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.