ILARIS- canakinumab injection, solution
Novartis Pharmaceuticals Corporation
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This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: November 2024 | |
Medication Guide
ILARIS® (i-LAHR-us) (canakinumab) injection, for subcutaneous use |
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What is the most important information I should know about ILARIS?
ILARIS can cause serious side effects, including:
See "What are possible side effects of ILARIS?" for more information about side effects. |
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What is ILARIS?
ILARIS is a prescription medicine injected by your healthcare provider just below the skin (subcutaneous) used to treat:
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Who should not receive ILARIS?
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Before you receive ILARIS, tell your healthcare provider about all your medical conditions, including if you:
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How should I receive ILARIS?
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What are the possible side effects of ILARIS?
ILARIS can cause serious side effects, including:
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◦ swelling of the lips, tongue, mouth, or face ◦ trouble breathing ◦ wheezing ◦ severe itching | ◦ skin rash, hives, redness, or swelling outside of the injection site area ◦ dizziness or fainting ◦ fast heartbeat or pounding in your chest (tachycardia) ◦ sweating |
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When ILARIS is used for the treatment of CAPS: |
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• cold symptoms | • headache | • feeling like you are spinning (vertigo) |
• diarrhea | • cough | • weight gain |
• flu (influenza) | • body aches | • injection-site reactions (such as redness, swelling, warmth, or itching) |
• runny nose | • nausea, vomiting, and diarrhea (gastroenteritis) | • nausea |
When ILARIS is used for the treatment of TRAPS, HIDS/MKD, and FMF: | ||
• cold symptoms | • runny nose | • nausea, vomiting, and diarrhea (gastroenteritis) |
• upper respiratory tract infection | • sore throat | • injection-site reactions (such as redness, swelling, warmth, or itching) |
When ILARIS is used for the treatment of Still’s disease (AOSD and SJIA): | ||
• cold symptoms | • runny nose | • nausea, vomiting, and diarrhea (gastroenteritis) |
• upper respiratory tract infection | • sore throat | • stomach pain |
• pneumonia | • urinary tract infection | • injection-site reactions (such as redness, swelling, warmth, or itching) |
When ILARIS is used for the treatment of gout flares: | ||
• cold symptoms | • urinary tract infection | |
• upper respiratory tract infection | • increased levels of triglycerides in the blood | |
• back pain | ||
Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of ILARIS. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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General information about the safe and effective use of ILARIS.
Medicines are sometimes prescribed for purposes other than those listed in this Medication Guide. You can ask your pharmacist or healthcare provider for information about ILARIS that was written for health professionals. |
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What are the ingredients in ILARIS?
Active ingredient: canakinumab. Inactive ingredients: Solution for Injection: L-histidine, L-histidine HCl monohydrate, mannitol, polysorbate 80, sterile water for injection. |
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What are Periodic Fever Syndromes?
Periodic Fever Syndromes is the name for several different autoinflammatory diseases, including CAPS, TRAPS, HIDS/MKD, and FMF. People with these diseases cannot keep certain chemicals made by their body (interleukin-1 beta, also called IL-1β) at the correct level. All these diseases have symptoms that often come and go, with irritated body parts (inflammation) and elevated body temperature (fever). These conditions have a dysregulation of IL-1β production and share similar clinical features of recurrent episodes of inflammation and fever, such as rash, headache, pain (mostly in the joints, belly, eyes, muscles), fatigue, inflammation of other organs, such as heart, lungs, spleen, and brain. What is Still’s Disease (AOSD and SJIA)? Still’s disease (which is referred to as AOSD in adults and SJIA in children) is an autoinflammatory disorder which can be caused by having too much or being too sensitive to certain proteins, including interleukin-1 beta (IL-1β), and can lead to symptoms such as fever, rash, headache, feeling very tired (fatigue), or painful joints and muscles. What is Gout Flare? A gout flare is caused when a chemical called urate builds-up in the body, and needle-shaped crystals form in and around the joint. These crystals lead to inflammation with excessive production of certain proteins, such as interleukin-1 beta (also called IL-1β), which in turn can lead to sudden, severe pain, redness, warmth and swelling in a joint. What is Macrophage Activation Syndrome (MAS)? MAS is a syndrome associated with Still’s disease and some other autoinflammatory diseases like HIDS/MKD that can lead to death. Tell your healthcare provider right away if your AOSD or SJIA symptoms get worse or if you have any of these symptoms of an infection:
Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 US License Number 1244 Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 © Novartis For more information about ILARIS, call 1-888-669-6682 or visit www.ILARIS.com. Kineret®, Arcalyst®, Enbrel®, Humira®, Remicade®, Simponi®, and Cimzia® are trademarks of Amgen, Regeneron, Immunex Corporation, AbbVie Biotechnology Ltd., Centocor Ortho Biotech Inc., Janssen Biotech Inc., and the UCB Group of companies, respectively. |
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