INFLIXIMAB (Page 12 of 13)


  1. Turner D, Otley AR, Mack D, et al. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: A prospective multicenter study. Gastroenterology. 2007;133:423–432.


How Supplied

Infliximab for injection is supplied in a carton containing one single-dose vial (NDC 57894-160-01).

Each single-dose vial contains 100 mg of infliximab as a sterile, preservative-free, white lyophilized powder for reconstitution and dilution (more than one vial may be needed for a full dose) [see Dosage and Administration (2.11)].

Storage and Handling

Store unopened Infliximab vials in a refrigerator at 2°C to 8°C (36°F to 46°F).

If needed, unopened Infliximab vials may be stored at room temperatures up to a maximum of 30°C (86°F) for a single period of up to 6 months but not exceeding the original expiration date. The new expiration date must be written in the space provided on the carton. Once removed from the refrigerator, Infliximab cannot be returned to the refrigerator.

For storage conditions of the reconstituted and diluted product for administration, see Dosage and Administration (2.11).


Advise the patient or their caregiver to read the FDA-approved patient labeling (Medication Guide).

Patients or their caregivers should be advised of the potential benefits and risks of Infliximab. Healthcare providers should instruct their patients or their caregivers to read the Medication Guide before starting Infliximab therapy and to reread it each time they receive an infusion.


Inform patients that Infliximab increases the risk for developing serious infections. Instruct patients of the importance of contacting their healthcare provider if they develop any symptoms of an infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections [see Warnings and Precautions (5.1, 5.3)].


Malignancies have been reported among children, adolescents and young adults who received treatment with TNF blockers. Patients should be counseled about the risk of lymphoma and other malignancies while receiving Infliximab [see Warnings and Precautions (5.2)].


Instruct patients to seek medical attention if they develop signs or symptoms of hepatotoxicity (e.g., jaundice) [see Warnings and Precautions (5.4)].

Heart Failure

Instruct patients to seek medical attention and consult their prescriber if they develop signs or symptoms of heart failure [see Contraindications (4) and Warnings and Precautions (5.5)].

Hematologic Reactions

Instruct patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever) while on Infliximab [see Warnings and Precautions (5.6)].


Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.7)].

Cardiovascular and Cerebrovascular Reactions During and After Infusion

Advise patients to seek immediate medical attention if they develop any new or worsening symptoms of cardiovascular and cerebrovascular reactions which have been reported during and within 24 hours of initiation of Infliximab infusion [see Warnings and Precautions (5.8)].

Neurologic Reactions

Advise patients to seek medical attention if they develop signs or symptoms of neurologic reactions [see Warnings and Precautions (5.9)].

Live Vaccines/Therapeutic Infectious Agents

Instruct Infliximab-treated patients to avoid receiving live vaccines or therapeutic infectious agents [see Warnings and Precautions (5.13)].

Manufactured by:
Janssen Biotech, Inc. Horsham, PA 19044

U.S. License No. 1864

MEDICATION GUIDE Infliximab for injection, for intravenous use
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: October 2021
Read the Medication Guide that comes with Infliximab before you receive the first treatment, and before each time you get a treatment of Infliximab. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment.
What is the most important information I should know about Infliximab?
Infliximab may cause serious side effects, including:
1. Risk of infection
Infliximab is a medicine that affects your immune system. Infliximab can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving Infliximab. 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 Infliximab.
  • Your doctor should monitor you closely for signs and symptoms of TB during treatment with Infliximab.
Before starting Infliximab, tell your doctor if you:
  • think you have an infection. You should not start receiving Infliximab 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 Infliximab. 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 Infliximab.
After starting Infliximab , 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. Infliximab 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.
  • For children and adults receiving TNF blocker medicines, including Infliximab, the chances of getting lymphoma or other cancers may increase.
  • Some people receiving TNF blockers, including Infliximab, 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 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 Infliximab, 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 Infliximab.
  • Some women being treated for rheumatoid arthritis with Infliximab have developed cervical cancer. For women receiving Infliximab, 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.
See the section “What are the possible side effects of Infliximab?” below for more information.
What is Infliximab?
Infliximab is a prescription medicine that is approved for patients with:
  • Rheumatoid Arthritis — adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate.
  • Crohn’s Disease — children 6 years and older and adults with Crohn’s disease who have not responded well to other medicines.
  • Ankylosing Spondylitis in adults
  • Psoriatic Arthritis in adults
  • Plaque Psoriasis — adult patients with plaque psoriasis that is chronic (does not go away), severe, extensive, and/or disabling.
  • Ulcerative Colitis — children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines.
Infliximab blocks the action of a protein in your body called tumor necrosis factor-alpha (TNF-alpha). TNF-alpha is made by your body’s immune system. People with certain diseases have too much TNF-alpha that can cause the immune system to attack normal healthy parts of the body. Infliximab can block the damage caused by too much TNF-alpha.
It is not known if Infliximab is safe and effective in children under 6 years of age.
Who should not receive Infliximab?
You should not receive Infliximab if you have:
  • heart failure, unless your doctor has examined you and decided that you are able to receive Infliximab. Talk to your doctor about your heart failure.
  • had an allergic reaction to Infliximab, or any of the other ingredients in Infliximab. See the end of this Medication Guide for a complete list of ingredients in Infliximab.
What should I tell my doctor before starting treatment with Infliximab?
Your doctor will assess your health before each treatment.
Tell your doctor about all of your medical conditions, including if you:
  • have an infection (see “What is the most important information I should know about Infliximab?“).
  • have other liver problems including liver failure.
  • have heart failure or other heart conditions. If you have heart failure, it may get worse while you receive Infliximab.
  • have or have had any type of cancer.
  • have had phototherapy (treatment with ultraviolet light or sunlight along with a medicine to make your skin sensitive to light) for psoriasis. You may have a higher chance of getting skin cancer while receiving Infliximab.
  • have COPD, a specific type of lung disease. Patients with COPD may have an increased risk of getting cancer while receiving Infliximab.
  • have or have had a condition that affects your nervous system such as:
    • multiple sclerosis, or Guillain-Barré syndrome, or
    • if you experience any numbness or tingling, or
    • if you have had a seizure.
  • have recently received or are scheduled to receive a vaccine. Adults and children receiving Infliximab should not receive live vaccines (for example, the Bacille Calmette-Guérin [BCG] vaccine) or treatment with a weakened bacteria (such as BCG for bladder cancer). Adults and children should have all of their vaccines brought up to date before starting treatment with Infliximab.
  • are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. You and your doctor should decide if you should receive Infliximab while you are pregnant or breastfeeding.
If you have a baby and you were receiving Infliximab during your pregnancy, it is important to tell your baby’s doctor and other health care professionals about your Infliximab use so they can decide when your baby should receive any vaccine. Certain vaccinations can cause infections.
If you received Infliximab while you were pregnant, your baby may be at higher risk for getting an infection. 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. This includes live vaccines such as the BCG, rotavirus, or any other live vaccines. For other types of vaccines, talk with your doctor.
How should I receive Infliximab?
  • You will be given Infliximab through a needle placed in a vein (IV or intravenous infusion) in your arm.
  • Your doctor may decide to give you medicine before starting the Infliximab infusion to prevent or lessen side effects.
  • Only a healthcare professional should prepare the medicine and administer it to you.
  • Infliximab will be given to you over a period of about 2 hours.
  • If you have side effects from Infliximab, the infusion may need to be adjusted or stopped. In addition, your healthcare professional may decide to treat your symptoms.
  • A healthcare professional will monitor you during the Infliximab infusion and for a period of time afterward for side effects. Your doctor may do certain tests while you are receiving Infliximab to monitor you for side effects and to see how well you respond to the treatment.
  • Your doctor will determine the right dose of Infliximab for you and how often you should receive it. Make sure to discuss with your doctor when you will receive infusions and to come in for all your infusions and follow-up appointments.
What should I avoid while receiving Infliximab?
Do not take Infliximab together with medicines such as KINERET (anakinra), ORENCIA (abatacept), ACTEMRA (tocilizumab), or other medicines called biologics that are used to treat the same conditions as Infliximab.
Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. These include any other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.
What are the possible side effects of Infliximab?
Infliximab can cause serious side effects, including:
See “What is the most important information I should know about Infliximab?
Serious Infections
  • Some patients, especially those 65 years and older have had serious infections while receiving Infliximab. 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 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
  • 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 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 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
  • 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 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
  • swelling of ankles or feet
  • sudden weight gain
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 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 doctor right away if you have any of these symptoms.
Liver Injury
Some patients receiving Infliximab 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, 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 have developed problems with their nervous system. Tell your doctor if you have:
  • changes in your vision
  • numbness or tingling in any part of your body
  • seizures
  • weakness in your arms or legs
Some patients have experienced a stroke within approximately 24 hours of their infusion with Infliximab. 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. 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. 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 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:
  • 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 Infliximab.
  • 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
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.
The most common side effects of Infliximab 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 Infliximab. Symptoms of infusion reactions may include:
  • fever
  • chills
  • chest pain
  • low blood pressure or high blood pressure
  • shortness of breath
  • rash
  • itching
Children who received Infliximab in studies for Crohn’s disease showed some differences in side effects compared with adults who received Infliximab for 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 received 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 Infliximab. 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.
General information about Infliximab
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
You can ask your doctor or pharmacist for information about Infliximab that is written for health professionals.
For more information call 1-800-JANSSEN (1-800-526-7736).
What are the ingredients in Infliximab?
The active ingredient is Infliximab.
The inactive ingredients in Infliximab include: dibasic sodium phosphate dihydrate, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose. No preservatives are present.
Manufactured by: Janssen Biotech, Inc. Horsham, PA 19044 U.S. License No. 1864

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