Renflexis (infliximab-abda) is a monocloncal antibody used to treat a range of inflammatory autoimmune diseases.
Renflexis is a biological drug and one of four biosimilars of Remicade (infliximab). Biosimilar of Remicade are highly similar versions of the drug, which are designed to have the same effect, but which are not identical.
Renflexis 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). Renflexis binds to TNF-alpha, which stops it from interacting with its receptors and activating certain 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.
Renflexis was approved by the US Food and Drug Administration (FDA) in 2017, almost 20 years after the original version of infliximab started being used.
Renflexis side effects
Serious side effects of Renflexis include:
See “Important information” above.
Serious Infections
Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as Renflexis. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with Renflexis your doctor will treat your infection and may need to stop your Renflexis treatment.
Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving Renflexis:
a fever
feel very tired
have a cough
have flu-like symptoms
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 Renflexis and during treatment with Renflexis.
Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving Renflexis. 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 Renflexis. 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 Renflexis and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
feel unwell
tiredness (fatigue)
poor appetite
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 Renflexis. Your congestive heart failure may get worse while you are receiving Renflexis. 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 Renflexis 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 an infliximab product. 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
weakness in your arms or legs
seizures 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 Renflexis treatment or shortly afterward. Your doctor may need to stop or pause your treatment with Renflexis 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 3 to 12 days after receiving treatment with an infliximab product. Tell your doctor right away if you have any of these signs of delayed allergic reaction to Renflexis:
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 Renflexis.
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 Renflexis.
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 Renflexis. 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 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 Renflexis. 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.
Before taking Renflexis
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Renflexis harms your unborn baby. Renflexis should be given to a pregnant woman only if clearly needed. Talk to your doctor about stopping Renflexis if you are pregnant or plan to become pregnant.
If you have a baby and you were receiving Renflexis during your pregnancy, it is important to tell your baby’s doctor and other health care professionals about your Renflexis use so they can decide when your baby should receive any vaccine. Certain vaccinations can cause infections.
If you received Renflexis 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. It is not known whether Renflexis passes into your breast milk. Talk to your doctor about the best way to feed your baby while receiving Renflexis. You should not breast-feed while receiving Renflexis.
Renflexis is administered by intravenous infusion over a period of not less than 2 hours.
Crohn’s Disease
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response.
Pediatric Crohn’s Disease
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Ulcerative Colitis
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Pediatric Ulcerative Colitis
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Rheumatoid Arthritis
In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every 4 weeks.
Ankylosing Spondylitis
5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.
Psoriatic Arthritis and Plaque Psoriasis
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Warnings
Renflexis may cause serious side effects, including:
1. Risk of infection
Renflexis is a medicine that affects your immune system. Renflexis can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving Renflexis. 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 Renflexis.
Your doctor should monitor you closely for signs and symptoms of TB during treatment with Renflexis.
Before starting Renflexis, tell your doctor if you:
think you have an infection. You should not start receiving Renflexis 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 Renflexis. 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 Renflexis.
After starting Renflexis, 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. Renflexis 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 TNF-blocker medicines, such as Renflexis.
For children and adults receiving TNF-blocker medicines, including Renflexis, the chances of getting lymphoma or other cancers may increase.
Some people receiving TNF-blockers, including Renflexis, 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 Renflexis, 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 Renflexis, 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 Renflexis.
Some women being treated for rheumatoid arthritis with infliximab products have developed cervical cancer. For women receiving Renflexis, 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 Renflexis?” below for more information.
What other drugs will affect Renflexis
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.
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