Avsola

Gastrointestinal Conditions

Avsola is used to treat certain chronic inflammatory bowel diseases in adults and children 6 years of age and older. These include:

• Crohn’s Disease: It is prescribed for moderate to severe cases that have not responded well to other treatments. It helps reduce symptoms, achieve remission, and treat complications such as draining fistulas.
• Ulcerative Colitis: It is used for moderate to severe cases to help reduce symptoms and maintain clinical remission.

Joint and Bone Conditions

In adults, Avsola is used to manage several types of inflammatory arthritis:

• Rheumatoid Arthritis: It is used in combination with methotrexate to reduce symptoms, improve physical function, and slow the progression of joint damage.
• Ankylosing Spondylitis: It helps reduce the signs and symptoms of this active inflammatory disease affecting the spine.
• Psoriatic Arthritis: It is used to reduce symptoms and improve physical function in patients with this condition.

Skin Conditions

Avsola is approved for adults with chronic severe plaque psoriasis. It is generally used for patients who require systemic therapy or phototherapy and whose condition is considered widespread or disabling.

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.

Common Side Effects

Many people experience mild to moderate side effects while receiving Avsola. These often include:

• Upper respiratory infections, such as sinus infections or sore throat
• Headache
• Stomach pain or nausea
• Cough
• Infusion-related reactions, which may cause fever, chills, itching, or chest pain during or shortly after the injection

Serious Side Effects

While less common, some side effects can be severe and require immediate medical attention. These include:

• Serious infections, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria
• Liver injury, with symptoms like yellowing of the skin or eyes (jaundice), dark brown urine, or pain on the right side of the stomach
• New or worsening heart failure, characterized by shortness of breath, swelling of the ankles or feet, or sudden weight gain
• Blood disorders, such as low white blood cell or platelet counts, which may cause persistent fever, bruising, or bleeding
• Nervous system problems, including multiple sclerosis or seizures, which may cause numbness, tingling, or vision changes
• Lupus-like syndrome, which can cause chest pain, joint pain, or a skin rash on the cheeks or arms that is sensitive to the sun
• Allergic reactions, including hives, swelling of the face or throat, and difficulty breathing
• Increased risk of certain types of cancer, such as lymphoma or skin cancer

Serious Infections

Avsola can lower the ability of the immune system to fight infections. There is an increased risk of serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial sepsis, and invasive fungal infections such as histoplasmosis. Testing for TB is necessary before starting treatment and periodically during therapy. If a serious infection develops, treatment is typically interrupted.

Malignancy

Lymphoma and other cancers, some fatal, have been reported in children and adolescent patients treated with TNF blockers. A rare and often fatal type of cancer called hepatosplenic T-cell lymphoma has occurred, primarily in young men with Crohn's disease or ulcerative colitis who were also taking other immunosuppressants. Periodic skin examinations are recommended to check for non-melanoma skin cancers.

Liver Injury

Severe liver reactions, including acute liver failure, jaundice, and hepatitis, have occurred in patients taking infliximab products. Monitoring of liver enzymes is required. Signs of liver problems may include yellowing of the skin or eyes, dark brown urine, or pain on the right side of the abdomen.

Heart Failure

New or worsening heart failure has been reported. This medication is generally avoided in people with moderate to severe heart failure. Those with mild heart failure who receive this treatment require close monitoring, and the medication may be discontinued if symptoms worsen.

Infusion and Hypersensitivity Reactions

Serious allergic reactions, including anaphylaxis, can occur during or shortly after the infusion. Symptoms may include hives, difficulty breathing, or low blood pressure. Delayed reactions, such as fever, rash, headache, or joint pain, may also occur three to 12 days after treatment.

Neurologic and Hematologic Events

TNF blockers have been associated with the onset or worsening of central nervous system demyelinating disorders, such as multiple sclerosis or Guillain-Barré syndrome. Additionally, some patients may experience a significant decrease in blood cells that help fight infection or stop bleeding, such as leukopenia or thrombocytopenia.

Vaccinations

Live vaccines should not be administered while using Avsola. It is recommended that pediatric patients be brought up to date with all vaccinations according to current guidelines before starting treatment. Infants exposed to infliximab in the womb should wait at least six months after birth before receiving any live vaccine.

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.

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.

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.

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.