Description
Canakinumab injection is used to treat cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). CAPS is a rare, inherited disease of the immune system.
Canakinumab injection is also used to treat tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial Mediterranean fever (FMF).
Canakinumab injection is also used to treat active Still's disease, including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA).
Canakinumab injection is also used to treat gout flares in patients who are not able to receive or tolerate treatment, or have not responded to treatment with colchicine and NSAIDs. It is also used to treat gout flares in patients who are not able to receive repeated treatment with steroid medicines.
CAPS, TRAPS, HIDS/MKD, and FMF are autoinflammatory periodic fever syndromes and Still's disease is an autoinflammatory disease. Autoinflammatory conditions occur when the body produces too much of a chemical called interleukin-1 beta. This chemical causes inflammation (swelling) and patients may have a fever, headache, skin rash, joint or muscle pain, or unusual tiredness or weakness. Canakinumab is an interleukin-1 beta blocker. It helps prevent inflammation by keeping the interleukin-1 beta from working properly.
This medicine is to be given only by or under the direct supervision of a doctor.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of canakinumab injection in children with TRAPS, HIDS/MKD, and FMF. However, safety and efficacy have not been established in children with gout flares, in children with CAPS, FCAS, or MWS younger than 4 years of age, and in children with SJIA younger than 2 years of age.
Geriatric
Appropriate studies on the relationship of age to the effects of canakinumab injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Ebola Zaire Vaccine, Live
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Hepatitis B, history of or
- Hepatitis C, history of or
- Immune system problem (eg, HIV or AIDS) or
- Infection, active or history of or
- Tuberculosis, active or history of—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you or your child this medicine in a hospital or clinic setting. This medicine is given as a shot under your skin.
This medicine is given every 8 weeks for CAPS and every 4 weeks for TRAPS, HIDS/MKD, FMF, AOSD, and SJIA.
This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly.
You will need to have a skin test for tuberculosis (TB) before you or your child start receiving this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a TB test.
Your body's ability to fight an infection may be reduced while you are being treated with canakinumab. It is very important that you call your doctor right away if you or your child have a fever, chills, cough, hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may increase your risk of cancer. Talk to your doctor if you have concerns about this risk.
Canakinumab may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, lightheadedness or dizziness, swelling of the face, tongue, and throat, trouble breathing or swallowing, or chest pain after you or your child receive the medicine.
This medicine may cause serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.
Do not get any immunizations (vaccines), especially the live vaccines (eg, nasal flu virus vaccine) without your doctor's approval while you are being treated with this medicine.
This medicine may cause a life-threatening condition called macrophage activation syndrome (MAS). This usually occurs in patients with rheumatic conditions, including Still's disease, and must be treated immediately. Tell your doctor right away if you have a fever that lasts longer than 3 days, a cough that does not go away, redness in one part of your body, or warm feeling or swelling of your skin, or if symptoms of AOSD and SJIA become worse.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- bone pain
- chest tightness
- chills
- cough
- diarrhea
- difficult, burning, or painful urination
- dryness or soreness of the throat
- ear congestion
- fever
- frequent urge to urinate
- headache
- hoarseness
- joint pain
- loss of appetite
- loss of voice
- lower back or side pain
- muscle aches and pains
- nausea
- shivering
- sneezing
- stomach pain
- stuffy or runny nose
- sweating
- tender, swollen glands in the neck
- trouble breathing or swallowing
- trouble sleeping
- unusual tiredness or weakness
- voice changes
- vomiting
Incidence not known
- Black, tarry stools
- chest pain
- lightheadedness or dizziness
- skin rash, itching
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the face, tongue, and throat
- unusual bleeding or bruising
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- feeling of constant movement of self or surroundings
- increased weight
- sensation of spinning
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20073102
