infliximab

Generic Name: infliximab (in FLIX ih mab)Brand Names: Remicade

What is infliximab?

Infliximab reduces the effects of a substance in the body that can cause inflammation.

Infliximab is used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease, and ankylosing spondylitis. Infliximab is also used to treat severe or disabling plaque psoriasis (raised, silvery flaking of the skin).

Infliximab is often used when other medicines have not been effective.

Infliximab may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about infliximab?

Before you start treatment with infliximab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Serious and sometimes fatal infections may occur during treatment with infliximab. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if you feel short of breath.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Infliximab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Do not receive a "live" vaccine while you are being treated with infliximab.

Using infliximab may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes) or autoimmune disorders (such as a lupus-like syndrome). This risk may be greater in children and young adults. Talk to your doctor about your specific risk.

What should I discuss with my healthcare provider before using infliximab?

You should not use this medication if you are allergic to infliximab, if you have severe heart failure, or if you are also being treated with anakinra (Kineret).

Before using infliximab, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using infliximab, tell your doctor if you have:

• an active or recent infection;

• open sores or skin wounds;

• hepatitis B;

• congestive heart failure;

• epilepsy or other seizure disorder;

• chronic obstructive pulmonary disease (COPD);

• a history of cancer;

• a disease that affects the nerves or muscles, such as multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome;

• if you have recently been vaccinated with BCG (Bacille Calmette-Guerin); or

• if you are scheduled to receive any vaccines.

FDA pregnancy category B. Infliximab is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether infliximab passes into breast milk. Do not use infliximab without first talking to your doctor if you are breast-feeding a baby. Infliximab is not for use in children younger than 6 years old.

Treatment with infliximab may increase your risk of certain types of cancer, such as breast, colon, skin cancer, or lymphoma (cancer of the lymph nodes). This risk may be greater in children and young adults. You may also develop an autoimmune disorder (such as a lupus-like syndrome). Talk with your doctor about your specific risk.

How should I use infliximab?

Before you start treatment with infliximab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Infliximab is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. This medicine is usually given at intervals of 2 to 8 weeks.

Infliximab must be injected slowly, over about 2 hours. Your doctor may wish to observe you after the injection to make sure the medicine has not caused any serious side effects.

You may be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to mix the medicine, give the injection, and properly dispose of needles and other items used in giving the medicine.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using infliximab.

Infliximab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis.

If you have chronic hepatitis B, you may develop liver symptoms while using remicade. Your doctor may also want to check your liver function at regular visits while you are using remicade. Do not miss any scheduled appointments.

If you store infliximab at home, keep it in the refrigerator. Do not use the medicine beyond the expiration date.

What happens if I miss a dose?

Contact your doctor if you miss a dose of infliximab.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of infliximab is not expected to produce life-threatening symptoms.

What should I avoid while using infliximab?

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with infliximab.

Infliximab side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Serious and sometimes fatal infections may occur during treatment with infliximab. Stop using infliximab and call your doctor right away if you have signs of infection such as:

• fever, sweating, chills, tired feeling;

• feeling short of breath;

• cough, sore throat;

• flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

• chest pain, ongoing cough, coughing up blood;

• shortness of breath with swelling of your ankles or feet;

• numbness or tingling;

• weak feeling in your arms or legs;

• problems with vision;

• seizure (convulsions);

• pain or burning when you urinate;

• easy bruising or bleeding, pale skin, unusual weakness;

• red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• stuffy nose, sinus pain;

• mild stomach pain;

• mild skin rash; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Infliximab Dosing Information

Usual Adult Dose for Crohn's Disease -- Acute:

5 mg/kg actual body weight (ABW), given as an induction regimen by IV infusion at weeks 0, 2 and 6, followed by a maintenance regimen of 5 mg/kg ABW every 8 weeks thereafter for the treatment of moderately to severely active Crohn's disease or fistulizing disease; doses up to 10 mg/kg may be given to patients who respond and then lose their responseStudy (n=14)Fistula therapy:Infliximab in combination with azathioprine: 5 mg/kg IV in 250 mL of normal saline infused over 2 hours, then repeated at weeks 2 and 6, plus oral azathioprine 2 to 2.5 mg/kg started within 2 days of initial infliximab infusion

Usual Adult Dose for Rheumatoid Arthritis:

3 mg/kg ABW, via IV infusion in combination with oral methotrexate therapySubsequent IV doses based on 3 mg/kg ABW are repeated at 2 weeks and 6 weeks following the initial infusion, and every 8 weeks thereafter. Patients generally receive 8 doses of infliximab during the first year of therapy and 6 doses during subsequent years.Infliximab dosages up to 10 mg/kg ABW, via IV infusion every 4 or 8 weeks, concomitantly with oral methotrexate therapy, have been studied (n=428) in the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with concomitant Therapy [ATTRACT].

Usual Adult Dose for SAPHO Syndrome:

Case (n=1)3 mg/kg ABW, via IV infusion every 4 weeks

Usual Adult Dose for Psoriasis:

Chronic severe plaque psoriasis (i.e., extensive and/or disabling): 5 mg/kg via IV infusion at weeks 0, 2, and 6, then every 8 weeks thereafterStudies - Moderate to severe plaque psoriasis: 5 to 10 mg/kg via IV infusion at weeks 0, 2, and 6Case reports (n=2)Plaque psoriasis: 5 to 10 mg/kg as a single IV infusion administered over 3 hoursCase reports (n=3)Pustular psoriasis: 5 to 10 mg/kg via IV infusion at weeks 0, 2, and 6

Usual Adult Dose for Sarcoidosis:

5 mg/kg ideal body weight via IV infusion then repeated at weeks 2, and every 4 to 8 weeks thereafter

Usual Adult Dose for Ankylosing Spondylitis:

5 mg/kg ABW via IV infusion at weeks 0, 2, and 6, then every 6 weeks thereafter

Usual Adult Dose for Behcet's Disease:

Study (n=5)5 mg/kg as a single IV infusion over 3 hours

Usual Adult Dose for Giant Cell Arteritis:

Study (n=4)3 mg/kg at weeks 0, 2, and 6, as an IV infusion over 2 hours

Usual Adult Dose for Uveitis:

Case (n=1)5 mg/kg as a single IV infusion at weeks 0, 2, and 6, then every 2 months thereafterCase (n=10)5 mg/kg as a single IV infusion administered over 3 hours

Usual Adult Dose for Psoriatic Arthritis:

5 mg/kg as an IV infusion over 2 hours, at weeks 0, 2, and 6, then every 8 weeks thereafter; it may be used with or without methotrexateStudy (n=10)5 mg/kg as an IV infusion over 2 hours, at weeks 0, 2, and 6, thereafter for weeks 10 to 54, patients received 3 mg/kg every 8 weeksStudy (n=16)3 mg/kg IV at weeks 0, 2, 6, 14, 22, and 30, given to patients with at least 6 months of methotrexate at stable dosage

Usual Adult Dose for Ulcerative Colitis:

5 mg/kg ABW, given as an induction regimen by IV infusion at weeks 0, 2, and 6, followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafterStudy (n=8)Refractory ulcerative colitis: 5 mg/kg ABW, single IV dose infused over 2 hours

Usual Adult Dose for Polychondritis:

Cases (n=2)5 mg/kg ABW, via IV infusion at weeks 0, 2, 6, 14, 22, 30, and 38, concomitantly with oral prednisone

Usual Adult Dose for Sjogren's Syndrome:

Pilot study (n=16)3 mg/kg via IV infusion at weeks 0, 2, and 6Case (n=1)3 mg/kg via IV infusion at weeks 0, 2, and 6, and every 12 weeks thereafter

Usual Adult Dose for Celiac Disease:

Case (n=1)5 mg/kg via IV infusion, as a single dose, over 2 hours

Usual Adult Dose for Toxic Epidermal Necrolysis:

Case (n=1)5 mg/kg via IV infusion, as a single dose therapy

Usual Adult Dose for Subcorneal Pustular Dermatosis:

Case (n=1)5 mg/kg as an IV infusion, as a single dose, over 2 hours

Usual Adult Dose for Pyoderma Gangrenosum:

Cases (n=3)5 mg/kg via IV infusion at weeks 0, 2, 4, 8 and 10, then every 6 to 8 weeks thereafter

Usual Adult Dose for Pulmonary Fibrosis:

Case (n=1)3 mg/kg via IV infusion at week 0, 2 and 6, and every other 8 weeks thereafter

Usual Pediatric Dose for Crohn's Disease -- Acute:

Moderately-to-severely active Crohn's disease:6 years or older: 5 mg/kg ABW, via IV infusion at weeks 0, 2 and 6, followed by a maintenance regimen of 5 mg/kg every 8 weeksStudy (n=19)9 years or older: 5 mg/kg ABW, via IV infusion over 2 hoursOver the 12 weeks of the study patients received from 1 to 3 infusions.

Usual Pediatric Dose for Crohn's Disease -- Maintenance:

Moderately-to-severely active Crohn's disease:6 years or older: 5 mg/kg ABW, via IV infusion at weeks 0, 2 and 6, followed by a maintenance regimen of 5 mg/kg every 8 weeksStudy (n=19)9 years or older: 5 mg/kg ABW, via IV infusion over 2 hoursOver the 12 weeks of the study patients received from 1 to 3 infusions.

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

Cases (n=2)10 years or older: 3 mg/kg via IV infusion at weeks 0, 2, and 6, followed by infusions every 8 weeks

Usual Pediatric Dose for Kawasaki Disease:

Case (n=1)Refractory Kawasaki disease:3 years or older: 5 mg/kg via IV infusion, then repeated on days 45, 59, and 89

What other drugs will affect infliximab?

There may be other drugs that can interact with infliximab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about infliximab.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 8.02. Revision Date: 4/12/2009 4:43:25 PM.