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Arcalyst

 
  Generic Name: Rilonacept (ril ON a sept)
 
  Brand Names: 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 other purposes not listed in this medication guide.

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

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 a history of tuberculosis.

Do not receive a "live" vaccine while you are being treated with rilonacept. The live 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. Make sure you are current on all vaccines before you start treatment with rilonacept. To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Do not miss any follow-up visits to your doctor for blood or urine tests.

Contact your doctor at once if you develop 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.

Do not use this medication more often than once per week unless your doctor has told you to.

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.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using rilonacept, tell your doctor if you have a history of tuberculosis.

FDA pregnancy category C. Rilonacept may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. 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 use this medication in a child younger than 12 years old unless your doctor has told you to.

How should I use rilonacept?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Rilonacept is given as an injection under the skin of your stomach, thigh, or upper arm. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. 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.

Rilonacept is usually given to adults in two injections at a time, each on a different place on your body. The two injections are then given once per week.

Children may be given one or two injections at a time once per week. Follow your doctor's instructions.

Do not use this medication more often than once per week unless your doctor has told you to.

You will need to mix rilonacept 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 medication. After mixing rilonacept with a diluent, you must use it within 3 hours.

Each vial (bottle) of rilonacept is for a single use only. Throw the vial away after one use, even if there is still medication left in it.

Use each disposable needle only one time. 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.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Do not miss any follow-up visits to your doctor for blood or urine tests.

Contact your doctor at once if you develop 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.

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.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a rilonacept overdose are not known.

What should I avoid while using rilonacept?

Do not receive a "live" vaccine while you are being treated with rilonacept. The live 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. Make sure you are current on all vaccines before you start treatment with rilonacept.

Rilonacept side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using rilonacept and call your doctor at once if you have a serious side effect such as:

  • new signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding, or unusual weakness;

  • black, bloody, or tarry stools;

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

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

  • pain or burning when you urinate.

Less serious side effects may include:

  • sneezing, runny or stuffy nose, sore throat, cough;

  • nausea, stomach pain, diarrhea; or

  • pain, swelling, redness, itching, bleeding, or other irritation where the medicine was injected;

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect rilonacept?

Tell your doctor about all other medications you use, especially:

  • etanercept (Enbrel);

  • adalimumab (Humira);

  • infliximab (Remicade);

  • a blood thinner such as warfarin (Coumadin);

  • cyclosporine (Gengraf, Neoral, Sandimmune);

  • digoxin (digitalis, Lanoxin, Lanoxicaps);

  • theophylline (Elixophyllin, Theo-24, Uniphyl);

  • seizure medication such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene); or

  • a heart rhythm medication such as disopyramide (Norpace), procainamide (Procan, Pronestyl), or quinidine (Quinidex, Quin-Release Quin-G).

This list is not complete and there may be other drugs that can interact with rilonacept. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your 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.
  • 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 using, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 4/12/2009 4:46:26 PM.;
 
 
 
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