Remicade (generic: infliximab) is a prescription medication used to treat conditions in which the immune system attacks the body causing inflammation. This includes rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriasis, and ulcerative colitis. Remicade belongs to a group of drugs called tumor necrosis factor-alpha (TNF-alpha) inhibitors which block natural substances that cause inflammation.
This medication comes in an injectable form that is given directly into a vein (IV) by a healthcare provider.
Common side effects of Remicade include sinus infection, headaches, and cough.
Remicade is a prescription medication used for patients with:
- Rheumatoid Arthritis - adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate
- Crohn's Disease - children 6 years and older and adults with Crohn's disease who have not responded well to other medicines
- Ankylosing Spondylitis
- Psoriatic Arthritis
- Plaque Psoriasis - adult patients with plaque psoriasis that is chronic (doesn't go away) severe, extensive, and/or disabling.
- Ulcerative Colitis - children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Remicade can cause serious side effects, including:
See "Drug Precautions".
- Some patients, especially those 65 years and older have had serious infections while receiving Remicade. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with Remicade your doctor will treat your infection and may need to stop your Remicade treatment.
- Tell your doctor right away if you have any of the following signs of an infection while taking or after taking Remicade:
- 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 Remicade and during treatment with Remicade.
- Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are taking Remicade. Patients who had a negative TB skin test before receiving Remicade 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 Remicade. 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 Remicade 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 and/or joint pain
If you have a heart problem called congestive heart failure, your doctor should check you closely while you are taking Remicade. Your congestive heart failure may get worse while you are taking Remicade. 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 Remicade may need to be stopped if you get new or worse congestive heart failure.
In rare cases, some patients taking Remicade 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)
- extreme tiredness (severe fatigue)
In some patients taking Remicade, 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
In rare cases, patients taking Remicade have developed problems with their nervous system. Tell your doctor if you have
- changes in your vision
- weakness in your arms and/or legs
- numbness or tingling in any part of your body
Some patients have had allergic reactions to Remicade. Some of these reactions were severe. These reactions can happen while you are getting your Remicade treatment or shortly afterward. Your doctor may need to stop or pause your treatment with Remicade 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
Some patients treated with Remicade have had delayed allergic reactions. The delayed reactions occurred 3 to 12 days after receiving treatment with Remicade. Tell your doctor right away if you have any of these signs of delayed allergic reaction to Remicade:
- sore throat
- muscle or joint pain
- swelling of the face and hands
- difficulty swallowing
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 Remicade.
- 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
Some people using Remicade 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 Remicade.
The most common side effects of Remicade include:
- respiratory infections, such as sinus infections and sore throat
- stomach pain
Infusion reactions can happen up to 2 hours after your infusion of Remicade. Symptoms of infusion reactions may include:
- chest pain
- low blood pressure or high blood pressure
- shortness of breath
Children who took Remicade in studies for Crohn's disease showed some differences in side effects compared with adults who took Remicade for 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 took Remicade 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 Remicade. Ask your doctor or pharmacist for more information.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- warfarin (Coumadin)
- cyclosporin (Neoral, Sandimmune)
- theophylline (Theolair)
This is not a complete list of Remicade drug interactions. Ask your doctor for more information.
Remicade may cause serious side effects, including:
1. Risk of infection
Remicade is a medicine that affects your immune system. Remicade can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving Remicade. 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 Remicade.
- Your doctor should monitor you closely for signs and symptoms of TB during treatment with Remicade.
Before starting Remicade, tell your doctor if you:
- think you have an infection. You should not start taking Remicade 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 take Remicade. 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) or Actemra (tocilizumab)
After starting Remicade, 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. Remicade 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 TNF-blocking agents.
- For children and adults taking TNF-blocker medicines, including Remicade, the chances of getting lymphoma or other cancers may increase.
- Some patients with Crohn's disease or ulcerative colitis have developed Hepatosplenic T-cell Lymphoma, a rare type of cancer. Most of the patients were teenage or young adult males. This type of cancer results in death. All of these patients had received medicines known as azathioprine or 6-mercaptopurine together with Remicade.
- 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.
- Patients with COPD (a specific type of lung disease) may have an increased risk for getting cancer while being treated with Remicade.
- 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.
You should not receive Remicade if you have:
- heart failure, unless your doctor has examined you and decided that you are able to take Remicade. Talk to your doctor about your heart failure.
- had an allergic reaction to Remicade, or any of the other ingredients in Remicade.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Remicade there are no specific foods that you must exclude from your diet when receiving Remicade.
Tell your doctor about all of your medical conditions, including if you:
- have an infection (see "Drug Precautions").
- have other liver problems including liver failure.
- have heart failure or other heart conditions. If you have heart failure, it may get worse while you take Remicade.
- have or have had any type of cancer.
- have had phototherapy (treatment with ultraviolet light or sunlight along with a medicine to make your skin sensitive to light) for psoriasis. You may have a higher chance of getting skin cancer while receiving Remicade.
- have COPD (Chronic Obstructive Pulmonary Disease), a specific type of lung disease. Patients with COPD may have an increased risk of getting cancer while taking Remicade.
- have or have had a condition that affects your nervous system such as
- multiple sclerosis, or Guillain-Barré syndrome, or
- if you experience any numbness or tingling, or
- if you have had a seizure.
- have recently received or are scheduled to receive a vaccine. Adults and children should not receive a live vaccine while taking Remicade. Children should have all of their vaccines brought up to date before starting treatment with Remicade.
- are pregnant or planning to become pregnant. It is not known if Remicade harms your unborn baby. Remicade should be given to a pregnant woman only if clearly needed. Talk to your doctor about stopping Remicade if you are pregnant or planning to become pregnant.
- are breast-feeding or planning to breast-feed. It is not known whether Remicade passes into your breast milk. Talk to your doctor about the best way to feed your baby while taking Remicade. You should not breast-feed while taking Remicade.
Tell your doctor if you are pregnant or planning to become pregnant. It is not known if Remicade harms your unborn baby. Remicade should be given to a pregnant woman only if clearly needed. Talk to your doctor about stopping Remicade if you are pregnant or planning to become pregnant.
If you have a baby and you were using Remicade during your pregnancy, tell your baby's doctor about your Remicade use before the baby receives any vaccine.
Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known whether Remicade passes into your breast milk. Talk to your doctor about the best way to feed your baby while taking Remicade. You should not breastfeed while taking Remicade.
- You will be given Remicade through a needle placed in a vein (IV or intravenous infusion) in your arm.
- Your doctor may decide to give you medicine before starting the Remicade infusion to prevent or lessen side effects.
- Only a healthcare professional should prepare the medicine and administer it to you.
- Remicade will be given to you over a period of about 2 hours.
- If you have side effects from Remicade, the infusion may need to be adjusted or stopped. In addition, your healthcare professional may decide to treat your symptoms.
- A healthcare professional will monitor you during the Remicade infusion and for a period of time afterward for side effects. Your doctor may do certain tests while you are taking Remicade to monitor you for side effects and to see how well you respond to the treatment.
- Your doctor will determine the right dose of Remicade for you and how often you should receive it. Make sure to discuss with your doctor when you will receive infusions and to come in for all your infusions and follow-up appointments.
The recommended dose of Remicade 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. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue Remicade in these patients.
Pediatric Crohn's Disease
The recommended dose of Remicade 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.
The recommended dose of Remicade 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.
Pediatric Ulcerative Colitis
The recommended dose of Remicade 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.
The recommended dose of Remicade 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. Remicade should be given in combination with methotrexate. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses.
The recommended dose of Remicade 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.
The recommended dose of Remicade 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. Remicade can be used with or without methotrexate.
The recommended dose of Remicade 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) plaque psoriasis.
Remicade is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.
Active ingredient is Infliximab.
Inactive ingredients: sucrose, polysorbate 80, monobasic sodium phosphate monohydrate, and dibasic sodium phosphate dihydrate. No preservatives are present.
Keep all your medical and laboratory appointments. For the best possible benefit, it is important to receive each scheduled dose of Remicade as directed. If you miss a dose, contact your doctor right away.
WARNING: SERIOUS INFECTIONS and MALIGNANCY
Patients treated with Remicade are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Remicade should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include:
- Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Remicade use and during therapy.1,2 Treatment for latent infection should be initiated prior to Remicade use.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with Remicade should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Remicade, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Remicade.
Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including Remicade. These cases have had a very aggressive disease course and have been fatal. All reported Remicade cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. All of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with Remicade at or prior to diagnosis.