Indications

AVSOLA® is indicated for: Moderate to Severe Crohn’s Disease: Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven’t... Read more

Prescribing Information Indications Medication Guide Visit AmgenBiosimilars.com

FOR PATIENTS

WHAT IS AVSOLA®?

 

For Patients / What is MVASI™

AVSOLA® is a medicine called a biosimilar1

AVSOLA® is a biosimilar of the biologic medicine Remicade® (infliximab). Your doctor may prescribe AVSOLA® to treat your chronic inflammation disease.

A biosimilar is a complex medicine2

A biosimilar is a highly similar version of an approved biologic medicine. Biologics and biosimilars are both made from living cells. Biosimilars must provide the same treatment benefit as the original biologic.

Compared with their original biologics, biosimilars:3

  • checklist Are given the same way
  • checklist Provide the same treatment benefit
  • checklist Have the same potential side effects

AVSOLA® was carefully made and rigorously tested1,4,5

The FDA approved AVSOLA® as a biosimilar to Remicade® because it:

  • works similarly in the body Works similarly in the body
  • Is similarly effective Is similarly effective
  • Has similar safety Has similar safety
1:1

The FDA sets rigorous standards for making and approving biosimilars so patients and healthcare professionals can rely on the safety and effectiveness of the biosimilar, just as they would the original biologic. 2

FDA = Food and Drug Administration.

Learn more about how biosimilars are made and approved

AVSOLA® helps treat the following diseases of the immune system:1

INFLAMMATORY ARTHRITIS DISEASES Chronic inflammation in joints and other tissues

INFLAMMATORY BOWEL DISEASES Chronic inflammation in parts of the digestive tract

Understanding Rheumatoid Arthritis (RA)6

RA is the most common type of autoimmune arthritis, affecting more than 1.3 million Americans. RA is a chronic condition that causes joint pain, stiffness, swelling, and decreased movement, most commonly affecting the small joints in the hands and feet.

How AVSOLA® can help in moderately to severely active Rheumatoid Arthritis (RA)1,*†

AVSOLA® is approved by the FDA as a biosimilar to Remicade® for the treatment of the same diseases. It was tested in a global multicenter study for safety and efficacy.1
ra-circle
  • Improvements in:
    • Pain and stiffness
    • Physical function
  • Helps stop further joint damage

*In combination with methotrexate.

†Individual results may vary.

AVSOLA® has similar safety to Remicade®4

Can I take AVSOLA® if I've already started Remicade®?

In a comparative study, patients who switched from Remicade® to AVSOLA® experienced similar safety and effectiveness.4

You and your doctor may consider treatment with AVSOLA® if you are new to infliximab therapy, or if you are currently stable on Remicade®.
HELPFUL RESOURCES FOR YOU THROUGHOUT YOUR TREATMENT JOURNEY

Links to these third-party organizations are for your information only. Amgen does not endorse and is not responsible for the content included by these organizations.

Visit these websites for more information about your inflammatory disease and support groups near you.

Arthritis Foundation Logo

AMERICAN COLLEGE OF RHEUMATOLOGY
Understanding Psoriatic Arthritis (PsA)7,8

PsA typically attacks the joints and areas where tissues attach to bone, like fingers, toes, wrists, and knees. Most people have skin symptoms before joint symptoms, as about 30% of people with psoriasis (a condition that causes redness and itching) develop PsA. Unlike many other autoimmune diseases, men and women are equally at risk for developing PsA.

How AVSOLA® can help in active Psoriatic Arthritis (PsA)1,*

AVSOLA® is approved by the FDA as a biosimilar to Remicade® to treat the same inflammation diseases.
ra-circle
  • Improvements in:
    • Pain and stiffness
    • Skin symptoms
  • Helps stop further joint damage

AVSOLA® has similar safety to Remicade®4

Can I take AVSOLA® if I've already started Remicade®?

In a comparative study, patients who switched from Remicade® to AVSOLA® experienced similar safety and effectiveness.4

You and your doctor may consider treatment with AVSOLA® if you are new to infliximab therapy, or if you are currently stable on Remicade®.

*Individual results may vary.

HELPFUL RESOURCES FOR YOU THROUGHOUT YOUR TREATMENT JOURNEY

Links to these third-party organizations are for your information only. Amgen does not endorse and is not responsible for the content included by these organizations.

Visit these websites for more information about your inflammatory disease and support groups near you.

NATIONAL PSORIASIS FOUNDATION

Arthritis Foundation Logo

AMERICAN COLLEGE OF RHEUMATOLOGY
UNDERSTANDING ANKYLOSING SPONDYLITIS (AS)9

AS is a type of arthritis that affects the spine, causing redness, heat, swelling, and pain in the spine or in the joint where the bottom of the spine meets the pelvic bone. In severe cases, swelling can cause bones in the spine to fuse together.

How AVSOLA® can help in active Ankylosing Spondylitis (AS)1,*

AVSOLA® is approved by the FDA as a biosimilar to Remicade® to treat the same inflammation diseases.
ra-circle
  • Improvements in:
    • Pain and inflammation

AVSOLA® has similar safety to Remicade®4

Can I take AVSOLA® if I've already started Remicade®?

In a comparative study, patients who switched from Remicade® to AVSOLA® experienced similar safety and effectiveness.4

You and your doctor may consider treatment with AVSOLA® if you are new to infliximab therapy, or if you are currently stable on Remicade®.

*Individual results may vary.
HELPFUL RESOURCES FOR YOU THROUGHOUT YOUR TREATMENT JOURNEY

Links to these third-party organizations are for your information only. Amgen does not endorse and is not responsible for the content included by these organizations.

Visit these websites for more information about your inflammatory disease and support groups near you.

UNDERSTANDING CROHN’S DISEASE (CD)10

CD is an inflammatory bowel disease that causes chronic inflammation in your digestive tract. CD can affect any part of the digestive tract, but it most commonly affects the end of the small intestine where it joins the beginning of the colon. Inflammation in your digestive tract can lead to abdominal pain, persistent diarrhea, fatigue, and other symptoms.

How AVSOLA® can help in moderately to severely active Crohn’s Disease (CD)1,*

AVSOLA® is approved by the FDA as a biosimilar to Remicade® to treat the same inflammation diseases.
ra-circle
  • Improvements in:
    • Signs and symptoms

AVSOLA® has similar safety to Remicade®4

Can I take AVSOLA® if I've already started Remicade®?

In a comparative study, patients who switched from Remicade® to AVSOLA® experienced similar safety and effectiveness.4

You and your doctor may consider treatment with AVSOLA® if you are new to infliximab therapy, or if you are currently stable on Remicade®.

*Individual results may vary.
HELPFUL RESOURCES FOR YOU THROUGHOUT YOUR TREATMENT JOURNEY

Links to these third-party organizations are for your information only. Amgen does not endorse and is not responsible for the content included by these organizations.

Visit these websites for more information about your inflammatory disease and support groups near you.

Crohn's Colitis Foundation Logo

American Gastroenterological Association Logo

UNDERSTANDING ULCERATIVE COLITIS (UC)11

UC is an inflammatory bowel disease that causes chronic inflammation in your digestive tract. UC causes inflammation in the innermost lining of the large intestine (colon) and rectum.

How AVSOLA® can help in moderately to severely active Ulcerative Colitis (UC)1,*

AVSOLA® is approved by the FDA as a biosimilar to Remicade® to treat the same inflammation diseases.
ra-circle
  • Improvements in:
    • Signs and symptoms
    • Digestive tract healing

AVSOLA® has similar safety to Remicade®4

Can I take AVSOLA® if I've already started Remicade®?

In a comparative study, patients who switched from Remicade® to AVSOLA® experienced similar safety and effectiveness.4

You and your doctor may consider treatment with AVSOLA® if you are new to infliximab therapy, or if you are currently stable on Remicade®.

*Individual results may vary.
HELPFUL RESOURCES FOR YOU THROUGHOUT YOUR TREATMENT JOURNEY

The link to this third-party organization is for your information only. Amgen does not endorse and is not responsible for the content included by this organization.

Visit this website for more information about your inflammatory disease and support groups near you.

Crohn's Colitis Foundation Logo

HOW DO INFLAMMATORY IMMUNE DISEASES AFFECT THE BODY?1

When you have an inflammatory immune disease, the body makes too much of a certain protein called called tumor necrosis factor-alpha (TNF-𝛂)(TNF-𝛂). This can cause your immune system to attack healthy parts of the body, which can lead to inflammation and pain.

HOW DO INFLAMMATION DISEASES AFFECT THE BODY? How do inflammation diseases affect the body?

HOW DOES AVSOLA® TREAT INFLAMMATORY IMMUNE DISEASES?1

AVSOLA® targets and blocks extra TNF-𝛂

Blocking extra TNF-α can help relieve symptoms like inflammation and prevent further joint damage.

How can AVSOLA® (infliximab-axxq) help treat inflammation? How can AVSOLA® (infliximab-axxq) help treat inflammation?
AVSOLA® targets specific parts of the immune system that cause inflammation

AVSOLA® targets specific parts of the immune system that cause inflammation 1

Important Safety Information

Only your doctor can recommend a course of treatment after checking your health condition. AVSOLA® (infliximab-axxq) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with AVSOLA®.

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking infliximab products and azathioprine or 6-mercaptopurine. For children and adults taking TNF-blockers, including AVSOLA®, the chances of getting lymphoma or other cancers may increase.

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

You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take AVSOLA®?

You should let your doctor know if you have or ever had any of the following:

  • Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start AVSOLA®.
  • Lived in a region where certain fungal infections like histoplasmosis, coccidioidomycosis or blastomycosis are common.
  • Infections that keep coming back, have diabetes or an immune system problem.
  • Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
  • Heart failure or any heart condition. Many people with heart failure should not take AVSOLA®.
  • Hepatitis B virus (HBV) infection or think you may be a carrier of HBV. Your doctor will test you for HBV. Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).

Also tell your doctor if you:

  • Use the medicines Kineret (anakinra), Orencia (abatacept) or Actemra (tocilizumab) or other medicines called biologics used to treat the same problems as AVSOLA®.
  • Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using AVSOLA® during your pregnancy. You and your doctor should decide if you should receive AVSOLA® while you are pregnant or breastfeeding. Tell your baby’s doctor about your AVSOLA® use. 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.
  • Recently received or are scheduled to receive a vaccine. Adults and children taking AVSOLA® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer) while taking AVSOLA®.
What should I watch for and talk to my doctor about before or while taking AVSOLA®?

The following serious (sometimes fatal) side effects have been reported in people taking AVSOLA®.

You should tell your doctor right away if you have any of the signs listed below:

  • Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. AVSOLA® can make you more likely to get an infection or make any infection that you have worse.
  • Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
  • Lymphoma, or any other cancers in adults and children.
  • Skin cancer—any changes in or growths on your skin.
  • Cervical cancer—your doctor may recommend that you be regularly screened. Some women with rheumatoid arthritis, particularly those over 60, have developed cervical cancer.
  • Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
  • Other heart problems within 24 hours of infusion, including heart attack, low blood flow to the heart, or abnormal heart rhythm—chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat.
  • Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
  • Blood disorders—fever that doesn’t go away, bruising, bleeding or severe paleness.
  • Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
  • Stroke within 24 hours of infusion—numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking; dizziness; loss of balance or coordination; or a sudden, severe headache.
  • Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, and fever or chills.
  • Delayed allergic reactions (3 to 12 days after infusion)—fever, rash, headache, sore throat, muscle or joint pain, swelling of the face and hands, or difficulty swallowing.
  • Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.
  • Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

The most common side effects of infliximab products include respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.

Please read the full Prescribing Information and Medication Guide for AVSOLA® and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATIONS

AVSOLA® is indicated for:

Moderate to Severe Crohn’s Disease: Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven’t responded well to other therapies

Moderate to Severe Pediatric Crohn’s Disease: Can reduce signs and symptoms, and induce and maintain remission, in children (ages 6-17) with moderately to severely active Crohn’s disease who haven’t responded well to other therapies

Moderate to Severe Ulcerative Colitis (UC): Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active UC who haven’t responded well to other therapies

Moderate to Severe Pediatric Ulcerative Colitis: Can reduce signs and symptoms, and induce and maintain remission, in children (ages 6-17) with moderately to severely active ulcerative colitis who haven’t responded well to other therapies

Moderate to Severe Rheumatoid Arthritis (RA): Can reduce signs and symptoms, help stop further joint damage, and improve physical function in adult patients with moderately to severely active RA, in combination with methotrexate

Psoriatic Arthritis (PsA): Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in adult patients with PsA

Ankylosing Spondylitis (AS): Can reduce signs and symptoms in adult patients with active AS

Chronic Severe Plaque Psoriasis: Approved for the treatment of adult patients with severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if AVSOLA® is appropriate considering other available therapies

Please see full Prescribing Information.

AVSOLA® is a registered trademark of Amgen, Inc.

Important Safety Information

Only your doctor can recommend a course of treatment after checking your health condition. AVSOLA® (infliximab-axxq) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with AVSOLA®.

 

References: 1. AVSOLA® (infliximab-axxq) Prescribing Information, Amgen. 2. US Food and Drug Administration. What is a biosimilar? Accessed April 11, 2022. www.fda.gov/media/108905/download 3. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. Accessed April 11, 2022. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf 4. Genovese M, Sanchez-Burson J, Oh M, et al. Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis. Arthritis Res Ther. 2020;22:60. Published 2020 Mar 26. 5. Chow V, Oh M, Gessner M, Fanjiang G. Pharmacokinetic similarity of ABP 710, a proposed biosimilar to infliximab: results from a randomized, single-blind, single-dose, parallel-group study in healthy subjects. Clin Pharmacol Drug Dev. 2019. doi:10.1002/cpdd.738 6. American College of Rheumatology. Rheumatoid arthritis. Accessed March 2, 2022. www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis 7. National Institutes of Health. Psoriatic Arthritis. Accessed April 13, 2022. www.niams.nih.gov/health-topics/psoriatic-arthritis 8. Arthritis Foundation. New Drug Treatments for Psoriatic Arthritis. Accessed April 11, 2022. www.arthritis.org/diseases/more-about/newer-drug-treatments-for-psoriatic-arthritis 9. National Institutes of Health. Ankylosing spondylitis. Accessed April 11, 2022. 10. National Institutes of Health. National Institute of Diabetes and Digestive and Kidney Disease. Definition and facts for Crohn’s disease. Accessed April 13, 2022. www.niddk.nih.gov/health-information/digestive-diseases/crohns-disease/definition-facts# 11. National Institutes of Health. National Institute of Diabetes and Digestive and Kidney Disease. Ulcerative Colitis. Accessed April 11, 2022. www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis/definition-facts#