Class: Biological Therapy
Generic Name: infliximab-dyyb
Trade Name: Inflectra®
How is this drug used? Inflectra is approved for the treatment of adults with moderate to severe rheumatoid arthritis (RA) in combination with methotrexate; for adults or children over six years old with Crohn’s disease or adults with ulcerative colitis (UC) who have not responded well to other therapies; for adults with psoriatic arthritis (PsA) or anklosing spondylitis (AS); and for adults with severe plaque psoriasis.
What is the mechanism of action? Inflectra is a biosimilar to Remicade®. A biosimilar is a drug that is very similar to an FDA approved biologic drug. The similarities include how the drug is composed, how it works, and its safety. So, like Remicade, Inflectra is an antibody that works by blocking the inflammatory effects of a protein called tumor necrosis factor alpha (TNFα) in RA and other conditions associated with inflammation. The body produces TNFα when there is inflammation.
How is Inflectra given (administered)? Inflectra is given by an IV infusion by your doctor. Over the 2-hour infusion period and afterwards, you will be monitored for side effects and your response to treatment.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Inflectra, and evaluated periodically during treatments thereafter. Patients will especially be monitored for tuberculosis (TB) as serious infections have happened in patients taking Inflectra. Your healthcare provider should test you for TB before starting treatment.
What are the most common side effects of treatment with Inflectra?
- Injection site reactions
- Upper respiratory tract infections
- Stomach pain
What are some of the less common but potentially serious side effects of Inflectra?
- Serious infections
- Heart failure
- Liver problems
- Blood problems
- Nervous system disorders
- Allergic reactions
- Lupus-like syndrome
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What should patients tell their healthcare provider before using Inflectra?
Before using Inflectra, tell your healthcare provider if you:
- Have an infection, a history of infections that keep coming back, or other problems that can increase your risk of infections.
- Have diabetes, HIV, or a weak immune system.
- Have TB, or have been in close contact with someone who has TB.
- Have liver problems.
- Have or have had Hepatitis B.
- Have heart failure or other heart conditions.
- Have had phototherapy treatment for psoriasis.
- Have COPD (lung disease).
- Have lived in certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of developing certain types of fungal infections.
- Have had any stomach-area pain or have been diagnosed with diverticulitis or ulcers in your stomach or intestines.
- Have had any type of cancer. They may be an increased risk of cancer (especially a certain type of lymphoma) for people taking TNF blockers, like Inflectra.
- Have had a reaction to infliximab or any of the ingredients of Inflectra before.
- Have had a condition that affects your nervous system such as Multiple Sclerosis (MS).
- Plan to have surgery or a medical procedure.
- Are scheduled to receive any vaccines. People using Inflectra should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Inflectra will harm your unborn baby.
- Are breastfeeding or plan to breastfeed. It is not known if Inflectra passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines and all herbal supplements as Inflectra and other medicines may affect each other and cause serious side effects. Especially tell your doctor if you:
- Take any other biologic medicines to treat your RA. Taking these medicines may increase your risk for infection.
When should patients notify their physician?
Contact your healthcare professional immediately if you have signs of any of the following:
- Serious infection: Fever, chills; unusual tiredness; warm, red, or painful skin; or open sores on your body.
- Heart failure: Shortness of breath, swelling of ankles or feet, or sudden weight gain.
- Liver problem: Jaundice, dark brown-colored urine, pain on right side of abdomen, fever, or extreme tiredness.
- Blood problems: Fever that doesn’t go away, bruise or bleed very easily, or look very pale.
- Allergic reaction: Swelling of face, lips, mouth or tongue; trouble breathing; wheezing; severe itching; dizziness or fainting; hives or rash; fast heartbeat or pounding in your chest; sweating.
- Nervous system reaction: Changes in vision, weakness in arms and legs, numbness tingling, or seizures.
- Lupus-like syndrome: Chest discomfort or pain, shortness of breath, joint pain, or rash on cheeks or arms that gets worse in sun.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Last updated on 12/16.
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