Infliximab Injection

This medication is used to treat certain types of arthritis (rheumatoid arthritis, arthritis of the spine, psoriatic arthritis), certain bowel diseases (Crohn's disease, ulcerative colitis), and a certain severe skin disease (chronic plaque psoriasis). In these conditions, the body's defense system (immune system) attacks healthy tissues. Infliximab works by blocking the actions of a certain natural substance (tumor necrosis factor alpha) in the body. This helps to decrease swelling (inflammation) and weaken your immune system, thereby slowing or stopping the damage from the disease.

See also Warning section.Headache, stomach pain, or nausea may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: pain/swelling at injection site, joint/muscle pain, swelling ankles/feet, easy bruising/bleeding, vision changes, seizures, confusion, muscle weakness, numbness/tingling of arms/legs, butterfly-shaped facial rash, chest pain, pain/redness/swelling of arms or legs, shortness of breath, fast/slow/irregular heartbeat.Tell your doctor immediately if you develop signs of infection while using this drug, such as: fever, chills, night sweats, persistent cough, persistent sore throat, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).This drug may rarely cause serious (possibly fatal) liver disease. Most cases occur 2 weeks to more than a year after starting infliximab. Tell your doctor immediately if you develop symptoms of liver disease, including dark urine, extreme tiredness, severe stomach/abdominal pain, or yellowing eyes/skin.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, difficulty swallowing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Laboratory and/or medical tests (such as complete blood count, liver function test, skin exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

• Tell all of your health care providers that you take infliximab injection. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may lower the ability of your bone marrow to make blood cells that your body needs. This can lead to very bad and sometimes deadly bleeding problems or infections. Tell your doctor right away if you have signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, a wound that will not heal; any bruising or bleeding; or if you feel very tired or weak.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Talk with your doctor before getting any vaccines. Use of some vaccines with this medicine may raise the chance of an infection.
• Do not get a weakened bacteria like BCG for bladder cancer while you use infliximab injection. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your skin checked. Tell your doctor if you have any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Hepatitis B testing may be done. A hepatitis B infection may get worse during care.
• Rarely, people using drugs like this one have had nervous system problems. Sometimes, these problems have not gone away. Call your doctor right away if you have a burning, numbness, or tingling feeling that is not normal; change in eyesight; dizziness; seizures; or weakness in your arms or legs.
• Very bad and sometimes deadly liver problems have happened with infliximab injection. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• If using in a child, make sure your child is up to date with all vaccines.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using infliximab injection while you are pregnant.
• If you used this medicine when you were pregnant, tell your baby's doctor. Your baby may have a higher chance of getting an infection for at least 6 months after birth. Your baby's doctor will also need to decide when your baby is to get any vaccines. Certain vaccines may cause infections that can lead to very bad health problems or death if given within 6 months after birth.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach or throwing up.
• Belly pain.
• Feeling tired or weak.
• Flushing.
• Irritation where the shot is given.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.