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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Infliximab
Generic Name
Infliximab
Active Ingredient
InfliximabCategory
Tumor Necrosis Factor Blocker [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 100 mg/10mL | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | INTRAVENOUS | 57894-160 |
Detailed information about Infliximab
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Infliximab, you must consult a qualified healthcare professional.
Infliximab is a chimeric monoclonal antibody and tumor necrosis factor (TNF) blocker used to treat chronic inflammatory conditions such as Crohn's disease, rheumatoid arthritis, and plaque psoriasis by neutralizing the pro-inflammatory cytokine TNF-alpha.
Infliximab dosing is weight-based, calculated as milligrams of medication per kilogram of body weight (mg/kg). The standard induction regimen involves infusions at week 0, week 2, and week 6, followed by maintenance infusions every 8 weeks thereafter. However, schedules may vary based on the specific condition being treated.
Infliximab is FDA-approved for use in pediatric patients (ages 6 to 17 years) for the treatment of Crohn's disease and ulcerative colitis.
Infliximab has not been specifically studied in patients with renal (kidney) impairment. However, because it is a large protein cleared by the immune system rather than the kidneys, dose adjustments are typically not required for patients with decreased kidney function. Your doctor will monitor your overall health closely.
There are no formal studies of Infliximab in patients with hepatic (liver) impairment. While dose adjustments are not standardized, Infliximab has been associated with rare cases of hepatotoxicity (liver damage). Patients with pre-existing liver disease should be monitored frequently for changes in liver function tests (LFTs).
Clinical studies did not include sufficient numbers of patients aged 65 and over to determine if they respond differently than younger patients. However, the incidence of serious infections is generally higher in the elderly population. Therefore, healthcare providers exercise extreme caution and perform frequent monitoring when treating older adults with Infliximab.
Infliximab is not a medication you take at home. It must be administered by a healthcare professional in a clinical setting through an intravenous (IV) line.
If you miss an appointment for an Infliximab infusion, contact your healthcare provider immediately to reschedule. Maintaining the prescribed schedule is vital for the medication's effectiveness and to prevent your body from developing antibodies against the drug, which could make it less effective or cause reactions in the future.
Because Infliximab is administered by medical professionals, an overdose is highly unlikely. In clinical trials, doses up to 20 mg/kg were administered without direct toxic effects. However, if an excessive dose is given, the patient would be monitored closely for any signs of adverse reactions or infections. In case of an emergency, contact your local poison control center or seek immediate medical attention.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not attempt to alter your infusion schedule without professional medical guidance.
Most patients tolerate Infliximab well, but because it affects the immune system, side effects are common. The most frequently reported side effects include:
> Warning: Stop taking Infliximab and call your doctor immediately if you experience any of these serious symptoms.
With prolonged use, the primary concern is the increased risk of certain types of cancer. Patients, especially those with rheumatoid arthritis or Crohn's disease, may have a higher risk of developing lymphoma (cancer of the lymph system). There is also an increased risk of non-melanoma skin cancers; therefore, regular skin examinations are recommended for all patients on long-term Infliximab therapy.
The FDA has issued the highest level of warning (Black Box) for Infliximab due to the following risks:
Report any unusual symptoms to your healthcare provider immediately to ensure safe management of your therapy.
Infliximab is a powerful medication that significantly alters the immune system's function. Before starting therapy, it is vital to understand that while it can control chronic inflammation, it also reduces your body's ability to fight off infections. Every patient must undergo a thorough screening process, including a tuberculosis (TB) skin or blood test and a hepatitis B virus (HBV) screening, prior to the first dose.
Infliximab carries two major FDA Black Box Warnings:
To ensure safety, your healthcare provider will require regular monitoring, including:
Infliximab generally does not interfere with the ability to drive or operate machinery. However, if you experience dizziness or fatigue following an infusion, you should avoid these activities until you feel alert and steady.
There is no direct contraindication between alcohol and Infliximab. However, because both alcohol and Infliximab (rarely) can affect liver function, excessive alcohol consumption should be avoided. Additionally, if you are taking methotrexate along with Infliximab, alcohol should be strictly limited as methotrexate carries a high risk of liver toxicity.
Stopping Infliximab should only be done under a doctor's supervision. There is no 'withdrawal syndrome' like there is with corticosteroids, but stopping the drug can lead to a 'flare' or return of your autoimmune symptoms. Furthermore, stopping and restarting Infliximab increases the risk of your body developing antibodies against the drug, which can lead to severe infusion reactions when the drug is resumed.
> Important: Discuss all your medical conditions, especially any history of infection, cancer, or heart problems, with your healthcare provider before starting Infliximab.
Certain medications should never be combined with Infliximab due to the extreme risk of life-threatening infections or other severe adverse events.
There are no known specific food interactions with Infliximab. Unlike some oral medications, its effectiveness is not affected by grapefruit, dairy, or high-fat meals. However, patients with Crohn's or Ulcerative Colitis are often advised to follow specific diets to manage their symptoms, which should be discussed with a nutritionist or gastroenterologist.
For each major interaction, the primary concern is the pharmacodynamic interaction, where the combined effect of two drugs on the immune system leads to increased toxicity (infections) or the immunogenic interaction, where one drug affects the body's ability to tolerate the other.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter drugs.
There are specific circumstances where the risk of using Infliximab clearly outweighs any potential benefit. In these cases, the medication must not be used.
Relative contraindications require a careful risk-benefit analysis by a specialist. These include:
Patients who are allergic to other TNF blockers (like adalimumab or etanercept) are not necessarily allergic to Infliximab, as the molecular structures are different. However, because Infliximab contains mouse proteins, it has a higher potential for 'immunogenicity' (causing an immune response) than fully human monoclonal antibodies. If you have had a reaction to any biologic medication, inform your doctor immediately.
> Important: Your healthcare provider will evaluate your complete medical history, including past infections and heart health, before prescribing Infliximab.
Infliximab is classified as a Pregnancy Category B medication (based on older FDA labeling systems). This means that animal studies have not shown a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women.
Infliximab is excreted into human breast milk in very small amounts. However, because it is a large protein, it is likely degraded in the infant's digestive tract and not absorbed into their bloodstream in significant quantities. Most clinical data suggest that breastfeeding while taking Infliximab is safe for the infant. Decisions should be made based on the mother's need for the drug and the benefits of breastfeeding.
Infliximab is approved for pediatric patients (6 years and older) for Crohn's disease and ulcerative colitis.
Patients aged 65 and older are at a naturally higher risk for serious infections and malignancies. In clinical trials, the incidence of serious infections was higher in elderly patients treated with Infliximab compared to those under 65. Physicians often use lower doses or monitor these patients more frequently for signs of infection or heart failure. Polypharmacy (taking multiple medications) is also a concern, as it increases the risk of drug interactions.
No specific dose adjustments are provided for patients with renal impairment. Since Infliximab is not cleared by the kidneys, its levels are not expected to be significantly affected by kidney disease. However, patients on dialysis should be monitored for overall stability and infection risk.
Infliximab has not been studied in patients with hepatic impairment. While the drug is not metabolized by the liver, it can cause rare, severe liver injury. Patients with a Child-Pugh score indicating moderate to severe liver disease should be treated with extreme caution, and liver enzymes (ALT, AST, Bilirubin) should be monitored at every infusion.
> Important: Special populations require individualized medical assessment and frequent follow-up with a specialist.
Infliximab is a chimeric IgG1κ monoclonal antibody. Its primary molecular target is Tumor Necrosis Factor-alpha (TNF-α). TNF-α is a potent pro-inflammatory cytokine that, when it binds to its receptors (TNFR1 and TNFR2), initiates a signaling cascade that activates the NF-κB pathway. This leads to the production of other inflammatory mediators, the expression of adhesion molecules on blood vessels, and the activation of white blood cells.
Infliximab binds with high affinity and specificity to both the soluble (circulating) and transmembrane (cell-surface) forms of TNF-α. By binding to TNF-α, Infliximab physically blocks the cytokine from interacting with its receptors. Furthermore, Infliximab can bind to cells that are expressing TNF-α on their surface and, through the Fc region of the antibody, recruit immune effector cells to destroy the inflammatory cell via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). This effectively reduces the inflammatory burden in tissues like the intestinal mucosa or the synovial joints.
Infliximab produces a rapid reduction in levels of C-reactive protein (CRP) and other markers of inflammation. In patients with rheumatoid arthritis, it reduces the infiltration of inflammatory cells into the joints. In patients with Crohn’s disease and ulcerative colitis, it promotes 'mucosal healing,' which is the actual repair of the intestinal lining. The onset of effect is typically seen within 2 to 4 weeks, though full clinical benefit may take several months. Tolerance (loss of response) can develop if the patient's immune system creates 'Anti-Drug Antibodies' (ADAs) against the murine portion of the Infliximab molecule.
| Parameter | Value |
|---|---|
| Bioavailability | 100% (Intravenous) |
| Protein Binding | Not applicable (Large Protein) |
| Half-life | 7 to 10 days |
| Tmax | Immediate (End of infusion) |
| Metabolism | Proteolysis (Non-CYP) |
| Excretion | Reticuloendothelial system |
Infliximab is classified as a Tumor Necrosis Factor Blocker [EPC]. It is part of the broader category of Biological Disease-Modifying Antirheumatic Drugs (bDMARDs). Related medications in this class include adalimumab (Humira), etanercept (Enbrel), certolizumab pegol (Cimzia), and golimumab (Simponi). Unlike Infliximab, which is chimeric, some of these others are fully human or pegylated fragments.
Common questions about Infliximab
Infliximab is primarily used to treat chronic inflammatory and autoimmune conditions where the body produces too much tumor necrosis factor (TNF). It is FDA-approved for adult and pediatric Crohn's disease and ulcerative colitis, as well as rheumatoid arthritis (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis, and severe plaque psoriasis. By blocking TNF, it helps reduce inflammation, pain, and tissue damage. It is typically reserved for patients who have not responded well to other treatments like corticosteroids or traditional DMARDs. Your healthcare provider will determine if your specific condition warrants the use of this biologic therapy.
The most common side effects reported by patients taking Infliximab include upper respiratory infections, such as the common cold or sinus infections, and headaches. Many patients also experience 'infusion reactions' during or shortly after the procedure, which can involve fever, chills, or a rash. Other frequent issues include stomach pain, nausea, and fatigue. Because the drug suppresses the immune system, minor infections may occur more frequently than usual. Most of these side effects are manageable, but you should always keep your medical team informed of how you feel after each session.
There is no known direct chemical interaction between Infliximab and alcohol that would make moderate drinking strictly prohibited. However, Infliximab can rarely cause liver toxicity, and alcohol is also processed by the liver, so excessive drinking could increase the risk of liver strain. Furthermore, many patients take Infliximab in combination with methotrexate, which carries a very high risk of liver damage when combined with alcohol. It is generally best to limit alcohol consumption and discuss your specific habits with your doctor to ensure your liver remains healthy during treatment. Always follow the specific guidance provided by your gastroenterologist or rheumatologist.
Infliximab is generally considered low-risk during pregnancy, but it should only be used if clearly needed to maintain the mother's health. While it does cross the placenta, especially in the third trimester, large studies have not shown an increased risk of birth defects or pregnancy complications. However, because the baby will have the drug in their system for several months after birth, they should not receive any live vaccines (like the rotavirus or BCG vaccine) for at least six months. Most doctors recommend continuing the medication if stopping it would cause a severe disease flare, which is more dangerous for the pregnancy. Always consult your obstetrician and specialist when planning a pregnancy on Infliximab.
Many patients begin to notice an improvement in their symptoms within 2 to 4 weeks after their first infusion, particularly regarding pain and fatigue. For conditions like Crohn's disease or ulcerative colitis, significant relief often occurs after the second or third induction dose (around week 6). However, for some patients, it can take up to 12 to 16 weeks to see the full clinical benefit of the medication. If there is no response by week 14, your doctor may re-evaluate the treatment plan. Consistency with the induction schedule is key to achieving the best possible results.
You should never stop taking Infliximab without first consulting your healthcare provider. While there is no immediate withdrawal danger like there is with stopping steroids, stopping Infliximab can cause your underlying autoimmune disease to flare up significantly. A major risk of stopping and then later restarting Infliximab is that your body may develop antibodies against the drug during the 'off' period. These antibodies can make the drug stop working or cause a severe allergic reaction when you try to start it again. If you are concerned about side effects or cost, talk to your doctor about alternatives rather than stopping abruptly.
If you miss an appointment for your Infliximab infusion, you should contact your infusion center or doctor's office as soon as possible to reschedule. Because Infliximab is given on a specific schedule to keep a steady level of the drug in your blood, being late can lead to a return of your symptoms. It also increases the risk of developing anti-drug antibodies, which can lead to future infusion reactions. Most clinics have a 'window' of a few days or a week where the dose can still be safely administered. Your doctor will advise you on the best way to get back on your regular schedule.
Weight gain is not a direct side effect of the Infliximab molecule itself, but many patients do experience weight gain during treatment. This is often because the medication is successfully treating their underlying condition, such as Crohn's disease or ulcerative colitis, allowing for better nutrient absorption and a return of appetite. Additionally, patients who were able to stop taking corticosteroids (like prednisone) because Infliximab worked may find their weight stabilizing or changing. If you notice rapid weight gain accompanied by swelling in your ankles or shortness of breath, contact your doctor immediately, as this could be a sign of heart failure. Otherwise, modest weight gain is often a sign of improving health.
Infliximab is frequently taken alongside other medications, such as methotrexate or low-dose corticosteroids, to improve its effectiveness. However, it should never be taken with other biologic drugs like Orencia or Kineret, as this dangerously increases the risk of life-threatening infections. It can also interact with live vaccines, which must be avoided during treatment. Because Infliximab can change how your liver processes other drugs as your inflammation goes down, your doctor may need to monitor levels of drugs like warfarin or theophylline more closely. Always provide your doctor with a complete list of all prescriptions, over-the-counter meds, and supplements you use.
Infliximab is a biologic drug, so it does not have a 'generic' in the traditional sense, but it does have 'biosimilars.' Biosimilars are highly similar versions of the original drug (Remicade) that have been FDA-approved to be just as safe and effective. Current biosimilars for Infliximab include Inflectra, Renflexis, and Avsola. These are often more affordable and are used interchangeably with the original brand depending on your insurance coverage. Your pharmacist or doctor can tell you which version you are receiving, but the clinical effects and side profile are expected to be the same.
Other drugs with the same active ingredient (Infliximab)