(infliximab-dyyb)

Prescribing Information
Download Prescribing Information

2 DOSAGE AND ADMINISTRATION

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Crohn's Disease

The recommended dosage of INFLECTRA is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adults with moderately to severely active CD or fistulizing CD. For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg every 8 weeks. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue INFLECTRA in these patients.

2.2 Dosage in Pediatric Crohn's Disease

The recommended dosage of INFLECTRA for pediatric patients 6 years and older with moderately to severely active CD is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.

2.3 Dosage in Adult Ulcerative Colitis

The recommended dosage of INFLECTRA is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adult patients with moderately to severely active UC.

2.4 Dosage in Pediatric Ulcerative Colitis

The recommended dosage of INFLECTRA for pediatric patients 6 years and older with moderately to severely active UC is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.

2.5 Dosage in Rheumatoid Arthritis

The recommended dosage of INFLECTRA is 3 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 3 mg/kg every 8 weeks thereafter for the treatment of moderately to severely active RA. INFLECTRA should be given in combination with methotrexate. For patients who have an incomplete response, consideration may be given to adjusting the dosage up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses per infusion or more frequent dosing [see Adverse Reactions (6.1)].

2.6 Dosage in Ankylosing Spondylitis

The recommended dosage of INFLECTRA is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 6 weeks thereafter for the treatment of active AS.

2.7 Dosage in Psoriatic Arthritis

The recommended dosage of INFLECTRA is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of PsA. INFLECTRA can be used with or without methotrexate.

2.8 Dosage in Plaque Psoriasis

The recommended dosage of INFLECTRA in adult patients is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of chronic severe (i.e., extensive and/or disabling) Ps.

2.9 Assessment for Latent and Active Tuberculosis

Prior to initiating INFLECTRA and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection [see Warnings and Precautions (5.1)].

2.10 Administration Instructions Regarding Infusion Reactions

Prior to treatment, ensure appropriate personnel and medication are available to treat reactions (e.g., hypersensitivity, other reactions) that occur during infusion and shortly after infusion. Prior to infusion with INFLECTRA, patient may be premedicated with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids [see Warnings and Precautions (5.7)].

For mild to moderate reactions during the infusion, consider slowing or stopping the infusion. Upon resolution of these reactions, may reinitiate at a lower infusion rate and/or with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids. Discontinue the infusion if the mild to moderate reactions reoccur.

Discontinue the infusion if severe hypersensitivity reactions occur during the infusion.

2.11 Reconstitution, Dilution, and Administration Instructions

INFLECTRA is intended for use under the guidance and supervision of a healthcare provider. The supplied lyophilized powder must be reconstituted and diluted prior to administration. The infusion solution should be prepared and administered by a trained medical professional using aseptic technique by the following procedure:

1.
Calculate the dose, total volume of reconstituted INFLECTRA solution required and the number of INFLECTRA vials needed. More than one vial may be needed for a full dose.
2.
Reconstitute each 100 mg INFLECTRA vial with 10 mL of Sterile Water for Injection, USP, to obtain a concentration of 10 mg/mL, using a syringe equipped with a 21-gauge or smaller needle as follows:
•
Remove the flip-top from the vial and wipe the top with an alcohol swab.
•
Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of Sterile Water for Injection, USP, to the glass wall of the vial. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder, which has a cake-like appearance. Avoid prolonged or vigorous agitation. DO NOT SHAKE. Foaming of the solution on reconstitution is not unusual.
•
Allow the reconstituted solution to stand for 5 minutes. Visually inspect the reconstituted solution for particulate matter and discoloration. The reconstituted solution should be colorless to light yellow and opalescent, and the solution may develop a few translucent particles as infliximab-dyyb is a protein. Do not use if the lyophilized powder has not fully dissolved or if opaque particles, discoloration, or other foreign particles are present. Do not store unused reconstituted INFLECTRA solution.
3.
Dilute the total volume of the reconstituted INFLECTRA solution to 250 mL1 with sterile 0.9% Sodium Chloride Injection, USP, (do not dilute with any other diluent) as follows:
•
Withdraw a volume from the 0.9% Sodium Chloride Injection, USP, 250 mL bottle or bag equal to the total volume of reconstituted INFLECTRA required for a dose. Slowly add the total volume of reconstituted INFLECTRA solution from the vial(s) to the 250 mL infusion bottle or bag.
•
Discard any unused portion of the reconstituted INFLECTRA solution remaining in the vial(s).
•
Gently invert the bag to mix the solution. The resulting infusion concentration should range between 0.4 mg/mL (minimum recommended concentration) and 4 mg/mL (maximum recommended concentration) of infliximab-dyyb.
4.
The INFLECTRA infusion should begin within 3 hours of reconstitution and dilution. The infusion must be administered intravenously for at least 2 hours with an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 µm or less).
5.
Given that the vials do not contain antibacterial preservatives, discard any unused portion of the infusion solution (do not store for reuse).

No physical biochemical compatibility studies have been conducted to evaluate the co-administration of INFLECTRA with other agents. INFLECTRA should not be infused concomitantly in the same intravenous line with other agents.

1
For volumes greater than 250 mL, either use a larger infusion bag (e.g. 500 mL) or multiple 250 mL infusion bags to ensure that the concentration of the infusion solution does not exceed 4 mg/mL.
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.

Logo

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

 

Submit a medical question for a Pfizer medicine or a vaccine. 

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.