Renflexis is biosimilar to Remicade, meaning the active ingredient it contains is similar to that of an already approved biological product, called a reference product. In this case Remicade.
Here we will explain how they work, their similarities and differences, their side effects, and more. This should provide you with the basics to better understand your options.
What is Renflexis?
Renflexis is an FDA-approved (U.S. Food and Drug Administration) biologic medication manufactured by Merck. Renflexis contains infliximab-abda, a tumor necrosis factor blocker (TNF inhibitor), and is used to treat:
- Moderately to severely Active Crohn’s Disease – to reduce the signs and symptoms in adult patients with moderate to severely active disease who have not responded to conventional therapy, and to reduce the number of draining enterocutaneous and rectovaginal fistulas and maintain fistula closure in adult patients with fistulizing disease
- Pediatric Crohn’s Disease – to reduce the signs and symptoms in pediatric patients with moderate to severely active disease who have not responded to conventional therapy
- Ulcerative colitis – to reduce the signs, symptoms, and help mucosal healing, and eliminate corticosteroid use in adult patients with moderate to severely active disease in patients who have not responded to conventional therapy
- Moderately to severely Active Rheumatoid Arthritis in combination with methotrexate to reduce the signs and symptoms, inhibit structural damage, and improve physical function in patients with moderate to severely active disease
- Ankylosing Spondylitis – to reduce the signs and symptoms
- Psoriatic Arthritis (PSA) – to reduce the signs and symptoms of active arthritis, prevent the progression of structural damage, and improve physical function
- Plaque Psoriasis – in adult patients with chronic severe (extensive or disabling) plaque psoriasis, who are candidates for systemic therapy and where other therapies are less appropriate
Renflexis dosage
Renflexis is available in injection form, in the following doses: 100 mg of lyophilized infliximab-abda in a 20 mL vial for intravenous infusion
Please read the full prescribing information and medication guide provided with this medicine and always speak with a healthcare professional about any changes to your dose so they can monitor and evaluate your condition.
What is Remicade?
Remicade is an FDA (U.S. Food and Drug Administration) approved medication manufactured by Janssen Biotech, Inc. Remicade is a medication used to treat specific autoimmune diseases, and other similar diseases, in adults and children. It is given as an intravenous infusion directly into one of your veins.
Remicade is prescribed to treat inflammatory autoimmune diseases like rheumatoid arthritis, psoriasis, psoriatic arthritis, and ankylosing spondylitis. It can also be used to treat similar inflammatory conditions, such as Crohn’s disease, and ulcerative colitis.
Your immune system is a collection of processes and substances your body uses to protect itself from infection. Autoimmune diseases are conditions where your immune system targets a normal, healthy part of your own body by mistake, rather than an infection. Different immune diseases affect different parts of your body and they can cause a wide range of symptoms. Many autoimmune diseases cause inflammation. This inflammation can cause damage and disrupt how your body works. Some other diseases aren’t caused by your immune system, but also result in inflammation, like Crohn’s disease and ulcerative colitis.
Remicade helps to manage and reduce the symptoms of inflammatory diseases. It blocks an important stage of the inflammation process inside your body. This reduces the amount of inflammation the diseases cause, providing relief from their symptoms.
Remicade dosage
Remicade is available in lyophilized powder form, in the following doses: 100 mg in a 20 mL vial for intravenous infusion.
The active ingredient in Remicade is called infliximab. Infliximab reduces the inflammation caused by some autoimmune diseases and some inflammatory diseases. Inflammation is a natural process your immune system uses to clear itself of infections. When your immune system detects infections, or when it accidentally attacks normal cells in your body, it releases a substance called TNF. TNF travels to the site of infection where it triggers inflammation.
Infliximab blocks this process. It binds with TNF, stopping it from working, and reducing your levels of inflammation. This can ease the symptoms of your disease, limit the damage they can cause, and reduce the severity and frequency of flare-ups.
Common side effects of Renflexis and Remicade
The most common side effects of Renflexis in clinical trials include:
- Infections such as upper respiratory, sinusitis, and pharyngitis
- Infusion-related reactions
- Headache
- Abdominal pain
More serious side effects of Renflexis include:
- Increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, and invasive fungal infections such as histoplasmosis
- Lymphoma and other malignancies, some fatal, in children and adolescent patients treated with TNF blockers such as infliximab products
- Cases of fatal hepatosplenic T-cell lymphoma (HSTCL) – almost all had received azathioprine or mercaptopurine. The majority of cases were reported in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males
- Hepatitis B virus reactivation
- Hepatotoxicity
- Heart failure – new onset or worsening symptoms may occur
- Cytopenias
- Hypersensitivity – serious infusion reactions including anaphylaxis or serum sickness-like reactions
- Demyelinating disease
- Lupus-like syndrome
The most common side effects of Remicade in clinical trials include:
- Stomach pain
- Nausea
- Headaches
- Upper respiratory infections
- Viral infections
More serious side effects of Remicade include
- Allergic reactions
- Heart problems
- Liver and kidney conditions
- Nervous system conditions
- Severe skin reactions
- Certain forms of cancer
- Development of antibodies causing the drug to be less effective for you
These aren’t all the side effects Renflexis or Remicade can cause. You can find more details in the patient leaflet that comes with your medication. If you have any concerns about side effects, talk to your physician or pharmacist.
Renflexis and Remicade drug interactions
Renflexis can interact with other medications. These include:
- Drugs that weaken the immune system and increase the risk of infection such as abatacept, anakinra, tocilizumab
- Treatment with weakened bacteria or viruses such as live vaccines
- Other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis
- Antipsychotics – clozapine
- Corticosteroids – betamethasone, cortisone, dexamethasone
- Immunosuppressants – fingolimod, ozanimod, siponimod
- Immunomodulatory drugs – abatacept, lenalidomide, thalidomide
- Immunosuppressants – cyclosporine, voclosporin
- Cancer treatments – idelalisib and asciminib
Remicade can interact with other medications. These include:
- Any medications that affect your immune system
- Kineret (anakinra), used to treat rheumatoid arthritis
- Orencia (abatacept), used to treat other autoimmune diseases
- Vaccinations that contain live viruses
- Corticosteroids – betamethasone, cortisone, dexamethasone
- Antisphychotics – clozapine
- Immunosuppressants – fingolimod, ozanimod, siponimod
- DMARDs – leflunomide, teriflunomide
Renflexis and Remicade can interact with other medications. This can change how Renflexis and Remicade and other medications work and can make side effects more likely. Tell your prescribing physician about all your drugs, including vitamins and dietary supplements.
Renflexis and Remicade contraindications
You should not use Renflexis if you:
- Are allergic to the active ingredient infliximab-abda
- Have had an allergic reaction to any of the other ingredients in Renflexis or to any murine proteins
- Are pregnant or are planning to become pregnant
Talk to your doctor before using Renflexis if you:
- Are taking any of the medications that could interact with Renflexis
- Have moderate to severe heart failure
- Have tuberculosis
- Have an infection
- Have a blood or bone marrow disorder
- Have a nervous system disorder such as multiple sclerosis
- Have breast cancer, or skin cancer
- Have chronic obstructive pulmonary disease (COPD)
- Have hepatitis B
- Are having light treatment for psoriasis (phototherapy)
- Are breastfeeding or are planning to breastfeed
You should not use Remicade if you:
- Are allergic to the active ingredient infliximab
- Are allergic to any of the other ingredients in Remicade (listed in the leaflet which comes with the medication)
- Are allergic to proteins that come from mice
- Have had moderate to severe heart failure
- Have tuberculosis (TB) or another serious infection like pneumonia or sepsis
Talk to your doctor before using Remicade if you:
- Have been treated with Remicade before
- Have any form of infection
- Have ever lived in or traveled to regions where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common
- Have ever had tuberculosis (TB) or been in close contact with someone who has
- Are a carrier of hepatitis B or you have ever had it
- Have had mild heart failure or any other heart problems
- Have ever had lymphoma (a type of blood cancer)
- Have any other type of cancer
- Have Chronic Obstructive Pulmonary Disease (COPD)
- Are a heavy smoker
- Have or have ever had a condition that affects your nervous system, like multiple sclerosis or Guillain-Barre syndrome
- Have any fistulae (abnormal skin openings)
- Have recently had a vaccine, or are due to have one
- Are scheduled to have an operation or dental procedure
- Are pregnant or trying to become pregnant
- Are breastfeeding or plan to breastfeed
- Are under six years of age
- Are over 65 years of age
Other drugs for Autoimmune diseases
If you have any concerns about Renflexis or Remicade side effects, talk to your physician, or pharmacist for medical advice. Also inform your healthcare provider about any medical conditions, supplements, and over-the-counter meds you are taking. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
