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What you should know before using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatrics

Studies of this medicine for treatment of Crohn's with fistulas, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and plaque psoriasis have been done only in adult patients, and there is no specific information comparing use of infliximab in children for these conditions with use in other age groups.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of infliximab for the treatment of Crohn's disease in children 6 years of age and older.

Your child's vaccinations need to be current before he/she begins taking infliximab. Be sure to ask your child's doctor if you have any questions about this.

A very serious kind of cancer called hepatosplenic T-cell lymphoma has been reported in some teenagers and young adults who were taking this medicine. They were also taking azathioprine or 6-mercaptopurine. The connection between infliximab and this cancer is unclear.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of infliximab in the elderly with use in other age groups. However, older adults generally get more infections than do younger adults, and it is not known if infliximab may affect the number of infections that older people get.

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of infiximab to treat rheumatoid arthritis and plaque psoriasis in the elderly.

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abatacept
  • Anakinra

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood problems, ongoing or in the past—Caution should be used.
  • Cancer, history—This medicine should be used with caution. If you have a history of cancer, you may be more susceptible to lymphoma (a type of blood cancer).
  • Heart disease—Infliximab is not recommended for patients with a certain type of heart disease called congestive heart failure.
  • Hepatitis B—Infliximab could cause your hepatitis B to become active again if you have a history of hepatitis B.
  • Infection—Infliximab is not recommended for patients with an active infection. Caution should be used if you have a chronic infection or history of a recurring infection.
  • Inactive tuberculosis infection—Should be treated before starting infliximab therapy.
  • Nervous system problems or
  • Seizures—Caution should be used; your doctor will consider discontinuing this medicine if you develop serious CNS reactions.

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