Remicade (Infliximab): Uses, Dosage, Side Effects, and Warnings

Remicade (infliximab) is a prescription biologic medication used to treat several inflammatory autoimmune conditions, including rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. It works by blocking a protein involved in inflammation. Read on to learn about Remicade’s uses, mechanism of action, dosage, side effects, and important safety warnings. 

Remicade Introduction and Uses

Remicade is a brand-name prescription product used to treat several autoimmune disorders. It is a biologic belonging to a drug class called tumor necrosis factor (TNF) blockers or anti-TNF agents. Biologics, also called biological products, are medications that are made in a lab using living cells.

The active molecule in Remicade is infliximab. Infliximab is a monoclonal antibody that can suppress, mimic, or enhance your immune response. 

Biosimilars are biologic medications that are highly similar to an FDA-approved biologic, such as Remicade, with no clinically meaningful differences in safety, purity, or effectiveness. Biosimilars to Remicade include:

• Inflectra (infliximab-dyyb)
• Renflexis (infliximab-abda)
• Ixifi (infliximab-qbtx)
• Avsola (infliximab-axxq)

Remicade is FDA-approved to treat the following autoimmune conditions:

• Rheumatoid arthritis in adults with moderately to severely active disease, together with methotrexate
• Crohn’s disease in adults and children 6 years and older that has not responded well to other medications
• Ankylosing spondylitis in adults
• Ulcerative colitis in adults and children 6 years and older that has not responded well to other medications
• Psoriatic arthritis in adults (psoriatic arthritis causes joint pain and stiffness, and skin rashes)
• Long-lasting, severe, or disabling plaque psoriasis in adults (plaque psoriasis causes itchy, scaly, discolored patches on the skin)

Remicade Mechanism of Action

Remicade works by blocking the action of a protein in the immune system known as tumor necrosis factor-alpha (TNF-alpha). TNF-alpha plays a role in inflammation associated with several autoimmune conditions. HighTNF-alpha activity can contribute to inflammation and damage to healthy tissues.  

By blocking the effects of TNF-alpha, Remicade lowers inflammation to help improve the symptoms of certain autoimmune conditions. 

Important Remicade Warnings

Remicade carries FDA boxed warnings for serious infections and malignancies (cancers). 

Risk of Serious Infection

This medication may increase the risk of serious infections, potentially leading to death. Examples of infections include tuberculosis (TB) and bacterial, viral, or fungal diseases that can spread throughout the body. 

Before starting treatment with Remicade, your healthcare provider will test you for TB. During treatment, they will monitor you for TB signs and symptoms. If you get a serious infection during treatment, they will stop treatment with this medication. 

Remicade may also reactivate hepatitis B in people who have previously had the infection. Your healthcare provider may screen you for hepatitis B before treatment and monitor you for signs of reactivation. 

Risk of Certain Cancers

There have been reports of certain cancers in patients taking Remicade. These include lymphoma, cervical cancer, and skin cancer. Some of these cancers may be fatal. 

Rare cases of hepatosplenic T-cell lymphoma, a potentially fatal type of cancer, have also been reported in patients receiving TNF blockers, including Remicade. 

Talk to your healthcare provider about cancer risk specific to you. 

Before Taking Remicade

Before you receive your first dose of Remicade, inform your healthcare provider if you:

• Are allergic to this product, any product component, biosimilars to Remicade, or mouse proteins
• Think you have any infection
• Are receiving treatment 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
• Have a recurrent infection
• Have diabetes
• Have a weakened immune system 
• Have TB or been exposed to someone with TB 
• Live or have lived in the Ohio and Mississippi River valleys
• Have or have had hepatitis B 
• Are currently taking Kineret (anakinra), Orencia (abatacept), Actemra (tocilizumab), or other biological products
• Are scheduled to get vaccinated or have been recently vaccinated
• Are undergoing surgery 
• Are pregnant or plan to get pregnant
• Are breastfeeding
• Have received phototherapy for psoriasis 

Also, tell your healthcare provider if you have ever had:

• Heart failure or other heart conditions
• Liver failure or other liver disorders
• Cancer 
• Seizures
• Numbness or tingling on any body part
• Multiple sclerosis 
• Guillain-Barré syndrome

Remicade may not be appropriate for people with heart failure. Doses greater than 5 mg/kg are contraindicated in patients with moderate or severe heart failure. 

You should not receive Remicade if you have had a severe allergic reaction to infliximab, mouse proteins, or other ingredients in the medication.

Avoid receiving live vaccines during Remicade treatment. Talk to your healthcare provider about which vaccines are appropriate before and during treatment. 

After Taking Remicade

Contact your healthcare provider promptly if you develop signs of infection, such as fever, cough, flu-like symptoms, or open cuts or sores that may be infected.

Seek emergency medical attention if you experience difficulty breathing, chest pain, or swelling of the face or throat.

Remicade Administration

Remicade injection comes in a carton containing one single-dose vial. Each vial contains 100 mg of infliximab as a white powder. A healthcare provider will mix the appropriate quantity of the powder with sterile water to prepare a solution. Then, they will administer the solution as an intravenous (IV) infusion, typically over at least 2 hours. Your healthcare team will monitor you for infusion-related reactions. 

Remicade Dosage

• Crohn’s disease (adults and children): 5 mg/kg IV at 0, 2, and 6 weeks. Then, 5 mg/kg IV every 8 weeks.
• Ulcerative colitis (adults and children): 5 mg/kg IV at 0, 2, and 6 weeks. Then, 5 mg/kg IV every 8 weeks.
• Rheumatoid arthritis: 3 mg/kg IV at 0, 2, and 6 weeks. Then, 3 mg/kg IV every 8 weeks, in combination with methotrexate. 
• Ankylosing spondylitis: 5 mg/kg IV at 0, 2, and 6 weeks. Then, 5 mg/kg IV every 6 weeks. 
• Psoriatic arthritis: 5 mg/kg IV at 0, 2, and 6 weeks. Then, 5 mg/kg IV every 8 weeks. 
• Plaque psoriasis: 5 mg/kg IV at 0, 2, and 6 weeks. Then, 5 mg/kg IV every 8 weeks. 

Your healthcare provider may adjust your dosage based on your condition and response to treatment. 

Remicade Side Effects

Common Side Effects

Common side effects of Remicade include respiratory infections, headache, stomach pain, and infusion-related reactions. Contact your healthcare provider if your symptoms persist or worsen. 

• Stuffy nose
• Sinus pain
• Sore throat
• Cough
• Headache
• Feeling light-headed
• Rash
• Stomach pain

Fever, chills, and changes in blood pressure may occur during infusion reactions. Contact your healthcare provider if you experience these symptoms. 

Seek immediate medical attention if you experience chest pain, difficulty breathing, or other symptoms of a severe reaction. 

Serious Side Effects

Remicade can cause serious side effects that require prompt medical attention. Seek emergency care for symptoms of a heart attack, stroke, or severe allergic reaction. 

New or worsening heart failure

• Shortness of breath
• Edema (swelling, particularly in your feet)
• Sudden weight gain

Symptoms of a Possible Heart Attack 

• Pain or discomfort in the chest
• Arm pain
• Shortness of breath
• Anxiety
• Fainting
• Sweating
• Nausea or vomiting

Symptoms of a Possible Stroke 

• Weakness on one side of your body
• Confusion
• Difficulty speaking, seeing, or walking
• Dizziness
• Severe headache

Liver problems

• Tiredness
• Fever
• Jaundice (yellowing of the skin and eyes)
• Dark-colored urine
• Pain on the right side of the stomach

Lupus-like syndrome

• Joint pain or swelling
• Chest discomfort
• Shortness of breath
• Skin rash that can worsen in sunlight

Other serious side effects can include:

• Fast or slow heart rate
• Easy bruising or bleeding 
• Frequent infections 
• Seizures
• Vision changes 
• New or worsening psoriasis 
• Tuberculosis 
• Cancer 

Delayed Allergic Reactions

Delayed allergic reactions may occur several days after receiving Remicade, including up to 12 days after an infusion. Symptoms can include:

• Fever
• Sore throat
• Difficulty swallowing
• Headache
• Joint or muscle pain
• Skin rash
• Swelling in the face or hands

Remicade Cost

Remicade costs vary depending on your dosage, insurance coverage, and infusion location. Your insurance plan may require prior authorization before covering treatment. Manufacturer assistance programs may help eligible patients reduce their out-of-pocket costs. Contact us if you are interested in financial or copay assistance for Remicade.