INFLECTRA® (infliximab-dyyb) 8 USE IN SPECIFIC POPULATIONS

(infliximab-dyyb)

Prescribing Information

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available observational studies in pregnant women exposed to infliximab products showed no increased risk of major malformations among live births as compared to those exposed to non-biologics. However, findings on other birth and maternal outcomes were not consistent across studies of different study design and conduct (see Data).

Monoclonal antibodies such as infliximab products are transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see Clinical Considerations). Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with infliximab products. In a developmental study conducted in mice using an analogous antibody, no evidence of maternal toxicity or fetal harm was observed (see Data).

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Published data suggest that there is an increased risk of adverse pregnancy outcomes in women with inflammatory bowel disease or rheumatoid arthritis associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2.5 kg) and small for gestational age at birth.

Fetal/Neonatal Adverse Reactions

As with other IgG antibodies, infliximab products cross the placenta. Infliximab products have been detected in the serum of infants up to 6 months following birth. Consequently, these infants may be at increased risk of infection, including disseminated infection which can become fatal. At least a six month waiting period following birth is recommended before the administration of live vaccines (e.g., BCG vaccine or other live vaccines, such as the rotavirus vaccine) to these infants [see Warnings and Precautions (5.13)]. Cases of agranulocytosis in infants exposed in utero have also been reported [see Adverse Reactions (6.3)].

Data

Human Data

Two prospective cohort studies were conducted assessing birth outcomes as well as the health status of infants up to the age of one year in women exposed to infliximab compared to non-biologic comparators including methotrexate, azathioprine, 6-mercaptopurine and systemic corticosteroids used for the treatment of similar diseases. The first study was conducted in an IBD pregnancy registry in the United States and assessed pregnancy outcomes in 294 women with inflammatory bowel disease exposed to infliximab during pregnancy compared with 515 women on a non-biologic treatment. Infliximab exposure was not associated with increased rates of major congenital malformations, miscarriage/stillbirth, infants of low birth weight, small for gestational age, or infection in the first year of life. The second study among IBD and non-IBD patients in Sweden, Finland, and Denmark compared 97, 7, and 166 women exposed to infliximab to 2,693, 2,499 and 1,268 women on non-biologic systemic therapy, respectively. In this study, comparing pooled data across the three countries, exposure to infliximab was not associated with increased rates of congenital anomalies or infant death. Infliximab in combination with immunosuppressants (mainly systemic corticosteroids and azathioprine) was associated with increased rates of preterm birth, small for gestational age, low birth weight, and infant hospitalization for infection compared with non-biologic systemic treatment. Although the study did not show any associations with infliximab monotherapy, the analyses could have been underpowered to detect an association. There were additional methodological limitations with these studies that may account for the study findings in both studies: the concomitant use of other medications or treatments was not controlled and disease severity was not assessed; in the U.S. study, patient reported outcomes were collected without clinical validation. These methodological limitations hinder interpretation of the study results.

Animal Data

Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with infliximab products. An embryofetal development study was conducted in pregnant mice using cV1q anti-mouse TNFα, an analogous antibody that selectively inhibits the functional activity of mouse TNFα. This antibody administered in mice, during the period of organogenesis on gestation days (GDs) 6 and 12, at IV doses up to 40 mg/kg produced no evidence of maternal toxicity, fetal mortality, or structural abnormalities. Doses of 10 to 15 mg/kg in pharmacodynamic animal models with the anti-TNF analogous antibody produced maximal pharmacologic effectiveness. Analyses of fetal samples on GD 14 indicated placental transfer of the antibody and exposure of the fetuses during organogenesis. In a peri-and post-natal development study in mice, no maternal toxicity or adverse developmental effects in offspring were observed when dams were administered IV doses of 10 or 40 mg/kg of the analogous antibody on GDs 6, 12 and 18 and lactation days 3, 9 and 15.

8.2 Lactation

Risk Summary

Published literature show that infliximab is present at low levels in human milk. Systemic exposure in a breastfed infant is expected to be low because infliximab products are largely degraded in the gastrointestinal tract. A U.S. multi-center study of 168 women treated with infliximab for inflammatory bowel disease (breast milk samples obtained, n=29) showed that infants exposed to infliximab through breast milk had no increase in rates of infections and developed normally. There are no data on the effects of infliximab products on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for INFLECTRA and any potential adverse effects on the breastfed child from INFLECTRA or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of INFLECTRA have been established in pediatric patients 6 to 17 years of age for induction and maintenance treatment of CD and UC. [see Dosage and Administration (2.2, 2.4) and Adverse Reactions (6.1)]. However, the safety and effectiveness of INFLECTRA in pediatric patients <6 years of age with CD or UC have not been established. The safety and effectiveness of INFLECTRA in the treatment of pediatric patients with Ps and juvenile rheumatoid arthritis (JRA) have not been established.

Pediatric Crohn's Disease

The safety and effectiveness of INFLECTRA have been established for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy. The use of INFLECTRA for this indication is supported by evidence from a randomized, open-label pediatric CD study of infliximab in 112 pediatric patients aged 6 years and older [see Clinical Studies (14.2)].

Infliximab has been studied only in combination with conventional immunosuppressive therapy in pediatric CD. The longer term (greater than 1 year) safety and effectiveness of infliximab products in pediatric CD patients have not been established in clinical trials.

Postmarketing cases of HSTCL have been reported in pediatric patients treated with TNF blockers including infliximab products. Due to the risk of HSTCL, a careful risk-benefit assessment should be made when INFLECTRA is used in combination with other immunosuppressants in pediatric CD patients [see Boxed Warning, Warnings and Precautions (5.2)].

Pediatric Ulcerative Colitis

The safety and effectiveness of INFLECTRA for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients aged 6 years and older with moderately to severely active UC who have had an inadequate response to conventional therapy have been established. The use of INFLECTRA for this indication is supported by evidence from adequate and well-controlled studies of infliximab in adults with additional safety and pharmacokinetic data from an open-label pediatric UC Study in 60 pediatric patients aged 6 years and older [see Dosage and Administration (2.4), Adverse Reactions (6.1), and Clinical Studies (14.4)]. The effectiveness of infliximab in inducing and maintaining mucosal healing in pediatric UC was not established. Although 41 patients had a Mayo endoscopy subscore of 0 or 1 at the Week 8 endoscopy, the induction phase was open-label and lacked a control group. Only 9 patients had an optional endoscopy at Week 54. Approximately half of the patients were on concomitant immunomodulators (AZA, 6-MP, MTX) at study start.

Due to the risk of HSTCL, a careful risk-benefit assessment should be made when INFLECTRA is used in combination with other immunosuppressants in pediatric UC patients [see Boxed Warning and Warnings and Precautions (5.2)].

The longer term (greater than 1 year) safety and effectiveness of infliximab products in pediatric UC patients have not been established in clinical trials.

Juvenile Rheumatoid Arthritis (JRA)

The safety and effectiveness of INFLECTRA in the treatment of pediatric patients with juvenile rheumatoid arthritis (JRA) have not been established.

The safety and efficacy of INFLECTRA in patients with JRA is based on the evaluation of infliximab in a multicenter, randomized, placebo-controlled, double-blind study for 14 weeks, followed by a double-blind, all-active treatment extension, for a maximum of 44 weeks. Patients with active JRA between the ages of 4 and 17 years who had been treated with MTX for at least 3 months were enrolled. Concurrent use of folic acid, oral corticosteroids (≤0.2 mg/kg/day of prednisone or equivalent), NSAIDs, and/or disease modifying antirheumatic drugs (DMARDs) was permitted.

Doses of 3 mg/kg of infliximab or placebo were administered intravenously at Weeks 0, 2 and 6. Patients randomized to placebo crossed-over to receive 6 mg/kg of infliximab at Weeks 14, 16, and 20, and then every 8 weeks through Week 44. Patients who completed the study continued to receive open-label treatment with infliximab for up to 2 years in a companion extension study.

The study failed to establish the efficacy of infliximab in the treatment of JRA. Key observations in the study included a high placebo response rate and a higher rate of immunogenicity than what has been observed in adults. Additionally, a higher rate of clearance of infliximab was observed than had been observed in adults.

Population pharmacokinetic analysis showed that in pediatric patients with JRA with a body weight of up to 35 kg receiving 6 mg/kg infliximab and pediatric patients with JRA with body weight greater than 35 kg up to adult body weight receiving 3 mg/kg infliximab, the steady state area under the concentration curve (AUCss) was similar to that observed in adults receiving 3 mg/kg of infliximab.

A total of 60 patients with JRA were treated with doses of 3 mg/kg and 57 patients were treated with doses of 6 mg/kg. The proportion of patients with infusion reactions who received 3 mg/kg infliximab was 35% (21/60) over 52 weeks compared with 18% (10/57) in patients who received 6 mg/kg over 38 weeks. The most common infusion reactions reported were vomiting, fever, headache, and hypotension. In the 3 mg/kg infliximab group, 4 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions). In the 6 mg/kg infliximab group, 2 patients had a serious infusion reaction, 1 of whom had a possible anaphylactic reaction. Two of the 6 patients who experienced serious infusion reactions received infliximab by rapid infusion (duration of less than 2 hours). Antibodies to infliximab developed in 38% (20/53) of patients who received 3 mg/kg infliximab compared with 12% (6/49) of patients who received 6 mg/kg.

A total of 68% (41/60) of patients who received 3 mg/kg of infliximab in combination with MTX experienced an infection over 52 weeks compared with 65% (37/57) of patients who received 6 mg/kg of infliximab in combination with MTX over 38 weeks. The most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was pneumonia. Other notable infections included primary varicella infection in 1 patient and herpes zoster in 1 patient.

8.5 Geriatric Use

Of the total number of infliximab-treated patients in RA and Ps clinical studies, 256 (9.6%) were 65 years old and over, while 17 (0.6%) were 75 years old and over. In these trials, no overall differences in safety or effectiveness were observed between geriatric patients (patients ≥65 years old) and younger adult patients (patients 18 to 65 years old). However, the incidence of serious adverse reactions in geriatric patients was higher in both infliximab and control groups compared to younger adult patients.

Of the total number of infliximab-treated patients in CD, UC, AS, and PsA clinical studies, 76 (3.2%) were 65 years old and over, while 9 (0.4%) were 75 years old and over. In the CD, UC, AS, and PsA studies, there were insufficient numbers of geriatric patients to determine whether they respond differently from younger adults.

The incidence of serious infections in infliximab-treated geriatric patients was greater than in infliximab-treated younger adult patients; therefore close monitoring of geriatric patients for the development of serious infections is recommended [see Warnings and Precautions (5.1), and Adverse Reactions (6.1)].

Medication Guide

MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: September 2025
MEDICATION GUIDE INFLECTRA® (In-flec-tra) (infliximab-dyyb) for injection, for intravenous use
Read the Medication Guide that comes with INFLECTRA before you receive the first treatment, and before each time you get a treatment of INFLECTRA. 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 INFLECTRA? INFLECTRA may cause serious side effects, including: 1. Risk of infection INFLECTRA is a medicine that affects your immune system. INFLECTRA can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving INFLECTRA. 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 INFLECTRA. • Your doctor should monitor you closely for signs and symptoms of TB during treatment with INFLECTRA. Before starting INFLECTRA, tell your doctor if you: • think you have an infection. You should not start receiving INFLECTRA 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 INFLECTRA. 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 INFLECTRA. After starting INFLECTRA, 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. INFLECTRA 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 INFLECTRA. • For children and adults receiving TNF blocker medicines, including INFLECTRA, the chances of getting lymphoma or other cancers may increase. • Some people receiving TNF blockers, including INFLECTRA, 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 INFLECTRA, 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 INFLECTRA, 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 INFLECTRA. • Some women being treated for rheumatoid arthritis with infliximab products have developed cervical cancer. For women receiving INFLECTRA, 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 INFLECTRA?" below for more information.
What is INFLECTRA? INFLECTRA 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. INFLECTRA 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. INFLECTRA can block the damage caused by too much TNF-alpha. It is not known if INFLECTRA is safe and effective in children under 6 years of age.
Who should not receive INFLECTRA? You should not receive INFLECTRA if you have: • heart failure, unless your doctor has examined you and decided that you are able to receive INFLECTRA. Talk to your doctor about your heart failure. • had an allergic reaction to infliximab products or any of the ingredients in INFLECTRA. See the end of this Medication Guide for a complete list of ingredients in INFLECTRA.
What should I tell my doctor before starting treatment with INFLECTRA? 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 INFLECTRA?"). • 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 INFLECTRA. • 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 INFLECTRA. • have COPD (Chronic Obstructive Pulmonary Disease), a specific type of lung disease. Patients with COPD may have an increased risk of getting cancer while receiving INFLECTRA. • have or have had a condition that affects your nervous system such as: o multiple sclerosis, or Guillain-Barré syndrome, or o if you experience any numbness or tingling, or o if you have had a seizure. • have recently received or are scheduled to receive a vaccine. Adults and children receiving INFLECTRA 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 INFLECTRA. • are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. You and your doctor should decide if you should receive INFLECTRA while you are pregnant or breastfeeding. If you have a baby and you were receiving INFLECTRA during your pregnancy, it is important to tell your baby's doctor and other healthcare professionals about your INFLECTRA use so they can decide when your baby should receive any vaccine. Certain vaccinations can cause infections. If you received INFLECTRA 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 INFLECTRA? • You will be given INFLECTRA 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 INFLECTRA infusion to prevent or lessen side effects. • Only a healthcare professional should prepare the medicine and administer it to you. • INFLECTRA will be given to you over a period of about 2 hours. • If you have side effects from INFLECTRA, 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 INFLECTRA infusion and for a period of time afterward for side effects. Your doctor may do certain tests while you are receiving INFLECTRA to monitor you for side effects and to see how well you respond to the treatment. • Your doctor will determine the right dose of INFLECTRA 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 INFLECTRA? Do not take INFLECTRA 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 INFLECTRA. 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 INFLECTRA? INFLECTRA can cause serious side effects, including: See "What is the most important information I should know about INFLECTRA?". Serious Infections • Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as INFLECTRA. 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 INFLECTRA your doctor will treat your infection and may need to stop your INFLECTRA treatment. • Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving INFLECTRA:
	o a fever o feel very tired o have a cough o have flu-like symptoms o 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 INFLECTRA and during treatment with INFLECTRA. • Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving INFLECTRA. 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 INFLECTRA. 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 INFLECTRA and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
	o feel unwell o poor appetite o tiredness (fatigue) o 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 INFLECTRA. Your congestive heart failure may get worse while you are receiving INFLECTRA. 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 INFLECTRA 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 products. 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 • 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 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 INFLECTRA treatment or shortly afterward. Your doctor may need to stop or pause your treatment with INFLECTRA 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 within 3 to 12 days after receiving treatment with infliximab products. Tell your doctor right away if you have any of these signs of delayed allergic reaction to INFLECTRA:
	• 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 INFLECTRA.
	• 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 receiving 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 INFLECTRA. 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 INFLECTRA. 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 who received infliximab 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 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 INFLECTRA. 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 INFLECTRA Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your doctor or pharmacist for information about INFLECTRA that is written for health professionals. For more information go to www.pfizer.com or call 1-800-383-7504.
What are the ingredients in INFLECTRA? The active ingredient is infliximab-dyyb. The inactive ingredients in INFLECTRA include: dibasic sodium phosphate dihydrate, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose. No preservatives are present. Not made with natural rubber latex.
Manufactured by: CELLTRION, Inc. 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of Korea U.S. License No. 1996 ©CELLTRION, Inc. Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10001 For more information go to www.pfizer.com or call 1-800-383-7504.

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