How does this medication work? What will it do for me?
Ustekinumab belongs to the class of medications called selective immunomodulating agents, also known as biologics. It is used to treat chronic, moderate-to-severe plaque psoriasis. It may also be used alone or with methotrexate to treat to treat psoriatic arthritis. It works by blocking the action of 2 proteins in the body that are part of the immune system. This decreases the activity of parts of the immune system that are believed to be involved in psoriasis.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each mL of sterile solution contains ustekinumab 90 mg. It is available as a pre-filled syringe containing 45 mg (0.5 mL) or 90 mg (1.0 mL) of ustekinumab. Nonmedicinal ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.
How should I use this medication?
To treat either plaque psoriasis or psoriatic arthritis, the usual dose is 45 mg injected under the skin. The dose is repeated in 4 weeks, and then every 12 weeks thereafter. For people who weigh more than 100 kg, a dose of 90 mg may be used. When treating plaque psoriasis, some people may need to receive this medication every 8 weeks. The dose may be injected on top of the thigh or around the abdomen (about 2 inches away from the belly button).
Most people using this medication can be trained by a health care professional to give themselves the injection. Ustekinumab is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject this medication on your own until you completely understand how to inject a dose.
Follow the instructions from your doctor or pharmacist when administering the medication. The solution should be colourless or slightly yellow and may contain a few small clear or white particles of protein. Do not use the injection if it appears cloudy or discoloured, or if you see other particles floating in it. After taking the medication out of the refrigerator, preparing the syringe, and choosing the injection site, inject the dose under the skin as instructed by your health care provider.
Use a different site for each injection to decrease the risk of skin irritation. Dispose of your used needles in an appropriate sharps container.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.
It is important that this medication be given exactly as recommended by your doctor. If you miss a dose and your psoriasis has not come back, inject the dose as soon as you remember. If you miss a dose and your psoriasis returns, contact your doctor. Do not inject a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication in the refrigerator, protect it from light, and keep it out of the reach of children. Do not freeze or shake the medication.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not use ustekinumab if you:
- are allergic to ustekinumab or any ingredients of this medication, including latex
- have severe infections such as sepsis (bacterial infections that have spread throughout the body), tuberculosis, and opportunistic infections (infections that occur in people with weakened immune systems)
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is used in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who uses this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people using this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- back pain
- injection site reactions such as pain, redness, or swelling
- muscle or joint pain
- symptoms of upper respiratory tract infections such as the common cold or sinus infections (e.g., face discomfort or pain, nasal congestion, runny nose, sore throat, tiredness)
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- increased redness and shedding of skin
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- signs of skin cancer, such as unusual moles (moles with irregular borders, multicoloured moles, moles larger than the size of a pencil eraser, or asymmetrical moles); small pearl-coloured bumps on the skin that may bleed easily; or red, raised, scaly patches of skin
- signs of skin infection, such as redness, swelling, pain, and warmth
Stop using the medication and seek immediate medical attention if any of the following occur:
- signs of an allergic reaction such as difficulty breathing; hives; swelling of face, lips, tongue, or throat
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are using this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
November 21, 2014
Health Canada has issued new restrictions concerning the use of Stelara® (ustekinumab). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Allergic reaction: In rare cases, some people may develop a serious allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, seek immediate medical attention.
Allergy shots: This medication may affect allergy shots. If you are receiving or have received allergy shots, especially for severe allergic reactions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Immune system and infections: Ustekinumab may lower your ability to fight infections and may increase the risk of infections and reactivate inactive infections. Your doctor may test for tuberculosis before starting this medication.
Your doctor will do regular tests of immune system function while you are using this medication. If you develop a severe infection, contact your doctor as soon as possible.
Latex: The needle cover on the pre-filled syringe contains dry natural rubber (a form of latex). If you are allergic to latex, talk to your doctor before using the pre-filled syringe.
Malignancies (cancer): Ustekinumab may increase the risk of cancer. If you have cancer or have had cancer in the past, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): This is a rare disease of the brain that may occur when using medications like ustekinumab. If you have had a previous episode of RPLS, ustekinumab may not be an appropriate medication for you. Make sure your doctor knows you have experienced this before. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness or vision changes, contact your doctor immediately.
Serious infections: Ustekinumab can affect the way your body's natural defences work to fight infection. This makes the body more likely to develop infections due to bacteria, viruses, and fungi. This effect is increased if you are taking ustekinumab with other medications that reduce the body's ability to fight infection. For some people, these infections have been fatal. If you have a history of chronic or frequent infections, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Stop taking the medication and tell your doctor right away if you notice symptoms of a serious infection, such as fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in the sputum, shortness of breath, night sweats, weight loss, nausea, vomiting, diarrhea, frequency or burning while passing urine, redness or swelling of skin or joint, cold sores, tooth pain, or new or worsening pain in any part of the body.
If you have an active infection, you should not use this medication until the infection resolves.
Serious skin conditions: There have been reports of rare serious skin conditions (exfoliative dermatitis and erythrodermic psoriasis) in people receiving ustekinumab. If you experience redness and shedding of skin over most of the entire area of the body, contact your doctor immediately.
Tuberculosis: Some people who have had tuberculosis (a lung infection) in the past have had this infection return when they are using ustekinumab. If you have a history of tuberculosis, or have come into recent contact with someone who has tuberculosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Vaccinations: People taking this medication should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with this medication.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this medication, contact your doctor immediately.
Breast-feeding: It is not known if this medication passes into breast milk. If you are a breast-feeding mother and are taking ustekinumab, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children and adolescents 18 years of age and younger.
What other drugs could interact with this medication?
There may be an interaction between ustekinumab and any of the following:
- immunosuppressants (e.g., prednisone, dexamethasone, chemotherapy, azathioprine, tacrolimus, cyclosporine)
- live vaccines (e.g., BCG, measles, mumps, rubella; chickenpox; polio, meningococcal)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.