Canakinumab (Subcutaneous Route)

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, so patients with CAPS may have a fever, headache, skin rash, joint or muscle pain, or unusual tiredness or weakness. Canakinumab helps prevent the inflammation by keeping the interleukin-1 beta from working properly.

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Powder for Solution

Before Using

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:

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.

Pediatric

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 younger than 4 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of canakinumab injection in the elderly.

Pregnancy

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.

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.

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.

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 or


• Hepatitis B, history of or


• Hepatitis C, history of or


• HIV or


• Immune system problem or


• Infection, active or


• Tuberculosis, active or history ofa€”Use with caution. May decrease your bodya€™s ability to fight infection and make these conditions worse.

Proper Use

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

Precautions

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

You or your child 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 or your child have a fever or chills; cough or hoarseness; lower back or side pain; or painful or difficult urination .

Do not get any immunizations (vaccines) without your doctor`s approval while you or your child are being treated with this medicine. Canakinumab may lower your body`s ability to fight infections and there is a chance you might get the infection the immunization is meant to prevent.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. 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


• Cough producing mucus


• Diarrhea


• Difficulty with breathing


• Dryness or soreness of the throat


• Fever


• General feeling of discomfort or illness


• Headache


• Hoarseness


• Joint pain


• Loss of appetite


• Muscle aches and pains


• Nausea


• Runny nose


• Shivering


• Shortness of breath


• Sneezing


• Sore throat


• Stuffy or runny nose


• Sweating


• Tender, swollen glands in the neck


• Tightness in the chest


• Trouble with sleeping


• Trouble with swallowing


• Unusual tiredness or weakness


• Voice changes


• Vomiting


• Wheezing

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.