Infliximab

What is Infliximab?

Infliximab (Remicade) is a tumor necrosis factor (TNF) blocker used in:

• adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy;
• adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;
• patients with moderately to severely active rheumatoid arthritis in combination with methotrexate;
• patients with active ankylosing spondylitis (arthritis of the spine);
• patients with active psoriatic arthritis;
• adult patients with chronic severe plaque psoriasis.

Infliximab structure2

What are the uses of this medicine?

Infliximab (Remicade) is a prescription medicine that is approved 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 in adults
• Psoriatic Arthritis in adults
• Plaque Psoriasis - adult patients with plaque psoriasis that is chronic (does not 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.

How does this medicine work?

• Remicade blocks the action of a protein in your body called tumor necrosis factor-alpha (TNF-alpha).
• TNF-alpha is made by your body's immune system.
• People with certain diseases have too much TNF-alpha that can cause the immune system to attack normal healthy parts of the body.
• Remicade can block the damage caused by too much TNF-alpha.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have heart failure, unless your doctor has examined you and decided that you are able to receive Remicade. Talk to your doctor about your heart failure.
• had an allergic reaction to Remicade, or any of the other ingredients in Remicade.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• abatacept (Orencia)
• anakinra (Kineret)
• methotrexate (Otrexup, Rasuvo, Trexall, Xatmep)
• steroids such as dexamethasone, methylprednisolone (Medrol), prednisolone (Orapred ODT, Pediapred, Prelone), or prednisone; or tocilizumab (Actemra)
• anticoagulants (blood thinners) such as warfarin (Coumadin), cyclosporine (Gengraf, Neoral, Sandimmune), and theophylline (Elixophyllin, Theo-24, Theochron).

Is this medicine FDA approved?

• Infliximab was approved for use in the United States in 1998 and current indications include rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and severe psoriasis, Crohn disease (adult and pediatric) and ulcerative colitis. Infliximab is considered a disease modifying antirheumatic drug (DMARD) and has been shown to improve symptoms as well as joint and cartilage damage in the inflammatory arthritis.

How should this medicine be used?

• Prior to treatment, ensure appropriate personnel and medication are available to treat reactions (e.g., hypersensitivity) that occur during infusion and shortly after infusion.

Recommended dosage:

• In Crohn's Disease: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg every 8 weeks if they later lose their response.
• In Pediatric Crohn's Disease (≥ 6 years old): 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• In Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• In Pediatric Ulcerative Colitis (≥ 6 years old): 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• In Rheumatoid Arthritis: In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks.
• In Ankylosing Spondylitis: 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.
• In Psoriatic Arthritis and Plaque Psoriasis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Administration:

• Infliximab injection products come as a powder to be mixed with sterile water.
• 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 receiving 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 100 mg of infliximab as a lyophilized powder in a single-dose vial for reconstitution and dilution.

This medicine is available in fallowing brand namesː

• Remicade

What side effects can this medication cause?

The most common side effects of this medicine include:

• respiratory infections, such as sinus infections and sore throat
• headache
• coughing
• stomach pain

Infusion reactions can happen up to 2 hours after your infusion of Remicade. Symptoms of infusion reactions may include:

• fever
• chills
• chest pain
• low blood pressure or high blood pressure
• shortness of breath
• rash
• itching

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.

Remicade can cause serious side effects, including:

• Risk of infection
• Risk of Cancer
• Serious Infections
• Heart Failure
• Liver Injury
• Blood Problems
• Nervous System Disorders
• Allergic Reactions
• Lupus-like Syndrome
• Psoriasis

What special precautions should I follow?

• Do not take Remicade together with medicines such as KINERET (anakinra), ORENCIA (abatacept), ACTEMRA (tocilizumab), or other medicines called biologics that are used to treat the same conditions as Remicade.
• Patients treated with Remicade are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Do not give Remicade during an active infection. If an infection develops, monitor carefully and stop Remicade if infection becomes serious.
• Malignancies have been reported among children, adolescents and young adults who received treatment with TNF blockers. Patients should be counseled about the risk of lymphoma and other malignancies while receiving Remicade.
• Use of TNF blockers, including Remicade, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Test for HBV infection before starting Remicade. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Remicade and begin anti-viral therapy.
• Severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis, have been reported in postmarketing data in patients receiving Remicade.Stop Remicade in cases of jaundice and/or marked liver enzyme elevations.
• Instruct patients to seek medical attention and consult their prescriber if they develop signs or symptoms of heart failure.
• Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with a fatal outcome, have been reported in patients receiving Remicade.
• Remicade has been associated with hypersensitivity reactions that vary in their time of onset and required hospitalization in some cases.
• Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of Remicade infusion.
• Remicade and other agents that inhibit TNF have been associated with CNS manifestation of systemic vasculitis, seizure and new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Advise patients to seek medical attention if they develop signs or symptoms of neurologic reactions.
• There is insufficient information regarding the concurrent use of Remicade with other biological products used to treat the same conditions as Remicade. The concurrent use of Remicade with these biological products is not recommended because of the possibility of an increased risk of infection.
• Treatment with Remicade may result in the formation of autoantibodies and in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Remicade, treatment should be discontinued.
• Instruct Remicade-treated patients to avoid receiving live vaccines or therapeutic infectious agents.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.

Can this medicine be used in pregnancy?

• Available observational studies in pregnant women exposed to Remicade showed no increased risk of major malformations among live births as compared to those exposed to non-biologics.
• Monoclonal antibodies such as infliximab are transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant.
• If you have a baby and you were receiving Remicade during your pregnancy, it is important to tell your baby's doctor and other health care professionals about your Remicade use so they can decide when your baby should receive any vaccine. Certain vaccinations can cause infections.
• If you received Remicade while you were pregnant, your baby may be at higher risk for getting an infection. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death. This includes live vaccines such as the BCG, rotavirus, or any other live vaccines. For other types of vaccines, talk with your doctor.

Can this medicine be used in children?

• It is not known if Remicade is safe and effective in children under 6 years of age.

What are the active and inactive ingredients in this medicine?

• The active ingredient is Infliximab.
• The inactive ingredients in Remicade include: dibasic sodium phosphate dihydrate, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose. No preservatives are present.

Who manufactures and distributes this medicine?

Manufactured by: Janssen Biotech, Inc. Horsham, PA

What should I know about storage and disposal of this medication?

• Store unopened Remicade vials in a refrigerator at 2°C to 8°C (36°F to 46°F).
• If needed, unopened Remicade vials may be stored at room temperatures up to a maximum of 30°C (86°F) for a single period of up to 6 months but not exceeding the original expiration date.
• The new expiration date must be written in the space provided on the carton. Once removed from the refrigerator, Remicade cannot be returned to the refrigerator.

• Dailymed label info on Infliximab
• FDA Infliximab

Infliximab Resources
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