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Inflectra

Generic name: infliximab-dyyb
Dosage form: intravenous (infusion) injection
Drug class: TNF alfa inhibitors

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 25, 2023.

What is Inflectra?

Inflectra (infliximab-dyyb) is a monocloncal antibody used to treat a range of inflammatory autoimmune diseases.

Inflectra is a biological drug and one of four biosimilars of Remicade (infliximab). Biosimilar of Remicade are highly similar to it and are designed to have the same effect, but they are not identical.

Inflectra works in the same way as the other versions of infliximab, by blocking the damage that results from too much tumor necrosis factor-alpha (TNF-alpha). Inflectra binds to TNF-alpha, which stops it from interacting with its receptors and certain activating processes.

TNF-alpha is a protein and inflammatory cytokine which plays a key role in your normal immune response. It is involved in your inflammatory response and also helps to fight off infection and cancer. Some people, however, produce too much TNF-alpha and this can cause an autoimmune disease to develop.

Inflectra was approved by the US Food and Drug Administration (FDA) in 2016, 18 years after the original version of infliximab was introduced. It was the first biosimilar of Remicade to be approved.

What is Inflectra used for?

Inflectra is a prescription medicine that is approved for patients with:

It is not known if Inflectra is safe and effective in children under 6 years of age.

Important information

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.

Before starting Inflectra, tell your doctor if you:

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

See the section “What are the possible side effects of Inflectra?” below for more information.

Who should not receive Inflectra?

You should not receive Inflectra if you have:

What should I tell my doctor before receiving Inflectra?

Your doctor will assess your health before each treatment. Tell your doctor about all of your medical conditions, including if you:

How should I receive Inflectra?

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 this medication.

Dosing information

Inflectra is administered by intravenous infusion for at least 2 hours.

What are the side effects of Inflectra?

Serious side effects of Inflectra include:

The most common side effects of infliximab products include:

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

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

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

These are not all of the side effects with 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-FDA1088.

Interactions

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.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Inflectra harms your unborn baby. Inflectra should be given to a pregnant woman only if clearly needed. Talk to your doctor about stopping Inflectra if you are pregnant or plan to become pregnant.

If you have a baby and you were receiving Inflectra during your pregnancy, it is important to tell your baby’s doctor and other health care 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.

Tell your doctor if you are breastfeeding or plan to breastfeed. You and your doctor should decide if you should receive Inflectra while breastfeeding.

Storage

Store unopened Inflectra vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF).

Do not use Inflectra beyond the expiration date (Exp) located on the carton and the vial. This product contains no preservative.

What are the ingredients in Inflectra?

Active ingredient: infliximab-dyyb.

Inactive ingredients: : dibasic sodium phosphate dihydrate, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose. No preservatives are present.

Inflectra is manufactured by Celltrion, Inc. 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of Korea and distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017

Popular FAQ

A biosimilar is a biological product that is similar to a reference biologic (usually the original product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. As an example, the biosimilar Amjevita (adalimumab-atto) was approved as the first biosimilar to Humira (adalimumab). Continue reading

Infliximab works by binding specifically to a protein called TNF-α (tumor necrosis factor-alpha), which is released by white blood cells as part of our body’s immune response to infection or foreign substances. Overproduction of TNF-α can cause inflammation which can damage tissues, bones, and cartilage, and also cell death. When infliximab binds to TNF-α, it blocks its effects, and this reduces inflammation. Increased levels of TNF-alfa have been found in conditions such as rheumatoid arthritis, psoriasis, and ankylosing spondylitis. Continue reading

Inflectra (infliximab-dyyb) is a biosimilar to Remicade (infliximab). They belong to the same class of drugs called tumor necrosis factor (TNF) alfa inhibitors. Inflectra can be prescribed for the same uses as Remicade, including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, and plaque psoriasis. Continue reading

Renflexis (infliximab-abda) is a tumor necrosis factor (TNF) blocker that is biosimilar to Remicade (infliximab). A biosimilar has no clinically meaningful differences in terms of safety and effectiveness from the reference product.

Renflexis is given as an intravenous (IV) infusion similar to Remicade, and is used for the same conditions, including rheumatoid arthritis, Crohn's disease and psoriatic arthritis. Biosimilars may lead to cost-savings due to a lower price and are preferred by some insurance companies. Continue reading

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.