Ilaris

DRUG DESCRIPTION

Canakinumab is a recombinant, human anti-human-IL-1? monoclonal antibody that belongs to the IgG1/K isotype subclass. It is expressed in a murine Sp2/0-Ag14 cell line and comprised of two 447- (or 448-) residue heavy chains and two 214-residue light chains, with a molecular mass of 145157 Daltons when deglycosylated. Both heavy chains of canakinumab contain oligosaccharide chains linked to the protein backbone at asparagine 298 (Asn 298).

The biological activity of canakinumab is measured by comparing its inhibition of IL-1?-dependent expression of the reporter gene luciferase to that of a canakinumab internal reference standard, using a stably transfected cell line.

ILARIS (canakinumab injection) is supplied in a sterile, single-use, colorless, 6mL glass vial with coated stopper and aluminum flip-off cap. Each vial contains 180 mg of canakinumab as a white, preservative-free, lyophilized powder. Reconstitution with 1 mL of preservative-free Sterile Water for Injection is required prior to subcutaneous administration of the drug. The reconstituted canakinumab is a 150 mg/mL solution essentially free of particulates, clear to slightly opalescent, and is colorless or may have a slightly brownish-yellow tint. A volume of up to 1 mL can be withdrawn for delivery of 150mg/mL canakinumab for subcutaneous administration. Each reconstituted vial contains 180 mg canakinumab, sucrose, L-histidine, L-histidine HCL monohydrate, polysorbate 80 and Sterile Water for Injection. No preservatives are present.

What are the possible side effects of canakinumab (Ilaris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness;
  • cough with yellow or green mucus;
  • stabbing chest pain, feeling short of breath;...

Read All Potential Side Effects and See Pictures of Ilaris

What are the precautions when taking canakinumab injection (Ilaris)?

Before using canakinumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems (such as HIV infection), current/recent/returning infection (including hepatitis and tuberculosis), cancer.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before starting this drug, you should take a tuberculosis (TB) skin test to check for a type of...

Read All Potential Precautions of Ilaris


Ilaris Consumer (continued)

SIDE EFFECTS: Redness, itching, pain, warmth, or swelling at the injection site may occur. Dizziness, nausea, diarrhea, or headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can affect your immune system. It can lower your body's ability to fight an infection. You may be more likely to get serious infections, such as pneumonia, bone/joint infections, skin infections, or sinusitis. It may also be harder to fight an infection you already have. Tell your doctor immediately if you develop any signs of an infection, such as fever/chills, cough, or cold/flu symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using canakinumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems (such as HIV infection), current/recent/returning infection (including hepatitis and tuberculosis), cancer.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before starting this drug, you should take a tuberculosis (TB) skin test to check for a type of tuberculosis that may not be causing any symptoms (latent TB). If you are diagnosed with TB, you must first be treated for it before you start canakinumab to prevent a serious TB infection.

Canakinumab can make you more likely to get infections or may worsen any current infections. Therefore, do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Also avoid contact with people who have infections that may spread to others (such as chickenpox, flu). Wash your hands well to prevent the spread of infections.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Ilaris Patient Information Including Side Effects

Brand Names: Ilaris

Generic Name: canakinumab (Pronunciation: KAN a KIN ue mab)

  • What is canakinumab (Ilaris)?
  • What are the possible side effects of canakinumab (Ilaris)?
  • What is the most important information I should know about canakinumab (Ilaris)?
  • What should I discuss with my health care provider before using canakinumab (Ilaris)?
  • How should I use canakinumab (Ilaris)?
  • What happens if I miss a dose (Ilaris)?
  • What happens if I overdose (Ilaris)?
  • What should I avoid while using canakinumab (Ilaris)?
  • What other drugs will affect canakinumab (Ilaris)?
  • Where can I get more information?

What is canakinumab (Ilaris)?

Canakinumab reduces the effects of a substance in the body that can cause inflammation.

Canakinumab is used to treat rare genetic conditions such as Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children who are at least 4 years old.

Canakinumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of canakinumab (Ilaris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness;
  • cough with yellow or green mucus;
  • stabbing chest pain, feeling short of breath; or
  • severe dizziness or spinning sensation.

Less serious side effects may include:

  • runny or stuffy nose;
  • diarrhea, mild nausea;
  • headache;
  • joint or muscle pain;
  • mild dizziness; or
  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about canakinumab (Ilaris)?

You should not use this medication if you are allergic to canakinumab.

Before using canakinumab, tell your doctor if you have an active infection, a history of recurrent infections, a weak immune system, or a history of tuberculosis.

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Make sure you are current on all vaccines before you start treatment with canakinumab.

Canakinumab can make it easier for you to get sick. Avoid being near people who have colds, the flu, or other contagious illnesses.

Serious and sometimes fatal infections may occur during treatment with canakinumab. Contact your doctor right away if you have signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

Treatment with canakinumab may increase your risk of developing cancer. Talk to your doctor about your individual risk.

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