering is done to avoid or minimize withdrawal symptoms to eventually discontinue or lower the maintenance dose of a drug.
X
X
X-ray
A test that shows images of certain structures in the body. It can be used to check for an enlarged heart (which can indicate fluid in the pericardium).