ARCALYST^® (RILONACEPT) RESOURCES AND FAQs

Active flare

The time when a person is actively experiencing the signs and symptoms of pericarditis or recurrent pericarditis, including chest pain that feels worse when breathing in or lying down.

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.

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).

Cardiac tamponade

A risk of pericarditis 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 treatment of heart diseases such as pericarditis or recurrent pericarditis.

CHRONIC PERICARDITIS

A pericarditis episode that lasts for more than 3 months.

CLINICAL TRIALS (PHASES 1, 2, AND 3)

Clinical trials of drugs go through different phases to test safety, effectiveness, and tolerability. The US Food and Drug Administration (FDA) typically requires Phase 1, 2, and 3 trials to be conducted before approving a drug. 

Each clinical trial phase has a different purpose: 

COLCHICINE

A medicine that reduces inflammation and pain, most often used for treating gout. Although not indicated to treat recurrent pericarditis, colchicine is sometimes prescribed to address symptoms when recurrent pericarditis flares occur.

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 (acute) pericarditis episode or after recurrent (repeat) pericarditis episodes.

CORTICOSTEROIDS (ALSO KNOWN AS STEROIDS)

Medications that reduce inflammation; however, they can also cause side effects including fluid retention, changes in the body’s ability to process sugar, high blood pressure, behavioral and mood changes, increased appetite, and weight gain.

C-REACTIVE PROTEIN (CRP)

This is a protein made by your liver in response to inflammation. The CRP blood test is used to help confirm a diagnosis of pericarditis or recurrent pericarditis.

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.

DULL CHEST PAIN

A common sign of pericarditis or recurrent pericarditis defined as a dull ache or pressure behind the breastbone or in the left side of your chest. It may feel like a vise that is squeezing the heart. In pericarditis or recurrent pericarditis, the dull chest pain becomes worse when breathing in or lying down.

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 pericarditis 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.

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 “acute pericarditis.”

Heart attack

An entirely different medical condition than pericarditis or recurrent pericarditis that happens when blood flow to the heart is blocked. The chest pain that people experience during pericarditis or recurrent pericarditis can be severe. Sometimes people mistakenly believe they are having a heart attack.

HEART PALPITATIONS

A possible sign of pericarditis or recurrent pericarditis defined by a sensation that the heart is racing or skipping a beat.

Idiopathic cause

Often, pericarditis is due to an unknown cause. In such cases, the condition is called “idiopathic pericarditis.”

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.

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.

LOW-GRADE FEVER

A possible effect of pericarditis or recurrent pericarditis and inflammation in the body defined by a slightly higher than normal body temperature.

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. An MRI is considered the most accurate and detailed imaging test.

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 pericarditis 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.

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. 

PERICARDIAL EFFUSION

A risk of pericarditis 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. This can be done in a number of ways including cutting under the bottom of the breastbone to get to the pericardium, cutting between the ribs to reach the pericardium, or making small incisions on the side of the chest.

PERICARDIECTOMY

A surgical procedure during which the pericardium is partially or completely removed. The surgery can have serious risks. So it is considered a “last option” that doctors work with patients to avoid.

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.

RECURRENT PERICARDITIS

An autoinflammatory disease in which pericarditis flares last for fewer than 6 weeks, then return more than 4 weeks after the previous flare has resolved (with or without treatment).

RHEUMATOLOGIST

A doctor who specializes in the treatment of autoimmune conditions, such as lupus and rheumatoid arthritis, and has a special understanding of autoinflammation.

SHARP CHEST PAIN

The main sign of pericarditis or recurrent pericarditis defined as stabbing or piercing pain behind the breastbone or in the left side of your chest. In pericarditis or recurrent pericarditis, the sharp chest pain becomes 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.

SHORTNESS OF BREATH

A common sign of pericarditis or recurrent pericarditis defined by trouble breathing or coughing while breathing during an active flare.

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.

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.

TRAUMA

A cause of pericarditis defined as injury to the heart or chest that may occur as a result of a car accident or other mishap.

TRAVELING PAIN

A common sign of pericarditis or recurrent pericarditis defined as pain that moves from the chest into the left shoulder and neck.

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).