Remicade is a brand-name prescription medication. It’s FDA-approved to treat certain autoimmune diseases in adults and children. These are conditions in which your immune system mistakenly attacks your body’s own tissues or organs. Conditions that Remicade is used to treat are:

Remicade is a treatment option for people whose disease is moderate to severe. For Crohn’s disease, ulcerative colitis, and plaque psoriasis, the drug is usually prescribed for people who tried other medications that didn’t ease their symptoms. For more information on how Remicade is used, see the “Remicade uses” section below.

Remicade drug class and form

Remicade contains the drug infliximab, which is a biologic (a drug made from parts of living organisms). Remicade belongs to a drug class called tumor necrosis factor-alpha (TNF-alpha) blockers. A class of drugs is a group of medications that work in a similar way.

Remicade comes as a vial of powder that’s mixed with a liquid solution. The drug is available in one strength: 100 milligrams (mg).

A healthcare professional will give you Remicade as an IV infusion. This is an injection into your vein that’s given over a period of time. Remicade infusions are typically about 2 hours long. You’ll usually receive an infusion every few weeks, but the timing depends on the condition that’s being treated.

Effectiveness

For information on the effectiveness of Remicade, please see the “Remicade uses” section below.

Remicade is available only as a brand-name medication. It contains the active drug ingredient infliximab.

The Food and Drug Administration (FDA) has approved four biosimilar versions of Remicade: Avsola, Inflectra, Ixifi, and Renflexis.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

Remicade can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Remicade. These lists don’t include all possible side effects.

For more information on the possible side effects of Remicade, talk with your doctor or pharmacist. They can also give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Remicade, you can do so through MedWatch.

More common side effects

The more common side effects of Remicade can include:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Remicade aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • New or worsening heart failure. Symptoms can include:
    • shortness of breath
    • edema (swelling, typically in your ankles and feet)
    • sudden weight gain
  • Heart attack. Symptoms can include:
  • Irregular heart rhythms. Symptoms can include:
    • fast or slow heart rate
    • fluttering heart rate
    • pounding in the chest
  • Stroke. Symptoms can include:
    • weakness on one side of the body
    • confusion
    • trouble speaking or understanding others
    • trouble seeing in one or both eyes
    • trouble standing or walking
    • dizziness
    • severe headache
  • Liver problems. Symptoms can include:
    • tiredness
    • fever
    • jaundice (yellowing of your skin and the white of your eyes)
    • dark-colored urine
    • pain on the right side of your belly
  • Blood disorders, such as a low level of white blood cells. Symptoms can include:
    • bruising or bleeding easily
    • pale skin
    • fever that lasts longer than 48 hours
    • frequent infections
  • Nervous system disorders, such as seizures or vision problems. Symptoms can include:
    • numbness or tingling of body parts
    • weakness in your arms or legs
    • vision loss or changes in how you see color
  • New or worsening psoriasis (a condition in which itchy, discolored patches form on your skin). Symptoms include:
    • scaly patches on skin, which may look pink, red, purple, or dark brown
    • raised bumps on skin that are filled with pus
  • Infusion reactions (symptoms or side effects that typically occur within 2 hours of your infusion). Symptoms can include:
  • Certain cancers,* such as lymphomas (cancers of the lymphatic system). Symptoms can include:

Other serious side effects, explained in more detail below in “Side effect details,” include:

* Remicade has boxed warnings for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “Side effect details” below.

Side effects in children

In clinical trials, children with Crohn’s disease or ulcerative colitis had certain side effects more often than adults.

Side effects that occurred more often in children were:

  • anemia (low level of red blood cells)
  • low level of white blood cells
  • flushing
  • bacterial and viral infections
  • bone fractures
  • allergic reactions of the throat and lungs

Your doctor will monitor your child for these side effects during and after Remicade treatment.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may or may not cause. In addition to the information below, you can also refer to this article about Remicade’s side effects.

Allergic reaction

As with most drugs, you may have an allergic reaction after taking Remicade. In clinical trials of people who took Remicade to treat rheumatoid arthritis (RA), at least 0.2% had an allergic reaction. Remicade wasn’t compared with a different drug or a placebo (treatment with no active drug.

In a clinical trial of children with Crohn’s disease, 6% of those who took Remicade had an allergic reaction that affected their lungs. Remicade wasn’t compared with a different drug or a placebo.

And in a clinical trial of adults with plaque psoriasis, 1% of people who took Remicade had a possible allergic reaction that occurred within 2 weeks after the infusion. Again, Remicade wasn’t compared with a different drug or a placebo.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing

It’s also possible to have an allergic reaction after taking Remicade for a while. Or you may have an allergic reaction if you receive a Remicade infusion after a break in treatment. In addition to the usual allergic reaction symptoms, you may have:

  • fever
  • headache
  • sore throat
  • muscle and joint pain

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Remicade. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Long-term side effects

Side effects can occur if Remicade is taken over a long period time of time. These long-term side effects are similar to those seen in clinical trials.

In one long-term study, 23.3% of people who took Remicade had long-term side effects. This was compared with 11% of people who took a different TNF inhibitor. However, long-term side effects may vary depending on what condition you’re using the drug to treat and what other medications you’re taking with Remicade.

Safety concerns with long-term Remicade use include:

  • increased risk of infections, such as TB or hepatitis B
  • new or worsening heart failure or other heart problems, such as heart attack
  • blood disorders, such as a low level of white blood cells
  • liver problems, which can lead to jaundice
  • nervous system disorders, such as seizures
  • lupus-like syndrome (an immune system reaction)
  • increased risk of certain cancers, such as lymphomas (cancers in the lymphatic system)

Some people treated with Remicade develop antibodies to the drug. These antibodies are immune system proteins that mistakenly attack the drug. If this occurs, Remicade may no longer work for you.

If you’re concerned about possible long-term side effects of Remicade, talk with your doctor.

Headache

Headache was one of the most common side effects seen in Remicade clinical trials. For example, 18% of people with RA who received Remicade had headaches. This was compared with 14% of people who took a placebo. Rates of headache may vary depending on what condition you’re using Remicade to treat.

Headache may also be a symptom of infusion reactions. These are symptoms or side effects that occur during or shortly after an infusion. Infusion reactions were one of the most common reasons that people stopped taking Remicade.

A headache may also be part of a delayed allergic reaction. This can occur several hours to days after an infusion.

A severe headache could be a sign of something more serious, such as a stroke. Other signs of a stroke include trouble walking or speaking, dizziness, or confusion.

If you have a headache that’s very painful or doesn’t improve with medication, call your doctor right away. If you feel like you’re having a medical emergency, call 911.

Rash

In a clinical trial of people with RA, 10% of those who took Remicade had rashes. In comparison, rash occurred in 5% of people who took a placebo. Rates of rash may vary depending on what condition you’re using Remicade to treat.

Rash is also a symptom of infusion reactions. These are side effects or symptoms that occur during or shortly after an infusion.

In addition, rash is a common symptom of lupus-like syndrome, an immune system reaction that can occur during Remicade treatment.

If you develop a rash while taking Remicade, talk with your doctor about possible remedies. If the rash is mild, they may recommend topical medication (treatment applied to the skin). If the rash is more serious, they may want you to stop taking Remicade and switch to a different drug.

Fatigue

In clinical trials, 9% of people with RA who took Remicade had fatigue (lack of energy). In comparison, 7% of people who took a placebo had fatigue. Rates of fatigue may vary depending on what condition you’re using Remicade to treat.

Fatigue can also be a symptom of more serious Remicade side effects, such as infections or liver problems.

In addition, fatigue is a common symptom of many autoimmune diseases (conditions in which your immune system attacks your body by mistake). Fatigue may be caused by:

  • inflammation (swelling)
  • stress
  • lack of sleep
  • pain
  • other factors

If fatigue is affecting your quality of life while you take Remicade, talk with your doctor. They can suggest ways to boost your energy levels.

Joint pain

In clinical trials, 8% of people with RA who took Remicade had joint pain.

Joint pain was also a side effect of delayed reactions, along with muscle pain, fever, and rash.

In addition, joint pain was reported in people whose tuberculosis (TB) or hepatitis B reactivated (came back) or who developed a new case of lupus-like syndrome (an immune system reaction).

Remicade is used to treat conditions that have symptoms such as joint pain. So it may be hard to determine whether Remicade or the disease is causing the joint pain.

If you have new or worsening joint pain, talk with your doctor. They’ll check to see if there are other conditions that may be causing the pain. Your doctor can also recommend pain medication to help ease your discomfort.

Lupus

Lupus-like syndrome (an immune system reaction) has been reported in clinical trials of Remicade. Symptoms include:

  • shortness of breath
  • chest pain or discomfort
  • joint pain
  • rashes on arms or cheeks, which tend to get worse in sunlight

Some people have also had fever, weight loss, and malaise (feeling weak, tired, and not well). Rare but serious symptoms of lupus-like syndrome can include lung inflammation (swelling), nerve problems, and blood clots. Symptoms can occur within months to years of starting Remicade use.

It’s thought that Remicade causes a lupus-like syndrome because of the development of autoantibodies following treatment. Autoantibodies are immune system proteins made in your body. They can mistakenly attack your own tissues or organs.

If you have lupus-like syndrome, your doctor may recommend that you stop taking Remicade. Symptoms usually go away within weeks to months after ending Remicade treatment.

Cancer, including lymphoma

New cases of cancers* were reported in people who took Remicade in clinical trials and in people taking the drug after it was made available to the public. Cancer cases were also reported in people who took other drugs in the tumor necrosis factor-alpha (TNF-alpha) blocker class. This is the drug class that Remicade is in.

It’s not clear whether Remicade causes cancer. However, it’s important to note that Remicade has a boxed warning for cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Types of cancer

About half of the cancers were lymphomas (cancers in the lymphatic system). Cells in the lymph system usually fight off infections, but they can become cancerous. Types of lymphatic system cancers include Hodgkin lymphoma and non-Hodgkin lymphoma.

Other types of cancers reported were skin cancer, cervical cancer, breast cancer, colorectal cancer, and the rare hepatosplenic T-cell lymphoma.

People with chronic obstructive pulmonary disease (COPD) also had new cases of lung cancer, or head or neck cancer. Many cases of cancer occurred in children, teenagers, and young adults. Most of the new cancer cases occurred in people who were taking additional drugs that reduced the activity of their immune system.

The following people may be at greater risk for developing cancer when taking Remicade:

  • those with COPD
  • females* older than age 60 years who have RA
  • those with Crohn’s disease or ulcerative colitis and who are taking a TNF-alpha blocker as well as azathioprine or methotrexate
  • those who have a very active autoimmune disease (a condition in which your immune system attacks your body by mistake) and have been treated for a long time

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

Statistics from studies

In clinical trials of various conditions,* new lymphoma cancers occurred at a rate of 1 case for every 1,000 people who took Remicade for a year. This rate is about four times higher than is seen in the general population.

In these trials, new cases of cancer (excluding lymphoma and skin cancer) occurred at a rate of about 5 cases for every 1,000 people who took Remicade for a year. This rate is similar to what’s expected in the general population.

* Rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis.

Possible risk of cancer with Remicade

Again, it’s not known whether Remicade actually causes cancer. A review of multiple studies found that the evidence of cancer risk was conflicting. Analyses of studies and registries that collect information from larger populations also have conflicting results.

If you have concerns about cancer, talk with your doctor about your medical history and your risk for cancer. They’ll explain the benefits and risks of taking Remicade.

Serious infections

Remicade can increase the risk of serious infections.* These infections include tuberculosis (TB), hepatitis B, fungal infections throughout the body, and other bacterial and viral infections.

Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

In clinical trials of Remicade, 36% of people who took Remicade received treatment for an infection. This was compared with 25% of people who took a placebo. It’s not known how many people may have had an infection but didn’t receive treatment for it.

Serious infections occurred at lower rates, however. For example, in clinical trials of RA, 5.3% of people who took Remicade had a serious infection. This was compared to 3.4% of people who took a placebo. Both groups also took methotrexate.

In one clinical trial of children with ulcerative colitis, 12% of those who took Remicade had a serious infection. Remicade wasn’t compared with a different drug or a placebo.

Symptoms of serious infections

Symptoms of serious infections can include:

  • cough
  • fever
  • tiredness
  • lack of appetite
  • rash
  • flu-like symptoms (such as a runny nose, chills, and muscle aches)

Your doctor will monitor you closely for symptoms of infection during and after Remicade treatment. You may need to be treated for an infection before you start to take Remicade. This is for cases in which you have an infection but don’t have symptoms yet.

Weight gain

Weight gain wasn’t a side effect reported in the initial clinical trials of Remicade.

However, it has been seen in some other studies:

  • A small survey was conducted in people with various conditions who took tumor necrosis factor-alpha (TNF-alpha) drugs. This is the drug class that includes Remicade. (A drug class is a group of medications that work in a similar way.) The survey found that 13.3% of the people gained weight. The average weight gain was about 12 pounds (5.5 kilograms).
  • In another small study, 68% of people with Crohn’s disease gained weight after taking Remicade for a year. Remicade wasn’t compared with a different drug or a placebo.
  • And in a different small study of people with psoriasis, those treated with Remicade gained about 6 pounds (2.9 kilograms) on average. In comparison, no weight gain was reported in people who took the psoriasis drugs ustekinumab or secukinumab.

Very sudden weight gain may also be a sign of new or worsening heart failure.

If you’re concerned about weight gain, talk with your doctor about possible causes. They can suggest ways you can manage your weight.

Depression (not a side effect)

Depression wasn’t reported as a side effect in Remicade clinical trials. However, many people who have an autoimmune disease (a condition in which your immune system attacks your body by mistake) do have depression because of their disease. This depression may be caused by:

  • inflammation (swelling)
  • pain
  • stress
  • lack of sleep
  • other factors

In clinical trials of people with inflammation conditions, such as psoriasis or Crohn’s disease, Remicade was found to be significantly more effective for easing depressive symptoms than a placebo. It’s not clear why, but a reduction in inflammation may have played a role.

If you think you might have depression, talk with your doctor. They can recommend treatments to help ease your symptoms.

Hair loss (not a side effect)

Hair loss wasn’t a side effect reported in clinical trials of Remicade.

In one trial, about 3% of people had hair loss while taking tumor necrosis factor-alpha (TNF-alpha) medications. These drugs are in the same class as Remicade. (A drug class is a group of medications that work in a similar way.) The TNF-alpha drugs weren’t compared with a different drug or a placebo.

In another trial, people who took Remicade had new or worsening cases of psoriasis. Symptoms can include itchy rashes or plaques (red or purple, inflamed patches) on the scalp. These can lead to hair loss in that area. Plaques can also form on the arms or legs, which can lead to hair loss there, too.

It’s not known why Remicade causes psoriasis in some people because the Food and Drug Administration (FDA) has approved the drug to actually treat psoriasis.

In some cases, people’s hair started growing again after they stopped taking Remicade.

If your doctor wants you to keep using Remicade, topical treatments may help lessen hair loss due to psoriasis. (Topical treatments are applied to the skin.) If you have any concerns about hair loss, talk with your doctor.

Effects on teeth (not a side effect)

In clinical trials, people who took Remicade didn’t have any side effects related to teeth.

However, people taking Remicade are at an increased risk of infections. These can include infections that may occur following dental procedures.

If you’re taking Remicade, talk with your doctor and dentist. They can advise you on how to keep your mouth healthy and help prevent infections related to dental procedures.

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Remicade, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are prescribed off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for moderate to severe Crohn’s disease

According to treatment guidelines, other drugs that may be used to treat Crohn’s disease include:

  • oral corticosteroids, such as prednisone
  • azathioprine (Azasan, Imuran)
  • 6-mercaptopurine (Purinethol, Purixan)
  • methotrexate (Trexall, Rasuvo, Otrexup, others)
  • adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)
  • vedolizumab (Entyvio)
  • natalizumab (Tysabri)
  • ustekinumab (Stelara)

Alternatives for ulcerative colitis

According to treatment guidelines, other drugs that may be used to treat ulcerative colitis include:

  • oral corticosteroids, such as prednisone
  • sulfasalazine (Azulfidine)
  • mesalamine (Apriso, Asacol HD, Canasa, SfRowasa)
  • balsalazide (Colazal, Giazo)
  • olsalazine (Dipentum)
  • rectal hydrocortisone (Cortifoam)
  • azathioprine (Azasan, Imuran)
  • 6-mercaptopurine (Purinethol, Purixan)

Alternatives for rheumatoid arthritis

According to treatment guidelines, other drugs that may be used to treat rheumatoid arthritis include:

  • oral corticosteroids, such as prednisone
  • methotrexate (Trexall, Rasuvo, Otrexup, others)
  • sulfasalazine (Azulfidine)
  • hydroxychloroquine (Plaquenil)
  • leflunomide (Arava)
  • adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)
  • golimumab (Simponi)
  • certolizumab pegol (Cimzia)
  • etanercept (Enbrel, Erelzi)
  • abatacept (Orencia)
  • tocilizumab (Actemra)

Alternatives for ankylosing spondylitis

According to treatment guidelines, other drugs may be used to treat ankylosing spondylitis. Some of these drugs are:

Alternatives for psoriatic arthritis

According to treatment guidelines, other drugs that may be used to psoriatic arthritis are:

  • NSAIDS, such as naproxen (Aleve, Naprosyn) and celecoxib (Celebrex)
  • oral or injectable corticosteroids, such as prednisone, methylprednisolone (Depo-Medrol, Medrol), hydrocortisone (Solu-Cortef)
  • methotrexate (Trexall, Rasuvo, Otrexup, others)
  • sulfasalazine (Azulfidine)
  • adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)
  • golimumab (Simponi)
  • certolizumab pegol (Cimzia)
  • etanercept (Enbrel, Erelzi)
  • ustekinumab (Stelara)
  • secukinumab (Cosentyx)
  • abatacept (Orencia)

Alternatives for plaque psoriasis

According to treatment guidelines, other drugs that may be used to treat plaque psoriasis include:

  • topical (treatment applied to the skin) corticosteroids
  • topical vitamin D analogues, such as calcipotriene (Dovonex, Enstilar, Sorilux), calcitriol (Vectical)
  • topical retinoids, such as tazarotene (Tazorac)
  • topical coal tar
  • methotrexate (Trexall, Rasuvo, Otrexup, others)
  • etanercept (Enbrel, Erelzi)
  • adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)

Like Humira (discussed below), the drug Inflectra (infliximab-dyyb) has uses similar to those of Remicade. Here’s a comparison of how Remicade and Inflectra are alike and different.

Ingredients

Remicade contains the drug infliximab.

Inflectra contains infliximab-dyyb, a biosimilar of infliximab.

Biosimilars are biologic drugs made from living organisms. They are very similar to another medication (a reference drug) approved by the Food and Drug Administration (FDA).

Remicade is the reference drug for Inflectra. The “-dyyb” ending is added to the drug name to show that Remicade and Inflectra are two different products.

The FDA has reviewed how safe and effective biosimilars and their reference drugs are. The two medications act in very similar ways in the body. There aren’t any major differences in how they work. So the information for Remicade and its biosimilar Inflectra is alike.

Uses

Remicade and Inflectra are FDA-approved to treat people with the following conditions:

Remicade and Inflectra are considered treatment options for people whose disease is moderate to severe. For Crohn’s disease, ulcerative colitis, and plaque psoriasis, these drugs are usually prescribed for people who tried other medications that didn’t ease their symptoms. For more information on how Remicade is used, see the “Remicade uses” section below.

Drug forms and administration

Remicade and Inflectra both come as a vial of powder. Your healthcare professional will mix it with a liquid to make a solution.

Both drugs are given as an infusion. This is an injection into your vein that’s given over a period of time.

You’ll go to your doctor’s office or a clinic to have the infusions. Remicade and Inflectra infusions are usually about 2 hours long. The usual dosing schedule is once every 8 weeks after you complete the first stage of dosing.

Side effects and risks

Because Inflectra is a biosimilar of infliximab (the active drug in Remicade), Inflectra and Remicade have the same side effects. Examples of common and serious side effects for each drug are listed below.

More common side effects

This list contains more common side effects that can occur with both Remicade and Inflectra (when taken individually):

Serious side effects

Here are examples of serious side effects that can occur with Remicade and Inflectra (when taken individually):

* Remicade and Inflectra have boxed warnings for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see the “Remicade side effects” section above.

Effectiveness

Remicade and Inflectra have the same FDA-approved uses.

The FDA has reviewed how safe and effective Remicade biosimilars, such as Inflectra, are. Remicade and Inflectra act in very similar ways in the body. There aren’t any major differences in how they work.

A clinical trial looked at people with Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, or plaque psoriasis. The people either switched from Remicade to Inflectra or kept taking Remicade. Inflectra helped control symptoms about as well Remicade.

A review article that included several clinical studies also found that switching from Remicade to biosimilars (such as Inflectra) provided similar symptom control.

However, current evidence of the long-term effectiveness of Remicade compared with its biosimilars is limited.

Costs

Remicade and Inflectra are both brand-name drugs. Remicade has four biosimilars: Avsola, Inflectra, Ixifi, and Renflexis. Inflectra is a biosimilar of Remicade.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

Remicade generally costs more than Inflectra per vial. The actual price you’ll pay for either drug depends on your dose, your location, and your insurance plan.

Note: For more details about how Remicade and Inflectra compare, you can refer to this article.

The Food and Drug Administration (FDA) approves prescription drugs such as Remicade to treat certain conditions. Remicade may also be prescribed off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Approved uses for Remicade

Remicade is approved by the FDA to treat several autoimmune diseases (conditions in which your immune system attacks your body by mistake).

Remicade for Crohn’s disease

Crohn’s disease is a kind of inflammatory bowel disease (IBD) in which you have inflammation (swelling) in your digestive tract. To learn more, you can refer to our IBD hub.

Remicade is FDA-approved to treat moderate to severe Crohn’s disease in adults as well as children ages 6 years and older. It’s approved for use when other commonly used medications haven’t eased Crohn’s disease symptoms well enough.

Remicade for ulcerative colitis

Ulcerative colitis is also a type of IBD, but you have inflammation in your colon (large intestine). To learn more about ulcerative colitis, you can refer to our IBD hub.

Remicade is FDA-approved to treat moderate to severe ulcerative colitis in adults as well as children ages 6 years and older. It’s approved for use when other conventional medications haven’t eased ulcerative colitis symptoms well enough.

Remicade for plaque psoriasis

Plaque psoriasis is a type of psoriasis in which itchy patches form on your skin. The patches may be pink, red, purple, or brown. To learn more about this condition, you can see our psoriasis hub.

Remicade is FDA-approved to treat chronic, severe plaque psoriasis in adults who:

  • can take oral or injectable drugs that are systemic (work throughout the body)
  • can’t take other conventional medications

Remicade for rheumatoid arthritis

With rheumatoid arthritis (RA), you have pain and inflammation in your joints and other body parts. For details about this condition, refer to our RA hub.

Remicade is FDA-approved to treat moderate to severe RA in adults. It’s used with the drug methotrexate.

Remicade for ankylosing spondylitis

Ankylosing spondylitis is a form of arthritis that mostly affects your spine. To learn more about this condition, you can see our arthritis hub.

Remicade is approved by the FDA to treat active ankylosing spondylitis in adults. “Active” means that you currently have symptoms.

Remicade for psoriatic arthritis

Psoriatic arthritis is a kind of joint swelling that can occur with the skin condition psoriasis.

Remicade is FDA-approved to treat active psoriatic arthritis in adults. “Active” means that you currently have symptoms.

To learn more about psoriatic arthritis, you can see our psoriasis hub and arthritis hub.

Remicade effectiveness

Here are some examples of the effectiveness of Remicade in clinical studies:

  • Crohn’s disease in adults. In a clinical trial, adults with Crohn’s disease took Remicade. Between 39% and 46% of them were in disease remission (free from symptoms) after 30 weeks. In comparison, 25% of people who had one dose of Remicade followed by a placebo (treatment with no active drug) every 8 weeks had this result.
  • Crohn’s disease in children. In a clinical trial, children with Crohn’s disease took Remicade every 8 weeks or every 12 weeks. After 30 weeks of treatment, 60% of those who took Remicade every 8 weeks were free from symptoms. In comparison, 35% of children who took Remicade every 12 weeks had this response. Remicade wasn’t compared with a different drug or a placebo.
  • Ulcerative colitis in adults. In clinical trials, people with ulcerative colitis took Remicade. Between 26% and 37% of them were free from symptoms after 30 weeks. In comparison, between 11% and 16% of people who took a placebo had this result.
  • Ulcerative colitis in children. In a clinical trial, children with ulcerative colitis took Remicade every 8 weeks or every 12 weeks. Of those who took Remicade every 8 weeks, 38% were free from symptoms after 54 weeks. Of those who took the drug every 12 weeks, 18% had this result. Remicade wasn’t compared with a different drug or a placebo.
  • Rheumatoid arthritis. In a clinical trial, people with rheumatoid arthritis took Remicade or a placebo. Both groups also took methotrexate. After 30 weeks, between 26% and 31% of the Remicade group saw a 50% improvement in symptoms. In comparison, 5% of people in the placebo group had this result.
  • Ankylosing spondylitis. In a clinical trial, people with ankylosing spondylitis took Remicade or a placebo. After 24 weeks, 44% of those who took Remicade saw their symptoms improve by at least 50%. In comparison, 9% of people who took a placebo had this result.
  • Psoriatic arthritis. In a clinical trial, people with psoriatic arthritis took Remicade or a placebo. After 6 months, 41% of those who took Remicade saw their symptoms improve by at least 50%. In comparison, 4% of people who took a placebo had this result.
  • Plaque psoriasis. In a clinical trial, people with plaque psoriasis took Remicade or placebo. After 10 weeks, 80% of those who took Remicade had no symptoms or minimal symptoms. In comparison, 4% of people who took a placebo had these results.

In many of these cases, people took other medications with Remicade. Examples of these drugs are methotrexate and corticosteroids, such as prednisone. How well Remicade works for you will depend on many factors. These include the symptoms of your disease, other health conditions you have, other medications you take, and your dose and treatment schedule.

Uses that are not approved

The FDA hasn’t approved Remicade to treat conditions other than the ones mentioned above. But sometimes the drug may be used off-label for other inflammatory diseases, which involve inflammation (swelling). Some of these conditions include:

Remicade for children

Remicade is approved by the FDA to treat children ages 6 years and older with moderate to severe Crohn’s disease or moderate to severe ulcerative colitis.

For information on the effectiveness of Remicade in treating these conditions, see the “Remicade effectiveness” section above.

As with all medications, the cost of Remicade can vary. The actual price you’ll pay depends on your insurance coverage and your location.

Your insurance plan may require you to get prior authorization before approving coverage for Remicade. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Remicade.

If you’re not sure if you’ll need to get prior authorization for Remicade, contact your insurance company.

Financial assistance

If you need financial support to pay for Remicade, help is available. Janssen, the manufacturer of Remicade, offers a program called Janssen CarePath. Other programs may also be available, depending on your insurance coverage. For more information and to find out if you’re eligible for support, visit the drug’s website.

The Remicade dosage that your doctor prescribes will depend on several factors. These include:

  • the condition you’re using Remicade to treat
  • how much you weigh
  • how well your body responds to Remicade treatment

The following information describes dosages that are commonly used or recommended. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Remicade comes as a vial of powder, and each vial contains 100 milligrams (mg) of infliximab (the active drug in Remicade). Your healthcare professional will add a liquid to the vial to make a solution.

Then the healthcare professional will give you the Remicade solution as an infusion. This is an injection into your vein that’s given over a period of time.

Remicade infusions are typically about 2 hours long.

Dosage for FDA-approved indications

Your Remicade dosage will be based on your weight and the condition you’re taking Remicade for.

Remicade is given in two stages: an induction (beginning) stage and a maintenance stage.

In the induction stage, you’ll receive Remicade infusions at week 0, week 2, and week 6. After the induction stage, you’ll receive maintenance infusions every 6 or 8 weeks.

You may need higher doses or more frequent doses to help control your condition.

Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis

Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis have the same recommended dosing for adults. You’ll receive induction infusions of 5 milligrams per kilogram of body weight (mg/kg)* at weeks 0, 2, and 6. Then you’ll have maintenance infusions of 5 mg/kg every 8 weeks thereafter.

Here’s an example of how Remicade dosages are usually calculated: Someone weighing 176 pounds (lb), which is around 80 kilograms (kg)*, and taking Remicade for Crohn’s disease would receive a dose of about 400 mg in each infusion.

* One kg equals about 2.2 lb.

Rheumatoid arthritis

For rheumatoid arthritis (RA) in adults, the recommended dosing is induction infusions of 3 mg/kg at weeks 0, 2, and 6. Then you’ll have maintenance infusions of 3 mg/kg every 8 weeks thereafter. If needed in some cases, infusions may be given every 4 weeks.

Ankylosing spondylitis

For ankylosing spondylitis in adults, the recommended dosing is induction infusions of 5 mg/kg at weeks 0, 2, and 6. Then you’ll have maintenance infusions of 5 mg/kg every 6 weeks thereafter.

Pediatric dosage

The Food and Drug Administration (FDA) has approved Remicade to treat Crohn’s disease or ulcerative colitis in children.

The dosage for children is the same as for adults. The induction (beginning) stage of dosing is 5 mg/kg (5 mg/2.2 lb) at weeks 0, 2, and 6. That’s followed by maintenance dosing of 5 mg/kg every 8 weeks.

What if I miss a dose?

It’s important to attend all your infusion visits. This gives you the best chance of improving your condition. If you regularly miss infusion appointments, your condition may worsen.

If you can’t make an appointment or forget to go, call your doctor’s office right away. The staff can reschedule your infusion. They may adjust the timing of your next visit based on when you had your most recent infusion.

When you make an appointment, write it down on a calendar. Or put a reminder on your phone so you can stay on track with your infusions.

Will I need to use this drug long term?

Remicade is meant to be used as a long-term treatment. If you and your doctor determine that Remicade is safe and effective for you, you’ll likely take it long term.

Note: For more information about Remicade’s dosage, you can refer to this article.

You may wonder how Remicade compares with other medications that are prescribed for similar uses. Here we look at how Remicade and Humira are alike and different.

Ingredients

Remicade contains the drug infliximab. Humira contains the drug adalimumab.

Uses

The Food and Drug Administration (FDA) has approved both Remicade and Humira to treat the following conditions:

Humira is also FDA-approved to treat:

Remicade and Humira are considered treatment options for people whose disease is moderate to severe. For Crohn’s disease, ulcerative colitis, and plaque psoriasis, the drugs are usually prescribed for people who tried other medications that didn’t ease their symptoms. For more information on how Remicade is used, see the “Remicade uses” section below.

Drug forms and administration

Remicade comes as a vial of powder. Your healthcare professional will mix it with a liquid to make a solution. They will then give you the Remicade solution as an infusion. This is an injection into your vein that’s given over a period of time.

You’ll go to your doctor’s office or a clinic to have the infusions. Remicade infusions are typically around 2 hours long. The usual dosing schedule is once every 8 weeks after you complete the first stage of dosing.

Humira comes in three forms:

  • a prefilled, single-dose syringe
  • a prefilled, single-dose pen
  • a single-dose vial for use only by a healthcare professional

Humira is given as an injection just under your skin (subcutaneous). A healthcare professional can give you the injections, or you can inject yourself at home. The usual dosing schedule is one injection every other week.

Side effects and risks

Remicade and Humira work in different ways but have some similar side effects. Examples of common and serious side effects for each drug are listed below.

People in both Remicade clinical trials and Humira clinical trials had side effects. But these may be symptoms of other side effects. For example, a fever may be a symptom of an infection. Side effects may overlap between the drugs.

More common side effects

Here are examples of more common side effects that can occur with Remicade, with Humira, or with both drugs (when taken individually).

Serious side effects

Here are examples of serious side effects that can occur with Remicade, with Humira, or with both drugs (when taken individually).

* Remicade and Humira have boxed warnings for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see the “Remicade side effects” section above.

Effectiveness

Remicade and Humira have different FDA-approved uses. But they’re both used to treat the following conditions:

  • Crohn’s disease
  • ulcerative colitis
  • rheumatoid arthritis
  • ankylosing spondylitis
  • psoriatic arthritis
  • plaque psoriasis

These drugs haven’t been directly compared in clinical studies, but studies have found both Remicade and Humira to be effective for treating the conditions mentioned above.

Costs

Remicade and Humira are both brand-name drugs. Biosimilars of both Remicade and Humira are FDA-approved.

  • Remicade’s biosimilars are Inflectra, Ixifi, Avsola, and Renflexis.
  • Humira’s biosimilars are Hadlima, Cyltezo, Hyrimoz, Abrilada, and Amjevita.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

The cost of Remicade and Humira depends on many factors, including the form used, the dosage, and the length of treatment.

Some people’s immune systems will develop antidrug antibodies to Remicade. Antibodies are immune system proteins that the body develops in response to foreign substances. Antibodies to Remicade will mistakenly attack the drug and clear it from your body more quickly.

Developing antibodies to Remicade can cause the drug to be less effective for you. It may also increase your risk of having a reaction to Remicade infusions. If you have a reaction, your doctor may recommend switching to a different medication.

In one study, researchers reviewed several clinical trials. They found that people who took Remicade had one of the highest rates of antidrug antibody formation. This was compared with people who took other biologic drugs for their conditions. (A biologic drug is made from parts of living organisms.)

If you’re taking higher doses of Remicade or taking Remicade with other drugs, you’re more likely to develop antibodies to Remicade.

If you have any questions about antibodies and Remicade, talk with your doctor.

If you can become pregnant, are breastfeeding, or using birth control, it’s important to consider whether Remicade is a safe choice for you.

You can also refer to this article for more information. If you have additional questions, talk with your doctor.

Remicade and alcohol don’t interact with each other.

While you take Remicade, it’s important to follow a healthy lifestyle. This helps your immune system work as well as possible.

Drinking too much alcohol can reduce the activity of your immune system. When your immune system isn’t strong enough to fight germs, you may be at risk for serious infections.*

Remicade has been linked to serious liver problems, which can lead to jaundice (yellowing of your skin and the white of your eyes). Drinking too much alcohol can damage your liver as well. So taking Remicade while drinking too much alcohol can increase your risk for liver problems.

If you drink alcohol, and you want to drink it during treatment with Remicade, talk with your doctor about whether this is safe for you.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see the “Remicade side effects” section above.

Remicade is often used with other drugs in certain situations.

Combination therapy with methotrexate and other drugs

Your doctor may prescribe medication for you to take with Remicade to better control your symptoms. These drugs often ease inflammation (swelling) by treating different parts of your immune system than Remicade does.

For example, the American College of Gastroenterology recommends combination therapy for people with moderate to severe Crohn’s disease. The guidelines suggest using Remicade with medications such as azathioprine (Azasan, Imuran) or methotrexate (Otrexup, Rasuvo, RediTrex, Trexall, Xatmep). They also recommend taking corticosteroids, such as prednisone, with Remicade or other similar drugs.

Examples of other medications that may be used with Remicade to treat symptoms of rheumatoid arthritis (RA) include:

Examples of other medications that may be used with Remicade to treat symptoms of plaque psoriasis include:

  • topical (treatment applied to the skin) corticosteroids, such as betamethasone (Beta-Val)
  • topical calcipotriene (Dovonex, Enstilar, Sorilux)
  • coal tar

Many of the conditions that Remicade treats can also be treated with similar additional medications. Talk with your doctor about the safety and effectiveness of all over-the-counter or prescription drugs you’re considering for your treatment.

Infusion reaction medications

Some people may have mild or moderate reactions during or shortly after receiving Remicade. Examples of possible symptoms include:

It’s common to take medications shortly before Remicade treatment to help prevent these reactions. These premedications include:

Remicade can interact with several other medications. It can also interact with certain supplements and foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Remicade and other medications

Below is a list of medications that can interact with Remicade. This list doesn’t contain all drugs that may interact with Remicade.

Before taking Remicade, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Remicade with methotrexate

It’s not known exactly whether Remicade and methotrexate interact with each other. However, Remicade is prescribed with methotrexate for many autoimmune diseases (conditions in which your immune system attacks your body by mistake). These include rheumatoid arthritis (RA) and psoriatic arthritis.

In fact, taking methotrexate with Remicade may lower the risk of developing antibodies to Remicade. (Antibodies are immune system proteins that attack substances, such as Remicade, and can make them less effective.) Methotrexate may also increase how much Remicade circulates through your body. In both cases, Remicade may be more effective.

It’s also possible that taking Remicade with another medication that reduces the activity of your immune system could increase your risk for infections and cancer.* Your doctor will monitor you closely for infections and cancer if you take Remicade, with or without methotrexate.

* Remicade has boxed warnings for serious infections and cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see the “Remicade side effects” section above.

Remicade and certain medications that reduce activity of the immune system

Taking Remicade with certain biologic medications (drugs made from living organisms) can further reduce your immune system activity. This increases your risk for serious infections.*

Examples of medications that can reduce the activity of the immune system and should not be taken with Remicade include:

If you’re taking any of these medications, talk with your doctor before you start taking Remicade. They may recommend other treatment options.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see the “Remicade side effects” section above.

Remicade and live vaccines

You shouldn’t receive live vaccines while taking Remicade. The drug decreases your immune system’s ability to fight infections.* So you may be at risk for the infection that the vaccine typically helps prevent.

Examples of live vaccines to avoid while taking Remicade include:

Before starting Remicade, make sure you’re up to date on all vaccines. If you need a live vaccine, get it before you start your Remicade treatment.

Live vaccines and babies

If you took Remicade while pregnant, your baby shouldn’t get live vaccines until they’re at least 6 months old. Babies exposed to Remicade before birth and who get vaccines too soon can have a higher risk for infections, serious complications, or death.

Here are some live vaccines that your baby shouldn’t receive for at least 6 months after birth:

If you have questions about what vaccines your baby needs and when they should have them, talk with your child’s doctor.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see the “Remicade side effects” section above.

Remicade and warfarin

Taking Remicade with warfarin (Jantoven) may affect how quickly your body metabolizes (breaks down) warfarin. This could change how effective warfarin is at helping prevent blood clots. When you start or stop taking Remicade, your doctor will monitor your body’s response to warfarin. You may need a different dose of warfarin.

Remicade and theophylline

Taking Remicade with theophylline (Theocron, Theo-24, others) may affect how your body metabolizes (breaks down) theophylline. This could change how safe and effective theophylline will be. When you start or stop taking Remicade, your doctor will monitor your body’s response to theophylline. You may need a different dose of theophylline.

Remicade and cyclosporine

Taking Remicade with cyclosporine (Restasis, Sandimmune, others) may affect how your body metabolizes (breaks down) cyclosporine. This could change how safe and effective cyclosporine will be. When you start or stop taking Remicade, your doctor will monitor your body’s response to cyclosporine. You may need a different dose of cyclosporine.

Remicade and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Remicade, according to the drug’s manufacturer.

However, you should still check with your doctor or pharmacist before using any of these products while taking Remicade.

Remicade and foods

There aren’t any foods that have been specifically reported by the manufacturer that interact with Remicade. If you have any questions about eating certain foods with Remicade, talk with your doctor.

Here are answers to some frequently asked questions about Remicade.

Will I have withdrawal symptoms if I stop taking Remicade?

No, you won’t have actual withdrawal symptoms. These are symptoms that occur when you stop taking a drug your body has become dependent on. But you may have more symptoms of your condition or they may worsen if you stop taking Remicade.

In a small study, researchers tested the outcomes of stopping Remicade treatment. They found that 72.1% of people needed medication to treat their condition after they stopped taking Remicade.

This study included people with Crohn’s disease. They were in clinical remission (free from symptoms) at the time they stopped using Remicade. People stayed symptom free for an average of 1 year after they stopped taking Remicade.

If you have questions about what to expect when your doctor ends your Remicade treatment, talk with them.

Is Remicade a form of chemotherapy?

No, Remicade isn’t a form of chemotherapy. Remicade is a biologic, which means it’s made from living organisms. Specifically, Remicade is monoclonal antibody that’s made from immune system cells in a lab. Monoclonal antibodies only block the activity of certain proteins in the body.

Chemotherapy, on the other hand, is a chemical drug that destroys rapidly growing cells throughout the body. It’s typically used to treat cancer. Chemotherapy medications affect many types of cells and organs. This is different from the very specific actions of monoclonal antibodies, such as Remicade.

Can Remicade cause cancer?

It’s not clear whether Remicade causes cancer.

There have been reports of new or unusual cancers* with the use of Remicade and other drugs in the tumor necrosis factor-alpha (TNF-alpha) blockers class. (A class of drugs is a group of medications that work in a similar way.)

Some of the cancers included lymphoma (cancer of the lymphatic system), skin cancer, and cervical cancer. Many of the cases occurred in younger males,† with the exception of cervical cancer.

However, in a review of multiple studies, the evidence for cancer risk was conflicting. Analyses of studies and registries that collect information from larger populations have also had conflicting results.

If you have concerns about cancer, talk with your doctor about your medical history and your risk for cancer. They’ll explain the benefits and risks of taking Remicade. For more information about Remicade and cancer, see the “Remicade side effects” section above.

* Remicade has a boxed warning for cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).
† Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

Could Remicade stop working for me?

Yes. Remicade may become less effective for you over time. This can occur if your body’s immune system starts to recognize Remicade as a foreign invader and makes antibodies to Remicade. Antibodies are immune system proteins that fight foreign substances, including medications such as Remicade.

If your body makes anti-Remicade antibodies, the drug will clear from your system faster and won’t be as effective.

Remicade may also stop working for a time because of stress, dietary choices, or other health conditions.

If you’re concerned about how effective Remicade is in treating your condition, talk with your doctor.

Can I get vaccines while being treated with Remicade?

Yes and no. You can get inactive (not live) vaccines while taking Remicade. Inactive vaccines are made from germs that have been killed. Many of the vaccines that doctors recommend are inactive.

However, Remicade can reduce your immune system’s ability to fight infections.* So you should not get live vaccines during treatment. Live vaccines are made from weakened forms of germs. Examples of live vaccines to avoid while taking Remicade include the measles, mumps, and rubella (MMR) vaccine and the yellow fever vaccine. For more information, see the “Remicade interactions” section above.

Before you start taking Remicade, check with your doctor to see if you’re up to date on your vaccines.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see the “Remicade side effects” section above.

Remicade is used to treat certain autoimmune diseases. These are conditions in which your immune system mistakenly attacks your body’s own tissues or organs.

Remicade blocks the action of tumor necrosis factor-alpha (TNF-alpha). It’s an immune system protein in your body that’s involved in inflammation (swelling).

Most people with autoimmune diseases have higher-than-usual levels of TNF-alpha and too much inflammation. By blocking the activity of TNF-alpha, Remicade helps limit your immune system’s attack on healthy organs and body parts.

How long does it take to work?

Remicade starts to affect your immune system right away. But you may not see your symptoms improve for several days to weeks.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Serious infections. People who take Remicade have an increased risk for serious infections that may lead to a hospital stay or death. These include tuberculosis (TB), fungal infections throughout the body, and other bacterial and viral infections. Before you start taking Remicade, your doctor will test you for TB and monitor you for it during your treatment. If you develop a serious infection while using Remicade, your doctor will have you stop taking the drug.

Cancers. Certain cancers, including lymphoma (cancer of the lymphatic system) and skin cancer, have been reported in people who took Remicade or other medications called tumor necrosis factor (TNF) blockers. (Remicade is a TNF blocker.) Some of the cases that occurred in children and teens were fatal.

One specific kind of lymphoma was hepatosplenic T-cell lymphoma. Most of the people who developed it were teenage or young adult males* who had ulcerative colitis or Crohn’s disease. Nearly all of them were also taking a TNF blocker with the drugs azathioprine or 6-mercaptopurine.

Your doctor will screen you regularly for cancer during and after Remicade treatment.

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

Other precautions

Before taking Remicade, talk with your doctor about your health history. Remicade may not be right for you if you have certain medical conditions. These include:

  • Current infections. Remicade can reduce the activity of your immune system, making it less able to fight germs. This can lead to serious infections. Talk with your doctor about any current or past infections you’ve had. If you have a history of certain infections, you may need to delay starting Remicade until the infection has been treated.
  • Cancers. Cancers have been reported in people treated with Remicade. Tell your doctor if you’ve had cancer in the past. They can discuss the risks and benefits of Remicade treatment.
  • Hepatitis B. Remicade can reactivate the hepatitis B virus if you were infected with the virus in the past. Your doctor will test you for hepatitis B before you start taking Remicade. If you test positive for hepatitis B, your doctor will monitor you closely for signs and symptoms of the virus during your Remicade treatment. You may require more treatment for hepatitis B.
  • Liver damage. Severe liver damage has been reported in people who received Remicade. In certain cases, liver damage led to liver failure, liver transplant, and death. Talk with your doctor about any history of liver damage or liver disease you have. They’ll monitor you closely for signs and symptoms of worsening liver function during your Remicade treatment.
  • Heart failure. People have had new or worsening heart failure while receiving Remicade. Certain doses of Remicade aren’t safe for people with moderate or severe heart failure. Tell your doctor if you have heart failure or a history of heart disease. They’ll discuss the risks and benefits of Remicade treatment.
  • Blood disorders. Blood disorders, including low levels of white blood cells, have been reported with Remicade treatment. Some cases have led to death. Tell your doctor if you have a history of blood disorders. They’ll monitor you closely for signs and symptoms of worsening blood disorders while you receive Remicade.
  • Serious infusion reactions. People have had serious cardiovascular (heart and blood vessel) or brain problems during or within hours of receiving a Remicade infusion. Examples of these problems include heart attack, stroke, low or high blood pressure, and irregular heart rhythms (heartbeat that’s too fast, too slow, or irregular). Tell your doctor if you have a history of serious infusion reactions or cardiovascular or brain problems. They’ll monitor you closely during and after your infusions.
  • Nervous system reactions. Some people have had new or worsening central nervous system disorders while taking Remicade. These include seizures and multiple sclerosis. Tell your doctor if you have a nervous system disorder or had one in the past. They’ll monitor you closely for new or worsening symptoms during your Remicade treatment.
  • Allergic reaction. If you’ve had a severe allergic reaction to Remicade or any of its ingredients, you shouldn’t take Remicade. Ask your doctor what other treatments are better choices for you.
  • Pregnancy. It’s not known whether Remicade is safe to take during pregnancy. For more information, please see the “Remicade and pregnancy” section above.
  • Breastfeeding. Breastfeeding while taking Remicade isn’t recommended. For more information, please see the “Remicade and breastfeeding” section above.

Note: For more information about the potential negative effects of Remicade, see the “Remicade side effects” section above.

The following information is provided for clinicians and other healthcare professionals.

Indications

Remicade (infliximab) is FDA-approved to treat the following:

Administration

Remicade is administered by intravenous infusion.

Mechanism of action

Remicade is a monoclonal antibody that binds to tumor necrosis factor-alpha ligand and prevents it from binding to receptors. This results in decreased downstream immune system activation, including induction, migration, and activity of cytokines and immune system proteins and cells.

Pharmacokinetics and metabolism

Distribution is primarily in the vasculature. Metabolism is expected to occur via catabolism to smaller peptides and amino acids.

The median terminal half-life of Remicade is 7.7 to 9.5 days. There is no evidence of systemic accumulation following repeated doses, but clearance is increased in the presence of anti-infliximab antibodies.

Age, weight, and gender have no effect on clearance or volume of distribution.

Contraindications

Remicade in doses greater than 5 mg/kg is contraindicated for use in people with moderate to severe heart failure.

Remicade is also contraindicated in people with:

  • a history of severe hypersensitivity reactions to the drug
  • a history of hypersensitivity to any component of the drug or to murine proteins

Storage

Unopened vials of Remicade should be stored in the refrigerator at temperatures of 36°F to 46°F (2°C to 8°C).

Unopened vials may also be stored at room temperature (maximum of 86°F/30°C) for up to 6 months (but not exceeding the original expiration date). If storing vials at room temperature, the new expiration date should be written on the carton. Do not return the vials to the refrigerator.

Remicade vials do not contain preservatives.

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.

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