Ilaris

What is Ilaris?

• Ilaris (Canakinumab) is an interleukin-1β blocker used for the treatment of Periodic Fever Syndromes.

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.

Canakinumab bound to IL-1β

What are the uses of this medicine?

• ILARIS (Canakinumab) is injected by your healthcare provider just below the skin (subcutaneous) used to treat:

The following Periodic Fever Syndromes:

• Adults and children 4 years of age and older who have auto-inflammatory diseases called Cryopyrin-Associated Periodic Syndromes (CAPS), including:
• Familial Cold Auto-inflammatory Syndrome (FCAS)
• Muckle-Wells Syndrome (MWS)
• Adults and children who have an auto-inflammatory disease called Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS)
• Adults and children who have an auto-inflammatory disease called Hyperimmunoglobulin D Syndrome (HIDS) (also known as Mevalonate Kinase Deficiency [MKD]).
• Adults and children who have an auto-inflammatory disease called Familial Mediterranean Fever (FMF).
• Still’s disease, including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in children 2 years of age and older.

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-1β (IL-1β), and can lead to symptoms such as fever, rash, headache, feeling very tired (fatigue), or painful joints and muscles.

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:

• a fever lasting longer than 3 days.
• a cough that does not go away.
• redness in one part of your body.
• warm feeling or swelling of your skin.

How does this medicine work?

• Canakinumab (kan” a kin’ ue mab) is a human monoclonal antibody to IL-1 beta.

* The antibody reactivity is specific for IL-1 beta with no cross reactivity to other members of the IL-1 family or other cytokines. 

• IL-1 is a key proinflammatory cytokine that medicates local and systemic inflammatory reactions and can induce fever, pain sensitization, bone and cartilage destruction and acute phase plasma protein reactions.
• In several controlled trials and open label studies, canakinumab has been shown to improve symptoms and laboratory abnormalities associated with juvenile idiopathic arthritis (formerly juvenile rheumatoid arthritis or Still disease) and several rare autoinflammatory conditions such as cryopyrin associated periodic syndrome (CAPS), Schnitzler syndrome and familial Mediterranean fever.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to canakinumab or any of the ingredients in ILARIS.

What drug interactions can this medicine cause?

No formal drug interaction studies have been conducted with ILARIS.

Tell your healthcare provider if you take:

• medicines that affect your immune system
• medicines called IL-1 blocking agents, such as Kineret® (anakinra), Arcalyst® (rilonacept)
• medicines called Tumor Necrosis Factor (TNF) inhibitors, such as Enbrel® (etanercept), Humira® (adalimumab), Remicade® (infliximab), Simponi® (golimumab), or Cimzia® (certolizumab pegol)
• medicines that effect enzyme metabolism

Is this medicine FDA approved?

• Canakinumab was approved for use in periodic fever syndromes in the United States in 2009 and indications were expanded to include juvenile idiopathic arthritis in 2013.

How should this medicine be used?

Recommended dosage: Cryopyrin-Associated Periodic Syndromes (CAPS):

• 150 mg for CAPS patients with body weight greater than 40 kg and 2 mg/kg for CAPS patients with body weight greater than or equal to 15 kg and less than or equal to 40 kg. For children 15 to 40 kg with an inadequate response, the dose can be increased to 3 mg/kg. Administer subcutaneously every 8 weeks.

Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency (HIDS/MKD), and Familial Mediterranean Fever (FMF): Body weight less than or equal to 40 kg:

• The recommended starting dose is 2 mg/kg every 4 weeks.
• The dose can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate.

Body weight greater than 40 kg:

• The recommended starting dose is 150 mg every 4 weeks. The dose can be increased to 300 mg every 4 weeks if the clinical response is not adequate.

Still’s disease (AOSD and SJIA):

• 4 mg/kg (with a maximum of 300 mg) for patients with a body weight greater than or equal to 7.5 kg. Administer subcutaneously every 4 weeks.

Administration:

• ILARIS is given by your healthcare provider every 8 weeks for CAPS and every 4 weeks for TRAPS, HIDS/MKD, FMF, AOSD, and SJIA as subcutaneous injection.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 150 mg/mL solution in single-dose vials.

This medicine is available in fallowing brand namesː

• ILARIS

What side effects can this medication cause?

The most common side effects of this medicine include: When ILARIS is used for the treatment of CAPS:

• 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)

ILARIS can cause serious side effects, including:

• Increased risk of serious infections
• immunosuppression
• allergic reactions
• risk of infection with live vaccines

What special precautions should I follow?

• Interleukin-1 blockade may interfere with immune response to infections. Treatment with medications that work through inhibition of IL-1 has been associated with an increased risk of serious infections. ILARIS has been associated with an increased incidence of serious infections. Physicians should exercise caution when administering ILARIS to patients with infections, a history of recurring infections or underlying conditions which may predispose them to infections. Discontinue treatment with ILARIS if a patient develops a serious infection. Do not administer ILARIS to patients during an active infection requiring medical intervention.
• Live vaccines should not be given concurrently with ILARIS. Prior to initiation of therapy with ILARIS, patients should receive all recommended vaccinations.
• Treatment with immunosuppressants, including ILARIS, may result in an increase in the risk of malignancies.
• Hypersensitivity reactions have been reported with ILARIS therapy. ILARIS should not be administered to any patients with known clinical hypersensitivity to ILARIS. If a severe hypersensitivity reaction occurs, administration of ILARIS should be discontinued and appropriate therapy initiated.
• Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with rheumatic conditions, in particular Still’s disease, and should be aggressively treated.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No confirmed case of overdose has been reported.

Management of overdosage:

• In the case of overdose, it is recommended that the subject be monitored for any signs and symptoms of adverse reactions or effects, and appropriate symptomatic treatment be instituted immediately.

Can this medicine be used in pregnancy?

• Available human data from postmarketing experience and published case reports on ILARIS use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes.

Can this medicine be used in children?

• It is not known if ILARIS is safe and effective when used to treat SJIA in children under 2 years of age or when used to treat CAPS in children under 4 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: canakinumab
• Inactive ingredients: Solution for Injection: L-histidine, L-histidine HCl monohydrate, mannitol, polysorbate 80, sterile water for injection.

Who manufactures and distributes this medicine?

Manufactured by:

• Novartis Pharmaceuticals Corporation
• East Hanover, New Jersey

Distributed by:

• Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

What should I know about storage and disposal of this medication?

• The unopened vial must be stored refrigerated at 2°C to 8°C (36°F to 46°F).
• Do not freeze.
• Store in the original carton to protect from light.
• Do not use beyond the date stamped on the label.
• ILARIS does not contain preservatives.
• Discard any unused portions of ILARIS or waste material in accordance with local requirements.

• Dailymed label info on Ilaris
• FDA Ilaris

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