Arcalyst

Arcalyst is a prescription medication used to treat rare genetic auto-inflammatory conditions called Cryopyrin-Associated Periodic Syndromes (CAPS). This includes conditions known as Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.

Arcalyst belongs to a group of drugs called interleukin-1 blockers. These work by blocking the activity of a certain protein responsible for inflammation.

This medication is available in an injectable form to be given directly under the skin (subcutaneously) once weekly.

Common side effects of Arcalyst include upper respiratory infections and injection site reactions.

Arcalyst is a prescription medication used to treat auto-inflammatory diseases known as Cryopyrin-Associated Periodic Syndromes (CAPS), including:

• Familial Cold Autoinflammatory Syndrome (FCAS) 
• Muckle-Wells Syndrome (MWS)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Regeneron Pharmaceuticals. Inc.

Serious side effects have been reported with Arcalyst. See the "Drug Precautions" section.

Common side effects of Arcalyst include the following:

• Upper respiratory tract infections (such as a sinus infection)
• Cough
• Injection site reactions (redness, swelling, itching, or pain, typically lasting one to two days)
• Increases in cholesterol and lipid levels

This is not a complete list of Arcalyst side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines that block tumor necrosis factor (TNF) such as Cimzia (certolizumab), Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), or Simponi (golimumab)
• other medicines that block Interleukin-1 (IL-1), such as Kineret (anakinra) or Ilaris (canakinumab)
• medications that are eliminated through the enzyme CYP450 such as warfarin (Coumadin)
• corticosteroids such as prednisone

This is not a complete list of Arcalyst drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Arcalyst including the following:

Infections. Arcalyst can lower your immune system's ability to fight infections. Taking this medication may increase your risk of getting infections, including serious infections that are life-threatening, or may worsen infections that you already have. Tell your doctor immediately about any signs of an infection, including the following:

• fever
• cough
• flu-like symptoms
• open sores on your body

Malignancies. Because taking Arcalyst can lower your immune system's ability to work properly, you may be at an increased risk of developing cancer while taking this medication.

Decreased response to vaccines. Vaccines may not work as well when you are taking Arcalyst. It is recommended that you receive all recommended vaccinations before starting Arcalyst, including flu and pneumonia vaccines. Talk to your doctor about which vaccines you should receive before starting treatment with Arcalyst.

Lipid profile changes. Arcalyst can cause changes in your lipid panel, which includes cholesterol and triglycerides (a type of fat found in your blood). Your doctor perform blood tests to monitor for these changes.

Hypersensitivity. Serious allergic reactions have occurred with Arcalyst. Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:

• chest pain
• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing
• rash

Do not take Arcalyst if you are allergic to Arcalyst or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Arcalyst, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Arcalyst, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Arcalyst or to any of its ingredients
• think you might 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
• have diabetes
• have a problem with your immune system
• have tuberculosis (TB) or have been in close contact with someone who has had tuberculosis
• have or have had HIV, Hepatitis B, or Hepatitis C
• take any other medications that affect your immune system
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Arcalyst falls into category C. Based on animal data, this medication may cause harm to your unborn baby. No well-controlled studies have been done in humans. Arcalyst should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Arcalyst crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Arcalyst.

Take Arcalyst exactly as prescribed.

This medication is available in an injectable form to be given directly under the skin (subcutaneously) once weekly.

Follow your doctor's instructions on how to prepare and administer Arcalyst.

Your healthcare provider will tell and show you or your caregiver:

• how much Arcalyst to inject
• how to prepare your dose
• how to give the injection

Do not try to give Arcalyst injections until you are sure that you or your caregiver understands how to prepare and inject your dose. Call your healthcare provider or pharmacist if you have any questions about preparing and injecting your dose, or if you or your caregiver would like more training.

If you miss a dose of Arcalyst, inject it at soon as your remember, up to the day before your next scheduled dose. The next dose should be taken at the next regularly scheduled time. Contact your healthcare provider if you have any questions about taking missed doses.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends will depend on your age.

The recommended loading dose for patients 18 years or older is 320 mg (given as 2 different injections on the same day), followed by one injection of 160 mg once weekly.

The recommended initial loading dose for patients age 12 to 17 years is one dose of 4.4 mg per kg body weight, up to a maximum of 320 mg (given as 1 or 2 injections depending on the dose). Dosing should be continued with one injection of 2.2 mg/kg, up to a maximum of 160 mg, once weekly.

If you take too much Arcalyst, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Arcalyst is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Arcalyst in the refrigerator inside the original carton.
• Arcalyst may be kept at room temperature after mixing.
• Arcalyst should be used within 3 hours of mixing.
• Keep Arcalyst away from light.
• If you need to take Arcalyst with you when traveling, store the carton in a cool carrier with a cold pack and protect it from light.
• Keep this and all medications out of the reach of children.