Remicade Consumer Medicine Information

Infliximab

What is in this leaflet

This leaflet answers some common questions about Remicade. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Remicade against the benefits it is expected to have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What Remicade is used for

Remicade is an anti-inflammatory agent used to treat Crohn's disease and rheumatoid arthritis. The active ingredient, infliximab, is a human-mouse protein produced by recombinant technology.

Crohn's disease:

Crohn's disease is a chronic inflammatory disease of the bowel, affecting the distal small intestine and the colon. It may also affect any part of the gut. The cause of Crohn's disease is unknown. The naturally occurring protein, tumour necrosis factor alpha (TNFα), is thought to play an important role in Crohn's disease.

When TNFα is over-produced, it can cause inflammation which can induce damage to the bowel wall. Remicade can prevent the harmful effects of TNFα, thereby reducing the signs and symptoms of Crohn's disease.

Remicade can also lower the number of abnormal openings through the skin from the bowel (called enterocutaneous fistulae), a common complication of Crohn's disease.

Rheumatoid arthritis:

Rheumatoid arthritis is an inflammatory disease of the joints. The naturally occurring protein, TNFα, is thought to cause rheumatoid arthritis.

When TNFα is over-produced in the joints, it can cause inflammation which can induce damage to the joints. Remicade can prevent the harmful effects of TNFα, thereby reducing signs and symptoms, stopping and preventing joint damage and improving physical function of the affected joints. You will also be given a disease modifying medicine, methotrexate.

Your doctor, however, may prescribe Remicade for another purpose.

Ask your doctor if you have any questions about why Remicade has been prescribed for you.

Before you are given Remicade

When you must not be given it

Do not use Remicade if you have an allergy to mouse proteins or any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction to Remicade may include skin rash, hives, fatigue, wheezing, difficulty in breathing, and/or low blood pressure.

Do not use Remicade if you have tuberculosis, infected abscesses, another infection, a chronic infection or a history of recurrent infection.

If you have never been given Remicade and have moderate to severe congestive heart failure, you should not use it.

Before you are given it

You must tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Like most medicines, Remicade is not recommended in pregnancy and breast-feeding.

You must use adequate contraception to avoid falling pregnant for at least 6 months after the last treatment with Remicade.

If you are breastfeeding, your doctor will advise you to discontinue breastfeeding for at least 6 months after treatment with Remicade.

Remicade may affect the normal immune response. You might get infections more easily. Some cases of tuberculosis have been reported in patients treated with Remicade. Before starting Remicade, it is important to tell your doctor if you have ever had or been in close contact with tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, fever), or any other infection appear during therapy notify your doctor immediately.

If you have a long history of Crohn's disease and have been taking medicine that reduces the activity of the body's natural defences, you are more likely to develop infections and lymphomas. Your doctor will discuss with you the benefits of using Remicade against the potential risks.

If you suffer from mild congestive heart failure, ensure that your doctor is aware of your condition as steps must be taken to monitor any changes to your condition during treatment with Remicade.

Taking or being given other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may affect the way other medicines work. Your doctor or pharmacist will be able to tell you what to do when being given Remicade with other medicines.

How Remicade is given

Remicade is only available on prescription. Remicade is given by your doctor in a drip into a vein (called an infusion) over at least 2 hours. A period of observation follows treatment.

Crohn's disease:

The recommended dose for Crohn's disease is a single dose of 5 mg/kg.

The recommended dose for closure of fistulae is also 5mg/kg. You may be given two additional infusions at 2 and 6 weeks after the first infusion.

Rheumatoid arthritis:

The recommended starting dose for rheumatoid arthritis is an infusion of 3 mg/kg. You will get additional doses at 2 and 6 weeks after your first infusion and then every 8 weeks after that.

You will also be taking methotrexate as part of your treatment.

While you are given Remicade

Things you must do

If the medicine starts to upset you or your symptoms become worse, tell your doctor, nurse or pharmacist.

You should take adequate contraceptive measures to avoid pregnancy during treatment and for at least 6 months after the last infusion of Remicade.

Things to be careful of

Remicade may affect the normal immune response. There is a possibility that you may be more prone to infections. Tell your doctor if you think you have an infection. You will be watched closely.

Tell your doctor immediately if you develop a skin rash or hives. Your doctor may discontinue Remicade until the symptoms go away and then begin giving the medicine again. Symptoms will resolve with appropriate treatment.

Remicade is unlikely to make you drowsy. If you are tired, do not drive a car or work with machinery.

If you suffer from congestive heart failure, tell your doctor immediately if your condition worsens.

Side effects

Tell your doctor, nurse, or pharmacist as soon as possible if you do not feel well while you are being given Remicade.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

During the infusion of Remicade the following reactions may occur:

  • fever or chills
  • itchiness or hives
  • chest pain
  • low blood pressure
  • high blood pressure
  • shortness of breath.

These reactions are more likely to occur during the first and second infusion.

Side effects may appear up to six months after the last infusion.

Tell your doctor immediately if you notice any of the following:

  • pain or tenderness in chest, muscles, joints or jaw
  • swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • fever
  • rash
  • itching
  • symptoms that may indicate heart failure, e.g. shortness of breath, especially with exercise or lying down, or swelling of your feet.

Tell your doctor or nurse as soon as possible if you notice any of the following:

  • headache
  • nausea
  • itching
  • dizziness and light-headedness
  • fatigue
  • depression
  • fever
  • fungal infection
  • rash
  • hives
  • sore throat
  • mouth ulcers
  • coughing
  • hoarseness
  • shortness of breath
  • chest pain
  • diarrhoea
  • muscle pain
  • abdominal pain
  • vomiting
  • indigestion
  • weight loss, muscle wasting
  • problems with urination
  • changes in the way your heart beats, for example, if you notice it beating faster
  • flushing
  • skin redness
  • dry skin or increased sweating
  • your rheumatoid arthritis becomes worse.

Most of the side effects are mild to moderate in severity.

Other side effects not listed above may also occur in some patients.

Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After Remicade has been stopped

Tell your doctor immediately if you notice any of the following side effects, even if they occur several weeks after stopping treatment with Remicade.

  • skin rash or hives
  • frequent infections

Tell your doctor if you notice any other effects.

Storage

Remicade should be stored at 2C to 8C. (Refrigerate. Do not freeze.) Do not use beyond the expiration date.

Product description

What it looks like

Remicade comes as a white powder in a glass vial.

Ingredients

Active ingredient:

Infliximab 100 mg per vial

Inactive ingredients:

  • sodium phosphate monobasic monohydrate
  • sodium phosphate dibasic dihydrate
  • sucrose
  • polysorbate 80

Date of Preparation: 11 April 2003