Center for Inflammatory Bowel Disease Treatment and Research

Tacrolimus

Generic Name: tacrolimus

Brand Name: Prograf® or Protopic®

Drug Class: Immunosuppressant

What does this medication do?
Tacrolimus is a medication used to help treat patients with active ulcerative colitis that have not responded to other agents including steroids. It works by decreasing the activity of the immune system, which results in decreased inflammation in the intestine. Tacrolimus is typically used for 3 to 6 months and may be used with other medications like 6-mercaptopurine. It is usually given by mouth as a capsule or liquid. It is also available as an ointment to help patients with rectal disease.

How effective is tacrolimus in treating ulcerative colitis?
Tacrolimus induces a remission of colitis symptoms in approximately 80-90% of patients that have not responded to steroid therapy. For most patients, this means significant improvement in rectal bleeding, diarrhea, and abdominal pain.

What are the alternatives to tacrolimus?
Alternatives to tacrolimus therapy may include parenteral nutrition (resting the gut) and sometimes surgery to remove the inflammed colon. Other drug alternatives to tacrolimus include infliximab (Remicade) and cyclosporine.

What are the side effects?
Tacrolimus can temporarily reduce the activity of the immune system, and this can put you/your child at risk for developing infections. Therefore, we routinely prescribe an antibiotic (Bactrim or Atovaquone) to prevent the development of a particular type of pneumonia in patients receiving tacrolimus. Tacrolimus can also cause high blood sugar, low magnesium levels, and decreased kidney function. Therefore, we will monitor your/your child’s blood and urine tests closely, especially during the first few weeks of therapy. We may adjust the dose of medication depending on the blood levels and urine tests, so it is very important to follow your physician’s instructions for laboratory testing. Other side effects of tacrolimus include mild tremors (common) and more rare side effects like severe headaches and seizures. If you/your child experience headaches or severe tremors while taking this medication, you should call your doctor immediately. The use of immunosuppressant medications including tacrolimus may slightly increase your/your child’s risk of developing lymphoma (a tumor of the lymph glands). The precise risk is unknown, but it is a slight increase in risk over the other children and young adults of the same age who are not taking this medication.

How to take your medication and miscellaneous facts about tacrolimus:

• You should take this medication at the same time everyday.
• You should take this medication 1 hour before or 2 hours after a meal.
• Do not take this medication with grapefruit juice as it can increase the blood level of tacrolimus.
• You/your child should not receive live vaccines (ex. MMR, chicken pox, nasal flu) while taking this medication. Inactivated vaccines (ex. tetanus and influenza shot) are safe. It is a good idea to call your doctor or nurse before receiving any vaccinations.
• Check with your doctor or nurse practitioner before starting any new medications, herbs, or vitamins while taking this medication. Some medications such as erythromycin, biaxin, or ketoconazole will increase the level of tacrolimus in the blood; therefore, use of these medications should be monitored VERY closely by your physician.
• This medication may increase your/your child’s sensitivity to the sun. You should wear protective clothing and sunscreen with an SPF of 15 or greater when out in the sun.