Pronunciation: in FLIX ih mab

Brand: Inflectra, Remicade

What is the most important information I should know about infliximab?

Using infliximab may increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma that can be fatal. Ask your doctor about your specific risk.

Infliximab can lower blood cells that help your body fight infections. Serious and sometimes fatal infections may occur. Call your doctor right away if you have signs of infection such as fever, tiredness, flu symptoms, cough, or skin pain.

What is infliximab?

Infliximab reduces the effects of a substance in the body that can cause inflammation.

Infliximab is used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease, and ankylosing spondylitis. Infliximab is also used to treat severe or disabling plaque psoriasis.

Infliximab is often used when other medicines have not been effective.

Infliximab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving infliximab?

You should not be treated with infliximab if you are allergic to it.

To make sure infliximab is safe for you, tell your doctor if you have:

  • severe heart failure, or other heart problems;
  • an active or recent infection, fever, cough, flu symptoms, open sores or skin wounds;
  • diabetes;
  • liver disease (especially hepatitis B);
  • epilepsy or other seizure disorder;
  • chronic obstructive pulmonary disease (COPD);
  • a history of cancer;
  • a weak immune system;
  • numbness or tingling anywhere in your body;
  • a disease that affects the nerves or muscles, such as multiple sclerosis or Guillain-Barre syndrome;
  • if you have recently been vaccinated with BCG (Bacille Calmette-Guérin); or
  • if you are scheduled to receive any vaccines.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where certain infections are common (Ohio River Valley, Mississippi River Valley, and the Southwest).

Some people using infliximab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in male teenagers and young men using infliximab with other medicines to treat Crohn's disease or ulcerative colitis.

However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.

Using infliximab may increase your risk of developing other types of cancer, including skin cancer. Ask your doctor about your specific risk.

It is not known whether infliximab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you use infliximab while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to infliximab in the womb could affect your baby's vaccination schedule during the first 6 months of life.

It is not known whether infliximab passes into breast milk. You should not breast-feed while you are receiving infliximab.

Infliximab is not for use in children younger than 6 years old.

How is infliximab given?

Before you start treatment with infliximab, your doctor may perform tests to make sure you do not have tuberculosis (TB) or other infections. Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Infliximab is injected into a vein through an IV. A healthcare provider will give you this injection. You may be watched closely after receiving infliximab, to make sure the medicine has not caused any serious side effects.

Infliximab can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often, and you may need frequent TB tests.

If you need surgery, tell the surgeon ahead of time that you are using infliximab.

If you have ever had hepatitis B, infliximab can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your infliximab injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving infliximab?

Avoid activities that may increase your risk of bleeding injury.

Do not receive a "live" vaccine while using infliximab, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Make sure your child is current on all vaccines before he or she starts treatment with infliximab.

What are the possible side effects of infliximab?

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy or tingly, swollen, short of breath, or have a headache, fever, chills, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection.

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing; fever, chills, severe dizziness; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with infliximab. Call your doctor right away if you have signs of infection such as: fever, extreme tiredness, flu symptoms, cough, or skin symptoms (pain, warmth, or redness).

Call your doctor at once if you have:

  • skin changes, new growths on the skin;
  • pale skin, easy bruising or bleeding;
  • delayed allergic reaction (up to 12 days after receiving infliximab) --fever, sore throat, trouble swallowing, headache, joint or muscle pain, skin rash, or swelling in your face or hands;
  • liver problems --nausea, upper stomach pain, tiredness, joint pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lupus-like syndrome --joint pain or swelling, chest discomfort, feeling short of breath, skin rash on your cheeks or arms (worsens in sunlight);
  • nerve problems --numbness or tingling, problems with vision, or weak feeling in your arms or legs;
  • new or worsening psoriasis --skin redness or scaly patches, raised bumps filled with pus;
  • signs of heart failure --shortness of breath with swelling of your ankles or feet, rapid weight gain;
  • signs of lymphoma --fever, night sweats, weight loss, stomach pain or swelling, chest pain, cough, trouble breathing, swollen glands (in your neck, armpits, or groin); or
  • signs of tuberculosis --fever, cough, night sweats, loss of appetite, weight loss, feeling constantly tired.

Common side effects may include:

  • stuffy nose, sinus pain;
  • sore throat, cough
  • headache; or
  • stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect infliximab?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • abatacept (Orencia);
  • anakinra (Kineret);
  • tocilizumab (Actemra);
  • any "biologic" medications to treat your condition--adalimumab, certolizumab, etanercept, golimumab, natalizumab, rituximab, and others;
  • phototherapy for psoriasis; or
  • any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.

This list is not complete. Other drugs may interact with infliximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about infliximab.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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