What is RENFLEXIS?

Possible Side Effects

Important Information View Important Safety Information About RENFLEXIS® (infliximab-abda)

Possible Side Effects View Possible Side Effects of RENFLEXIS® (infliximab-abda)

What is the most important information I should know about RENFLEXIS?

RENFLEXIS may cause serious side effects, including:

1. Risk of infection

RENFLEXIS is a medicine that affects your immune system. RENFLEXIS can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving RENFLEXIS. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections.

• Your doctor should test you for TB before starting RENFLEXIS.

• Your doctor should monitor you closely for signs and symptoms of TB during treatment with RENFLEXIS.

Before starting RENFLEXIS, tell your doctor if you:

• think you have an infection. You should not start taking RENFLEXIS if you have any kind of infection.

• are being treated for an infection.

• have signs of an infection, such as a fever, cough, flu-like symptoms.

• have any open cuts or sores on your body.

• get a lot of infections or have infections that keep coming back.

• have diabetes or an immune system problem. People with these conditions have a higher chance for infections.

• have TB, or have been in close contact with someone with TB.

• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may develop or become more severe if you receive RENFLEXIS. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.

• have or have had hepatitis B.

• use the medicines Kineret^® (anakinra), Orencia^® (abatacept), Actemra^® (tocilizumab), or other medicines called biologics used to treat the same conditions as RENFLEXIS.

After starting RENFLEXIS, if you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. RENFLEXIS can make you more likely to get infections or make any infection that you have worse.

2. Risk of Cancer

• There have been cases of unusual cancers in children and teenage patients using tumor necrosis factor (TNF)-blocker medicines, such as RENFLEXIS.

• For children and adults receiving TNF-blocker medicines, the chances of getting lymphoma or other cancers may increase.

• Some people receiving TNF-blockers developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with a TNF-blocker and another medicine called azathioprine or 6-mercaptopurine.

• People who have been treated for rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis for a long time may be more likely to develop lymphoma. This is especially true for people with very active disease.

• Some people treated with infliximab products, such as RENFLEXIS, have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with RENFLEXIS, tell your doctor.

• Patients with Chronic Obstructive Pulmonary Disease (COPD), a specific type of lung disease, may have an increased risk for getting cancer while being treated with RENFLEXIS.

• Some women being treated for rheumatoid arthritis with RENFLEXIS have developed cervical cancer. For women receiving RENFLEXIS, including those over 60 years of age, your doctor may recommend that you continue to be regularly screened for cervical cancer.

• Tell your doctor if you have ever had any type of cancer. Discuss with your doctor any need to adjust medicines you may be taking.

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What are the possible side effects of RENFLEXIS?

RENFLEXIS can cause serious side effects, including:

Serious infections

• Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as RENFLEXIS. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with RENFLEXIS your doctor will treat your infection and may need to stop your RENFLEXIS treatment.

• Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving RENFLEXIS:

a fever

feel very tired

have a cough

have flu-like symptoms

warm, red, or painful skin

• 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 RENFLEXIS and during treatment with RENFLEXIS.

• Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving RENFLEXIS. Patients who had a negative TB skin test before receiving infliximab products 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 RENFLEXIS. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with RENFLEXIS and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:

feel unwell

poor appetite

tiredness (fatigue)

fever, skin rash, or joint pain

Heart Failure

If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving RENFLEXIS. Your congestive heart failure may get worse while you are receiving RENFLEXIS. Be sure to tell your doctor of any new or worse symptoms including:

shortness of breath

swelling of ankles or feet

sudden weight gain

Treatment with RENFLEXIS 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 infusion of an infliximab product. 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.

Liver Injury

Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:

jaundice (skin and eyes turning yellow)

dark brown-colored urine

pain on the right side of your stomach area (right-sided abdominal pain)

fever

extreme tiredness (severe fatigue)

Blood Problems

In some patients receiving infliximab products, 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

bruise or bleed very easily

look very pale

Nervous System Disorders

Some patients receiving infliximab products have developed problems with their nervous system. Tell your doctor if you have:

changes in your vision

weakness in your arms or legs

numbness or tingling in any part of your body

seizures

Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. 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 infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your RENFLEXIS treatment or shortly afterward. Your doctor may need to stop or pause your treatment with RENFLEXIS and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include:

hives (red, raised, itchy patches of skin)

difficulty breathing

chest pain

high or low blood pressure

fever

chills

Some patients treated with infliximab products have had delayed allergic reactions. The delayed reactions occurred 3 to 12 days after receiving treatment with an infliximab product. Tell your doctor right away if you have any of these signs of delayed allergic reaction to RENFLEXIS:

fever

rash

headache

sore throat

muscle or joint pain

swelling of the face and hands

difficulty swallowing

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 RENFLEXIS.

chest discomfort or pain that does not go away

shortness of breath

joint pain

rash on the cheeks or arms that gets worse in the sun

Psoriasis

Some people using infliximab products 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 RENFLEXIS.

The most common side effects of infliximab products include:

respiratory infections, such as sinus infections and sore throat

headache

coughing

stomach pain

Infusion reactions can happen up to 2 hours after your infusion of RENFLEXIS. Symptoms of infusion reactions may include:

fever

chills

chest pain

low blood pressure or high blood pressure

shortness of breath

rash

itching

Children with Crohn’s disease showed some differences in side effects of treatment compared with adults with Crohn's disease. The side effects that happened more in children were: anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract. Among patients who took infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults.

Tell your doctor about any side effect that bothers you or does not go away.

These are not all of the side effects with RENFLEXIS. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See the section "What is the most important information I should know about RENFLEXIS?" above for more information.

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Transitioning to RENFLEXIS? Switching From Remicade® (infliximab) to RENFLEXIS® (infliximab-abda)

Important Safety Information +

Only your doctor can recommend a course of treatment after checking your health condition. RENFLEXIS can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi, or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with RENFLEXIS.Only your doctor can recommend a course of treatment after checking your health condition. RENFLEXIS can cause serious side effects such as lowering your ability to fight infections.

Important Safety Information

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking infliximab products and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including RENFLEXIS, the chances of getting lymphoma or other cancers may increase.

You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take RENFLEXIS?

You should let your doctor know if you have or ever had any of the following:

Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start RENFLEXIS. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with, and during treatment with, RENFLEXIS. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are taking RENFLEXIS. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
Lived in a region where certain fungal infections like histoplasmosis, coccidioidomycosis, cryptococcosis, or blastomycosis are common. These infections may develop or become more severe if you take RENFLEXIS. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, cryptococcosis, or blastomycosis is common, ask your doctor.
Infections that keep coming back, diabetes, or an immune system problem.
Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
Heart failure or any heart condition. Many people with heart failure should not take RENFLEXIS.
Hepatitis B virus (HBV) infection or think you may be a carrier of HBV. Your doctor will test you for HBV.
Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).

Also tell your doctor if you:

Use the medicines Kineret^® (anakinra), Orencia^® (abatacept), or Actemra^® (tocilizumab) or other medicines called biologics used to treat the same problems as RENFLEXIS.
Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using RENFLEXIS during your pregnancy. Tell your baby's doctor about your RENFLEXIS use. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death.
Recently received or are scheduled to receive a vaccine. Adults and children taking RENFLEXIS should not receive live vaccines or treatment with a weakened bacteria (such as Bacille Calmette-Guérin [BCG] for bladder cancer) while taking RENFLEXIS.

What should I watch for and talk to my doctor about before or while taking RENFLEXIS?

The following serious (sometimes fatal) side effects have been reported in people taking RENFLEXIS.

You should tell your doctor right away if you have any of the signs listed below:

Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red, or painful skin or any open sores. RENFLEXIS can make you more likely to get an infection or make any infection that you have worse.
Lymphoma, or any other cancers in adults and children.
Skin Cancer—any changes in or growths on your skin.
Cervical Cancer—your doctor may recommend that you be regularly screened. Some women with rheumatoid arthritis, particularly those over 60, have developed cervical cancer.
Heart Failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash, and/or joint pain.
Other heart problems within 24 hours of infusion, including heart attack, low blood flow to the heart, or abnormal heart rhythm—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.
Liver Injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
Blood Problems—in some patients taking infliximab products, 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, bruising, bleeding, or severe paleness.
Nervous System Disorders—numbness, weakness, tingling, changes in your vision, or seizures.
Stroke within 24 hours of infusion—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 severe) during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
Delayed Allergic Reactions (3 to 12 days after infusion)—fever, rash, headache, sore throat, muscle or joint pain, swelling of the face and hands, or difficulty swallowing.
Lupus-like Syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.
Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

The more common side effects with infliximab products are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing, and stomach pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for RENFLEXIS, including the information about serious infections and cancers, and discuss it with your doctor. The physician Prescribing Information also is available.