Ixifi: Uses, Side Effects and Dosage

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 for injection and other similar medicines. Some patients with these infections have died. Prior to treatment with IXIFI, you should tell your doctor 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 doctor 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 IXIFI, you should tell your doctor right away.
• Prior to treatment with IXIFI, you should tell your doctor 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 doctor will evaluate you for tuberculosis and may begin treatment for tuberculosis before you are treated with IXIFI.
• Treatment with IXIFI must be interrupted if you develop a serious infection or sepsis. Tell your doctor if you have any symptoms of an infection (for example, fever, fatigue, cough, flu-like symptoms, or pain) while you are taking IXIFI and for 6 months after you receive the medicine.
• If you need surgery, tell your doctor that you have taken IXIFI.
• Lymphoma and other cancers, which may result in death, have been reported in children and teenage patients taking TNF- blockers, including Infliximab for injection. Some patients who have received TNF-blockers, including Infliximab for injection 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 TNF-blockers. You should also tell your doctor if you have had or develop lymphoma or other cancers while you are taking IXIFI.

What IXIFI is used for:

• IXIFI is a medicine that is used in people with moderate to severe rheumatoid arthritis (in combination with methotrexate) and ankylosing spondylitis. Your doctor has chosen to treat your rheumatoid arthritis with IXIFI because you have moderately to severely active rheumatoid arthritis. Your doctor has chosen to treat your ankylosing spondylitis with IXIFI because you have had an inadequate response to other treatments or because you cannot tolerate other treatments.
• IXIFI is also used in people with moderate to severe plaque psoriasis. Your doctor has chosen to treat your plaque psoriasis with IXIFI because your disease is still active even though you have tried other treatments.
• IXIFI is also used in people with active psoriatic arthritis. Your doctor has chosen to treat your psoriatic arthritis with IXIFI because your disease is still active even though you have tried other treatments.
• IXIFI is also used in adults, children and teenagers with moderate to severe Crohn’s disease or with moderate to severe ulcerative colitis. Your doctor has chosen to treat your Crohn’s disease or ulcerative colitis with IXIFI because your disease is still active even though you have tried other treatments.

How IXIFI 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 IXIFI 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.

IXIFI is a medicine that affects your immune system. IXIFI can lower the ability of your immune system to fight infections.

The ingredients in IXIFI are:

Medicinal ingredients: Infliximab

Non-medicinal ingredients: Disodium succinate hexahydrate, polysorbate 80, succinic acid, sucrose. No preservatives are present.

IXIFI comes in the following dosage forms:

IXIFI is supplied as lyophilized concentrate for intravenous infusion in individually-boxed single-use vials of 100 mg infliximab.

Tell all doctors involved in your care that you take IXIFI.

Do not use IXIFI if:

• you have a severe infection, such as sepsis (an infection in the bloodstream), abscess, tuberculosis or other serious infection
• you have heart failure that is moderate or severe.
• you are allergic to infliximab or any ingredient in IXIFI (disodium succinate hexahydrate, polysorbate 80, succinic acid and sucrose) or if you have a history of allergies to mouse proteins.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IXIFI. Talk about any health conditions or problems you may have, including if you:

• Congestive heart failure: If you have mild heart failure and you are being treated with IXIFI, your heart failure status must be closely monitored by your doctor. If you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your feet), you must contact your doctor 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 for injection. 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 doctor right away if you have any of these symptoms.
• Immediate allergic reactions: Some patients who have received infliximab for injection 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 doctor may decide to stop IXIFI treatment for severe reactions. Your doctor can prescribe medicines to treat these effects.
• Delayed allergic reactions: Some allergic reactions can occur 3 to 12 days after IXIFI retreatment. The symptoms of this type of delayed reaction include muscle or joint pain with fever or rash. Tell your doctor if you notice any of these symptoms.
• Nervous system diseases: Tell your doctor 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 IXIFI.
• Autoimmune disease: Some patients treated with infliximab for injection have developed symptoms that suggest an autoimmune disease called lupus-like syndrome. Tell your doctor 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 doctor will evaluate your condition and may decide to stop your treatment with IXIFI.
• Liver injury: There have been cases where people taking infliximab for injection 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 doctor immediately if you develop any of these symptoms.
• Previous phototherapy: Tell your doctor 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 doctor right away.

• Stroke: Some patients have experienced a stroke within approximately 24 hours of their infusion of infliximab for injection. Tell your doctor 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 IXIFI 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 doctor about this as this may impact the decision to start or continue treatment with IXIFI. Your doctor should do a blood test for hepatitis B virus before you start treatment with IXIFI.
• Vaccination: Tell your doctor that you have received IXIFI if you need to get a vaccination. It is not known if medicines like IXIFI can interfere with vaccinations. You should not receive live vaccines while you are taking IXIFI. 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 IXIFI.
• Therapeutic infectious agents: Tell your doctor 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 IXIFI, you must avoid becoming pregnant by using adequate contraception during your treatment and for 6 months after your last IXIFI injection. Tell your doctor if you think you may be pregnant, are breastfeeding, or planning to conceive a child. Your doctor will help you decide whether or not to use IXIFI.

  If you have a baby and you were using IXIFI during your pregnancy, it is important to tell your baby’s doctor and other healthcare professionals about your IXIFI 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 IXIFI while you were pregnant, your baby may be at higher risk for getting an infection. It is important that you tell your baby’s doctors and other health care professionals about your IXIFI use before the baby receives any vaccine. Administration of BCG vaccine within 12 months after birth to the baby whose mother received IXIFI while pregnant may result in infection in the newborn with severe complications, including death. For other types of vaccines, discuss with your doctor.

  If you are breast-feeding, it is important that you tell your baby’s doctors and other healthcare professionals about your IXIFI 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 doctor recommends otherwise.

  Severely decreased numbers of white blood cells have also been reported in infants born to women treated with infliximab for injection during pregnancy. If your baby has continual fevers or infections, contact your baby’s doctor immediately.

  It is not known if IXIFI 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 infliximab for injection 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 for injection 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 doctor.

Some women being treated for rheumatoid arthritis with infliximab for injection have developed cervical cancer. For women taking IXIFI, including those over 60 years of age, your doctor 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 IXIFI treatment. If you have COPD, you should discuss with your doctor whether IXIFI 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 IXIFI:

• Tell your doctor about all medicines that you have recently taken or are taking during your treatment with IXIFI. 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 IXIFI 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 IXIFI. In studies of infliximab for injection, patients were also taking antibiotics, antivirals, corticosteroids, mercaptopurine (6MP), azathioprine (AZA), methotrexate (MTX), and aminosalicylates along with infliximab for injection. Patients who took immunosuppressants, such as methotrexate, corticosteroids, mercaptopurine, azathioprine, had a lower risk of allergic reactions during infusion.
• Especially, tell your doctor if you take KINERET^® (anakinra) or ORENCIA^® (abatacept). IXIFI should not be taken together with anakinra or abatacept.
• If you have a baby or if you breastfed your baby while you are using IXIFI, tell your baby’s doctor about your IXIFI use before the baby receives any live vaccines.

How to take IXIFI:

IXIFI 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. If you have Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis, the infusion will take about 2 hours. If you have rheumatoid arthritis, the first 3 infusions will be given to you over a period of about 2 hours, after the third infusion your doctor 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 doctor may:

• ask you to take other medicines along with IXIFI.
• Delay your treatment with IXIFI if you have a surgery planned.

Where may I receive the infusion?

Your doctor will decide where you will receive the infusion. The IXIFI Patient Assistance Program (PfizerFlex^TM)facilitates the administration of IXIFI. Clinics are staffed by qualified healthcare professionals specially trained in the administration of IXIFI infusions and are available across Canada. Information about the IXIFI Patient Assistance Program (PfizerFlex^TM) can be obtained by calling 1-855-935-3539.

Tell all doctors involved in your care that you take IXIFI.

Usual dose:

Rheumatoid Arthritis

The recommended dose of IXIFI 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. IXIFI should be given in combination with methotrexate.

Ankylosing Spondylitis

The recommended dose of IXIFI is one initial infusion of 5 mg/kg followed by infusions of 5 mg/kg 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 IXIFI 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 doctor may consider doing a blood test (therapeutic drug monitoring) to determine how much infliximab for injection is in your blood stream in order to optimize your dose of IXIFI.

Children (9 years of age or older)

The recommended dose of IXIFI 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 IXIFI 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 doctor will monitor your response to IXIFI and may change your dose. Your doctor may consider doing a blood test (therapeutic drug monitoring) to determine how much infliximab for injection is in your blood stream in order to optimize your dose of IXIFI.

Children (6 years of age or older)

The recommended dose of IXIFI 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 IXIFI 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 IXIFI should be given.

Plaque Psoriasis

The recommended dose of IXIFI 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 IXIFI 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 IXIFI, 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 signs or symptoms.

Missed Dose:

If you forget or miss an appointment to receive IXIFI, make another appointment as soon as possible to find out when to receive your next dose of IXIFI.

Possible side effects from using IXIFI:

These are not all the possible side effects you may have when taking IXIFI. If you experience any side effects not listed here, tell your healthcare professional.

Some patients had side effects that caused them to stop infliximab for injection 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. IXIFI may have a minor influence on the ability to drive and use machines. Dizziness may occur following administration of IXIFI.

Children and teenagers who took infliximab for injection 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 injection 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 IXIFI can be serious and may require treatment.

Tell your doctor 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

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting)) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

IXIFI is stored in the original package in the refrigerator before use. Only at the location of reconstitution, unopened IXIFI can also be stored in the original carton outside of refrigerated storage up to a maximum of 30°C for a single period of up to 6 months; but not beyond the expiration date. In this situation, do not return to refrigerated storage again. In this situation, write the non-refrigerated expiry date on the carton including month/year and do not return to refrigerated storage again. 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. It should not be used beyond the expiration date.

Keep out of reach and sight of children.

If you want more information about IXIFI:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website Pfizer.ca, or by calling 1-800-463-6001.

Date of Authorization: October 20, 2025

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