rilonacept

Generic Name: rilonacept (ril ON a sept)
Brand Name: Arcalyst

What is rilonacept?

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.

Rilonacept 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.

Rilonacept may also be used for purposes not listed in this medication guide.

What is the most important information I should know about rilonacept?

Serious and sometimes fatal infections may occur during treatment with rilonacept. 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.

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You should not use this medication if you are allergic to rilonacept, or if you have any type of infection.

Before using rilonacept, 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 rilonacept.

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 rilonacept. 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.

What should I discuss with my healthcare provider before using rilonacept?

You should not use this medication if you are allergic to rilonacept, or if you have any type of infection.

To make sure rilonacept is safe for you, tell your doctor if you have any of these conditions:

  • an active or chronic infection;

  • a history of tuberculosis or recurrent infections; or

  • high cholesterol or triglycerides (a type of fat in blood).

Make sure you are current on all vaccines before you start treatment with rilonacept.

Using rilonacept 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 rilonacept will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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 this medicine to a child younger than 12 years old without medical advice.

How is rilonacept given?

Follow the directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Rilonacept 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.

Rilonacept 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 rilonacept, 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 powder medicine 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 rilonacept 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 rilonacept 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 while using rilonacept?

Do not receive a "live" vaccine while using rilonacept. 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.

Rilonacept side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with rilonacept. Call your doctor right away if you have any new signs of infection such as:

  • fever, chills, sore throat, flu symptoms;

  • easy bruising or bleeding (nosebleeds, bleeding gums);

  • nausea and vomiting, loss of appetite;

  • mouth sores; or

  • unusual weakness.

Call your doctor at once if you have any other serious side effect such as:

  • bloody, black, or tarry stools;

  • coughing up blood or vomit that looks like coffee grounds;

  • wheezing, chest tightness, trouble breathing;

  • pain or burning when you urinate; or

  • headache, neck stiffness, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Other common side effects may include:

  • cold symptoms such as stuffy nose, sneezing, cough, sore throat;

  • nausea, stomach pain, diarrhea;

  • numbness or tingly feeling; or

  • 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)

Rilonacept dosing information

Usual Adult Dose for Familial Cold Autoinflammatory Syndrome:

Loading dose: 320 mg delivered as two, 2 mL, subcutaneous injections of 160 mg each given on the same day at two different sites.

Dosing should be continued with a once-weekly injection of 160 mg administered as a single, 2-mL, subcutaneous injection.

Rilonacept should not be given more often than once weekly.

Usual Adult Dose for Muckle Wells Snydrome:

Loading dose: 320 mg delivered as two, 2 mL, subcutaneous injections of 160 mg each given on the same day at two different sites.

Dosing should be continued with a once-weekly injection of 160 mg administered as a single, 2-mL, subcutaneous injection.

Rilonacept should not be given more often than once weekly.

Usual Pediatric Dose for Familial Cold Autoinflammatory Syndrome:

Greater then or equal to 12 years of age:
Loading dose: 4.4 mg/kg, up to a maximum of 320 mg, delivered as one or two subcutaneous injections with a maximum single-injection volume of 2 mL. If the initial dose is given as two injections, they should be given on the same day at two different sites.

Dosing should be continued with a once-weekly injection of 2.2 mg/kg, up to a maximum of 160 mg, administered as a single subcutaneous injection, up to 2 mL.

Rilonacept should not be given more often than once weekly.

Usual Pediatric Dose for Muckle Wells Snydrome:

Greater then or equal to 12 years of age:
Loading dose: 4.4 mg/kg, up to a maximum of 320 mg, delivered as one or two subcutaneous injections with a maximum single-injection volume of 2 mL. If the initial dose is given as two injections, they should be given on the same day at two different sites.

Dosing should be continued with a once-weekly injection of 2.2 mg/kg, up to a maximum of 160 mg, administered as a single subcutaneous injection, up to 2 mL.

Rilonacept should not be given more often than once weekly.

What other drugs will affect rilonacept?

Tell your doctor about all medications you use, and those you start or stop using during your treatment with rilonacept, especially:

  • adalimumab (Humira);

  • certolizumab (Cimzia)

  • etanercept (Enbrel);

  • fingolimod (Gilenya);

  • golimumab (Simponi);

  • infliximab (Remicade);

  • leflunomide (Arava); or

  • a blood thinner such as warfarin (Coumadin, Jantoven).

This list is not complete. Other drugs may interact with rilonacept, including prescription, over-the-counter, vitamin, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about rilonacept.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2012-11-15, 9:52:22 AM.

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