Read all of this leaflet carefully before you start taking this medicine.
In addition to this leaflet, you will also receive a patient card with important safety information that you need to know before you are given Remicade and during your treatment with Remicade.
- Keep this leaflet and the patient card. You may need to read them again.
- If you have any further questions, talk to your doctor or pharmacist.
In this leaflet:
1. What Remicade is and what it is used for
2. What you need to know before you take Remicade
3. How to use Remicade
4. Possible side effects
5. How to store Remicade
6. Further information
Remicade 100 mg powder for concentrate for solution for infusion.
- The active substance is infliximab.
- The other ingredients are sucrose, polysorbate 80, monobasic sodium phosphate and dibasic sodium phosphate.
1. WHAT IS REMICADE AND WHAT IS IT USED FOR? Remicade is used to treat Crohn's disease, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. All of these diseases involve excessive inflammation, and Remicade inhibits this inflammatory response.
In dermatology, the drug is used not only for psoriasis but also for a number of special and rare inflammatory skin diseases, such as pyoderma gangrenosum and severe forms of hidradenitis suppurativa. The drug is not registered for these rare conditions. This is called off-label use.
The active substance, infliximab, is a monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to other unique proteins. Infliximab binds to a special protein in the body called tumor necrosis factor-alpha, or TNF-α, which plays an important role in various inflammatory responses in the body. Elevated levels of TNF-α are common in inflammatory conditions such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Infliximab (anti-TNF-α) inhibits the inflammatory response by binding to TNF-α.
The drug is only available as an intravenous solution. This means that for administration, you must be admitted to the hospital and receive an intravenous drip in your arm.
Rheumatoid arthritis:
Rheumatoid arthritis is an inflammation of the joints. If you have active rheumatoid arthritis, you will first be given other medicines. If you are taking other medicines and still have signs and symptoms of your disease, you will be given Remicade in combination with methotrexate to:
- reduce the signs and symptoms of your disease
- slow the damage to your joints
- improve your physical function
Crohn's disease:
Crohn's disease is an inflammation of the bowel. If you have Crohn's disease, you will first be given other medicines. If you still have signs and symptoms of your disease, you will be given Remicade to:
- treat severe, active disease that has not been controlled with a corticosteroid and/or a medicine to suppress the immune system; or if you are intolerant to medicines such as these;
- reduce the number of draining enterocutaneous fistulas (abnormal openings through the skin from the bowel) that have not responded to treatment with other medicines or surgery.
Ulcerative colitis:
Ulcerative colitis is an inflammation of the bowel. If you have ulcerative colitis, you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Remicade to reduce the signs and symptoms of your disease.
Ankylosing spondylitis:
Ankylosing spondylitis is an inflammation of the spine. If you have ankylosing spondylitis, you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Remicade to:
- reduce the signs and symptoms of your disease
- improve your physical function
Psoriatic arthritis:
Psoriatic arthritis is an inflammation of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Remicade to reduce the signs and symptoms of your disease.
Psoriasis:
Psoriasis is an inflammation of the skin. If you have moderate to severe plaque psoriasis, you will first be given other medications or, for example, phototherapy. If you do not respond sufficiently to these treatments, you will be given Remicade to reduce the signs and symptoms of your psoriasis.
Hidradenitis suppurativa (unapproved indication):
Hidradenitis suppurativa is a rare inflammatory skin disease in which fistulas develop under the skin. Cavities and passages develop that repeatedly become inflamed and can proliferate under the skin. Remicade is only used for this condition in severe cases that do not respond to standard therapies.
Pyoderma gangrenosum (not a registered indication):
Pyoderma gangrenosum is a very rare skin condition in which ulcers develop spontaneously or after skin damage, spreading in all directions and causing severe damage. The condition occurs in Crohn's disease and ulcerative colitis, among others, but also in other internal diseases, and in healthy individuals. Remicade is used for this skin condition when other medications such as prednisone, ciclosporin, or sulfasalazine are not effective enough or cause too many side effects.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE REMICADEDo not use Remicade:- if you are hypersensitive (allergic) to infliximab, to any of the other ingredients of Remicade, or to mouse (mouse and rat) proteins.
- if you have a serious infection, including tuberculosis (see: "Take special care with Remicade"). It is important that you tell your doctor if you have any symptoms of infection, e.g. fever, feeling unwell, wounds, dental problems.
- if you have moderate or severe heart failure. It is important that you tell your doctor if you have or have had a serious heart condition.
If you think you have any of the above, it is important that you see your doctor.Take special care with Remicade:Some patients have experienced allergic reactions within 2 hours of receiving Remicade. These reactions were generally mild to moderate; however, in rare cases they have been severe. Symptoms of such reactions typically included rash, hives, fatigue, wheezing or difficulty breathing, and/or low blood pressure. If you experience any of these symptoms, tell your doctor.
If these symptoms occur during the infusion, your doctor may reduce the infusion rate. Your doctor may also stop administering the medication until the symptoms disappear and then restart it. Your doctor may also treat your symptoms with other medications (paracetamol, antihistamines, corticosteroids, bronchodilators, and/or adrenaline).
In most cases, you can still receive Remicade even if these symptoms occur. However, in some cases, your doctor may decide that it is best to discontinue Remicade.
There is an increased risk of hypersensitivity reactions if you are re-treated after an interval of more than 16 weeks. Therefore, it is not recommended to restart Remicade after a period of more than 16 weeks without medication.
An allergic reaction may occur up to 12 days after the infusion. This reaction can be severe. Signs and symptoms include muscle weakness or pain, rash, fever, joint or jaw pain, swelling of the hands or face, difficulty swallowing, itching, sore throat, and/or headache. Tell your doctor immediately if you notice any of these symptoms.
You may be more likely to get an infection. It is important to tell your doctor if you have any symptoms of infection, such as fever, feeling generally unwell, wounds, or dental problems.
If you have purulent fistulas, tell your doctor.
Because cases of tuberculosis have been reported in patients treated with Remicade, you will be tested for tuberculosis before starting Remicade. The test consists of a detailed medical history, and it is very important that you tell your doctor if you have ever had tuberculosis or been in contact with someone who has had tuberculosis. You will also undergo a tuberculin skin test and a chest X-ray. Your doctor should record on your patient record when these tests were performed.
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, fever) or another infection occur during treatment, consult your doctor immediately.
If you have recently received or are due to receive a vaccine, tell your doctor.
If you are about to have surgery or dental work, tell your doctor or dentist that you are taking Remicade.
If you have mild heart failure and are being treated with Remicade, your doctor should closely monitor your heart failure. If you develop new or worsening symptoms of heart failure (for example, shortness of breath or swelling of the feet), contact your doctor immediately.
In rare cases, you may develop signs and symptoms of lupus (persistent rash, fever, joint pain, and fatigue). If these symptoms occur, contact your doctor.
Before taking Remicade, tell your doctor if you have had lymphoma (a type of blood cancer) or any other cancer. Taking Remicade may increase your risk of developing lymphoma or other cancers. You should also tell your doctor if you develop lymphoma or other cancers while taking Remicade.
Reports of lymphoma in patients treated with Remicade are rare, but occur more frequently than expected in the general population. A patient with more severe rheumatoid arthritis who has had the disease for a long time may be more likely to develop lymphoma.
In rare cases, a specific and serious form of lymphoma has been reported in young people or adolescents with Crohn's disease who were treated with Remicade plus azathioprine or 6-mercaptopurine.
Cancers other than lymphoma have also been reported in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD). Patients with COPD and/or heavy smokers may have an increased risk of cancer during treatment with Remicade. If you have COPD or are a heavy smoker, discuss with your doctor whether Remicade is suitable for you.
Pregnancy:
Remicade will not be given to you if you are pregnant.
If you are given Remicade, you must avoid becoming pregnant by using appropriate contraception during your treatment and for at least six months after the last Remicade infusion.
Breastfeeding
It is not known whether infliximab is excreted in breast milk. If you are breastfeeding, you should stop breastfeeding when you are due to receive Remicade. Your last treatment with Remicade should have been at least six months before you start breastfeeding.
Special patient groups
No studies have been conducted on the administration of Remicade to children (0-17 years) with rheumatoid arthritis or Crohn's disease. Until safety and efficacy data in children are available, treatment with Remicade should be avoided.
Specific studies of Remicade have not been conducted in elderly patients or in patients with liver or kidney problems.
Driving and using machines:
It is not known whether Remicade affects the ability to drive or use machines. If you feel tired or unwell after taking Remicade, you should not drive or operate machinery.
Taking Remicade with other medicines:
In general, patients with rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, or psoriasis are already taking several medicines to treat their disease, such as methotrexate, azathioprine, or 6-mercaptopurine. These medicines may themselves cause side effects.
Tell your doctor if you are taking or have recently taken any other medicines, even medicines not prescribed. If you experience any additional side effects or any other new symptoms, tell your doctor.
3. HOW TO USE REMICADE Remicade is available as a powder for concentrate for solution for infusion. This means that Remicade must first be mixed with water for injections before you are given it. The resulting solution is then further diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Remicade is available in packs containing 1, 2 or 3 vials. Not all pack sizes may be marketed. Each vial of Remicade (glass bottle) contains 100 mg of the active substance infliximab.
Remicade will be given to you as an infusion into a vein, usually in your arm, over a period of 2 hours in a healthcare facility. Your doctor or healthcare professional will monitor you during the administration of your Remicade dose and for 1 to 2 hours afterward.
Depending on your condition and how you respond, your doctor will determine your individual dose and dose interval. This may include additional doses 2 and 6 weeks after your first dose. Treatment may also be continued after this time. The total amount of infliximab you receive is based on the dose and your body weight. Your doctor will advise you on any other medications you should continue taking while you are being treated with Remicade.
Rheumatoid arthritis:
The recommended dose is 3 mg infliximab per kg body weight.
Crohn's disease:
The recommended dose for severe, active Crohn's disease is 5 mg infliximab per kg body weight. For closure of enterocutaneous fistulas, the recommended dose is 5 mg infliximab per kg body weight.
Ankylosing spondylitis:
The recommended dose is 5 mg infliximab per kg body weight.
Psoriatic arthritis:
The recommended dose is 5 mg infliximab per kg body weight.
Ulcerative colitis:
The recommended dose is 5 mg infliximab per kg body weight.
Psoriasis:
The recommended dose is 5 mg infliximab per kg body weight.
Schedule: weeks 0, 2, 6 and then every 8 weeks (adjusted if necessary)
Pyoderma gangrenosum and hidradenitis suppurativa:
The recommended dose is 5 mg infliximab per kg body weight.
Schedule: Weeks 0, 2, 6, and then every 8 weeks (adjustable as needed)
4. POSSIBLE SIDE EFFECTSLike all medicines, Remicade can have side effects. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur up to six months after the last infusion.Consult your doctor immediately if you notice any of the following:- pain or weakness in the chest, muscles, joints or jaw
- swollen hands, feet, ankles, face, lips, mouth or throat, which may
make breathing or swallowing difficult
- hives or other signs of an allergic reaction
- fever
- rash -
itching
- shortness of breath during exercise or when lying down, or swollen feetConsult your doctor as soon as possible if you notice any of the following:- signs of infection
- difficulty breathing and dry cough
- problems urinating
- changes in the way your heart beats, for example, you notice it beating faster
- feeling light-headed
- tiredness
- hoarseness
- cough
- headache -
tingling -
numbness to touch
- double vision or other problems with your eyes
- floppy arms or legs
- signs of liver or spleen problems: yellowing eyes or skin, dark
brown urine, upper abdominal pain
- weight loss
- night sweats
- painful joints
The symptoms described above may be signs of the side effects seen with Remicade classified below.
Common: headache, dizziness, nausea, abdominal symptoms, allergic reactions, rash, hives, viral infections (for example, herpes), respiratory infections (colds, sinus infections, bronchitis, pneumonia). In patients with hidradenitis suppurativa, joint symptoms may occur which resolve after stopping infliximab.
Uncommon: Depression, agitation, sleep disorders, poor wound healing, bacterial infections (for example tuberculosis, urinary tract infections, deep skin infections, sepsis), fungal infections, asthma, abnormal liver function, low blood cell counts including anaemia, worsening demyelinating nerve disease, activation of autoimmune diseases (SLE, lupus), worsening heart failure, hair loss, bleeding, allergic anaphylactic reactions, injection site reactions.
Rare: Gastrointestinal bleeding or perforation, circulatory disorders, multiple sclerosis, lymphoma.
Your doctor may also perform tests to check your liver function and/or blood values.
If you notice any side effects not mentioned in this leaflet, please inform your doctor.
5. HOW TO STORE REMICADE Keep out of the reach and sight of children.
Store in a refrigerator at 2°C – 8°C.
Do not freeze.
The reconstituted, diluted solution for infusion is stable for 24 hours at room temperature (25°C), but for bacteriological reasons, it is recommended to use it as soon as possible. The infusion must be started within 3 hours of reconstitution and dilution.
If reconstitution and dilution are performed aseptically, Remicade solution for infusion can be used within 24 hours, provided it is stored at 2°C–8°C.
Remicade will not be administered to you if opaque particles, discoloration, or other foreign particles are present. |
