Question 1

What is Avsola?

Accepted Answer

Avsola is a monoclonal antibody that targets a specific protein called tumor necrosis factor-alpha (TNF-alpha) . This protein is naturally produced by the immune system, but an overabundance of it can lead to excessive inflammation and tissue damage. By binding to and neutralizing TNF-alpha, this medication helps to block the inflammatory process and manage the underlying causes of inflammation.

Question 2

What is Avsola used for?

Accepted Answer

Avsola is used to treat the following conditions:

Rheumatoid arthritis

Crohn's disease

Ulcerative colitis

Others

Question 3

How does Avsola work?

Accepted Answer

Targeting Inflammation

Avsola belongs to a class of medications known as tumor necrosis factor (TNF) blockers. TNF-alpha is a protein naturally produced by the body's immune system. In a healthy body, it helps coordinate the response to infections and injuries. However, in people with certain autoimmune conditions, the body produces too much TNF-alpha, which leads to excessive inflammation and damage to healthy tissues.

How Avsola Interacts with the Body

Avsola is a monoclonal antibody designed to recognize and attach to TNF-alpha. When the medication is infused into the bloodstream, it seeks out these proteins and binds to them. This action prevents TNF-alpha from connecting with its receptors on the surface of cells.

By blocking this connection, Avsola helps to:

Reduce the inflammatory response in the joints, skin, and digestive tract.

Decrease the activity of the immune system that is attacking the body's own tissues.

Slow down the progression of physical damage caused by chronic inflammation.

Because it targets a specific part of the immune system, Avsola is considered a biologic therapy. While it specifically neutralizes TNF-alpha to manage disease symptoms, this action can also lower the body's ability to fight off certain infections.

Question 4

What are the active ingredients in Avsola?

Accepted Answer

The active ingredient in Avsola is infliximab .

Question 5

What are the side effects of Avsola?

Accepted Answer

Common side effects of Avsola may include:

upper respiratory tract infection

headache

rash

and others

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Avsola?

Accepted Answer

Avsola belongs to the TNF inhibitor drug class.

Question 7

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

Accepted Answer

Administration

Avsola is given as an injection into a vein (intravenous infusion) by a healthcare provider. This procedure is typically performed in a clinical setting, such as a doctor's office, hospital, or infusion center. Each infusion session generally lasts at least two hours.

Dosing Schedule

The treatment process usually involves two phases:

Induction phase: You will receive several initial doses over the first few weeks of treatment to help the medication reach effective levels in your body.

Maintenance phase: After the initial doses, you will receive the medication at regular intervals, typically every several weeks, to keep the condition under control.

Your healthcare provider will monitor your response to the medication and determine the exact timing of your treatments based on the condition being treated.

Preparation

To help prevent infusion-related reactions, your doctor may provide other medications before the infusion begins. These may include antihistamines, acetaminophen, or corticosteroids.

Missed Doses

If you miss an appointment for an infusion, it is important to contact your healthcare provider immediately to reschedule. Maintaining a consistent schedule helps ensure the medication remains effective.

Question 8

Is Avsola safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

Available data on the use of infliximab products during pregnancy have not shown a clear increase in the risk of major birth defects or pregnancy loss. However, the medication is known to cross the placenta, especially during the third trimester. This results in the drug being detectable in the blood of infants at birth, where it may remain for several months.

Because the medication can affect the infant's immune system, special precautions are necessary regarding vaccinations. It is generally recommended to wait at least six months after birth before giving live vaccines to an infant who was exposed to Avsola in the womb.

Breastfeeding

Infliximab has been detected at low levels in human breast milk. There is currently limited information regarding the effects of the drug on the breastfed infant or its impact on milk production. Patients should discuss the potential benefits and risks of breastfeeding while receiving treatment with their healthcare provider.

Question 9

What forms and strengths does Avsola come in?

Accepted Answer

Dosage Forms

Avsola is supplied as a sterile, white, lyophilized powder in a single-dose vial. It is a preservative-free formulation intended for single use only.

Route of Administration

This medication is administered only by intravenous infusion. A healthcare provider must prepare the solution by reconstituting the powder and then diluting it before it is delivered directly into a vein.

Question 10

What is the FDA approval status of Avsola?

Accepted Answer

FDA Approval and Biosimilar Status

Avsola (infliximab-axxq) is approved by the U.S. Food and Drug Administration (FDA) as a biosimilar to Remicade (infliximab). As a biosimilar, it is a biological product that is highly similar to the reference medicine, with no clinically meaningful differences in safety or effectiveness. It belongs to a class of drugs known as tumor necrosis factor (TNF) blockers.

Approved Indications

The FDA has approved Avsola for the treatment of the following conditions:

Crohn’s disease in adults and children (6 years and older) who have not responded well to conventional therapy.

Ulcerative colitis in adults and children (6 years and older).

Rheumatoid arthritis in adults, used in combination with methotrexate.

Ankylosing spondylitis.

Psoriatic arthritis.

Chronic severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Boxed Warning

Avsola carries a boxed warning, the most serious type of warning required by the FDA, regarding the following risks:

Serious Infections: Patients treated with Avsola 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 Avsola and monitored for signs of infection during treatment.

Malignancy: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers. Cases of hepatosplenic T-cell lymphoma, a rare and often fatal cancer, have occurred primarily in adolescent and young adult males with inflammatory bowel disease who were also taking other immunosuppressants.

Question 11

What should I know about Avsola and infusion?

Accepted Answer

How Avsola is Administered

Avsola is given through a needle placed in a vein, a process known as an intravenous (IV) infusion. This procedure must be performed by a healthcare provider in a hospital or infusion center. The infusion usually takes at least two hours to complete.

Monitoring and Safety

Because infusion-related reactions can occur, healthcare providers will monitor you closely during the treatment and for a period of time afterward. Some patients may receive medications such as antihistamines, acetaminophen, or corticosteroids before the infusion starts to help prevent or reduce the severity of potential reactions.

Potential Infusion Reactions

Infusion reactions can happen during the treatment or shortly after. You should notify your healthcare provider immediately if you experience any of the following symptoms:

Fever or chills

Shortness of breath or wheezing

Chest pain

Rash or itching

High or low blood pressure

Dizziness or lightheadedness

In some cases, reactions can occur several days after the infusion. These delayed reactions may include muscle or joint pain, fever, rash, or swelling of the face and hands.

Infusion Schedule

The timing of infusions depends on the condition being treated and the patient's response. Most patients follow an initial schedule with doses at week 0, week 2, and week 6. After these initial doses, maintenance infusions are typically given once every eight weeks.

Avsola

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Infusion Information

FAQ

📚References

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