Arthritis Treatment Biologics What to Know About Inflectra (Infliximab-Dyyb) A Remicade biosimilar for RA and other inflammatory conditions By Carol Eustice facebook Carol Eustice is a writer covering arthritis and chronic illness, who herself has been diagnosed with both rheumatoid arthritis and osteoarthritis. Learn about our editorial process Carol Eustice Medically reviewed by Medically reviewed by Mary Choy, PharmD on June 24, 2020 twitter linkedin Mary Choy, PharmD, is board-certified in geriatric pharmacotherapy. She currently serves as the director of pharmacy practice of the New York State Council of Health-System Pharmacists. Learn about our Medical Review Board Mary Choy, PharmD Updated on July 03, 2020 Print Table of Contents View All Table of Contents Uses Before Taking Dosage Side Effects Warnings/Interactions Inflectra (infliximab-dyyb) is a biosimilar to Remicade (infliximab). This medication is given intravenously (through a vein) as a treatment for a variety of inflammatory conditions, including rheumatoid arthritis, plaque psoriasis, and Crohn's disease. caiaimage/Martin Barraud/OJO+/Getty Images A biosimilar drug is "highly similar" to a biologic drug. Inflectra, like Remicade, blocks the action of an immune-system cell called tumor necrosis factor (TNF). This class of drugs is called TNF antagonists, anti-TNF drugs, or TNF blockers. Inflectra was the first Remicade biosimilar to be approved. The FDA has since approved several others: Renflexis (infliximab-abda), Ixifi (infliximab-qbtx), and Avsola (infliximab-axxq). (To distinguish between the different products, these have been given a new brand name,in addition to a suffix containing four consonants to the end of each generic name.) Biosimilars vs. Biologics Uses Inflectra is FDA-approved for treating several diseases and conditions. Rheumatoid arthritis, moderately to severely active: In combination with the drug methotrexate, Inflectra reduces signs and symptoms, inhibits the progression of joint damage, and improves physical function.Ankylosing spondylitis, active: Reduces signs and symptomsPsoriatic arthritis, active: Reduces signs and symptoms, inhibits the progression of structural damage, and improves physical functionPlaque psoriasis (adults): Treats chronic, severe cases in candidates for systemic therapy, and when other systemic therapies are less medically appropriateCrohn's disease, moderately to severely active (adults, children over 6): Reduces signs and symptoms, induces and maintains clinical remission in those who've had an inadequate response to conventional treatment.Fistulating disease Crohn's disease (adults): Reduces the number of draining fistulas and maintains fistula closureUlcerative colitis, moderately to severely active (adults): Reduces signs and symptoms, induces and maintains clinical remission and mucosal healing, and eliminates corticosteroid use in those who've had an inadequate response to conventional therapy Clinicians may prescribe Inflectra for off-label use (without FDA approval) in other autoimmune and inflammatory conditions. Before Taking Before prescribing Inflectra or another TNF blocker, your doctor may perform tests to gauge your level of disease activity. This may include checking standard markers of inflammation, such as the erythrocyte sedimentation rate (ESR or sed rate) or C-reactive protein (CRP). It may also contain disease-specific tests such as the Vectra DA blood test for rheumatoid arthritis disease activity. Inflectra is sometimes given as a first-line treatment (the first one you try) but is more often a second-line treatment given only after other treatments have failed. Much of this depends on what it's prescribed for. For rheumatoid arthritis, Inflectra plus methotrexate may be used as a first-line treatment. Inflectra may also be a second-line treatment after methotrexate alone or methotrexate plus another TNF blocker have failed. For ankylosing spondylitis, psoriatic arthritis, and some cases of plaque psoriasis, it may be used as a first-line treatment or as a replacement for another TNF blocker that hasn't been successful. Inflectra is considered only as a second-line treatment for: Some cases of plaque psoriasisCrohn's diseaseUlcerative colitis Precautions and Contraindications Inflectra is not appropriate for everyone and must be used with caution in certain individuals. Pregnant and Breastfeeding Women Little is known about how taking Inflectra while pregnant or breastfeeding may affect your baby. However, infliximab products have been found to cross the placenta. In babies whose mothers took the drug, it has been found in their blood up to six months later. This could increase a child's risk of serious and even fatal infections. Breastfeeding is not recommended for women taking Inflectra. Children Inflectra and other infliximab products have not been studied for children under 6. Children this age and older being prescribed Inflectra should be brought up-to-date on their vaccinations before starting this drug. However, if an infant was exposed to Inflectra or infliximab in utero, there should be at least a six-month waiting period after birth before any live vaccine (e.g., BCG and rotavirus) is given because of the increased risk of infection. Your pediatrician should be able to guide you as to what vaccines are and aren't safe for your child. Comorbities/Risk Factors Inflectra should not be administered during an active infection of any kind. If you've ever had a hepatitis B infection, Inflectra may put you at risk for reactivation. Your doctor should test you for hepatitis B before you start taking this drug and monitor you closely if you test positive. Doses of Inflectra larger than 5 milligrams (mg) per kilogram (kg) of body weight should not be given to people with moderate-to-severe heart failure. Inflectra can worsen heart failure symptoms. Inflectra may exacerbate demyelinating diseases such as multiple sclerosis. Your doctor is unlikely to prescribe Inflectra if you have a demyelinating disease. The risks/benefits of using Inflectra should be assessed in patients with certain factors related to cancer in their medical history. Allergies Don't take Inflectra if you're allergic to infliximab, murine (rodent) proteins, or any of its inactive ingredients: SucrosePolysorbate 80Sodium dihydrogen phosphate monohydrateDi-Sodium hydrogen phosphate dihydrate Biologics are produced using living organisms or parts of living organisms. The U.S. Food and Drug Administration says biosimilar drugs must have "no clinically meaningful differences" from the original biologic. However, inactive ingredients may be different. Other Biosimilars for Systemic Inflammation Several biosimilars are on the market for treating diseases that involve systemic inflammation. Biologic Biosimilars Drug Humira Amgevita, Imraldi, Halimatoz, Hymroz, Hefiya, Julio, Idacio, Kromeya Adalimumab Enbrel Erelzi, Benepali Etanercept MebThera Blitzima, Ritemvia, Rituzena Rixathon, Riximyo, Truxima Rituximab Humira, Enbrel, and their biosimilars are classified as TNF blockers. MabThera and its biosimilars alter the immune system's level of B-cells, which (like TNF) are a part of your body's inflammatory response. Dosage and Schedule You'll go to a doctor's office, hospital, or infusion center to be given intravenous (IV) infusions of Inflectra. The dosage and infusion schedule will depend on your diagnosis. Expect the infusion to take at least two hours. Typical Infusion Schedule Disease/Condition Infusion Dose (mg/kg body weight) Second Dose Third Dose Maintenance Ankylosing spondylitis 5 mg/kg At two weeks At six weeks Every six weeks thereafter Crohn's Disease, plaque psoriasis, psoriatic arthritis, ulcerative colitis 5 mg/kg At two weeks At six weeks Every eight weeks thereafter Rheumatoid arthritis* 3 mg/kg At two weeks At six weeks Every eight weeks thereafter A kilogram is about 2.2 pounds. All listed dosages are according to the drug manufacturer. *If treatment results for rheumatoid arthritis aren't adequate at this dosage, your doctor may adjust it up to 10mg/kg or may shorten the time between infusions. However, these adjustments may increase your risk of side effects. Modifications If you have a mild-to-moderate reaction during an infusion, the process may be slowed down or suspended for a while. Depending on the nature of your reaction, you may be treated with acetaminophen, antihistamines, and/or corticosteroids. If you then continue to have a reaction, your infusion will be discontinued. If you have an allergic reaction, you'll need to go off of Inflectra right away. Facilities that do infusions should have the appropriate staffing and medication to deal with a severe allergic reaction such as anaphylaxis. Side Effects Unwanted side effects are possible with any medication. If you have side effects that are severe or don't diminish over time, let your doctor know about it. Common The most common adverse reactions, based on clinical trials of infliximab products, include: Infections (upper respiratory, sinusitis, and pharyngitis)Infusion-related reactions (shortness of breath, flushing, headache, rash)HeadacheAbdominal pain Severe Rare but serious reactions that can occur during the infusion include: AnaphylaxisConvulsionsErythematous rashLow blood pressure (hypotension) The infusion facility should be equipped to deal with these reactions. If you have a delayed reaction to Inflectra after you've left the facility, get medical help right away. Warnings and Interactions Certain drugs don't interact well when they're combined. While you're taking Inflectra, you should avoid: Kineret (anakinra)Orencia (abatacept)Actemra (tocilizumab)Other biologic drugs Neither live vaccines nor therapeutic infectious agents should be given while taking Inflectra or for three months after stopping the drug. Your doctor can help you find alternative vaccines and therapies that are appropriate for you. Certain other warnings have been established to both ensure the safe use of Inflectra and to guide cessation, if necessary. Your doctor should monitor you for the following complications while you're taking Inflectra. If you need to go off of the drug, get advice from your doctor on how to do so safely. Infections Inflectra poses a risk of invasive fungal infections. If you develop a systemic illness while using Inflectra and you live in a region where fungal conditions are endemic, an anti-fungal therapy should be considered. If an infection develops while using Inflectra, it should be monitored carefully and if it becomes serious, Inflectra should be stopped. Opportunistic infections (infections that occur more severely or frequently in those with weakened immune systems) have been reported in patients treated with TNF blockers. Also, reactivation of tuberculosis or new tuberculosis infections have occurred with the use of infliximab products. Malignancies The incidence of malignancies, including lymphoma, has been found to be greater in patients treated with TNF blockers than in controls. Any signs of cancer should be investigated with this in mind. Hepatotoxicity Rare severe hepatic reactions can occur. Some may be potentially fatal or require liver transplantation. With the development of jaundice or significantly elevated liver enzymes, Inflectra should be stopped. Heart Failure New-onset heart failure may occur with the use of Inflectra. If this happens to you, talk to your doctor about options for stopping Inflectra and finding another treatment. Cytopenias There may be a reduction in the number of blood cells with use of Inflectra. Patients should seek medical attention if symptoms of any type of cytopenia develop. These include anemia, thrombocytopenia, leukopenia, and pancytopenia. Hypersensitivity Serious infusion reactions may develop, including anaphylaxis or serum sickness-like reactions. Lupus-Like Syndrome A syndrome associated with lupus-like symptoms can develop with use of Inflectra. The drug should be stopped if the syndrome develops. Black Box Warnings Inflectra carries black box warnings, the FDA's most serious warning, with regard to: Increased risk of serious infectionIncreased risk of lymphomaImportance of testing for latent tuberculosis prior to starting the drug Need to Stop Inflectra? Going off your medication is a serious decision. Consider it carefully and talk to your doctor. They may recommend tapering off by increasing the time between infusions and/or lowering your dosage. Quitting Inflectra shouldn't cause withdrawal symptoms. Rather, tapering is done to minimize the return of disease symptoms. Was this page helpful? Thanks for your feedback! Dealing with chronic inflammation? An anti-inflammatory diet can help. Our free recipe guide shows you the best foods to fight inflammation. Get yours today! Sign Up You're in! Thank you, {{form.email}}, for signing up. There was an error. Please try again. What are your concerns? Other Inaccurate Hard to Understand Submit Article Sources Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. U.S. Food and Drug Administration. Biosimilar and interchangable products. Updated October 23, 2017. U.S. Food and Drug Administration: AccessData. Rituxan (rituximab) label. Updated February 2010. Rahier JF, Moutschen M, Van Gompel A, et al. Vaccinations in patients with immune-mediated inflammatory diseases. Rheumatology (Oxford). 2010;49(10):1815‐1827. doi:10.1093/rheumatology/keq183 Additional Reading U.S. Food and Drug Administration: FDA AccessData. Inflectra: Highlights of prescribing information. Published April 2016. U.S. Food and Drug Administration. FDA approves Inflectra, a biosimilar to Remicade. Published April 5, 2016.