Ilaris

Ilaris is used to treat cryopyrin-associated periodic syndromes (CAPS). This also includes familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). CAPS is a rare, inherited disease of the immune system. It occurs when the body produces too much of a chemical called interleukin-1 beta. This chemical causes inflammation, and patients with CAPS may have a fever, headache, skin rash, joint or muscle pain, or unusual tiredness or weakness.

Canakinumab helps prevent inflammation by keeping the interleukin-1 beta from working properly.
Canakinumab is also used to treat active systemic juvenile idiopathic arthritis (SJIA) in children 2 years of age and older.

This medicine is to be given only by or under the direct supervision of a doctor.

This product is available in the following dosage forms:

• Powder for Solution

Before using Ilaris, you must know all about the risks and complications associated with it.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

1. Allergies:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

2. Pediatric Population:
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of canakinumab injection in children. However, safety and efficacy have not been established in children with CAPS, FCAS, or MWS younger than 4 years of age and in children with SJIA younger than 2 years of age.

3. Geriatric Population:
Appropriate studies on the relationship of age to the effects of canakinumab injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date

4. Pregnancy:
Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

5. Breastfeeding:
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

6. Drug Interactions:
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
7. Other Interactions:
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

8. Other Medical Problems:
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• AIDS
• Hepatitis B, history of
• Hepatitis C, history of
• HIV
• Immune system problem
• Infection, active
• Tuberculosis, active or history of—Use with caution. May make these conditions worse.

To use Ilaris properly, you must follow all instructions given by your doctor.

A nurse or other trained health professional will give you this medicine in a hospital or clinic setting. This medicine is given as a shot under your skin.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Before using Ilaris, there are some precautions you must take.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test.

Your body's ability to fight an infection may be reduced while you are being treated with canakinumab. It is very important that you call your doctor right away if you have a fever, chills, cough, hoarseness, lower back or side pain, or painful or difficult urination.

Using this medicine may increase your risk of cancer. Talk to your doctor if you have concerns about this risk.

Canakinumab may cause allergic reactions. Tell your doctor right away if you have a rash, itching, lightheadedness or dizziness, swelling of the face, tongue, and throat, trouble breathing or swallowing, or chest pain after you or your child receive the medicine.

Do not get any immunizations (vaccines) without your doctor's approval while you are being treated with this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

As with many medications, there are several potential side effects associated with Ilaris.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Body aches or pain
• Chills
• Congestion
• Cough
• Diarrhea
• Dryness or Soreness of the throat
• Fever
• Headache
• Hoarseness
• Joint pain
• Loss of appetite
• Muscle aches and pains
• Nausea
• Shivering
• Shortness of breath
• Sneezing
• Stuffy or Runny nose
• Sweating
• Tender, Swollen glands in the neck
• Tightness in the chest
• Trouble sleeping
• Trouble swallowing
• Unusual tiredness or weakness
• Voice changes
• Vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or Stomach pain
• Bleeding, Blistering, Burning, Coldness, Discoloration of the skin, Feeling of pressure, Hives, Infection, Inflammation, Itching, Lumps, Numbness, Pain, Rash, Redness, Scarring, Soreness, Stinging, Swelling, Tenderness, Tingling, Ulceration, or Warmth at the injection site
• Dizziness or Lightheadedness
• Feeling of constant movement of self or surroundings
• Increased weight
• Muscle or Bone pain
• Sensation of spinning
• Weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.