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.
Avsola side effects
Avsola can cause serious side effects, including:
See "Important information" above.
Serious Infections
Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as Avsola. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body or cause infections in certain areas (such as skin). Some patients die from these infections. If you get an infection while receiving treatment with Avsola your doctor will treat your infection and may need to stop your Avsola treatment.
Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving Avsola:
a fever
feel very tired
have a cough
have flu-like symptoms
warm, red, or painful skin
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Avsola and during treatment with Avsola.
Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving Avsola. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with Avsola. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with Avsola and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
feel unwell
poor appetite
tiredness (fatigue)
fever, skin rash, or joint pain
Heart Failure If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving Avsola. Your congestive heart failure may get worse while you are receiving Avsola. Be sure to tell your doctor of any new or worse symptoms including:
shortness of breath
swelling of ankles or feet
sudden weight gain Treatment with Avsola may need to be stopped if you get new or worse congestive heart failure.
Other Heart Problems Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of infliximab products. Symptoms may include 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. Tell your doctor right away if you have any of these symptoms.
Liver Injury Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:
jaundice (skin and eyes turning yellow)
dark brown-colored urine
pain on the right side of your stomach area (right-sided abdominal pain)
fever
extreme tiredness (severe fatigue)
Blood Problems In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you:
have a fever that does not go away
bruise or bleed very easily
look very pale
Nervous System Disorders Some patients receiving infliximab products have developed problems with their nervous system. Tell your doctor if you have:
changes in your vision
weakness in your arms or legs
numbness or tingling in any part of your body
seizures
Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include: 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 Some patients have had allergic reactions to infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your Avsola treatment or shortly afterward. Your doctor may need to stop or pause your treatment with Avsola and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include:
hives (red, raised, itchy patches of skin)
difficulty breathing
chest pain
high or low blood pressure
fever
chills Some patients treated with infliximab products have had delayed allergic reactions. The delayed reactions occurred 3 to 12 days after receiving treatment with infliximab products. Tell your doctor right away if you have any of these signs of delayed allergic reaction to Avsola:
fever
rash
headache
sore throat
muscle or joint pain
swelling of the face and hands
difficulty swallowing
Lupus-like Syndrome Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with Avsola.
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 Some people receiving infliximab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with Avsola.
The most common side effects of infliximab products include:
respiratory infections, such as sinus infections and sore throat
headache
coughing
stomach pain
Infusion reactions can happen up to 2 hours after your infusion of Avsola.
Symptoms of infusion reactions may include:
fever
chills
chest pain
low blood pressure or high blood pressure
shortness of breath
rash
itching
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.
Before taking Avsola
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.
Dosage in adult Crohn’s Disease. The recommended dosage of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adults with moderately to severely active Crohn's disease or fistulizing Crohn's disease. For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg every 8 weeks. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue Avsola in these patients.
Dosage in pediatric Crohn’s Disease. The recommended dosage of Avsola for pediatric patients 6 years and older with moderately to severely active Crohn's disease is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.
Dosage in adult Ulcerative Colitis. The recommended dosage of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adult patients with moderately to severely active ulcerative colitis.
Dosage in pediatric Ulcerative Colitis. The recommended dosage of Avsola for pediatric patients 6 years and older with moderately to severely active ulcerative colitis is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.
Dosage in Rheumatoid Arthritis. The recommended dosage of Avsola is 3 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 3 mg/kg every 8 weeks thereafter for the treatment of moderately to severely active rheumatoid arthritis. Avsola should be given in combination with methotrexate. For patients who have an incomplete response, consideration may be given to adjusting the dosage up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses per infusion or more frequent dosing.
Dosage in Ankylosing Spondylitis. The recommended dosage of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 6 weeks thereafter for the treatment of active ankylosing spondylitis.
Dosage in Psoriatic Arthritis. The recommended dosage of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of psoriatic arthritis. Avsola can be used with or without methotrexate.
Dosage in Plaque Psoriasis. The recommended dosage of Avsola in adult patients is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of chronic severe (i.e., extensive and/or disabling) psoriasis.
See full prescribing information for further details about Avsola dosing.
Warnings
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.
Your doctor should test you for TB before starting Avsola.
Your doctor should monitor you closely for signs and symptoms of TB during treatment with Avsola.
Before starting Avsola, tell your doctor if you:
think you have an infection. You should not start receiving Avsola if you have any kind of infection.
are being treated for an infection.
have signs of an infection, such as a fever, cough, flu-like symptoms.
have any open cuts or sores on your body.
get a lot of infections or have infections that keep coming back.
have diabetes or an immune system problem. People with these conditions have a higher chance for infections.
have TB, or have been in close contact with someone with TB.
live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may develop or become more severe if you receive Avsola. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
have or have had hepatitis B.
use the medicines Kineret (anakinra), Orencia (abatacept), Actemra (tocilizumab), or other medicines called biologics used to treat the same conditions as Avsola.
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
There have been cases of unusual cancers in children and teenage patients using tumor necrosis factor TNF blocker medicines, such as Avsola.
For children and adults receiving TNF blocker medicines, including Avsola, the chances of getting lymphoma or other cancers may increase.
Some people receiving TNF blockers, including Avsola, developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with a TNF blocker and another medicine called azathioprine or 6-mercaptopurine.
People who have been treated for rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis for a long time may be more likely to develop lymphoma. This is especially true for people with very active disease.
Some people treated with infliximab products such as Avsola have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with Avsola, tell your doctor.
Patients with Chronic Obstructive Pulmonary Disease (COPD), a specific type of lung disease, may have an increased risk for getting cancer while being treated with Avsola.
Some women being treated for rheumatoid arthritis with infliximab products have developed cervical cancer. For women receiving Avsola, including those over 60 years of age, your doctor may recommend that you continue to be regularly screened for cervical cancer.
Tell your doctor if you have ever had any type of cancer. Discuss with your doctor any need to adjust medicines you may be taking.
See the section "What are the side effects of Avsola?" below for more information.
What other drugs will affect Avsola
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.
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
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
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