PfizerFlex Patient Support Program for IXIFI® – Safety Information

• 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 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).

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 6 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.

Breast feeding is not recommended during treatment and for 6 months after the last dose of IXIFI. Your doctor will help you decide whether or not to use IXIFI.

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.

Serious warnings and precautions

• 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.

These are not all the possible side effects you may feel when taking IXIFI. If you experience any side effects not listed here, contact 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 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 here or any other side effects.

Talk to your healthcare professional if you experience any of the following side effects.

Common:

• Serious infections: symptoms of fever, feel very tired, have a cough or develop flu-like symptoms or develop an abscess.

• Allergic reactions: while you are getting your IXIFI infusion or shortly afterwards, 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 IXIFI 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 doctor. 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 IXIFI.

• 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.

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, tell your healthcare professional.

Please refer to your patient leaflet for complete safety information.

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