Patient Medication Information: uses, side effects, how to take - Avsola
Serious warnings and precautions box
Serious infections, including sepsis, tuberculosis, legionellosis (a serious form of bacterial pneumonia), listeriosis (an infection that usually develops after eating food contaminated by bacteria called listeria) and opportunistic infections (such as systemic fungal, viral, and bacterial infections), have been reported in patients, especially those 65 years and older, receiving infliximab and other similar medicines. Some patients with these infections have died. Prior to treatment with AVSOLA, you should tell your healthcare professional if you have a chronic infection, a history of recurrent infection, or if you have lived in or traveled to an area where infections called histoplasmosis, coccidioidomycosis or blastomycosis are common. These infections are caused by fungus that can affect the lungs or other parts of your body. Ask your healthcare professional if you don’t know if these infections are common in the area in which you have lived or traveled. If you develop an infection during treatment with AVSOLA, you should tell your healthcare professional right away. Prior to treatment with AVSOLA, you should tell your healthcare professional if you have had tuberculosis, or if you have been exposed recently to anyone who might have tuberculosis, or if you have any other reason to believe you may be at risk for tuberculosis. Your healthcare professional will evaluate you for tuberculosis and may begin treatment for tuberculosis before you are treated with AVSOLA. Treatment with AVSOLA must be interrupted if you develop a serious infection or sepsis. Tell your healthcare professional if you have any symptoms of an infection (for example, fever, fatigue, cough, flu-like symptoms, or pain) while you are taking AVSOLA and for 6 months after you receive the medicine. If you need surgery, tell your healthcare professional that you have taken AVSOLA. Lymphoma and other cancers, which may result in death, have been reported in children and teenage patients taking TNF-blockers, including infliximab. Some patients who have received TNF-blockers, including infliximab have developed a rare type of cancer called hepatosplenic T-cell lymphoma. Of these patients, most were teenage or young adult males and most had either Crohn’s disease or ulcerative colitis. This type of cancer often results in death. Almost all patients had also received drugs known as azathioprine or 6-mercaptopurine in addition to |
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| TNF-blockers. You should also tell your healthcare professional if you have had or develop lymphoma or other cancers while you are taking AVSOLA. |
What AVSOLA is used for:
AVSOLA is a medicine that is used in people with moderate to severe rheumatoid arthritis (in combination with methotrexate) and ankylosing spondylitis. Your healthcare professional has chosen to treat your rheumatoid arthritis with AVSOLA because you have moderately to severely active rheumatoid arthritis. Your healthcare professional has chosen to treat your ankylosing spondylitis with AVSOLA because you have had an inadequate response to other treatments or because you cannot tolerate other treatments.
AVSOLA is also used in people with moderate to severe plaque psoriasis. Your healthcare professional has chosen to treat your plaque psoriasis with AVSOLA because your disease is still active even though you have tried other treatments.
AVSOLA is also used in people with active psoriatic arthritis. Your healthcare professional has chosen to treat your psoriatic arthritis with AVSOLA because your disease is still active even though you have tried other treatments.
AVSOLA is also used in adults, children and teenagers with moderate to severe Crohn’s disease or with moderate to severe ulcerative colitis. Your healthcare professional has chosen to treat your Crohn’s disease or ulcerative colitis with AVSOLA because your disease is still active even though you have tried other treatments.
How AVSOLA works:
Research has shown that in these diseases the body overproduces a substance known as tumour necrosis factor alpha (TNF alpha). The active ingredient in AVSOLA is called infliximab. Infliximab is a monoclonal antibody, a type of protein that recognises and binds to other unique proteins. Infliximab binds to and neutralises TNF alpha. Infliximab is made from mouse and human proteins.
AVSOLA is a medicine that affects your immune system. AVSOLA can lower the ability of your immune system to fight infections.
The ingredients in AVSOLA are:
Medicinal ingredients: Infliximab
Non-medicinal ingredients: Dibasic sodium phosphate anhydrous, monobasic sodium phosphate monohydrate, polysorbate 80 and sucrose. No preservatives are present.
AVSOLA comes in the following dosage form:
AVSOLA is supplied as a lyophilized concentrate for IV injection in individually-boxed single-use vials of 100 mg infliximab.
Vial stopper is free of natural rubber latex.
Tell all healthcare professionals involved in your care that you take AVSOLA.
Do not use AVSOLA if:
- you have a severe infection, such as sepsis (an infection in the bloodstream), abscess, tuberculosis or other serious infection, you must not take AVSOLA.
- you have heart failure that is moderate or severe, you must not take AVSOLA.
- you are allergic to infliximab or any ingredient in AVSOLA (polysorbate 80, sodium phosphate and sucrose), or if you have a history of allergies to mouse proteins, you should not take AVSOLA.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AVSOLA. Talk about any health conditions or problems you may have, including if you have:
- Congestive heart failure: If you have mild heart failure and you are being treated with AVSOLA, your heart failure status must be closely monitored by your healthcare professional. If you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your feet), you must contact your healthcare professional immediately.
- Other heart problems: Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of infliximab. Symptoms may include chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat. Tell your healthcare professional right away if you have any of these symptoms.
- Immediate allergic reactions: Some patients who have received infliximab have developed allergic reactions, including anaphylaxis. Some reactions can happen while you are getting your infusion or shortly afterwards. Some of these reactions have been serious. The symptoms include hives, difficulty breathing, chest pain and high or low blood pressure. Your healthcare professional may decide to stop AVSOLA treatment for severe reactions. Your healthcare professional can prescribe medicines to treat these effects.
- Delayed allergic reactions: Some allergic reactions can occur 3 to 12 days after AVSOLA retreatment. The symptoms of this type of delayed reaction include muscle or joint pain with fever or rash. Tell your healthcare professional if you notice any of these symptoms.
- Nervous system diseases: Tell your healthcare professional if you have a disease that affects your nervous system, like multiple sclerosis, neuropathies, Guillain-Barré syndrome, or seizures, or you have been diagnosed with optic neuritis, or if you experience painful and limited eye movements, loss of feeling in the forehead or vision loss (orbital apex syndrome); or any numbness, tingling, or visual disturbances. Some patients have reported that their nervous system disease got worse after receiving infliximab.
- Autoimmune disease: Some patients treated with infliximab have developed symptoms that suggest an autoimmune disease called lupus-like syndrome. Tell your healthcare professional if you notice symptoms of lupus-like syndrome, such as, prolonged chest discomfort or pain, shortness of breath, joint pain, or sun-sensitive rash on the cheeks or arms. Your healthcare professional will evaluate your condition and may decide to stop your treatment with AVSOLA.
- Liver injury: There have been cases where people taking infliximab have developed liver problems. Signs that you could be having a problem include: jaundice (skin and eyes turning yellow), dark brown-colored urine, right-sided abdominal pain, fever, and severe fatigue (tiredness). You should contact your healthcare professional immediately if you develop any of these symptoms.
- Previous phototherapy: Tell your healthcare professional if you have had phototherapy (treatment with ultraviolet light or sunlight along with a medicine to make your skin sensitive to light) for psoriasis. In clinical trials, skin cancers were more common in patients who received prior phototherapy.
- Blood Problems: In some instances, patients treated with TNF-blocking agents may develop low blood counts, including a severely decreased number of white blood cells. If you develop symptoms such as persistent fever or infections, bleeding, or bruising, you should contact your healthcare professional right away.
- Stroke: Some patients have experienced a stroke within approximately 24 hours of their infusion of infliximab. Tell your healthcare professional right away if you have symptoms of a stroke which may include: numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination or a sudden, severe headache.
- Hepatitis B: Treatment with TNF-blocking agents such as AVSOLA may result in a reactivation of the hepatitis B virus in people who carry this virus. If you have or have had hepatitis B infection or know or suspect you may be a carrier of hepatitis B virus, be sure to tell your healthcare professional about this as this may impact the decision to start or continue treatment with AVSOLA. Your healthcare professional should do a blood test for hepatitis B virus before you start treatment with AVSOLA.
- Vaccination: Tell your healthcare professional that you have received AVSOLA if you need to get a vaccination. It is not known if medicines like AVSOLA can interfere with vaccinations. You should not receive live vaccines while you are taking AVSOLA. The use of a ‘live’ vaccine may result in an infection caused by the ‘live’ vaccine or bacteria contained in the vaccine (when you have a weakened immune system). It is recommended that you be brought up to date with all vaccinations in agreement with current guidelines prior to starting AVSOLA.
- Therapeutic infectious agents: Tell your healthcare professional if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Pregnancy, breast-feeding and ability to have children: If you are being treated with AVSOLA, you must avoid becoming pregnant by using adequate contraception during your treatment and for 6 months after your last AVSOLA injection. Tell your healthcare professional if you think you may be pregnant, are breast-feeding, or planning to conceive a child. Your healthcare professional will help you decide whether or not to use AVSOLA.
If you have a baby and you were using AVSOLA during your pregnancy, it is important to tell your baby’s healthcare professional and other healthcare professionals about your AVSOLA use so they can decide when your baby should receive their vaccinations, including live vaccines, such as BCG (used to prevent tuberculosis), rotavirus vaccine or any other live vaccines.
If you received AVSOLA while you were pregnant, your baby may be at higher risk for getting an infection. It is important that you tell your baby’s healthcare professionals about your AVSOLA use before the baby receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis), rotavirus vaccine, or any other live vaccines. Administration of BCG vaccine within 12 months after birth to the baby whose mother received AVSOLA while pregnant may result in infection in the newborn with severe complications, including death. For other types of vaccines, discuss with your healthcare professional.
If you are breast feeding, it is important that you tell your baby’s healthcare professionals about your AVSOLA use before your baby is given any vaccine. Live vaccines should not be given to your baby while you are breast feeding unless your baby’s healthcare professional recommends otherwise.
Severely decreased numbers of white blood cells have also been reported in infants born to women treated with infliximab during pregnancy. If your baby has continual fevers or infections, contact your baby’s healthcare professional immediately.
It is not known if AVSOLA can affect your ability to have children in the future.
- Have any surgery planned
Other warnings you should know about:
Reports of a type of blood cancer called lymphoma in patients on AVSOLA or other TNF-blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn’s disease or ankylosing spondylitis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. There have been cases of cancers, including unusual types, in children and teenage patients taking TNF-blocking agents, which sometimes resulted in death. For children and adults taking TNF-blocker medicines, the chances of getting lymphoma or other cancers may increase.
Some patients treated with infliximab have developed certain kinds of skin cancer. If any changes in the appearance of the skin or growths on the skin occur during or after therapy, tell your healthcare professional.
Some women being treated for rheumatoid arthritis with infliximab have developed cervical cancer. For women taking infliximab, including those over 60 years of age, your healthcare professional may recommend that you continue to be regularly screened for cervical cancer.
Patients with a specific type of lung disease called COPD (Chronic Obstructive Pulmonary Disease) may be at increased risk for cancer with AVSOLA treatment. If you have COPD you should discuss with your healthcare professional whether AVSOLA is appropriate for you.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with AVSOLA:
- Tell your healthcare professional about all medicines that you have recently taken or are taking during your treatment with AVSOLA. These include any other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis. Drugs that may interact with AVSOLA include: prescription and non-prescription medicines, vitamins, and herbal supplements.
Patients with rheumatoid arthritis or Crohn’s disease often take other medicines that can cause side effects. Special studies have not been done to determine whether other
- medicines will react with AVSOLA. In studies of infliximab, patients were also taking antibiotics, antivirals, corticosteroids, mercaptopurine (6MP), azathioprine (AZA), methotrexate (MTX), and aminosalicylates along with infliximab. Patients who took immunosuppressants, such as methotrexate, corticosteroids, mercaptopurine, azathioprine, had a lower risk of allergic reactions during infusion.
- Especially, tell your healthcare professional if you take KINERET® (anakinra) or ORENCIA® (abatacept). AVSOLA should not be taken together with anakinra or abatacept.
- If you have a baby or if you breastfed your baby while you are using AVSOLA, tell your baby’s healthcare professional about your AVSOLA use before the baby receives any live vaccines.
How to take AVSOLA:
AVSOLA will be given to you by a healthcare professional. The medicine will be given to you through a needle placed in a vein in your arm. This is called an infusion. For adults with ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis, the infusion will take about 2 hours. For children with Crohn’s disease or ulcerative colitis, the infusion will take about 2 hours. For adults with rheumatoid arthritis, Crohn’s disease or ulcerative colitis, the first 3 infusions will be given over a period of about 2 hours, after the third consecutive 2-hour infusion your healthcare professional may decide to give you the infusion over a 1 hour period. During the infusion you will be monitored for side effects. You must stay for 1 to 2 hours after the infusion so that you can continue to be watched for any reactions to the medicine.
Your healthcare professional may:
- ask you to take other medicines along with AVSOLA.
- delay your treatment with AVSOLA if you have a surgery planned.
Where I may receive the infusion:
Your healthcare professional or the Entrust™ Patient Support Services will help you to decide where you will receive the infusion. The Entrust™ Patient Support Services Infusion Network consists of clinics located across Canada that are staffed by qualified healthcare professionals specially trained in the administration of AVSOLA infusions. Information about the Entrust™ Patient Support Services can be obtained by calling 1.877.936.2735.
Usual dose:
Rheumatoid Arthritis
The recommended dose of AVSOLA is 3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg doses at 2 and 6 weeks after the first infusion then every 8 weeks thereafter. AVSOLA should be given in combination with methotrexate.
Ankylosing Spondylitis
The recommended dose of AVSOLA is one initial infusion followed by infusions at 2 and 6 weeks after the first dose. Then you will receive an infusion every 6 to 8 weeks thereafter.
Crohn’s Disease and Fistulising Crohn’s Disease
Adults
The recommended dose of AVSOLA is 5 mg/kg given as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of moderate to severe, active Crohn’s disease. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg. Your healthcare professional may consider doing a blood test (therapeutic drug monitoring) to determine how much infliximab is in your blood stream in order to optimize your dose of AVSOLA.
Children (9 years of age or older)
The recommended dose of AVSOLA for children with moderately to severely active Crohn’s disease is 5 mg/kg given as an induction regimen of 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.
Ulcerative Colitis
Adults:
If you are receiving AVSOLA for ulcerative colitis, you will receive your first 5 mg/kg dose followed by additional 5 mg/kg doses at 2 and 6 weeks after the first dose. You will then receive a dose every 8 weeks thereafter. Your healthcare professional will monitor your response to AVSOLA and may change your dose. Your healthcare professional may consider doing a blood test (therapeutic drug monitoring) to determine how much infliximab is in your blood stream in order to optimize your dose of AVSOLA.
Children (6 years of age or older):
The recommended dose of AVSOLA for children with moderately to severely active ulcerative colitis is 5 mg/kg given as an induction regimen of 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.
Psoriatic Arthritis:
The recommended dose of AVSOLA is 5 mg/kg as an intravenous infusion followed with additional doses at 2 and 6 weeks after the first infusion then every 8 weeks thereafter. If you show no response at 24 weeks, no additional treatment with AVSOLA should be given.
Plaque Psoriasis:
The recommended dose of AVSOLA is 5 mg/kg given as an intravenous infusion followed with additional 5 mg/kg doses at 2 and 6 weeks after the first infusion then every 8 weeks thereafter. If you do not show an adequate response at Week 14, after infusions at Weeks 0, 2, and 6, no additional treatment with AVSOLA should be given.
Overdose:
Single doses up to 20 mg/kg have been administered without any direct toxic effect. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
| If you think you, or a person you are caring for, have taken too much AVSOLA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no symptoms. |
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Missed dose:
If you forget or miss an appointment to receive the AVSOLA infusion, make another appointment as soon as possible.
Possible side effects from using AVSOLA:
These are not all the possible side effects you may feel when taking AVSOLA. If you experience any side effects not listed here, contact your healthcare professional.
Some patients had side effects that caused them to stop infliximab treatment. The most common reasons were shortness of breath, rash, and headache.
Other common side effects besides the ones already mentioned in this leaflet include abdominal pain, back pain, coughing, diarrhea, dizziness, fatigue, itchiness, pain, upper respiratory infections (such as bronchitis, sinusitis, cold, sore throat), upset stomach, and urinary tract infections. AVSOLA may have a minor influence on the ability to drive and use machines.
Dizziness may occur following administration of AVSOLA.
Children and teenagers who took infliximab in studies for ulcerative colitis had similar side effects as adults with ulcerative colitis. The most common side effects observed in children with ulcerative colitis include: cough and cold symptoms including sore throat, stomach pain, fever, headache and anemia (low red blood cell count). Among patients who took infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults, including bladder infections, skin infections, and bronchitis.
Some of the side effects of AVSOLA can be serious and may require treatment.
Tell your healthcare professional if you experience any of the effects listed in this leaflet or any other side effects.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
| Only if severe | In all cases | ||||
| Only if severe | In all cases | ||||
| Only if severe | In all cases | ||||
| COMMON | |||||
| Serious infections: symptoms of fever, feel very tired, have a cough or develop flu-like symptoms or develop an abscess. | √ | ||||
| Allergic reactions: symptoms, while you are getting your AVSOLA infusion or shortly afterwards, of hives (red, raised, itchy patches of skin), difficulty breathing, chest pain and high or low blood pressure or symptoms 3 to 12 days after receiving AVSOLA including fever, rash, headache and muscle or joint pain. | √ | ||||
| UNCOMMON | |||||
| Liver injury: signs that you could be having a problem include: jaundice (skin and eyes turning | √ | ||||
| yellow), dark brown-colored urine, right sided abdominal pain, fever and severe fatigue (tiredness). | |||||
| Heart failure: If you have been told that you have a heart problem called congestive heart failure, you will need to be closely monitored by your healthcare professional. New or worse symptoms that are related to your heart condition, including shortness of breath or swelling of your ankles or feet. | √ | ||||
| Blood problems: symptoms of fever that doesn’t go away, bruising or bleeding very easily or looking very pale. | √ | ||||
| Nervous system disorders: signs include changes in your vision (including blindness), seizures, weakness in your arms and/or legs, and numbness or tingling in any part of your body. | √ | ||||
| Malignancy: if you have had or develop lymphoma or other cancers, including skin cancers, while you are taking AVSOLA. | √ | ||||
| Lupus: symptoms may include chest discomfort or pain that doesn’t go away, shortness of breath, joint pain, or a rash on the cheeks or arms that gets worse in the sun. | √ | ||||
| Paradoxical drug-induced immune disorders: the appearance of new inflammatory symptoms in the skin and/or other organs that are opposite to what should occur when taking this medicine. New symptoms could include but are not limited to: skin rashes, small pus-filled bumps that can spread over the body, shortness of breath, numbness or tingling in any part of your body or fever that doesn’t go away. | √ | ||||
| RARE | |||||
| Skin problems: skin rashes including redness, itching, skin peeling and blistering; Small pus-filled bumps that can spread over the body, sometimes with a fever (acute generalized exanthematous pustulosis); Itchy reddish-purple skin rash and/or | √ | ||||
| threadlike white-grey lines on mucous membranes (lichenoid reactions). | |||||
| Lung problems: symptoms of new or worsening shortness of breath. | √ | ||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Keep out of reach and sight of children.
AVSOLA is stored in the original package in the refrigerator before use. Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”. Only at the location of reconstitution, AVSOLA can also be stored at temperatures up to a maximum of 30˚C for a single period of up to 6 months, but not beyond the original expiry date. In this situation, do not return to refrigerated storage again. Write the non-refrigerated expiry date on the carton including day/month/year. Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
The vial must be kept sealed. Only a healthcare professional should prepare the medicine before use and administer it to you.
If you want more information about AVSOLA:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-
- products/drug-product-database.html); the manufacturer’s website www.amgen.ca, or by calling 1-866-502-6436.
Amgen Canada Inc. 6775 Financial Drive, Suite 300 Mississauga, Ontario L5N 0A4
Date of Authorization: 2026-07-29
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