Prograf - Consumer Medicine Information
|Condition:||Organ Transplant, Rejection Reversal, Organ Transplant, Rejection Prophylaxis|
|Ingredients:||tacrolimus, croscarmellose sodium, hydroxypropylmethylcellulose, lactose, magnesium stearate|
tacrolimus immediate release capsules
About this medication
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.
What the medication is used for:
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.
What it does:
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.
When it should not be used:
Prograf should not be used if you are hypersensitive (allergic) to tacrolimus or to any of the ingredients in the formulation (see “What the nonmedicinal ingredients are”).
What the medicinal ingredient is:
What the nonmedicinal ingredients are:
Prograf immediate release capsules contain croscarmellose sodium, hydroxypropylmethylcellulose, lactose and magnesium stearate. The 1 mg capsule shell contains gelatin and titanium dioxide and the 0.5 mg and 5 mg capsule shells contain gelatin, titanium dioxide and ferric oxide.
What dosage forms it comes in:
Prograf is available in 0.5 mg immediate release capsules and 1 mg immediate release capsules and 5 mg immediate release 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 mg capsules are grayish/red, oblong, and have “5 mg” written on the capsule top.
Warning and precautions
|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 stoppingyour 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 glucosegalactose malabsorption, because the capsules contain lactose
- Prograf is often given with other medications. Make sure you know if you are to stop, or continue, other drugs you had been taking
- 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
Interactions whith medicationTell 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, ethinylestradiol, methylprednisolone, nefazodone
- Protease inhibitors: boceprevir, nelfinavir, ritonavir, saquinavir, telaprevir
- Anticonvulsants: carbamazepine, phenobarbital, phenytoin
- Anti-infectives: rifampin, rifabutin, capsofungin
- Calcineurin inhibitor: sirolimus
*no longer marketed in Canada
Do not take any other drugs without asking your doctor first. This includes anything you can buy off the shelf such as overthe-counter drugs and herbal, especially St. John’s Wort (Hypericum perforatum), Schisandra sphenanthera extracts, or home remedies.
Prograf should not be taken with grapefruit or grapefruit juice.
Proper use of this medication
Your doctor will decide the dosage. The usual adult dosage is 3 mg taken once daily.
Make sure that you receive the same tacrolimus medicine every medicine is not the same as usual, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
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.
Try to take your doses at the same time every day.
|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.|
If you do miss a dose of Prograf, skip this dose and take the next one at the regular scheduled time; do not take twice your dose. 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.
Side effects and what to do about them
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
- 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
It is important to regularly tell your doctor how you are feeling and if you have developed any new symptoms while taking Prograf.
Serious side effects, how often they happen and what to do about them
|Symptom / effect||Talk with your
|Infection (urinary tract, sinusitis, gastroenteritis, influenza, upper respiratory tract)||✓|
|Early signs of high blood sugar or diabetes: more thirsty than usual, have to urinate more often, have blurred vision or seem to get confused.||✓|
|Decreased or increased urine volumes, dark coloured urine which may be a sign of kidney problems||✓|
|Posterior Encephalopathy Syndrome (PRES) with symptoms such as headache,
seizures, visual disturbances or altered mental state
*Unable to determine frequency since this is a post-marketing event
This is not a complete list of side effects. For any unexpected effects while taking Prograf, contact your doctor or pharmacist.
How to store it
Keep Prograf out of the reach and away from children. A child who accidentally takes Prograf may be seriously harmed. All drugs should be kept in a locked drawer or cupboard if there are children who may accidentally take your drugs. Should anyone accidentally or mistakenly take Prograf, contact your physician immediately.
Always store Prograf at room temperature (15°C to 30°C) in the container or package that was dispensed by your pharmacist.
|REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
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.
This document plus the full product monograph, prepared for health professionals can be found at:
or by contacting the sponsor, Astellas Pharma Canada, Inc., at: