- 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.
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)].
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)].
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)].
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.|
|Before starting Infliximab, tell your doctor if you:|
|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|
|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:|
|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:|
|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:|
|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?|
|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?“|
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|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:|
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|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.|
|Some patients receiving Infliximab have developed serious liver problems. Tell your doctor if you have:|
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|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:|
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|Nervous System Disorders|
|Some patients receiving Infliximab have developed problems with their nervous system. Tell your doctor if you have:|
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|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.|
|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:|
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|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:|
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|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.|
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|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:|
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|Infusion reactions can happen up to 2 hours after your infusion of Infliximab. Symptoms of infusion reactions may include:|
| || || |
|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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