100 mg powder for concentrate for solution for infusion
infliximab
What Remicade is and what it is used for
Remicade contains the active substance infliximab. Infliximab is a monoclonal antibody – a type of protein that binds to a specific target in the body called TNF alpha ( tumor necrosis factor-alpha).
Remicade belongs to a group of medicines called “TNF inhibitors”. It is used in adults for the following inflammatory diseases:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis (Bechterew’s disease)
- Psoriasis.
Remicade is also used in adults and children, 6 years and older in:
- Crohn’s disease
- Ulcerative colitis.
Remicade works by specifically binding to TNF alpha and blocking its function. TNF alpha participates in inflammatory processes in the body and by blocking them, inflammation in your body can be reduced.
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease that attacks the joints. If you have active rheumatoid arthritis, you will first be given other medicines. If these medicines do not work well enough, you will be given Remicade, which you will need to take in combination with another medicine called methotrexate to:
- Reduce signs and symptoms of the disease
- Reduce damage to the joints
- Improve your physical function.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be given other medicines. If these medicines do not work well enough, you will be given Remicade to:
- Reduce signs and symptoms of the disease
- Reduce damage to the joints
- Improve your physical function.
Ankylosing spondylitis (Bechterew’s disease)
Ankylosing spondylitis is an inflammatory disease of the spine. If you have ankylosing spondylitis, you will first be given other medicines. If these medicines do not work well enough, you will be given Remicade to:
- Reduce signs and symptoms of the disease
- Improve your physical function.
Psoriasis
Psoriasis is an inflammatory disease of the skin. If you have moderate or severe plaque psoriasis, you will first be given other medicines or treatments such as light therapy. If these medicines or treatments do not work well enough, you will be given Remicade to reduce the signs and symptoms of the disease.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will first be given other medicines. If these medicines do not work well enough, you will be given Remicade to treat the disease.
Crohn’s disease
Crohn’s disease is an inflammatory disease of the intestine. If you have Crohn’s disease, you will first be given other medicines. If these medicines do not work well enough, you will be given Remicade to:
- Treat active Crohn’s disease
- Reduce the number of abnormal passages ( fistulas ) through the skin from the intestine that has not been controlled with other drugs or surgery.
What you need to know before using Remicade
You will not receive Remicade if:
- You are allergic to infliximab or any of the other ingredients of Remicade (listed in section 6)
- You are allergic (hypersensitive) to protein that comes from mice
- You have tuberculosis (TB) or any other serious infection such as pneumonia or sepsis
- You have heart failure that is moderate or severe.
Do not use Remicade if any of the above apply to you. If you are not sure, talk to your doctor before taking Remicade.
Warnings and cautions
Talk to your doctor before or during treatment with Remicade if you have:
Received treatment with Remicade before
- Tell your doctor if you have previously received Remicade and are now starting treatment with Remicade again.
If you have had a break in your Remicade treatment for more than 16 weeks, there is an increased risk of allergic reactions when you start treatment again.
Infection is
- Tell your doctor before receiving Remicade if you have an infection, even if it is a very mild one.
- Tell your doctor before receiving Remicade if you have ever lived in or traveled to areas where infection called histoplasmosis, coccidioidomycosis or blastomycosis is common. These infections are caused by a special type of fungus that can affect the lungs or other parts of the body.
- You can more easily get your infection when you are treated with Remicade. If you are 65 years or older, the risk is higher.
- These infections can be serious and include tuberculosis, infections caused by viruses, fungi, bacteria, or other organisms in the environment, and blood poisoning that can be life-threatening.
Tell your doctor immediately if you get any signs of infection during treatment with Remicade. Such signs include fever, cough, flu-like signs, general malaise, red or hot skin, sores, or dental problems. Your doctor may recommend that Remicade treatment be stopped temporarily.
Tuberculosis (TBC)
- You must tell your doctor if you have ever had TB or if you have been in close contact with someone who has had or has TB.
- Your doctor will check if you have TB. Cases of TB have been reported in patients treated with Remicade, including in patients already treated with anti-TB drugs. Your doctor will note the examinations on your Patient’s Card
- If your doctor thinks you are at risk of getting TB, you can get TB medicine before you are given Remicade.
Tell your doctor immediately if you get any signs of TB during treatment with Remicade. Such signs include persistent cough, weight loss, feeling tired, fever, and night sweats.
Hepatitis B virus
- Tell your doctor before receiving Remicade if you are a hepatitis B carrier or if you have ever had it.
- Tell your doctor if you think you are at risk of getting hepatitis B.
- Your doctor will test you for the hepatitis B virus.
- Treatment with TNF -antagonists such as Remicade may reactivate the hepatitis B virus in patients carrying the virus, which in some cases may be life-threatening.
Heart problems
- Tell your doctor if you have heart problems such as mild heart failure.
- Your doctor will closely monitor your heart.
Tell your doctor immediately if you get new or worsening signs of heart failure during treatment with Remicade. Such signs include shortness of breath or swollen feet.
Cancer and lymphoma
- Tell your doctor before receiving Remicade if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
- Patients with severe rheumatoid arthritis who have had the disease for a long time may have a higher risk of developing lymphoma.
- Children and adults treated with Remicade may be at increased risk of developing lymphoma or any other cancer
- Some patients who have received TNF inhibitors, including Remicade, have developed a rare type of cancer called T-cell lymphoma in the liver and spleen. Of these patients, most were teenage boys or younger men, and most had either Crohn’s disease or ulcerative colitis. This type of cancer usually leads to death. In addition to TNF inhibitors, almost all patients had also received medicines containing azathioprine or 6-mercaptopurine.
- Some patients treated with infliximab have developed certain types of skin cancer. Tell your doctor if there are any changes in the skin or growths on the skin during or after the treatment.
- Some women who have been treated for rheumatoid arthritis with Remicade have developed cervical cancer. For women taking Remicade, even those over 60 years of age: Your doctor may recommend regular examination for cervical cancer.
Lung disease or heavy smoking
- Tell your doctor before receiving Remicade if you have a lung disease called chronic obstructive pulmonary disease (COPD), or if you are a heavy smoker.
- Patients who have COPD or patients who are heavy smokers may have a higher risk of developing cancer during treatment with Remicade.
Diseases of the nervous system
- Tell your doctor if you have or have had problems affecting your nervous system before receiving Remicade. These include multiple sclerosis, and Guillain-Barré syndrome if you have a seizure or have been diagnosed with “optic neuritis”.
Tell your doctor immediately if you experience symptoms of nerve disease during treatment with Remicade. Such signs include altered vision, weakness in the arms or legs, and numbness or tingling in any part of the body.
Fistulas
- Tell your doctor if you have any abnormal skin opening ( fistula ) before receiving Remicade.
Vaccinations
- Tell your doctor if you have recently had or are planning to get vaccinated
- You should receive recommended vaccinations before starting treatment with Remicade. You can get some vaccinations during treatment with Remicade but you should not get live vaccines (vaccines that contain a live but weakened infectious agent) as they can cause you an infection.
- If you received Remicade while you were pregnant, your baby may also have a higher risk of getting an infection, as a result of receiving a live vaccine during the first year of life. You must tell your child’s doctor and other healthcare professionals if you have been treated with Remicade. They can then decide when their child should receive any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis ).
- If you are breastfeeding, you must tell your child’s doctor and other healthcare professionals that you are using Remicade before your child receives any vaccine. For more information, see the section on pregnancy and breastfeeding.
Antimicrobial agents
- Tell your doctor if you have recently received or are planning to receive treatment with an antimicrobial agent (such as BCG installation which is used to treat cancer).
Operations or dental treatments
- Tell your doctor if you are going to have any surgery or dental treatment.
- Tell your doctor or dentist that you are being treated with Remicade by showing your Patient Card.
Liver problem
- Some patients receiving Remicade have developed severe liver problems.
Tell your doctor immediately if you experience symptoms of liver problems during treatment with Remicade. Such signs include yellowing of the skin and eyes, dark brown urine, pain or swelling in the upper right side of the abdomen, joint pain, rash, or fever.
Low blood levels
- In some patients receiving Remicade, the body may not be able to produce enough blood cells to help fight infections or to stop bleeding.
Tell your doctor immediately if you experience symptoms of low blood pressure during treatment with Remicade. Such signs include persistent fever, easy bleeding or bruising, and small red or purple spots caused by bleeding under the skin or pallor.
Problems with the immune system
- Some patients receiving Remicade have developed symptoms of an immune disorder called lupus.
Tell your doctor immediately if you develop symptoms of lupus during treatment with Remicade. Such signs include joint pain or rash on the cheeks or arms that are sensitive to the sun.
Children and young people
The above information also applies to children and young people. In addition:
- Some children and teens who have received TNF inhibitors, such as Remicade, have developed cancer, even rare types, which have sometimes led to death.
- More children taking Remicade to get you infection compared to adults
- Children should receive recommended vaccinations before starting treatment with Remicade. Children may receive certain vaccines during treatment with Remicade but should not receive live vaccines while using Remicade.
If you are not sure if any of the above applies to you, talk to your doctor before receiving Remicade.
Other medicines and Remicade
Patients with inflammatory diseases are already taking medication to treat their problems. These drugs can cause side effects. Your doctor will tell you which other medicines you must continue to use when you receive Remicade.
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis, or over-the-counter medicines such as vitamins and herbal remedies.
In particular, tell your doctor if you are taking any of the following medicines:
- Drugs that affect the immune system
- Kineret (anakinra). Remicade and Kineret should not be used together.
- Orencia (abatacept). Remicade and Orencia should not be used together.
You should not receive live vaccines when using Remicade. If you have been pregnant and taken Remicade at the same time, or if you are taking Remicade while breastfeeding, talk to your baby’s doctor and other healthcare professionals who have contact with your baby. Inform about your treatment with Remicade before the child receives any vaccine.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Remicade.
Pregnancy, breastfeeding, and fertility
- If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Remicade should only be used during pregnancy or breastfeeding if your doctor considers it necessary.
- You should avoid becoming pregnant when you are treated with Remicade and for 6 months after stopping treatment. Discuss the use of appropriate contraceptives during this time with your doctor.
- If you received Remicade during your pregnancy, your baby may be at higher risk of getting an infection.
- You must tell your child’s doctor and other healthcare professionals if you have been treated with Remicade before giving your child any vaccine. If you received Remicade during pregnancy and your baby is given the BCG vaccine (used to prevent tuberculosis ) within 12 months of birth, it can lead to infection with serious complications, even fatal. Live vaccines such as the BCG vaccine should not be given to your baby within 12 months of birth unless your baby’s doctor recommends otherwise. For more information, see the section on vaccinations.
- If you are breastfeeding, you must tell your child’s doctor and other healthcare professionals that you are using Remicade before your child receives any vaccine. Live vaccines should not be given to your baby while you are breastfeeding unless your baby’s doctor recommends otherwise.
- Sharp reductions in white blood cell counts have been reported in infants born to women treated with Remicade during pregnancy. If your child has a constant fever or infection, contact your child’s doctor immediately.
Driving and using machines
Remicade is unlikely to affect your ability to drive or use tools or machines. If you feel tired, dizzy, or unwell after receiving Remicade, do not drive or use any tools or machines.
Remicade contains sodium
Remicade contains less than 1 mmol (23 mg) sodium per unit dose, ie essentially ‘sodium-free’. Remicade is prepared with a sodium-containing solution before it is given to you. Talk to your doctor if you have been prescribed a low-salt (sodium-poor) diet.
How Remicade is given
Rheumatoid arthritis
The usual dose is 3 mg per kg body weight.
Psoriatic Arthritis, Ankylosing Spondylitis (Bechterew’s Disease), Psoriasis, Ulcerative Colitis, And Crohn’s Disease
The usual dose is 5 mg per kg body weight.
How Remicade is given
- Remicade will be given to you by a doctor or nurse.
- Your doctor or nurse will prepare the medicine for infusion.
- The drug will be given as an infusion (drip) (for 2 hours) into a vein, usually in your arm. After the third treatment, your doctor may decide to give you your dose of Remicade for 1 hour.
- You will be monitored while receiving Remicade and also 1-2 hours afterward.
Amount of Remicade given
- Your doctor will decide on your dose and how often you should receive Remicade. It depends on your illness, weight, and how well you respond to Remicade
- The table below shows how you will most likely receive this medicine after your first dose.
| 2nd dos en | 2 weeks after 1st dose one |
| 3rd dose en | 6 weeks after 1st dose one |
| Additional dose er | Every 6 to 8 weeks depending on the disease |
Use for children and adolescents
Remicade should only be given to children being treated for Crohn’s disease or ulcerative colitis. These children must be 6 years or older.
If you take more Remicade than you should
Because this medicine is given by a doctor or nurse, it is unlikely that you will receive too much.
There are no known side effects after taking too much Remicade.
If you forget or miss your Remicade infusion
If you have forgotten or missed a visit to get Remicade, book a new visit as soon as possible
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some patients may experience serious side effects that may require treatment. Side effects may also occur after treatment with Remicade has ended.
Tell your doctor immediately if you notice any of the following:
- Signs of an allergic reaction such as swelling of the face, lips, mouth, or throat, which can cause difficulty swallowing or breathing, skin rash, hives, swollen hands, feet, or ankles. Some of these reactions can be serious or life-threatening. An allergic reaction can occur within 2 hours after injection or later. Several signs of allergic side effects that can occur up to 12 days after injection include muscle pain, fever, joint or jaw pain, sore throat, or headache.
- Signs of heart problems such as discomfort or pain in the chest, pain in the arm, abdominal pain, shortness of breath, anxiety, dizziness, dizziness, fainting, sweating, nausea, vomiting, fluttering or throbbing beats in the chest, rapid or slow heartbeat, and/or swelling feet.
- Signs of infection (includes TBC) such as fever, tiredness, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhea, ulcers, accumulation of var in the intestine or around the anus (abscess), dental problems or burning sensation when urinating.
- Possible signs of cancer, include but are not limited to swollen lymph nodes, weight loss, fever, unusual lumps in the skin, changes in skin spots or skin color, or unusual bleeding from the abdomen.
- Signs of lung problems such as cough, difficulty breathing, or tightness in the chest.
- Signs of nervous system problems (including eye problems) such as signs of stroke (sudden numbness or weakness in the face, arms, or legs, especially on one side of the body; sudden confusion, difficulty speaking or understanding; difficulty seeing with one or both eyes, difficulty walking, dizziness, loss of balance or coordination, or severe headache), seizures, tingling/numbness in any part of the body, or weakness in the arms or legs, altered vision such as double vision or other eye problems.
- Signs of liver problems (including hepatitis B infection if you have previously had hepatitis B) such as yellowing of the skin or eyes, dark brown urine, pain or swelling in the upper right side of the abdomen, joint pain, rash, or fever.
- Signs of an immune disease such as joint pain or rash on the cheeks or arms that are sensitive to the sun (lupus) or cough, shortness of breath, fever, or rash ( sarcoidosis ).
- Signs of low blood levels such as persistent fever, easy to get bleeding or bruising, and small red or purple spots caused by bleeding under the skin or pallor.
- Signs of severe skin problems such as reddish spots, or round spots often with blisters in the middle, localized on the upper body, large areas of scaly and tender skin (exfoliation), cold sores, sores in the throat, nose, genitals, and eyes, or small lumps that are can spread throughout the body. These skin reactions may be accompanied by fever.
Tell your doctor immediately if you notice any of the above.
The following side effects have been observed with Remicade:
Very common: may affect more than 1 user in 10
- Abdominal pain, nausea
- Viral infections such as herpes or flu
- Upper respiratory tract infections such as sinusitis
- Headache
- A side effect is of an infusion
- Pain.
Common: may affect up to 1 in 10 users
- Changes in how the liver works, increase in liver enzyme values (shown by blood tests)
- Infection is in the lungs or breasts such as bronchitis or pneumonia
- Severe or painful breathing, chest pain
- Bleeding in the stomach or intestines, diarrhea, indigestion, heartburn, constipation
- Hives ( urticaria ), itchy rash, or dry skin
- Balance problems or dizziness
- Fever, increased sweating
- Circulatory problems such as low or high blood pressure
- Bruising, hot flashes or nosebleeds, hot, red skin ( redness )
- Feeling tired or weak
- Bacterial infections such as sepsis, abscess, or skin infection ( cellulite )
- Fungal infection of the skin
- Blood problems such as anemia or low white blood cell count
- Swollen lymph nodes
- Depression, sleep problems
- Eye problems that include red eyes and infection
- Rapid heartbeat ( tachycardia ) or palpitations
- Pain in joints, muscles, or back
- Urinary tract infection
- Psoriasis, skin problems such as eczema and hair loss
- Injection site reactions such as pain, swelling, redness, or itching
- Chills, accumulation of fluid under the skin that causes swelling
- Numbness or a stinging sensation.
Uncommon: may affect up to 1 in 100 people
- Poor blood supply, swelling in a blood vessel
- Accumulation of blood outside the blood vessels (hematoma) or bruising
- Skin problems such as blisters, warts, abnormal skin color or pigmentation or swollen lips, thickening of the skin, or red, scaly, and flaky skin
- Severe allergic reaction (eg anaphylaxis ), an immune disease called lupus, allergic reactions to foreign proteins
- Impaired wound healing
- Swollen liver ( hepatitis ) or gallbladder, liver damage
- Feeling forgetful, annoyed, confused, nervous
- Eye problems that include blurred vision or impaired vision, swollen eyes, or vagal
- New onset or worsening of existing heart failure, slow heartbeat
- Fainting
- Cramps, nerve problems
- Intestinal perforation or obstruction in the intestine, abdominal pain or cramps
- Swollen pancreas ( pancreatitis )
- Fungal infections such as yeast infection or fungal infection of the nails
- Lung problems (such as edema )
- Fluid around the lungs (alveolar discharge)
- Narrowing of the airways in the lungs that causes difficulty breathing
- Pneumonia, which causes sharp chest pain that worsens with breathing
- Tuberculosis
- Kidney infections
- Low platelet count, too many white blood cells
- Infection is in the vagina
- Blood tests that show antibodies are against your own body.
- Changes in cholesterol and fat levels in the blood.
Rare: may affect up to 1 in 1,000 users
- A type of blood cancer ( lymphoma )
- The blood does not supply enough oxygen to the body, and circulatory problems such as narrowing of a blood vessel
- Meningitis ( meningitis )
- Infection is caused by a weakened immune system
- Hepatitis B infection if you have had hepatitis B before
- Inflammation of the liver caused by problems with the immune system ( autoimmune hepatitis )
- Liver problems that cause yellowing of the skin or eyes (jaundice)
- Abnormal swelling or growth of tissue
- The severe allergic reaction may cause unconsciousness and may be life-threatening (anaphylactic shock )
- Swelling of small blood vessels ( vasculitis )
- Immune disorders that may affect the lungs, skin, and lymph nodes (such as sarcoidosis )
- Accumulation of immune cells resulting from an inflammatory response (granulomatous changes)
- Lack of interest or feelings
- Severe skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and acute generalized exanthematous pustulosis
- Other skin problems such as erythema multiforme, lichenoid reactions (itchy red-purple rash and/or thread-like white-gray lines on mucous membranes), blisters and scaly skin, or boils ( furunculosis )
- Severe nervous system disorders such as transverse myelitis, multiple sclerosis-like diseases, optic neuritis, and Guillain-Barré syndrome
- Inflammation of the eye that can cause changes in vision, including blindness
- Fluid around the pericardium (pouring into the pericardium)
- Severe lung problems (such as interstitial lung disease)
- Melanoma (a type of skin cancer)
- Cervical cancer
- Low blood levels, even greatly reduced white blood cell, count
- Small red or purple spots caused by bleeding under the skin
- Abnormal levels of a protein in the blood are called a “complement factor” that is part of the immune system.
Has been reported: occurs in an unknown number of users
- Cancer in children and adults
- An unusual blood cancer that mostly affects teenage boys or young men (T-cell lymphoma in the liver and spleen )
- Liver failure
- Merkel cell carcinoma (a type of skin cancer)
- Kaposi’s sarcoma, rare cancer associated with human herpes virus infection 8. Kaposi’s sarcoma usually appears as purple spots on the skin.
- Exacerbation of a condition called dermatomyositis (seen as a skin rash with muscle weakness)
- Heart attack
- Stroke
- Temporary vision loss during or within 2 hours after infusion
- Infection is caused by a live vaccine due to a weakened immune system.
Additional side effects are in children and adolescents
Children taking Remicade for Crohn’s disease had some differences in side effects compared to adults taking Remicade for Crohn’s disease. The most common side effects in children were: low red blood cell count ( anemia ), bloody stools, low white blood cell levels ( leukopenia ), red skin or redness (swelling), viral infections, low white blood cell levels fighting infection ( neutropenia ), bone fractures, bacterial infection and allergic reactions of the respiratory tract.
How to store Remicade
Remicade is usually stored by healthcare professionals. The storage instructions are as follows if you need to know them:
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
- Store in a refrigerator (2ºC-8ºC).
- This medicine can also be stored in the original package outside the refrigerator at a maximum of 25 ° C for a single period of up to 6 months, but without exceeding the original expiry date. In such a situation, it should not be stored in the refrigerator again. Write the new expiration date on the box, with day/month/year. Discard the medicine if it is not used before the new expiry date or the expiry date which is stated on the carton, whichever comes first.
- When Remicade is ready for infusion, it is recommended that it be used as soon as possible (within 3 hours). However, if the solution is prepared under bacteria-free conditions, it can be stored in a refrigerator at 2ºC-8ºC for up to 28 days and a further 24 hours at 25 ° C after removal from the refrigerator.
- Do not use this medicine if it is discolored or contains particles.
Contents of the pack and other information
Content declaration
- The active substance is infliximab. Each vial contains 100 mg of infliximab. After reconstitution, each ml contains 10 mg of infliximab.
- The other ingredients are sucrose, polysorbate 80, monobasic sodium phosphate, and dibasic sodium phosphate.
What the medicine looks like and the contents of the pack
Remicade is supplied in a glass vial containing a powder for concentrate for solution for infusion. The powder is a freeze-dried white pellet.
Remicade is manufactured in packs of 1, 2, 3, 4, or 5 vials. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Janssen Biologics BV
Einsteinweg 101
2333 CB Leiden
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
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