identifiable precipitating factors (eg, pre-existing cardiovascular disease), reported in postmarketing data If administering doses ≤5 mg/kg to patients with moderate or severe HF or to administer it (any approved dose) to patients with mild HF, closely monitor these patients during therapy, and discontinue if new or worsening symptoms of HF appear Drug interactions overview Anakinra Coadministration not recommended Serious infections and neutropenia reported with concurrent use of anakinra and etanercept (another TNF blocker) Similar toxicities may result with concomitant use of anakinra with other TNF blockers Abatacept Coadministration not recommended Coadministration of abatacept with TNF blockers may increase the risk of infections Other biologic products Coadministration not recommended Insufficient data are available regarding coadministration of infliximab products with other biological products Concurrent use with these biological products may increase the risk of infection Vaccinations Coadministration with live vaccines is not recommended Before initiating in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines In patients receiving TNF blockers, limited data are available on response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines Infliximab products cross the placenta and can detected up to 6 months following birth; recommend waiting at least 6 months following birth before administering of any live vaccine to infants exposed in utero to infliximab products Therapeutic infectious agents Coadministration not recommended Other uses of therapeutic infectious agents such as live attenuated bacteria (eg, BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections CYP450 substrates Monitor of effect (eg, warfarin) or drug concentration (eg, cyclosporine, theophylline) and the individual dose of the drug product may be adjusted as needed Upon initiation or discontinuation of infliximab in patients being treated with CYP450 substrates with a narrow therapeutic index, monitor effect (eg, warfarin) or drug concentration (eg, cyclosporine or theophylline) and adjust the individual dose of the CYP450 substrate may be adjusted as needed Formation of CYP450 enzymes may be suppressed by increased levels of cytokines (eg, TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation Therefore, it is expected that for a molecule that antagonizes cytokine activity, such as infliximab, the formation of CYP450 enzymes could be normalized Methotrexate (MTX) and other concomitant medications Use with caution Specific drug interaction studies, including interactions with MTX, have not been conducted Concomitant MTX use may decrease the incidence of anti-drug antibody production and increase infliximab product concentrations Pregnancy Available observational studies in pregnant women exposed to infliximab products showed no increased risk of major malformations among live births as compared to those exposed to non- biologics; however, findings on other birth and maternal outcomes were not consistent across studies of different study design and conduct Monoclonal antibodies such as infliximab products are transferred across placenta during third trimester of pregnancy and may affect immune response in the in utero exposed infant Because infliximab products do not cross-react with TNF in species other than humans and chimpanzees, animal reproduction studies have not been conducted with infliximab products In a developmental study conducted in mice using an analogous antibody, no evidence of maternal toxicity or fetal harm was observed Published data suggest that there is increased risk of adverse pregnancy outcomes in women with inflammatory bowel disease or rheumatoid arthritis associated with increased disease activity Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2.5 kg) and small for gestational age at birth As with other IgG antibodies, infliximab products cross the placenta; infliximab products have been detected in the serum of infants up to 6 months following birth Animal data No evidence of maternal toxicity, embryotoxicity or teratogenicity observed in a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNF alpha Lactation Published literature show that infliximab is present at low levels in human milk Systemic exposure in a breastfed infant is expected to be low because infliximab products are largely degraded in the gastrointestinal tract A U.S. multi-center study of 168 women treated with infliximab for inflammatory bowel disease (breast milk samples obtained, n=29) showed that infants exposed to infliximab through breast milk had no increase in rates of infections and developed normally There are no data on effects of infliximab products on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Recombinant humanized monoclonal anti-TNF-α antibody; prevents synovial and intestinal inflammation Absorption Onset: 2 wk (Crohn disease) Duration: 12 wk Distribution Vd: 3-6 L Metabolism Unknown Elimination Half-life: 7.7-9.5 days Development of antibodies to infliximab increased infliximab clearance Excretion: Unknown IV Compatibility 0.9% NaCl IV Incompatibilities Do not infuse with other agents IV Preparation Reconstitute vials aseptically with 10 mL SWI; swirl vial gently to dissolve powder, and do not shake Allow solution to stand for 5 minutes Remove volume from 250-mL sterile 0.9% NaCl infusion bag equal to drug volume of reconstituted infliximab being added Slowly add reconstituted infliximab solution to 250-mL infusion bag; gently mix; final diluted concentration: 0.4 - 4 mg/mL Discard if particulate matter is present or discoloration observed Begin infusion within 3 hr of preparation (product contains no preservatives) IV Administration Infuse over ≥2 hr Use an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 µm or less) Do not infuse in same line as other drugs Discontinue if infusion reaction occurs Vials do not contain antibacterial preservatives; discard any unused portion Storage Unopen vials Refrigerate at 2-8ºC (36-46ºF) or at temperatures up to 30°C (86°F) for a single period of up to 6 months but not exceeding the original expiration date New expiration date must be written on the carton Upon removal from refrigerator, vials cannot be returned to refrigerated storage Diluted solutions 0.4 mg/mL solutions: Refrigerate at 4°C for up to 14 days (Ikeda 2012) BRAND FORM. UNIT PRICE PILL IMAGE Remicade intravenous- 100 mg vialCopyright © 2010 First DataBank, Inc.Print Patient Educationinfliximab intravenous INFLIXIMAB - INJECTION (in-FLIX-i-mab) COMMON BRAND NAME(S): Avsola, Inflectra, Remicade, Renflexis WARNING: This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). You should have a tuberculosis (TB) skin test before and during treatment with this medication. Also tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. See Side Effects section for symptoms of infections to watch out for, and get medical help right away if you have any of these symptoms.The immune system also helps prevent and control cancer. There is a very small risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin cancer) due to this medication or due to your medical condition. A rare, mostly fatal cancer (hepatosplenic T-cell lymphoma) has occurred in people receiving this medication along with certain other drugs (azathioprine or 6-mercaptopurine) to treat Crohn's disease or ulcerative colitis. Talk to your doctor about the risks and benefits of treatment. Tell your doctor right away if you have symptoms such as unusual lumps/growths, swollen glands, swollen or painful abdomen, unexplained weight loss, unusual tiredness, loss of appetite, fever that doesn't go away, or night sweats. USES: This medication is used to treat certain types of arthritis (rheumatoid arthritis, arthritis of the spine, psoriatic arthritis), certain bowel diseases (Crohn's disease, ulcerative colitis), and a certain severe skin disease (chronic plaque psoriasis). In these conditions, the body's defense system (immune system) attacks healthy tissues. Infliximab works by blocking the actions of a certain natural substance (tumor necrosis factor alpha) in the body. This helps to decrease swelling (inflammation) and weaken your immune system, which slows or stops the damage from the disease.This monograph is about the following infliximab products: infliximab, infliximab-abda, infliximab-axxq, and infliximab-dyyb. HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using infliximab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein over at least 2 hours as directed by your doctor. The dosage is based on your medical condition, weight, and response to treatment. After the first dose, this medication is usually given again after 2 weeks and 6 weeks, then every 8 weeks (or every 6 weeks for arthritis of the spine), as directed by your doctor.Symptoms of an infusion reaction that may occur during infliximab treatment include pain/swelling at the injection site, shortness of breath, flushing, chills, fever, headache, and rash. If you have any of these symptoms, your healthcare professional may need to adjust/stop your infusion and treat your symptoms.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Your doctor may direct you to use other medications (to help prevent side effects) before using infliximab. Use those medications exactly as directed.Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to receive the medication.Tell your doctor if your condition lasts or gets worse. SIDE EFFECTS: See also Warning and How to Use section.Headache, stomach pain, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: joint/muscle pain, easy bruising/bleeding, seizures, confusion, muscle weakness, numbness/tingling of arms/legs, butterfly-shaped facial rash, pain/redness/swelling of arms or legs, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).Tell your doctor right away if you develop signs of infection while using this drug, such as: cough/sore throat that doesn't go away, fever, chills, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as: extreme tiredness, nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.This medication may cause serious heart problems (such as heart attack) during the infusion and up to 24 hours after the start of the infusion. Get medical help right away if you have any symptoms of heart problems such as chest/jaw/left arm pain, shortness of breath, unusual sweating, lightheadedness, dizziness, fainting, vision changes, or fast/irregular/slow heartbeat.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, difficulty swallowing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects.