About RENFLEXIS
RENFLEXIS is a prescription medicine that treats the following health conditions:
- Crohn’s Disease (moderately to severely active) Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven't responded well to other therapies
- Pediatric Crohn’s Disease (moderately to severely active)Can reduce signs and symptoms and induce and maintain remission in children (ages 6–17) with moderately to severely active Crohn's disease who haven't responded well to other therapies
- Ulcerative Colitis (moderately to severely active)Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven't responded well to other therapies
- Pediatric Ulcerative Colitis (moderately to severely active)Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in children (ages 6–17) with moderately to severely active ulcerative colitis who haven't responded well to other therapies
- Rheumatoid Arthritis (moderately to severely active)Can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate
- Psoriatic Arthritis (active)Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis
- Ankylosing Spondylitis (active)Can reduce signs and symptoms in patients with active ankylosing spondylitis
- Plaque Psoriasis (chronic severe)Approved for the treatment of adult patients with chronic (doesn’t go away) severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if RENFLEXIS is appropriate considering other available therapies
RENFLEXIS is biosimilar to Remicade (infliximab). A biosimilar is a medicine that the Food and Drug Administration (FDA) has approved as being highly similar to an already approved biologic medicine. The already approved biologic medicine is known as the reference product or the originator biologic product.
Biosimilars like RENFLEXIS are approved under a law called the Biologics Price Competition and Innovation Act. One of the goals of this act is to help more people get access to certain medicines.
RENFLEXIS is not right for everyone and individual results may vary. Talk to your doctor to see if RENFLEXIS is right for you.
The goal of your immune system is to help keep you healthy by protecting your body from harmful invaders. These include viruses, bacteria, and other foreign substances or cells. If your immune system isn’t working right, it can trigger inflammation in your body—and lead to your symptoms.
With your health condition, your immune system can overproduce a certain protein called tumor necrosis factor-alpha, or TNF-alpha. Having too much TNF-alpha plays a role in the inflammation that can lead to your symptoms.
RENFLEXIS works by blocking the action of TNF-alpha. This can help stop the underlying cause of inflammation.
Biosimilars are prescription medicines that have been approved by the Food and Drug Administration (FDA) as being highly similar to an already-approved biologic medicine. The already-approved biologic medicine is known as the reference product or originator biologic product.
Biosimilars are tested to prove that they are similar to the originator biologic products in terms of effectiveness and safety.
A biosimilar must show that it has no clinically meaningful differences in effectiveness and safety from the originator biologic product. To demonstrate this, the FDA requires a biosimilar to be tested to prove the medicine is similar in several ways, including:
- Similar efficacy and safety: A biosimilar has to prove that it is highly similar in efficacy and safety.
- Similar in how it works: A biosimilar works in the body in the same way to the originator biologic product.
- Similar structure: A biosimilar is developed in a way that ensures that it is similar in structure to the originator biologic product.
The Organon Access Program for RENFLEXIS may be able to help answer your questions about insurance, co-pay assistance for eligible, privately-insured patients, and more. You can:
- Speak to a live Organon Access Program representative by calling 866-847-3539.
- Find out about insurance coverage for RENFLEXIS, including any out-of-pocket costs to you.
- Learn about options for co-pay assistance for eligible, privately-insured patients.
Patients taking RENFLEXIS have access to educational materials. Visit the Education & Support page to see all of the resources available to you, including:
- Informative brochures about RENFLEXIS
- Tips to help you manage your condition
- A guide with questions to ask your doctor
- A video that explains what to expect with an infusion
When transitioning to RENFLEXIS from Remicade (infliximab), will my treatment routine stay the same?
Yes, your treatment routine stays the same with RENFLEXIS. The medicine is given the same way as the originator biologic product. A health care professional will give you RENFLEXIS as an intravenous (IV) infusion. This means a needle will be placed in a vein—most likely in your arm.
You’ll have the same treatment schedule with RENFLEXIS and your infusion will take about the same amount of time. As with any prescription medicine, your doctor will determine the right dose of RENFLEXIS for you.
Questions to consider asking your doctor
What are biosimilars?
What are the side effects of this treatment?
Will my treatment schedule change?
Does my insurance cover this treatment?
Is there educational information about this treatment?
How should I prepare for my treatment?
These may not be all your questions. Write down any others that you may have.