Avsola (infliximab-axxq) is a brand-name IV infusion that’s prescribed for certain autoimmune diseases, including rheumatoid arthritis, ulcerative colitis, and psoriasis. As with other drugs, Avsola can cause side effects, such as headache and infections.

Avsola has boxed warnings about the risk of serious infections and certain cancers. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section.

Avsola can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Avsola in clinical trials:

  • infusion-related reactions (See the “Side effect specifics” section)
  • upper respiratory infections, such as the common cold, sore throat, or sinusitis
  • headache
  • abdominal pain

Mild side effects can occur with Avsola use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Avsola’s prescribing information.

Mild side effects that have been reported with Avsola include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the FDA approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Avsola and want to tell the FDA about it, visit MedWatch.

Avsola may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Avsola’s prescribing information.

If you develop serious side effects while taking Avsola, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

  • blood cell problems, such as low levels of white blood cells or platelets, which may include symptoms such as:
    • bruising easily
    • unusual bleeding, such as nosebleeds or bleeding gums
    • fever
    • frequent infections
  • heart failure, which may include symptoms such as:
    • swelling of the lower legs or feet
    • shortness of breath
    • sudden weight gain
    • tiredness
  • liver problems, such as liver failure or hepatitis, which may include symptoms such as:
    • nausea and vomiting
    • abdominal pain
    • dark-colored urine
    • jaundice (yellowing of the skin or eyes)
  • nervous system problems, such as multiple sclerosis, which may include symptoms such as:
    • numbness or tingling
    • weakness
    • changes in vision
    • seizures
  • lupus-like syndrome (an immune system reaction), which may include symptoms such as:
    • rash on your cheeks or arms
    • joint pain
    • shortness of breath
    • chest pain
  • infusion-related reactions*
  • risk of serious infections*
  • risk of certain cancers*

* For more information about this side effect, see “Side effect specifics.”

ALLERGIC REACTION

For some people, Avsola can cause an allergic reaction.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Avsola infusion, your doctor may recommend taking a different medication instead.

Avsola may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

How do Avsola side effects compare with Remicade side effects?

Avsola and Remicade can cause similar side effects. This is because Avsola is a biosimilarTrusted Source of Remicade.

Remicade contains the active drug infliximab. Avsola contains the active drug infliximab-axxq. Biosimilars are like generics for biologic drugs. They are considered to be just as safe and effective as the parent drug.

If you have further questions about side effects of Avsola and Remicade, talk with your doctor or pharmacist.

Does Avsola cause hair loss?

No, Avsola is not known to cause hair loss. This side effect wasn’t reported in clinical trials of the drug.

However, new or worsening psoriasis has been reported in some people taking Avsola. If psoriasis affects the scalp, this can sometimes lead to hair loss. But it’s not known if new or worsening psoriasis is definitely caused by Avsola.

Keep in mind that hair loss may be a side effect of other drugs you may take with Avsola. For example, if you have rheumatoid arthritis, your doctor will usually prescribe methotrexate (Trexall, others) with Avsola. Methotrexate can cause hair loss.

If you experience hair loss while receiving treatment with Avsola, talk with your doctor. They can investigate the possible cause.

Is weight gain possible with Avsola?

No, Avsola doesn’t typically cause weight gain. Weight gain wasn’t reported in people who received Avsola in clinical trials.

However, Avsola can sometimes cause heart failure. Sudden weight gain is a possible symptom of heart failure. Other symptoms of heart failure can include swelling of the lower legs or feet and shortness of breath.

If you have unexpected weight gain while receiving Avsola treatment, consult your doctor. They can investigate the possible cause.

Learn more about some of the side effects that Avsola may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Avsola.

Risk of serious infections

Avsola has a boxed warning for the risk of serious infections. A boxed warning is the most serious warning from the FDA.

Avsola weakens your immune system and can increase your risk of infections, including infections that can be serious or even life threatening. In clinical trials, mild infections were commonly reported in people receiving Avsola, but serious reactions were rare.

Serious infections that have been reported in people taking Avsola include pneumonia, tuberculosis, widespread bacterial, fungal, and viral infections, and reactivation of hepatitis B.

Symptoms of infections can include:

  • fever
  • shortness of breath
  • cough that doesn’t get better
  • coughing up blood
  • weight loss
  • feeling very tired
  • warm, painful, red, or discolored areas of skin
  • burning pain when urinating

You may have a higher risk of infections with Avsola if you have diabetes or if you take other medications or have conditions that can weaken your immune system.

What you can do

Before you start treatment with Avsola, tell your doctor if you have any ongoing infections or infections that keep coming back. Also talk with your doctor about serious infections you have had in the past.

Your doctor will likely test you for tuberculosis and hepatitis B before prescribing Avsola. And they may prescribe medication to treat any infections that you currently have. Your doctor may also recommend getting certain vaccinations before you start Avsola treatment.

While receiving Avsola, you should talk with your doctor if you develop symptoms of infection. Your doctor will likely prescribe medication to treat the infection. They may also recommend stopping Avsola treatment and discuss alternative options with you.

If you have questions about the risk of infections during Avsola treatment, talk with your doctor.

Risk of certain cancers

Avsola also has a boxed warning for the risk of certain cancers.

Avsola may increase your risk of developing certain cancers, such as lymphoma, leukemia, and skin cancer.

Rare cases of cancer, including lymphoma, have been reported in children and teenagers taking drugs that are tumor necrosis factor (TNF) blockers, such as Avsola. In some cases, these cancers were fatal.

As well, a rare and aggressive form of lymphoma has been reported in teenage and young adult males* taking TNF blockers for Crohn’s disease or ulcerative colitis. Most cases occurred in those taking a TNF blocker with mercaptopurine (Purinethol, Purixan) or azathioprine (Azasan, Imuran). In many cases, these cancers were fatal.

In clinical trials, cancers were rarely reported in people receiving Avsola. Symptoms of cancer depend on the type of cancer but can include:

  • new skin lump or bump
  • skin sore that doesn’t heal
  • unexplained weight loss
  • fatigue with no obvious cause
  • fever
  • night sweats

You may have a higher risk of developing cancer if you have a history of heavy smoking or have had cancer in the past. You may also have a higher risk if you’ve had past phototherapy or treatment with other medications that weaken your immune system.

* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

What you can do

Before you start Avsola treatment, talk with your doctor about any risk factors you may have for developing cancer. This can help your doctor determine whether Avsola is safe for you.

Your doctor will likely monitor you for possible signs of cancer while you are receiving Avsola. If you develop any changes in your skin or any other possible symptoms of cancer, consult your doctor right away.

If you have questions or concerns about the risk of cancer with Avsola, talk with your doctor.

Infusion-related reactions

A health professional will administer your Avsola treatment by intravenous (IV) infusion. An IV infusion is an injection into a vein that’s given over a period of time.

It’s possible to have a reaction to Avsola infusion. This can occur either during or soon after the infusion and may be mild or serious. In clinical trials, mild infusion-related reactions were commonly reported in people receiving Avsola, but serious reactions were rare.

If they occur, infusion reactions typically happen during the infusion or within 1 hour after the infusion ends. An infusion reaction may cause symptoms such as:

  • fever or chills
  • shortness of breath
  • rash or itching
  • flushing
  • chest pain
  • headache
  • low or high blood pressure

In rare cases, stroke or heart problems, such as arrhythmias (abnormal heartbeats) or heart attack, may occur. These reactions occurred either during the infusion or up to 24 hours after the infusion ended.

Symptoms of heart problems or stroke can include:

  • heart palpitations
  • dizziness
  • pain, pressure, or tightness in your chest, back, neck, or jaw
  • sweating or clammy skin
  • shortness of breath
  • sudden weakness or numbness on one side of your face or body

What you can do

To help prevent infusion reactions, your doctor may prescribe certain medications to be given right before your Avsola infusions. These medications may include an antihistamine, such as famotidine (Pepcid), a corticosteroid, such as methylprednisolone (Solu-Medrol), and acetaminophen (Tylenol).

A healthcare professional will monitor you during your infusion and for a period of time after the infusion ends. If you have symptoms of an infusion reaction, tell your healthcare professional right away.

If you have symptoms during your infusion, your doctor may slow down or pause your infusion. They may also give you medications to treat your symptoms. If you have a severe infusion reaction, your doctor will likely stop your Avsola treatment.

If you experience symptoms of heart problems or stroke in the 24 hours after receiving an Avsola infusion, call 911 or your local emergency number right away.

If you have questions about the risk of infusion reactions with Avsola, talk with your doctor.

Below is important information you should consider before taking Avsola.

Avsola has boxed warnings about the risks of serious infections and certain cancers. A boxed warning is the most serious warning from the FDA. For details, see the “Side effect specifics” section.

Other precautions

Before taking Avsola, discuss your health history with your doctor. Avsola may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • heart failure
  • liver problems
  • chronic obstructive pulmonary disease (COPD)
  • history of cancer
  • past phototherapy for psoriasis
  • infections that are ongoing or keep coming back
  • history of tuberculosis or hepatitis B
  • weak immune system
  • diabetes
  • nervous system conditions, such as multiple sclerosis or epilepsy
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding
  • alcohol consumption
  • smoking
  • recent or upcoming vaccinations

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.