Q: What is Inflectra used for?

Inflectra is used to treat rheumatoid arthritis , Crohn's disease , ulcerative colitis , and others.

Q: How does Inflectra work?

Mechanism of Action Inflectra belongs to a class of medications known as tumor necrosis factor (TNF) blockers. It is a monoclonal antibody designed to target and neutralize a specific protein in the body called TNF-alpha. TNF-alpha is naturally produced by the immune system to help fight infections. However, in people with certain autoimmune diseases, the body produces too much of this protein. Excessive levels of TNF-alpha lead the immune system to attack healthy tissues, resulting in chronic inflammation, pain, and swelling. When Inflectra is administered, it works by: Binding to TNF-alpha: The medication attaches itself directly to the TNF-alpha proteins circulating in the blood and those located on cell surfaces. Neutralizing inflammation: By binding to these proteins, Inflectra prevents them from connecting to healthy cells and triggering the inflammatory process. Reducing immune activity: This action helps lower the overall activity of the immune system in specific areas of the body, such as the joints, skin, or digestive tract. By controlling inflammation, Inflectra helps manage symptoms and can help prevent further damage to the body caused by the underlying condition.

Q: What are the active ingredients in Inflectra?

The active ingredient in Inflectra is infliximab .

Q: What are the side effects of Inflectra?

Common side effects of Inflectra may include: infusion reactions upper respiratory infection fatigue Always consult with a healthcare professional about potential side effects.

Q: What drug class is Inflectra?

Inflectra belongs to the TNF inhibitor drug class.

Q: What is the dosage of Inflectra and how do I take it?

Administration Inflectra is given by a healthcare provider as an infusion into a vein. This procedure typically takes place in a medical setting, such as a doctor's office, clinic, or hospital. The infusion process usually lasts at least two hours. Dosing Schedule The frequency of treatments depends on the specific condition being treated. Generally, the medication is started with a series of initial doses given over the first several weeks. After these starting doses are completed, the medication is typically administered as a maintenance dose once every several weeks. What to Expect During and after the infusion, healthcare providers will monitor you closely for any signs of an infusion reaction. Some patients may receive other medications before the infusion to help prevent or reduce the risk of side effects. Missed Doses It is important to receive every scheduled dose of this medication. If you miss an appointment for an infusion, contact your healthcare provider immediately to reschedule your treatment as soon as possible.

Q: Is Inflectra safe during pregnancy and breastfeeding?

Pregnancy Limited data are available regarding the use of Inflectra in pregnant women. Infliximab products, including Inflectra, are known to cross the placenta and have been detected in the serum of infants born to mothers treated with the medication. Because of this exposure, the medication may affect the immune system of the developing fetus. If Inflectra is used during pregnancy, it is important to inform the infant's healthcare providers. Infants exposed to the drug in utero may have an increased risk of infection. It is generally recommended to wait at least six months after birth before administering live vaccines (such as the BCG vaccine) to these infants, unless otherwise directed by a physician. Breastfeeding Infliximab has been detected at low levels in human breast milk. While it is thought that the drug is likely broken down in the infant's digestive system and not absorbed in significant amounts, the potential for adverse effects is not fully known. The decision to breastfeed while using Inflectra should involve a discussion with a healthcare professional to weigh the benefits of breastfeeding against the mother's clinical need for the medication and any potential risks to the infant.

Q: What forms and strengths does Inflectra come in?

Inflectra is supplied in the following form: Lyophilized powder: This is a sterile, preservative-free powder contained in a single-dose vial. This medication is intended for intravenous use only. A healthcare provider must reconstitute the powder and dilute it before it is administered as an infusion into a vein.

Q: What is the FDA approval status of Inflectra?

FDA Approval and Biosimilar Status Inflectra (infliximab-dyyb) was approved by the FDA in 2016 as a biosimilar to Remicade (infliximab). It was the first biosimilar monoclonal antibody to receive approval in the United States. As a biosimilar, it is highly similar to the original reference product with no clinically meaningful differences in safety, purity, or potency. Approved Indications Inflectra is FDA-approved for the treatment of several autoimmune and inflammatory conditions in specific patient populations: Crohn’s disease in adults and children (6 years and older) Ulcerative colitis in adults Rheumatoid arthritis (used in combination with methotrexate) Ankylosing spondylitis Psoriatic arthritis Chronic severe plaque psoriasis Boxed Warning The FDA requires a Boxed Warning for Inflectra due to the risk of serious infections and malignancy. These risks include: Serious Infections: Patients treated with Inflectra are at increased risk for developing serious infections that may lead to hospitalization or death. These include tuberculosis (TB), bacterial sepsis, and invasive fungal infections. Patients should be tested for latent TB before starting treatment. Malignancy: Lymphoma and other cancers, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers. A rare and often fatal type of cancer called hepatosplenic T-cell lymphoma has occurred in some young adults and children with inflammatory bowel disease treated with these medications. Healthcare providers are required to monitor patients closely for signs of infection during and after treatment with Inflectra.

Question 1

What is Inflectra?

Accepted Answer

Inflectra is a biological medication known as a tumor necrosis factor (TNF) blocker. It works by binding to and neutralizing TNF-alpha, a substance produced by the body's immune system that can cause swelling and damage when present in excess.

By targeting this specific protein, the medication helps to decrease the inflammatory response associated with various conditions. It is a monoclonal antibody designed to interfere with the biological processes that lead to inflammation.

Question 2

What is Inflectra used for?

Accepted Answer

Inflectra is used to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis, and others.

Question 3

How does Inflectra work?

Accepted Answer

Mechanism of Action

Inflectra belongs to a class of medications known as tumor necrosis factor (TNF) blockers. It is a monoclonal antibody designed to target and neutralize a specific protein in the body called TNF-alpha.

TNF-alpha is naturally produced by the immune system to help fight infections. However, in people with certain autoimmune diseases, the body produces too much of this protein. Excessive levels of TNF-alpha lead the immune system to attack healthy tissues, resulting in chronic inflammation, pain, and swelling.

When Inflectra is administered, it works by:

Binding to TNF-alpha: The medication attaches itself directly to the TNF-alpha proteins circulating in the blood and those located on cell surfaces.
Neutralizing inflammation: By binding to these proteins, Inflectra prevents them from connecting to healthy cells and triggering the inflammatory process.
Reducing immune activity: This action helps lower the overall activity of the immune system in specific areas of the body, such as the joints, skin, or digestive tract.

By controlling inflammation, Inflectra helps manage symptoms and can help prevent further damage to the body caused by the underlying condition.

Question 4

What are the active ingredients in Inflectra?

Accepted Answer

The active ingredient in Inflectra is infliximab.

Question 5

What are the side effects of Inflectra?

Accepted Answer

Common side effects of Inflectra may include:

infusion reactions
upper respiratory infection
fatigue

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Inflectra?

Accepted Answer

Inflectra belongs to the TNF inhibitor drug class.

Question 7

What is the dosage of Inflectra and how do I take it?

Accepted Answer

Administration

Inflectra is given by a healthcare provider as an infusion into a vein. This procedure typically takes place in a medical setting, such as a doctor's office, clinic, or hospital. The infusion process usually lasts at least two hours.

Dosing Schedule

The frequency of treatments depends on the specific condition being treated. Generally, the medication is started with a series of initial doses given over the first several weeks. After these starting doses are completed, the medication is typically administered as a maintenance dose once every several weeks.

What to Expect

During and after the infusion, healthcare providers will monitor you closely for any signs of an infusion reaction. Some patients may receive other medications before the infusion to help prevent or reduce the risk of side effects.

Missed Doses

It is important to receive every scheduled dose of this medication. If you miss an appointment for an infusion, contact your healthcare provider immediately to reschedule your treatment as soon as possible.

Question 8

Is Inflectra safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

Limited data are available regarding the use of Inflectra in pregnant women. Infliximab products, including Inflectra, are known to cross the placenta and have been detected in the serum of infants born to mothers treated with the medication. Because of this exposure, the medication may affect the immune system of the developing fetus.

If Inflectra is used during pregnancy, it is important to inform the infant's healthcare providers. Infants exposed to the drug in utero may have an increased risk of infection. It is generally recommended to wait at least six months after birth before administering live vaccines (such as the BCG vaccine) to these infants, unless otherwise directed by a physician.

Breastfeeding

Infliximab has been detected at low levels in human breast milk. While it is thought that the drug is likely broken down in the infant's digestive system and not absorbed in significant amounts, the potential for adverse effects is not fully known. The decision to breastfeed while using Inflectra should involve a discussion with a healthcare professional to weigh the benefits of breastfeeding against the mother's clinical need for the medication and any potential risks to the infant.

Question 9

What forms and strengths does Inflectra come in?

Accepted Answer

Inflectra is supplied in the following form:

Lyophilized powder: This is a sterile, preservative-free powder contained in a single-dose vial.

This medication is intended for intravenous use only. A healthcare provider must reconstitute the powder and dilute it before it is administered as an infusion into a vein.

Question 10

What is the FDA approval status of Inflectra?

Accepted Answer

FDA Approval and Biosimilar Status

Inflectra (infliximab-dyyb) was approved by the FDA in 2016 as a biosimilar to Remicade (infliximab). It was the first biosimilar monoclonal antibody to receive approval in the United States. As a biosimilar, it is highly similar to the original reference product with no clinically meaningful differences in safety, purity, or potency.

Approved Indications

Inflectra is FDA-approved for the treatment of several autoimmune and inflammatory conditions in specific patient populations:

Crohn’s disease in adults and children (6 years and older)
Ulcerative colitis in adults
Rheumatoid arthritis (used in combination with methotrexate)
Ankylosing spondylitis
Psoriatic arthritis
Chronic severe plaque psoriasis

Boxed Warning

The FDA requires a Boxed Warning for Inflectra due to the risk of serious infections and malignancy. These risks include:

Serious Infections: Patients treated with Inflectra are at increased risk for developing serious infections that may lead to hospitalization or death. These include tuberculosis (TB), bacterial sepsis, and invasive fungal infections. Patients should be tested for latent TB before starting treatment.
Malignancy: Lymphoma and other cancers, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers. A rare and often fatal type of cancer called hepatosplenic T-cell lymphoma has occurred in some young adults and children with inflammatory bowel disease treated with these medications.

Healthcare providers are required to monitor patients closely for signs of infection during and after treatment with Inflectra.

Question 11

What should I know about Inflectra and inflectra cost?

Accepted Answer

Factors Influencing Cost

Several factors determine the total cost of treatment with Inflectra:

Dosage and Weight: Inflectra is typically dosed based on body weight (milligrams per kilogram). Patients who weigh more will require more medication per session, increasing the cost.
Treatment Frequency: After the initial loading doses, maintenance infusions are usually given every 8 weeks. More frequent dosing for certain conditions can lead to higher annual costs.
Administration Fees: Because Inflectra is administered by a healthcare professional through an intravenous (IV) infusion, the total price often includes facility fees and professional service charges from the clinic or hospital.

Insurance and Financial Assistance

Coverage for Inflectra depends on the specific health insurance plan. Many insurance providers require prior authorization before approving the medication. Patients may be responsible for deductibles, co-pays, or co-insurance amounts.

Financial assistance programs may be available to help reduce out-of-pocket expenses. These can include:

Manufacturer Copay Cards: Eligible patients with commercial insurance may use these to lower their out-of-pocket costs.
Patient Assistance Programs: These programs may provide the medication at little or no cost to individuals who meet specific income requirements and lack adequate insurance coverage.

Biosimilar Pricing

Inflectra is a biosimilar, meaning it is highly similar to the original biologic drug, Remicade. Biosimilars are often introduced to the market at a lower wholesale acquisition cost than the reference product to encourage competition and reduce overall healthcare spending.

Inflectra

📋Overview

How It Works

Uses

Active Ingredients

Common Side Effects

Warnings & Precautions

Dosage

Pregnancy & Breastfeeding

Frequently Asked Questions

📚References

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