What Is Inflectra?
How is Inflectra used to treat RA?1
Inflectra (infliximab-dyyb) is a monoclonal antibody that acts as a tumor necrosis factor inhibitor indicated for use in adults with moderate to severe RA. Inflectra is used in addition to methotrexate. It is also indicated for other inflammation-related conditions such as Crohn’s Disease, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis, and Ulcerative Colitis. For RA, Inflectra works to reduce signs and symptoms of RA, as well as improve physical function and inhibit the progression of structural damage. Inflectra is a biosimilar for Remicade (infliximab), and was approved by the FDA in April 2016. A medication is considered a biosimilar when it has no clinically meaningful differences in effectiveness and safety to its reference product, in this case, Remicade. However, Inflectra is not a generic for Remicade. There is an increased risk of developing serious infections while on Inflectra, and individuals receiving the medication should report all possible signs of infection to their provider.
What are the ingredients in Inflectra?
The active ingredient in Inflectra is infliximab-dyyb, the tumor necrosis factor inhibitor.
How does Inflectra work?
Inflectra’s active ingredient is a tumor necrosis factor inhibitor (TNF-inhibitor), working specifically to neutralize the protein TNF-alpha in the body. Conditions like RA are produced by an abnormal immune response, where the body mistakenly attacks healthy tissue, causing joint pain, stiffness, and swelling. In these instances, the body often produces a significant amount of TNF-alpha, which can help drive the inappropriate immune response. A TNF-inhibitor works to neutralize this protein product, to drive down the abnormal immune response happening in the body, thus, reducing inflammatory-related symptoms such as joint pain, swelling, and stiffness.
What are the possible side effects of Inflectra?
Multiple clinical trials evaluated the safety and efficacy of Inflectra across many different conditions. The most common side effects of Inflectra are nausea, respiratory infections, sore throat, headache, coughing, and stomach pain. Infusion reactions are also possible while receiving Inflectra. Although infusions can be preceded by medications that decrease the risk of infusion reaction, there is still a possibility of reaction up to 2 hours after administration. Alert your doctor immediately if you have any signs of reaction, including:
- Chest Pain
- Low or High blood Pressure
- Shortness of Breath
This is not an exhaustive list of all potential side effects of Inflectra. Talk to your healthcare provider or pharmacist for further information.
Things to note about Inflectra
Several rare but more serious side effects can accompany Inflectra including worsening of previous heart failure, and the development of liver failure, blood problems, or nervous system disorders. Alert your doctor if you experience any of the following.
- Shortness of breath, swelling of ankles or feet, sudden weight gain
- Jaundice, dark brown-colored urine, pain on the right side of your stomach, and extreme fatigue
- Fever that does not go away, very pale skins, or bruising or bleeding very easily
- Changes in your vision, numbness or tingling in body, weakness of limbs, or seizures
Inflectra weakens the immune system during treatment, and therefore, could lead to an increased risk of infection, including respiratory, skin, fungal, viral, and bacterial infection which can spread throughout the body. Alert your doctor if you have the following signs of infection, including open sores or cuts, chronic infections, cold sores, flu-like symptoms, cough, or fever.
There is also a risk of developing cancers or malignancies while on Inflectra, especially for children and young adults who are taking Inflectra for conditions other than RA. Follow your provider’s recommendations for regular malignancy and cancer screenings. There is an increased risk in developing malignancies for those taking Inflectra who also have COPD, or who have very active RA or who have been treated with Inflectra for an extended period of time. It is not known how Inflectra affects pregnant or breastfeeding woman.
Before staring Inflectra talk to your provider if you:
- Think you have an infection or are being treated for an infection
- Have signs of an infection such as flu-like symptoms, cough, or fever
- Frequently get infections or have infections that keep coming back
- Have any immune system problems, diabetes, heart failure, HIV, liver failure, or a history of cancer
- Have TB or have been in close contact with someone who has TB
- Live in an area where there is an increased risk in fungal infections
- Have or have had Hepatitis B
- Use any other biologics to treat the same conditions as Inflectra
- Are allergic to infliximab or any of the other ingredients in Inflectra
- Have recently received or are scheduled to receive a vaccine
- Are pregnant or are planning to become pregnant. It is not known if Inflectra will affect an unborn baby.
- Are breastfeeding or planning to breastfeed. It is not known if Inflectra can pass through breast milk.
Inflectra is administered intravenously (into a vein) by a healthcare provider. Your doctor will determine the appropriate dosage for you, however, you will receive three starter-doses over a 6-week period. After the starter period, you will receive one dose every 8 weeks following. Administration of Inflectra can take around 2 hours.
- Inflectra Prescribing Information. FDA.gov. Apr 2016. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf