Generic Name: rilonacept (ril-ON-a-sept)
Brand Name: Arcalyst
Arcalyst is used for:
Treating certain types of genetic syndromes (cryopyrin-associated periodic syndromes [CAPS]), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). It may also be used for other conditions as determined by your doctor.
Arcalyst is an interleukin-1 (IL-1) blocker. It works by blocking the activity of interleukin-1, which reduces inflammation.
Do NOT use Arcalyst if:
- you are allergic to any ingredient in Arcalyst
- you are using an interleukin-1 blocker (eg, anakinra) or tumor necrosis factor (TNF) blockers (eg, etanercept)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Arcalyst:
Some medical conditions may interact with Arcalyst. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have an infection (including an infection that will not go away) or tuberculosis (TB), have had a positive skin test for TB, or have recently been in close contact with someone who has had TB
- if you are at risk for developing an infection, have an open sore or wound, or have a history of infections that keep coming back
- if you have a history of lung or breathing problems (eg, asthma), high cholesterol or triglyceride levels, an immune system problem, HIV, hepatitis, or diabetes
- if you are scheduled for surgery, or you recently received a vaccine or are scheduled for a vaccine
- if you take warfarin
Some MEDICINES MAY INTERACT with Arcalyst. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Interleukin-1 blockers (eg, anakinra), TNF blockers (eg, etanercept), immunosuppressants (eg, cyclosporine), or corticosteroids (eg, prednisone) because the risk of serious infection may be increased
- Live vaccines because their effectiveness may be decreased by Arcalyst
This may not be a complete list of all interactions that may occur. Ask your health care provider if Arcalyst may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Arcalyst:
Use Arcalyst as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Arcalyst. Talk to your pharmacist if you have questions about this information.
- A health care provider will teach you how to use Arcalyst. Be sure you understand how to use Arcalyst. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Arcalyst if it contains particles, is discolored, or if the vial is cracked or damaged.
- Arcalyst may be injected into the abdomen, thigh, or upper arm. Rotate the injection site with each dose. Do not inject Arcalyst into a site that is bruised, red, tender, or hard.
- Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
- Do not use Arcalyst more often than 1 time per week.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal
- If you miss a dose of Arcalyst, use it as soon as possible, up to the day before your next scheduled dose. Take your next dose at the regularly scheduled time. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Arcalyst.
Important safety information:
- Arcalyst may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills. Tell your doctor if you have an open sore or wound.
- Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Tell your doctor or dentist that you take Arcalyst before you receive any medical or dental care, emergency care, or surgery.
- Do not receive a live vaccine (eg, measles, mumps) while you are using Arcalyst. Talk with your doctor before you receive any vaccine.
- You may need to have a TB skin test before you begin using Arcalyst. Contact your doctor with any questions you may have about whether you should receive a TB skin test before using Arcalyst.
- Treatment with medicines that suppress the immune system, including Arcalyst, may increase the risk of developing cancer. Discuss any questions or concerns with your doctor.
- Lab tests, including cholesterol and triglyceride levels, may be performed while you use Arcalyst. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Arcalyst should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
- Arcalyst may affect bone development in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Arcalyst.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Arcalyst while you are pregnant. It is not known if Arcalyst is found in breast milk. If you are or will be breast-feeding while you use Arcalyst, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Arcalyst:
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Mild pain, swelling, bruising, or redness at the injection site; stuffy nose.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool or stomach pain; fever, chills, cough, or persistent sore throat; flu-like symptoms; increased, decreased, or painful urination; loss of sensation or unusual numbness; unusual lumps or skin growths; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Before mixing, store Arcalyst in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. After mixing, Arcalyst may be kept at room temperature and should be used within 3 hours after mixing. Protect Arcalyst from light. Throw away any medicine that is left in the vial after you use your dose. Do not use Arcalyst after the expiration date on the vial. Keep Arcalyst out of the reach of children and away from pets.
- If you have any questions about Arcalyst, please talk with your doctor, pharmacist, or other health care provider.
- Arcalyst is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Arcalyst or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Arcalyst. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Arcalyst. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Arcalyst.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.