Remicade Information:

What is Remicade Used For?

Infliximab belongs to the class of medications called biological response modifiers ("biologics") or TNF blockers. It is used to treat:

• active ankylosing spondylitis in adults who have not responded to other therapies
• active psoriatic arthritis in adults
• fistulating Crohn's disease in adults who have not responded to other therapies
• moderate-to-severe chronic plaque psoriasis in adults
• moderate-to-severe active Crohn's disease in adults and children at least 9 years old who have not responded to other therapies
• moderatel-to-severe active ulcerative colitis in adults who have not responded to other therapies
• moderate-to-severe rheumatoid arthritis in adults when used in combination with methotrexate

For people with these conditions, their bodies overproduce a protein called tumour necrosis factor(TNF), which causes pain, inflammation, and damage. Infliximab blocks the production of TNF and decreases the inflammation in the joints and on the skin. You may start to notice an improvement in symptoms about 2 weeks after starting treatment.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

How to take Remicade?

The recommended dose of infliximab depends on the condition being treated, and it varies according to body weight.

It is injected intravenously (into a vein) by a health care professional, usually in a clinical setting such as a hospital clinic, over a period of time. This process is called an intravenous infusion. You should keep all your appointments and follow-ups as recommended by your doctor.

The appropriate dose for the following conditions is usually given 2 and 6 weeks after the first dose, then every 8 weeks thereafter:

• rheumatoid arthritis
• ulcerative colitis
• adults with fisulating Crohn's disease
• adults and children with active Crohn's disease
• psoriatic arthritis
• plaque psoriasis

For ankylosing spondylitis, the appropriate dose is usually given 2 and 6 weeks after the first dose, then every 6 to 8 weeks thereafter.

It is important to receive this medication exactly as recommended by your doctor. If you miss an appointment to receive infliximab, contact your doctor as soon as possible to reschedule your appointment.

Many things can affect the dose and schedule of medication that a person needs, such as body weight, other medical conditions, and other medications. Your doctor may choose a schedule different from the one above.

This medication must be refrigerated at 2 degrees C to 8 degrees C (do not freeze) and kept out of the reach of children. This medication does not contain preservatives and must be mixed with sterile water for injection before IV infusion. Once the powder has been mixed, it should be used within 3 hours.

Who should NOT take Remicade?

Infliximab should not be used by anyone who:

• is allergic to infliximab, mouse proteins, or to any of the ingredients of the medication
• is pregnant or breast-feeding
• has moderate-to-severe congestive heart failure
• has severe infections such as sepsis, abscesses, tuberculosis, or opportunistic infections (infections that strike people with weakened immune systems)
  

Remicade Dosage

Rheumatoid Arthritis

The recommended dose of REMICADE is 3 mg/kg given as an intravenous infusion followed with additional similar doses at 2 and 6 weeks after the first infusion then every 8 weeks thereafter. REMICADE should be given in combination with methotrexate. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks.

Crohn's Disease or Fistulizing Crohn's Disease

The recommended dose of REMICADE is 5 mg/kg given as an induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of moderately to severely active Crohn's disease or fistulizing disease. For patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg. Patients who do not respond by week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue REMICADE in these patients.

Preparation and Administration Instructions

Use aseptic technique.

REMICADE vials do not contain antibacterial preservatives. Therefore, the vials after reconstitution should be used immediately, not re-entered or stored. The diluent to be used for reconstitution is 10 mL of Sterile Water for Injection, USP. The total dose of the reconstituted product must be further diluted to 250 mL with 0.9% Sodium Chloride Injection, USP. The infusion concentration should range between 0.4 mg/mL and 4 mg/mL.

Possible Side Effects of Remicade

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• back pain
• cough
• diarrhea
• dizziness
• fatigue
• headache
• heartburn
• itch
• nausea or vomiting
• trouble sleeping
• upset stomach

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• fever or chills
• muscle or joint pain
• swelling of the hands or feet (if there is no shortness of breath)
• symptoms of an infection (e.g., fever, chills, pain, swelling, or pus)
• symptoms of liver damage (e.g., yellow skin or eyes, dark urine, loss of appetite, abdominal pain, fever, and fatigue)
• symptoms of upper respiratory infections (e.g., sore throat, fever, cough, fatigue, chest congestion)
• symptoms of vaginal yeast infections (e.g., itching, thick white discharge)

Seek immediate medical attention if any of the following occur:

• chest pain
• fainting
• seizures
• skin rash
• swelling of the hands or feet with shortness of breath
• symptoms of an allergic reaction (such as difficulty breathing, hives, swelling of the face or throat)
• symptoms of nervous system problems (such as confusion, seizures, vision changes, or movement problems)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Possible precautions or warnings for Remicade

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Drug Interactions

There may be an interaction between infliximab and any of the following:

• abatacept
• anakinra
• echinacea
• live vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

This article is for informational purposes only. For further instructions on Remicade consult with your doctor.