Skip to main content

Avsola

Generic name: infliximab-axxq
Dosage form: intravenous (infusion) injection
Drug class: TNF alfa inhibitors

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 4, 2023.

What is Avsola?

Avsola (infliximab-axxq) is a monoclonal antibody drug used to treat certain inflammatory autoimmune diseases. Avsola is a biological drug and one of four biosimilars of Remicade (infliximab). Biosimilars are highly similar versions of a drug that are designed to have the same effect, but they are not identical to the original version of the drug.

Avsola works the same as other versions of infliximab and blocks the damage caused by too much tumor necrosis factor-alpha (TNF-alpha). Avsola binds to TNF-alpha, which prevents it from interacting with its receptors and activating certain processes in your body.

TNF-alpha is a protein and inflammatory cytokine produced by your body, which plays an important role in your normal immune response. It is involved in your inflammatory response, and helps to fight off infection and cancer. Some people produce too much TNF-alpha, however, and this can cause an autoimmune disease to develop.

Avsola was approved by the US Food and Drug Administration (FDA) in 2019, more than 20 years after the original version of infliximab - Remicade - was approved.

What is Avsola used for?

Avsola is a prescription medicine that is approved for patients with:

It is not known if Avsola is safe and effective in children under 6 years of age.

Important information

Avsola may cause serious side effects, including:

1. Risk of infection

Avsola is a medicine that affects your immune system. Avsola can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving Avsola. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections.

Before starting Avsola, tell your doctor if you:

After starting Avsola, if you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. Avsola can make you more likely to get infections or make any infection that you have worse.

2. Risk of Cancer

See the section "What are the side effects of Avsola?" below for more information.

Who should not receive Avsola?

You should not receive Avsola if you have:

What should I tell my doctor before receiving Avsola?

Your doctor will assess your health before each treatment.

Tell your doctor about all of your medical conditions, including if you:

How should I receive Avsola?

What should I avoid while receiving Avsola?

Do not take Avsola together with medicines such as Kineret (anakinra), Orencia (abatacept), Actemra (tocilizumab), or other medicines called biologics that are used to treat the same conditions as Avsola.

Dosing information

See full prescribing information for further details about Avsola dosing.

What are the side effects of Avsola?

Avsola can cause serious side effects, including:

The most common side effects of infliximab products include:

Infusion reactions can happen up to 2 hours after your infusion of Avsola.

Symptoms of infusion reactions may include:

Children with Crohn's disease showed some differences in side effects of treatment compared with adults with Crohn's disease. The side effects that happened more in children were: anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract. Among patients who received infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults.

Tell your doctor about any side effect that bothers you or does not go away.

These are not all of the side effects with Avsola. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Interactions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These include any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis.

Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. You and your doctor should decide if you should receive Avsola while you are pregnant or breastfeeding.

If you have a baby and you were receiving Avsola during your pregnancy, it is important to tell your baby's doctor and other health care professionals about your Avsola use so they can decide when your baby should receive any vaccine. Certain vaccinations can cause infections.

If you received Avsola while you were pregnant, your baby may be at higher risk for getting an infection. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death. This includes live vaccines such as the BCG, rotavirus, or any other live vaccines. For other types of vaccines, talk with your doctor.

Storage

Store unopened Avsola vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light.

If needed, unopened Avsola vials may be stored at room temperatures up to a maximum of 30°C (86°F) for a single period of up to 6 months but not exceeding the original expiration date. The new expiration date must be written in the space provided on the carton. Once removed from the refrigerator Avsola cannot be returned to the refrigerator.

What are the ingredients in Avsola?

Active ingredient: infliximab-axxq.

Inactive ingredients: dibasic sodium phosphate anhydrous, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose. No preservatives are present.

Avsola is manufactured by Amgen, Inc. One Amgen Center Drive, Thousand Oaks, CA 91320-1799.

Popular FAQ

A biosimilar is a biological product that is similar to a reference biologic (usually the original product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. As an example, the biosimilar Amjevita (adalimumab-atto) was approved as the first biosimilar to Humira (adalimumab). Continue reading

Infliximab works by binding specifically to a protein called TNF-α (tumor necrosis factor-alpha), which is released by white blood cells as part of our body’s immune response to infection or foreign substances. Overproduction of TNF-α can cause inflammation which can damage tissues, bones, and cartilage, and also cell death. When infliximab binds to TNF-α, it blocks its effects, and this reduces inflammation. Increased levels of TNF-alfa have been found in conditions such as rheumatoid arthritis, psoriasis, and ankylosing spondylitis. Continue reading

Inflectra (infliximab-dyyb) is a biosimilar to Remicade (infliximab). They belong to the same class of drugs called tumor necrosis factor (TNF) alfa inhibitors. Inflectra can be prescribed for the same uses as Remicade, including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, and plaque psoriasis. Continue reading

Renflexis (infliximab-abda) is a tumor necrosis factor (TNF) blocker that is biosimilar to Remicade (infliximab). A biosimilar has no clinically meaningful differences in terms of safety and effectiveness from the reference product.

Renflexis is given as an intravenous (IV) infusion similar to Remicade, and is used for the same conditions, including rheumatoid arthritis, Crohn's disease and psoriatic arthritis. Biosimilars may lead to cost-savings due to a lower price and are preferred by some insurance companies. Continue reading

More FAQ

View more FAQ

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.