Canakinumab Injection

WHY is this medicine prescribed?

Canakinumab injection is used to treat certain periodic fever syndromes (inherited conditions in which the body attacks its own tissues and organs causing fever, inflammation, joint and muscle pain, eye redness or pain, stomach pain, rash, and fatigue) including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS) in adults and children 4 years of age or older; and tumor necrosis factor receptor-associated periodic syndrome (TRAPS), mevalonate kinase deficiency (MKD)/ hyperimmunoglobulin D syndrome (HIDS), and familial Mediterranean fever (FMF) in adults and children. Canakinumab injection is also used to treat Still's disease (a condition in which the body attacks its own tissues causing inflammation, fever, rash, headache, fatigue, and joint and muscle pain), including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age or older. It is also used to treat gout flares (sudden attacks of redness, swelling, pain, and heat in one or more joints) in adults who were not treated successfully with or who are not able to take or tolerate other treatments. Canakinumab is in a class of medications called interleukin antagonists. It works by blocking the activity of interleukin, a substance in the body that causes inflammation.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Canakinumab comes as a solution (liquid) to be injected subcutaneously (under the skin) by a doctor or nurse. To treat periodic fever syndromes, it is usually given once every 4 or 8 weeks, depending on the type of periodic fever syndrome being treated. To treat Still's disease, it is usually given once every 4 weeks. To treat gout flares, it is usually given as a single dose at the time of a gout flare. If new gout flares occur, additional doses may be given at least 12 weeks after a previous dose.

Your doctor may start you on a low dose of canakinumab injection and gradually increase your dose.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with canakinumab. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before receiving canakinumab injection,

• tell your doctor and pharmacist if you are allergic to canakinumab, any other medications, or any of the ingredients in canakinumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention other medications that affect the immune system. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had low white blood cell counts or any condition that affects your immune system.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using canakinumab injection, call your doctor.

• If you received canakinumab injection while you were pregnant and have given birth, tell your baby's doctor that you received canakinumab injection. Canakinumab may interfere with your baby's immune response to vaccines. Talk to your baby's doctor about vaccinations for your baby.

• you should know that canakinumab injection may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as herpes or cold sores), and chronic infections that do not go away. Also tell your doctor if you have or if you have ever had human immunodeficiency virus (HIV), hepatitis B virus infection (HBV; an ongoing liver infection) or hepatitis C virus infection (HCV; an ongoing liver infection). If you experience any of the following symptoms during or shortly after your treatment with canakinumab injection, call your doctor immediately: fever, sweats, or chills; sore throat; cough; warm, red, or painful skin or sores on your body; frequent, urgent, or painful urination; or other signs of infection.

• you should know that using canakinumab injection increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor may perform a skin test to see if you have an inactive TB infection. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.

• you should know that macrophage activation syndrome (MAS), a serious or life-threatening condition, may occur in patients with Still's disease (AOSD or SJIA) or other conditions in which the body attacks its own tissues. Call your doctor immediately if you have new or worsening symptoms of AOSD or SJIA or if you have a cough or fever that doesn't go away; redness, warmth, or swelling of the skin; or any other signs of infection.

• do not have any vaccinations without talking to your doctor. Also check with your doctor to see if you or your child need to receive any vaccinations. It is important that adults and children receive all age-appropriate vaccines before beginning treatment with canakinumab.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive canakinumab injection, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Canakinumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• injection site pain, bruising, bleeding, swelling, redness, warmth, or itching
• nausea
• vomiting
• diarrhea
• stomach pain
• stuffy nose
• headache
• weight gain
• dizziness
• back, muscle, or joint pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• hives; rash; itching; difficulty breathing or swallowing; lightheadedness; fainting; fast or irregular heartbeat

Canakinumab may increase the risk of developing certain types of cancer. Talk to your doctor about the risks of using this medication.

Canakinumab may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to canakinumab.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.