Infliximab

Infliximab (brand names Avsola, Inflectra, Remicade, and others) reduces inflammation and may be used to treat autoimmune conditions such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, severe plaque psoriasis, and ankylosing spondylitis. Infliximab infusion is a monoclonal antibody that targets TNF-alpha . The mechanism of action of infliximab is to bind to and neutralize tumor necrosis factor-alpha (TNF-alpha), a key inflammatory protein involved in autoimmune diseases. By inhibiting TNF-alpha, infliximab helps reduce inflammation and its associated symptoms. Infliximab first gained FDA approval on August 24, 1998 , under the brand Remicade . Since then, 4 biosimilars have been approved for Remicade, and one other product, Zymfentra , is similar to Remicade but can be injected under the skin, so isn't considered a biosimilar. The 4 biosimilars to Remicade are: Infliximab-ABDA (brand name Renflexis ) Infliximab-AXXQ (brand name Avsola ) Infliximab-DYYB (brand name Inflectra ) Infliximab-QBTX (brand name Ixifi ). A biosimilar is a biological product that is similar to a reference biologic (usually the originally approved product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency.

Infliximab (brand names Avsola, Inflectra, Remicade, and others) reduces inflammation and may be used to treat autoimmune conditions such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, severe plaque psoriasis, and ankylosing spondylitis. Infliximab infusion is a monoclonal antibody that targets TNF-alpha . The mechanism of action of infliximab is to bind to and neutralize tumor necrosis factor-alpha (TNF-alpha), a key inflammatory protein involved in autoimmune diseases. By inhibiting TNF-alpha, infliximab helps reduce inflammation and its associated symptoms. Infliximab first gained FDA approval on August 24, 1998 , under the brand Remicade . Since then, 4 biosimilars have been approved for Remicade, and one other product, Zymfentra , is similar to Remicade but can be injected under the skin, so isn't considered a biosimilar. The 4 biosimilars to Remicade are: Infliximab-ABDA (brand name Renflexis ) Infliximab-AXXQ (brand name Avsola ) Infliximab-DYYB (brand name Inflectra ) Infliximab-QBTX (brand name Ixifi ). A biosimilar is a biological product that is similar to a reference biologic (usually the originally approved product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency.

You should not be treated with infliximab if you are allergic to infliximab, Avsola, Inflectra, Ixifi, Remicade, Renflexis, Zymfentra, or any components of your infliximab infusion. Before starting infliximab, tell your healthcare provider about all your medical conditions, including if you: are being treated for an infection, have TB or hepatitis B, or have been in close contact with someone with TB or hepatitis B have signs of an infection, such as a fever, cough, flu-like symptoms have any open cuts or sores on your body have cancer have diabetes, COPD, heart problems, liver problems, or an immune system problem have a nerve-muscle disorder, such as multiple sclerosis or Guillain-Barré syndrome have numbness or tingling anywhere in your body live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk of getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may develop or become more severe if you receive infliximab. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor use or have used other biologics such as anakinra, abatacept, or tocilizumab to treat the same condition phototherapy for psoriasis seizures vaccination with BCG (Bacille Calmette-Guérin) or if you are scheduled to receive any vaccines are pregnant or intending to become pregnant are breastfeeding or intending to breastfeed. Make sure your child has received all their routine childhood vaccinations before starting infliximab. Infliximab is not for use in children younger than 6 years old.

The most common side effects of infliximab infusion are: respiratory infections, such as sinus infections and sore throat coughing stomach pain headache infusion reactions. These can happen up to 2 hours after an infliximab infusion. Symptoms may include fever, shortness of breath, chills, rash, chest pain, itching, low or high blood pressure.

Infliximab carries a Boxed Warning for serious infections and cancer. Serious infections . Infliximab affects your immune system and some patients, especially those 65 years and older have had serious infections while receiving infliximab infusion. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body or cause infections in certain areas (such as the skin). Some patients die from these infections. If you get an infection while receiving treatment with infliximab your doctor will treat your infection and may need to stop your infliximab treatment. Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving infliximab: a fever have flu-like symptoms feel very tired warm, red, or painful skin have a cough. Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with infliximab and during treatment with infliximab. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving infliximab. Patients who had a negative TB skin test before receiving infliximab have developed active TB. If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with infliximab. In some cases, patients have died as a result of the hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with infliximab and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms: feel unwell tiredness (fatigue) poor appetite fever, skin rash, or joint pain Risk of Cancer . Infliximab may increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma (called hepatosplenic T-cell lymphoma) that can be fatal. Skin cancers are also more common in people being treated with infliximab. Call your doctor if you notice any changes in the appearance of your skin. People at higher risk of developing cancer with infliximab include those with Chronic Obstructive Pulmonary Disease (COPD) and women over the age of 60 being treated for RA (an increased risk for cervical cancer). Infliximab can cause other serious side effects , including the following. Heart Failure . If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving infliximab. Your congestive heart failure may get worse while you are receiving infliximab. Be sure to tell your doctor of any new or worse symptoms including shortness of breath, sudden weight gain, or swelling of ankles or feet. Treatment with infliximab may need to be stopped if you get new or worse congestive heart failure. 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 infliximab infusion. 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 slow heartbeat. Tell your doctor right away if you have any of these symptoms. Liver Injury. Serious liver problems have been reported with infliximab infusion, some cases required liver transplantation or were fatal. Tell your doctor if you have: jaundice (skin and eyes turning yellow) fever dark brown-colored urine extreme tiredness (severe fatigue) pain on the right side of your stomach area (right-sided abdominal pain) Blood Problems . In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you have a fever that does not go away, look very pale, bruise or bleed very easily. Nervous System Disorders . Some patients receiving infliximab have developed problems with their nervous system. Tell your doctor if you have: changes in your vision seizures numbness or tingling in any part of your body weakness in your arms or legs. Some patients have experienced a stroke within approximately 24 hours of their infliximab infusion. 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. Allergic Reactions . Some patients have had allergic reactions to their infliximab infusion. Some of these reactions were severe. These reactions can happen while you are getting your infliximab treatment or shortly afterward. Your doctor may need to stop or pause your treatment with infliximab and may give you medicines to treat the allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives (red, raised, itchy patches of skin) high or low blood pressure difficulty breathing fever chest pain chills swelling of your face, lips, tongue, or throat. Some patients treated with infliximab have had delayed allergic reactions . The delayed reactions occurred 3 to 12 days after receiving treatment with infliximab. Tell your doctor right away if you have any of these signs of delayed allergic reaction to infliximab infusion such as fever, muscle or joint pain, rash, swelling of the face and hands, headache, difficulty swallowing, or a sore throat. Lupus-like Syndrome . Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with infliximab: chest discomfort or pain that does not go away joint pain shortness of breath rash on the cheeks or arms that gets worse in the sun. Infusion reactions . Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy, tingly, short of breath, or have a headache, fever, chills, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection. Psoriasis . Some people receiving infliximab had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with infliximab. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Infliximab carries a Boxed Warning for serious infections and cancer. Serious infections . Infliximab affects your immune system and some patients, especially those 65 years and older have had serious infections while receiving infliximab infusion. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body or cause infections in certain areas (such as the skin). Some patients die from these infections. If you get an infection while receiving treatment with infliximab your doctor will treat your infection and may need to stop your infliximab treatment. Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving infliximab: a fever have flu-like symptoms feel very tired warm, red, or painful skin have a cough. Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with infliximab and during treatment with infliximab. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving infliximab. Patients who had a negative TB skin test before receiving infliximab have developed active TB. If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with infliximab. In some cases, patients have died as a result of the hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with infliximab and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms: feel unwell tiredness (fatigue) poor appetite fever, skin rash, or joint pain Risk of Cancer . Infliximab may increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma (called hepatosplenic T-cell lymphoma) that can be fatal. Skin cancers are also more common in people being treated with infliximab. Call your doctor if you notice any changes in the appearance of your skin. People at higher risk of developing cancer with infliximab include those with Chronic Obstructive Pulmonary Disease (COPD) and women over the age of 60 being treated for RA (an increased risk for cervical cancer). Infliximab can cause other serious side effects , including the following. Heart Failure . If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving infliximab. Your congestive heart failure may get worse while you are receiving infliximab. Be sure to tell your doctor of any new or worse symptoms including shortness of breath, sudden weight gain, or swelling of ankles or feet. Treatment with infliximab may need to be stopped if you get new or worse congestive heart failure. 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 infliximab infusion. 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 slow heartbeat. Tell your doctor right away if you have any of these symptoms. Liver Injury. Serious liver problems have been reported with infliximab infusion, some cases required liver transplantation or were fatal. Tell your doctor if you have: jaundice (skin and eyes turning yellow) fever dark brown-colored urine extreme tiredness (severe fatigue) pain on the right side of your stomach area (right-sided abdominal pain) Blood Problems . In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you have a fever that does not go away, look very pale, bruise or bleed very easily. Nervous System Disorders . Some patients receiving infliximab have developed problems with their nervous system. Tell your doctor if you have: changes in your vision seizures numbness or tingling in any part of your body weakness in your arms or legs. Some patients have experienced a stroke within approximately 24 hours of their infliximab infusion. 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. Allergic Reactions . Some patients have had allergic reactions to their infliximab infusion. Some of these reactions were severe. These reactions can happen while you are getting your infliximab treatment or shortly afterward. Your doctor may need to stop or pause your treatment with infliximab and may give you medicines to treat the allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives (red, raised, itchy patches of skin) high or low blood pressure difficulty breathing fever chest pain chills swelling of your face, lips, tongue, or throat. Some patients treated with infliximab have had delayed allergic reactions . The delayed reactions occurred 3 to 12 days after receiving treatment with infliximab. Tell your doctor right away if you have any of these signs of delayed allergic reaction to infliximab infusion such as fever, muscle or joint pain, rash, swelling of the face and hands, headache, difficulty swallowing, or a sore throat. Lupus-like Syndrome . Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with infliximab: chest discomfort or pain that does not go away joint pain shortness of breath rash on the cheeks or arms that gets worse in the sun. Infusion reactions . Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy, tingly, short of breath, or have a headache, fever, chills, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection. Psoriasis . Some people receiving infliximab had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with infliximab. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

3 mg/kg (3 (3)) 24 hourly IV Inf — followed with additional similar doses at 2 and 6 weeks after the first infusion then every 8 weeks thereafter. (for Rheumatoid Arthritis). For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses. 5 mg/kg (5 (5)) 24 hourly IV Induction — at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks (For Crohn's disease). For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue Infliximab in these patients. 5 mg/kg (5 (5)) 24 hourly IV Inf — followed with additional similar doses at 2 and 6 weeks after the first infusion, then every 6 weeks thereafter. (for Ankylosing Spondylitis)

5 mg/kg (5 (5)) As recommended. IV infusion — Followed by additional 5mg/kg infusion doses at 2 & 6 weeks.

No neonatal dosage information is recorded for this medicine yet.

Some medications may affect how infliximab works or increase the risk of side effects. Tell your doctor about all your other medicines, especially: abatacept anakinra tocilizumab any "biologic" medications you take such as adalimumab, certolizumab, etanercept, golimumab, natalizumab, rituximab, and others; or any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis live vaccines, such as measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). This list is not complete. Other drugs may affect infliximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

No storage information is recorded for this medicine yet.