Arcalyst (rilonacept) is used to treat some of the symptoms of rare genetic conditions such as Familial Cold Auto-inflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS).
FCAS and MWS are inflammatory disorders in which the body develops certain symptoms without a known cause (such as virus, bacteria, or illness). These symptoms include fever, chills, fatigue, and joint pain. More serious symptoms may involve the bones and joints, the central nervous system (deafness, vision loss, mental impairment), or major organs such as the kidneys.
Arcalyst may treat or prevent the symptoms of Familial Cold Auto-inflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS). However, this medication is not a cure for these inherited conditions.
Arcalyst may also be used for purposes not listed in this medication guide.
Important information
Serious and sometimes fatal infections may occur during treatment with Arcalyst. Call your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.
You should not use Arcalyst if you are allergic to rilonacept, or if you have any type of infection.
Before using Arcalyst, tell your doctor if you have an active or chronic infection, a history of tuberculosis or recurrent infections, or high cholesterol or triglycerides. Make sure you are current on all vaccines before you start treatment with Arcalyst.
Tell your doctor about all other medications you use, especially drugs to treat arthritis, psoriasis, Crohn"s disease, or ankylosing spondylitis.
Do not receive a "live" vaccine while using Arcalyst. The vaccine may not work as well during this time, and may not fully protect you from disease. Avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.
Before using Arcalyst
You should not use Arcalyst if you are allergic to rilonacept, or if you have any type of infection.
To make sure Arcalyst is safe for you, tell your doctor if you have any of these conditions:
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an active or chronic infection;
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a history of tuberculosis or recurrent infections; or
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high cholesterol or triglycerides (a type of fat in blood).
Make sure you are current on all vaccines before you start treatment with Arcalyst.
Using Arcalyst may increase your risk of developing certain types of cancer. Talk with your doctor about your specific risk.
FDA pregnancy category C. It is not known whether Arcalyst will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether rilonacept passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Do not give Arcalyst to a child younger than 12 years old without medical advice.
How is Arcalyst given?
Use Arcalyst exactly as prescribed by your doctor. Follow the directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Arcalyst is injected under the skin. You may be shown how to use injections at home. Use exactly as prescribed by your doctor. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Your first dose may be given in two injections at a time, each on a different place on your body.
Arcalyst is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.
Use a different place on your stomach, thigh, or upper arm each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.
While using Arcalyst, you may need frequent blood tests at your doctor"s office.
Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Store the unmixed Arcalyst powder in the refrigerator and protected from light. Do not freeze. Keep each vial in the original container until you are ready to mix your medicine.
After mixing Arcalyst with a diluent, store at room temperature and use it within 3 hours. Protect from light.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Arcalyst injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.
What should I avoid?
Do not receive a "live" vaccine while using Arcalyst. The vaccine may not work as well during this time, and may not fully protect you from disease. Avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.
Live vaccines include: measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, yellow fever, varicella (chickenpox), zoster (shingles), oral typhoid vaccine, and nasal flu (influenza) vaccine.
Arcalyst side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Arcalyst: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with Arcalyst. Call your doctor right away if you have any new signs of infection such as:
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fever, chills, sore throat, flu symptoms;
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easy bruising or bleeding (nosebleeds, bleeding gums);
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nausea and vomiting, loss of appetite;
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mouth sores; or
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unusual weakness.
Call your doctor at once if you have any other serious side effect such as:
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bloody, black, or tarry stools;
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coughing up blood or vomit that looks like coffee grounds;
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wheezing, chest tightness, trouble breathing;
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pain or burning when you urinate; or
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headache, neck stiffness, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).
Other common Arcalyst side effects may include:
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cold symptoms such as stuffy nose, sneezing, cough, sore throat;
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nausea, stomach pain, diarrhea;
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numbness or tingly feeling; or
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pain, swelling, redness, itching, warmth, blistering, bleeding, or other irritation where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Arcalyst?
Tell your doctor about all medications you use, and those you start or stop using during your treatment with Arcalyst, especially:
This list is not complete. Other drugs may interact with Arcalyst, including prescription, over-the-counter, vitamin, and herbal products. Not all possible interactions are listed in this medication guide.
