Rheumatoid Arthritis Prograf^®

INFORMATION FOR THE RHEUMATOID ARTHRITIS PATIENT

IT IS VERY IMPORTANT that you read the following information carefully.

Your doctor, nurse, and pharmacist have explained Prograf to you, and this information will answer some of the questions you may have about your new medication. The success of treatment with this drug depends on how carefully you follow your doctor’s instructions. As you review this information, write down any questions that you may have. Then, talk with your doctor, nurse or pharmacist. This information should not replace your doctor’s or pharmacist’s advice.

Pregnancy should be avoided while taking Prograf because its effect on pregnancy or on an unborn baby is not known. Breast-feeding is not recommended while taking Prograf. It is important to notify your doctor right away if you become pregnant or father a child while taking Prograf.

What Is Prograf?
Prograf is the brand name for tacrolimus. You may have also heard it called FK506. Prograf is an immunosuppressant that is used alone or in combination with other drugs to reduce the symptoms experienced by patients with rheumatoid arthritis.

How Does Prograf Work?
Rheumatoid arthritis is an autoimmune disorder of unknown cause in which the bone joint lining (synovium) is attacked by the immune system. The mechanism of action of tacrolimus in rheumatoid arthritis is not known. Approximately 8 weeks of treatment with Prograf may be required before any significant improvement is noted in your symptoms of rheumatoid arthritis.

What Should I Tell My Doctor Before I Take Prograf?

Before you take Prograf, be sure you have told your doctor the following:

• If you have taken Prograf, FK506 or tacrolimus before and had a bad, unusual or allergic reaction;
• If you are pregnant, plan to become pregnant, or are breastfeeding a baby;
• About all other medicines or treatments you use, including any products you buy off the shelf such as over-the-counter drugs and herbal or home remedies;
• About all other health conditions you have now, or have had in the past.

What Does Prograf Look Like?
Prograf is available in one-half milligram capsules, 1 milligram capsules and 5 milligram capsules. The 0.5 mg capsules are light yellow and oblong with “0.5 mg” written on the capsule top. The 1 mg capsules are white and oblong, with “1 mg” written on the capsule top. The 5 milligram capsules are grayish/red, oblong, and have “5 mg” written on the capsule top.

How Much Prograf Should I Take?
Your doctor will decide the dosage. The usual adult dosage is 3 mg taken once a day.

When and How Do I Take Prograf?

• Try to take your doses at the same time every day.
• Prograf may be taken with or without food. But it is best to be consistent. Once you decide when you are going to take it in relation to food, do it the same way each time.
• Swallow the capsules whole. Do not cut, crush, or chew the Prograf capsule.

Are There Any Special Concerns For Women?
Prograf may cause fetal abnormalities and malformations. For this reason it is recommended that you do not take Prograf if you are, or become, pregnant. You must use a reliable method of birth control before, during your treatment and for 6 weeks after stopping your treatment with Prograf.

Should you become pregnant during the time you are taking Prograf, you should inform your doctor at once.

What Happens if I Miss a Dose of Prograf?
If you do miss a dose of Prograf, skip this dose and take the next one at the regular scheduled time. Call your doctor or pharmacist right away for advice. It is also a good idea to ask your doctor ahead of time what to do about missed doses. Do not allow your medication to run out between refills and be sure to take enough medication with you when you will be away from home for any extended period of time.

Are There Any Special Do’s and Don’ts About Taking Prograf?

• Prograf is often given with other medications. Make sure you know if you are to stop, or continue, other drugs you had been taking.
• It is not known what effect Prograf has on the effectiveness of vaccinations and on the risk of getting an illness from vaccination with a live vaccine. Do discuss this with your doctor before you get any vaccinations or immunizations.
• As with other immunosuppressive agents, owing to the potential risk of malignant skin changes, exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using sunscreen with a high protection factor.
• Be sure that you are taking the correct dose of Prograf prescribed by your doctor.
• Tell all health professionals you see that you are taking Prograf. It is also a good idea to wear a Medic- Alert bracelet.
• Prograf should not be taken with grapefruit or grapefruit juice.

What are the Side Effects of Prograf?

Like other medicines, Prograf may cause side effects in some people. If you think that you are having side effects, talk to your doctor right away.

• Because Prograf decreases the function of your immune system you may be more likely to get an infection. Tell your doctor right away about any cold or flu-like symptoms (such as fever or sore throat), any mouth sores or burning discomfort with urination.
• Be sure to tell your doctor right away if you notice any of these symptoms, and especially if they continue, bother you in any way, or seem to increase in intensity: diarrhea, nausea, vomiting, stomach pain; headache, tremors, convulsions, difficulty sleeping; pain and /or burning during urination which may be signs of a urinary tract infection; decreased or increased urine volumes, dark coloured urine which may be a sign of kidney problems or yellowing of the skin or eyes or back pain which may be a sign of liver problems; diabetes/increased blood sugar, swelling or tingling in your hands and feet; palpitations, abnormal heart rhythms, chest pain, high blood pressure; fever.
• Immunosuppressive drugs including Prograf may also increase your chances of developing certain types of cancer. The following are possible warning signs of cancer and should be reported to your doctor as soon as possible:
  • any sore that does not heal;
  • unusual bleeding or discharge;
  • the appearance of a lump or thickened areas in your breast or anywhere else on your body;
  • unexplained stomach upset or any trouble with swallowing;
  • any noticeable change in a wart or a mole;
  • a nagging cough or hoarseness;
  • night sweats;
  • persistent and severe headaches;
  • swollen lymph nodes;
  • a change in your bowel or bladder habits.

It is important to regularly tell your doctor how you are feeling and if you have developed any new symptoms while taking Prograf.

What Other Medications Can I Take With Prograf?
Tell your doctor, dentist, nurse, and pharmacist about all the drugs that you are taking. Other drugs may affect the way Prograf works for you and it is important that your doctor and pharmacist knows all the medications you are taking. Do not take any other drugs without asking your doctor first. This includes anything you can buy off the shelf such as over-the-counter drugs and herbal or home remedies.

Who Can I Call With Questions About Prograf?
If you have additional questions or would like to talk with someone to explain something you are worried about, ask your doctor, nurse, pharmacist. They are your best resource for guidance and information.