Prograf (Tacrolimus)

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.

BEFORE you use 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
• 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
• If you have the heart problem: congenital or acquired QT prolongation.
• About all other health conditions you have now, or have had in the past
• If you are pregnant, plan to become pregnant, or are breastfeeding a baby. Prograf may cause fetal abnormalities and malformations. Pregnancy should be avoided while taking Prograf because its effect on pregnancy or on an unborn baby is not known. You must use a reliable method of birth control before, during your treatment and for 6 weeks after stopping your treatment with Prograf. 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. It is recommended that you do not take Prograf if you are, or become, pregnant. However, never stop taking Prograf without first consulting your doctor
• 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
• If you have a rare hereditary disease of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, because the capsules contain lactose

Prograf may cause new onset diabetes in kidney transplant patients. Your doctor may order tests to monitor your blood glucose levels.

Precautions:

• Prograf is often given with other medications. Make sure you know if you are to stop, or continue, other immunosuppressive drugs you had been taking.
• Be sure that you are taking the correct dose and correct formulation of tacrolimus (Prograf, immediate release capsules) prescribed by your doctor.
• Be sure to keep all appointments at your transplant clinic. This is very important to help ensure that you receive the maximum benefit from your medications
• 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
• Tell all health professionals you see that you are taking Prograf. It is also a good idea to wear a Medic-Alert bracelet

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. DO NOT stop taking Prograf on your own.

• 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, constipation, vomiting, loss of appetite, stomach pain
  • headache, tremors, convulsions, tiredness or fatigue, difficulty sleeping, nightmares
  • urinary tract infection, weakness
  • decreased or increased urine volumes, kidney or liver problems
  • diabetes/increased blood sugar, swelling or tingling in your hands and feet
  • palpitations, abnormal heart rhythms, chest pain, high blood pressure
  • fever, back pain, changes in mood or emotions, difficulty in breathing
  • progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, changes in thinking, memory and orientation, confusion, personality changes, which could be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML)
  • headache, seizures, visual disturbances or altered mental state, which could be symptoms of posterior encephalopathy syndrome (PRES)
• 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
• Cases of pure red cell aplasia (PRCA- bone marrow stops producing red blood cells) have occurred in patients taking tacrolimus. Contact your doctor immediately if you suffer symptoms such as fatigue, malaise, weakness, dizziness, fainting, shortness of breath, rapid heartbeat, pallor (paleness of skin), pale stool.
• Cases of gastrointestinal perforation (hole in the stomach or intestine) have occurred in patients taking tacrolimus. If you suffer symptoms such as severe abdominal pain, burning pain, nausea, vomiting and later possibly chills or fever, get medical attention immediately.

Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate or extended release tacrolimus oral formulations, have been observed. This has led to serious adverse events, including graft rejection, or other side effects which could be a consequence of either under- or over-exposure to tacrolimus. You should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist.

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

Tell your doctor, dentist, nurse, and pharmacist about all the drugs that you are taking. Prograf blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Prograf, which may require an increase or decrease in Prograf dose. In particular, you should tell your doctor if you are taking or have recently taken medicines such as:

• Antacids: magnesium aluminum hydrochloride
• Antiarythmic: amiodarone
• Antifungals: clotrimazole, fluconazole, ketoconazole, itraconazole, voriconazole
• Calcium channel blockers: diltiazem, nicardipine, nifedipine, verapamil
• Gastrointestinal prokinetic agents: cisapride*, metoclopramide
• Macrolide antibiotics: erythromycin, clarithromycin, troleandomycin
• Proton pump inhibitors: lansoprazole, omeprazole
• Other drugs: bromocriptine, cimetidine, chloramphenicol, cyclosporine, danazol, ethinyl estradiol, methylprednisolone, nefazodone
• Protease inhibitors: boceprevir, nelfinavir, ritonavir, saquinavir, telaprevir
• Anticonvulsants: carbamazepine, phenobarbital, phenytoin
• Anti-infectives: rifampin, rifabutin, capsofungin
• Calcineurin inhibitor: sirolimus
• Potassium sparing diuretics

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, especially St. John's Wort (Hypericum perforatum), Schisandra sphenanthera extracts, or home remedies.

A high intake of potassium should be avoided during Prograf treatment.

Prograf should not be taken with grapefruit or grapefruit juice.

Usual dose:

Your doctor will give you specific instructions about how much Prograf you should take each day. Your doctor has decided the dose you should take based on your medical condition and response to the drug. It is very important to take the exact amount of Prograf that your doctor has told you.

Once your doctor has told you when and how many times a day to take Prograf:

• Try to take your doses at the same time every day. This will help keep the same amount of Prograf in your body so it can continue to protect your transplanted organ
• Space your doses of Prograf as evenly as you can throughout the day. For example, if you take Prograf twice a day, doses should be 12 hours apart. Ask your transplant nurse or pharmacist about a dosing schedule that best fits your lifestyle
• 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
• Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine. If the appearance of this medicine is not the same as usual, or if dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine

Blood tests are one of the ways your doctor decides how much Prograf you need. Based on these tests and your response to Prograf, your doctor may change your dose from time to time. Do not change your dose on your own.

Overdose:

In case of drug overdose, contact a healthcare practitioner (e.g. doctor), hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

Missing even a few doses of Prograf may cause your body to reject your transplanted organ. That is why it is very important to take each dose as your doctor prescribed. If you have trouble remembering doses, or if you are uncertain about how to take them, talk to your doctor, nurse or pharmacist and be sure to discuss any concerns you have about taking Prograf as prescribed.

If you do miss a dose of Prograf do not try to catch up on your own (do not take twice your dose); instead 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.

Never 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.