Canakinumab

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Generic Name: Canakinumab Brand Name(s): Generics only. No brands available.

Uses

What is Canakinumab used for?

Canakinumab is used to treat certain types of periodic fever syndromes, which include cryopyrin-associated periodic syndromes (CAPS), tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial Mediterranean fever (FMF). Canakinumab works by blocking a certain natural protein in your body (interleukin-1 beta) that may worsen the symptoms of these diseases. Canakinumab may help to lessen the symptoms, such as rash, joint/muscle pain, fever, eye redness, and tiredness.

Canakinumab is also used to treat a certain type of rheumatoid arthritis in children (systemic juvenile idiopathic arthritis-SJIA).

How should I take Canakinumab?

This medication is injected under the skin as directed by your doctor. If you are using this medication to treat CAPS, it is usually given every 8 weeks. If you are using this medication to treat TRAPS, HIDS/MKD, FMF, SJIA, it is usually given every 4 weeks. The dosage is based on your age, weight, medical condition, and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Do not shake the vial. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. The liquid should be clear, and either colorless or a pale brownish yellow color. Learn how to store and discard medical supplies safely.

Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site each time to avoid problem areas under the skin. Do not inject into skin that is tender, red, or hard. Never reuse syringes or needles.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder when you should get the next dose.

Tell your doctor if your condition does not improve or if it worsens.

How do I store Canakinumab?

Store intact vial at 2°C to 8°C (36°F to 46°F); do not freeze. After reconstitution of powder, vials may be stored at room temperature for up to 1 hour or in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 4 hours. Protect from light prior to and after reconstitution. Discard any unused portion.

There may be different brands of Canakinumab that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Canakinumab down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Canakinumab?

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.

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. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Canakinumab during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Canakinumab. Canakinumab is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Canakinumab?

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 right away 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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Canakinumab?

Some products that may interact with this drug include: other IL-1 blockers (such as anakinra, rilonacept), TNF-blockers (such as adalimumab, etanercept, infliximab).

Canakinumab may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Canakinumab?

Canakinumab may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

What health conditions may interact with Canakinumab?

Canakinumab may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Canakinumab.

What is the dose of Canakinumab for an adult?

Usual Adult Dose for Familial Cold Autoinflammatory Syndrome

40 kg or less: The manufacturer product information should be consulted.

Greater than 40 kg: 150 mg subcutaneously every 8 weeks

Use: Cryopyrin-associated periodic syndromes (CAPS) including familial cold autoinflammatory syndrome (FCAS) and muckle-wells syndrome (MWS)

Usual Adult Dose for Muckle Wells Snydrome

40 kg or less: The manufacturer product information should be consulted.

Greater than 40 kg: 150 mg subcutaneously every 8 weeks

Use: Cryopyrin-associated periodic syndromes (CAPS) including familial cold autoinflammatory syndrome (FCAS) and muckle-wells syndrome (MWS)

Usual Adult Dose for Cryopyrin-Associated Periodic Syndrome

40 kg or less: The manufacturer product information should be consulted.

Greater than 40 kg: 150 mg subcutaneously every 8 weeks

Use: Cryopyrin-associated periodic syndromes (CAPS) including familial cold autoinflammatory syndrome (FCAS) and muckle-wells syndrome (MWS)

Usual Adult Dose for Familial Mediterranean Fever

40 kg or less: The manufacturer product information should be consulted.

Greater than 40 kg: 150 mg subcutaneously every 4 weeks

-If the response is inadequate: Can increase to 300 mg subcutaneously every 4 weeks

Use: Autoinflammatory periodic fever syndromes including periodic tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin d syndrome/mevalonate kinase deficiency (MKD), and familial mediterranean fever (FMF)

Usual Adult Dose for Hyperimmunoglobulin D Periodic Fever Syndrome

40 kg or less: The manufacturer product information should be consulted.

Greater than 40 kg: 150 mg subcutaneously every 4 weeks

-If the response is inadequate: Can increase to 300 mg subcutaneously every 4 weeks

Use: Autoinflammatory periodic fever syndromes including periodic tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin d syndrome/mevalonate kinase deficiency (MKD), and familial mediterranean fever (FMF)

Usual Adult Dose for Tumor Necrosis Factor Receptor Associated Periodic Fever Syndrome

40 kg or less: The manufacturer product information should be consulted.

Greater than 40 kg: 150 mg subcutaneously every 4 weeks

-If the response is inadequate: Can increase to 300 mg subcutaneously every 4 weeks

Use: Autoinflammatory periodic fever syndromes including periodic tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin d syndrome/mevalonate kinase deficiency (MKD), and familial mediterranean fever (FMF)

Other Comments

Administration advice:

-Avoid injection into scar tissue.

-Vials are intended for single use in 1 patient; discard any unused portion.

Storage requirements:

-The manufacturer product information should be consulted.

Reconstitution/preparation techniques:

-The manufacturer product information should be consulted.

IV compatibility:

-The manufacturer product information should be consulted.

What is the dose of Canakinumab for a child?

Usual Pediatric Dose for Familial Cold Autoinflammatory Syndrome

4 years and older:

15 to 40 kg: 2 mg/kg subcutaneously every 8 weeks

-If the response is inadequate: Can increase to 3 mg/kg subcutaneously every 8 weeks

Greater than 40 kg: 150 mg subcutaneously every 8 weeks

Use: For the treatment of CAPS including FCAS and MWS

Usual Pediatric Dose for Muckle Wells Snydrome

4 years and older:

15 to 40 kg: 2 mg/kg subcutaneously every 8 weeks

-If the response is inadequate: Can increase to 3 mg/kg subcutaneously every 8 weeks

Greater than 40 kg: 150 mg subcutaneously every 8 weeks

Use: For the treatment of CAPS including FCAS and MWS

Usual Pediatric Dose for Cryopyrin-Associated Periodic Syndrome

4 years and older:

15 to 40 kg: 2 mg/kg subcutaneously every 8 weeks

-If the response is inadequate: Can increase to 3 mg/kg subcutaneously every 8 weeks

Greater than 40 kg: 150 mg subcutaneously every 8 weeks

Use: For the treatment of CAPS including FCAS and MWS

Usual Pediatric Dose for Familial Mediterranean Fever

2 years and older:

40 kg or less: 2 mg/kg subcutaneously every 4 weeks

-If the response is inadequate: Can Increase to 4 mg/kg subcutaneously every 4 weeks

Greater than 40 kg: 150 mg subcutaneously every 4 weeks

-If the response is inadequate: Can increase to 300 mg subcutaneously every 4 weeks

Use: For the treatment of autoinflammatory periodic fever syndromes including TRAPS, HIDS/MKD, and FMF

Usual Pediatric Dose for Hyperimmunoglobulin D Periodic Fever Syndrome

2 years and older:

40 kg or less: 2 mg/kg subcutaneously every 4 weeks

-If the response is inadequate: Can Increase to 4 mg/kg subcutaneously every 4 weeks

Greater than 40 kg: 150 mg subcutaneously every 4 weeks

-If the response is inadequate: Can increase to 300 mg subcutaneously every 4 weeks

Use: For the treatment of autoinflammatory periodic fever syndromes including TRAPS, HIDS/MKD, and FMF

Usual Pediatric Dose for Tumor Necrosis Factor Receptor Associated Periodic Fever Syndrome

2 years and older:

40 kg or less: 2 mg/kg subcutaneously every 4 weeks

-If the response is inadequate: Can Increase to 4 mg/kg subcutaneously every 4 weeks

Greater than 40 kg: 150 mg subcutaneously every 4 weeks

-If the response is inadequate: Can increase to 300 mg subcutaneously every 4 weeks

Use: For the treatment of autoinflammatory periodic fever syndromes including TRAPS, HIDS/MKD, and FMF

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

2 years and older weighing at least 7.5 kg: 4 mg/kg subcutaneously every 4 weeks

Maximum dose: 300 mg

Comments:

-Approved dosing is only for 7.5 kg or more.

Use: For the treatment of active systemic juvenile idiopathic arthritis (SJIA)

Precautions

CAPS: Safety and efficacy have not been established in patients younger than 4 years.

TRAPS, HIDS/MKD, FMF: Safety and efficacy have not been established in patients younger than 2 years.

SJIA: Safety and efficacy have not been established in patients younger than 2 years or weighing less than 7.5 kg.

How is Canakinumab available?

Canakinumab is available in the following dosage forms and strengths:

  • Subcutaneous powder for injection,
  • Subcutaneous solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Canakinumab, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: June 4, 2018 | Last Modified: June 4, 2018