The pericardium is the layer that surrounds the heart. The pericardium has two layers that work to lubricate the heart, protect it, and prevent it from filling up with too much blood. When this layer becomes inflamed, it is called pericarditis. When pericarditis comes back after you don’t have symptoms for at least 4 weeks, it is called recurrent pericarditis. Symptoms of pericarditis can range from mild to severe.
Arcalyst was approved in 2021 as the first medicine to treat recurrent pericarditis and to reduce the risk of it coming back.
How Does It Work for Recurrent Pericarditis?
Pericarditis can have many symptoms, some of which are listed below.
- Sharp, stabbing chest pain that can spread to the shoulders
- Shortness of breath
- Feeling of skipped heartbeats
- Fever
- Dry cough
- Swelling in your stomach, legs, or feet
- Anxiety
For most people, the cause of recurrent pericarditis is usually unknown. But there are a few potential causes of pericarditis that are listed below.
- Not treated properly the first time
- Triggered from autoimmune health conditions such as lupus
- Certain infections
- Certain medicines for seizures and irregular heartbeat
- Genetics
Inflammation (swelling) caused by pericarditis can also cause fluid buildup around the heart. People with recurrent pericarditis can have flare-ups where their symptoms are more noticeable.
Arcalyst is classified as an interleukin-1 (IL-1) blocker. IL-1 is a protein that is involved in inflammation. By blocking IL-1, Arcalyst stops the cycle of inflammation, which treats pericarditis flares and helps prevent future ones.
How Do I Use It?
Arcalyst comes in a single-dose vial for injecting under the skin. With a single-dose vial, you use one vial for one dose and throw away any unused portion in the vial. Arcalyst is used once a week and can be given by either yourself or a caregiver. Your health care provider will tell you how much Arcalyst to inject. The shot can be given in the stomach (2 inches away from the belly button) and thighs. If a caregiver is giving you Arcalyst, the medicine can be given in the upper arms.
Your first dose (loading dose) of Arcalyst will be given as two shots. The first dose will be higher than the subsequent once-a-week doses you will use (maintenance dose).
Arcalyst shots will require you to have injection supplies to properly give the dose. You can follow the Instructions For Use paper that comes with your prescription, which will tell you what supplies you will need and how to give the dose. If you have questions about how to prepare or inject your dose, call your health care provider or pharmacist. The drugmaker also has a program that can help you work with a clinical educator where you can set up training sessions on how to properly inject the medicine. You can find out more by calling 833-546-4572.
How Was It Studied?
One study looked at the safety and efficacy of Arcalyst. People with recurrent pericarditis who were having symptoms received either Arcalyst or a placebo, containing no medicine, once weekly. The study looked to see the time to recurrence of pericarditis. The average age of people in the study was 46 years old, and the study included White people (93%), Black people (6%), and those classified as “Other” (1%).
What Benefits Were Seen?
Of the people who used Arcalyst, 7% had a lower number of recurrent pericarditis cases, compared to 74% of those who used the placebo. This means that Arcalyst helped keep pericarditis symptoms under control.
How Long Does It Take to Work?
In clinical studies, Arcalyst worked to lower pericarditis-related pain levels and a protein called C-reactive protein (CRP) in as little as a few days. CRP levels help indicate inflammation in the body. Arcalyst works to treat pericarditis and prevent flare-ups by decreasing inflammation around your heart. You should start to notice your symptoms improving and have fewer flare-ups.
Call your health care provider if your pericarditis symptoms do not improve or get worse. Your health care provider can determine if they would like to change your dose, add on another medicine, or change you to a different medicine.
What Are the Side Effects and How Can I Manage Them?
The most common side effects seen with Arcalyst are listed below:
- Pain, itching, swelling, or redness near the injection site
- An infection in the nose or throat, a sore throat, or common cold symptoms
- Joint and muscle pain
Injection-site reactions can occur if you have pain, redness, swelling, or bruising where the needle went in. There are things that you can do to help prevent or lessen this, which are listed below. If your symptoms do not go away or they get worse, call your health care provider.
- Rotate injection sites to avoid getting a shot at the same site as previous injections
- Apply a numbing cream, such as lidocaine, at the injection site
- Apply an itching cream, such as hydrocortisone, at the injection site
- Do not give a shot on bruised or broken skin
- Use a cold pack
Call your health care provider if you have cold symptoms, joint pain, or muscle pain. Your health care provider will find out if you need any treatment for this, including if you need to keep over-the-counter medicines on hand.
What Types of Drug Interactions Can Happen?
It is not recommended to take Arcalyst with another IL-1 inhibitor such as anakinra (Kineret) or with a medicine called a tumor necrosis factor (TNF) inhibitor such as adalimumab (Humira), etanercept (Enbrel), or infliximab (Remicade). Using these medicines with Arcalyst can increase the risk of a serious infection.
Arcalyst may alter the blood levels of other medicines such as warfarin, which may require dose changes. These medicines are called cytochrome P450 substrates. Talk to your health care provider about all the medicines you take. Your health care provider will find out if you are taking a cytochrome P450 substrate medicine and if any adjustments to your medicines need to be made.
What Are Other Unique Considerations to Be Aware Of?
It is not recommended to receive live vaccines while using Arcalyst. Talk to your health care provider about all the vaccines you have received or are planning to receive. Your health care provider can find out which vaccines are live vaccines. Because Arcalyst can affect how your immune system responds to infections, your health care provider will also find out if they would like you to get other vaccines before starting Arcalyst.
What Do I Need to Do to Get It?
You will have Arcalyst delivered to your home or at a preferred location by a specialty pharmacy. The specialty pharmacy will reach out to speak with you before they can ship the medicine. Your health care provider may enroll you in the drugmaker’s support program, which connects you to a patient access lead (PAL), who can work with you to get your prescription through the specialty pharmacy.
Is There a Cost Savings Program?
There is a program offered by the drugmaker that may allow you to pay as little as $0 for your Arcalyst prescription. Whether you are eligible depends on the type of insurance you have. There is also another program offered by the drugmaker if you do not have insurance. You can find out more by visiting www.arcalyst.com/kiniksa-oneconnect-support or by calling 833-546-4572.
