Tacrolimus

About tacrolimus

The body produces white blood cells, called lymphocytes, to fight germs or foreign substances which have entered the body. Following an organ transplant the body's immune system recognises that this new organ is 'foreign' to you and will try to attack it with lymphocytes. Tacrolimus works by stopping the body from producing these lymphocytes and prevents the attack on the transplanted organ.

Before taking tacrolimus

Before taking tacrolimus make sure your doctor or pharmacist knows:

• If you are pregnant, trying for a baby or breast-feeding.
• If you suffer from liver, kidney or heart problems.
• If you suffer from gout, high levels of potassium in your blood or high blood pressure.
• If you suffer from diabetes.
• If you have an infection.
• If you have cancer.
• If you suffer from epilepsy.
• If you suffer from alcohol problems (Prograf® Infusion contains a small amount of alcohol).
• If you are a woman using a hormonal contraceptive such as the pill, injection, implant or intra-uterine progestogen-only system (IUS).
• If you suffer from porphyria (a blood disorder).
• If you have previously received a drug called ciclosporin.
• If you have ever had an allergic reaction to tacrolimus or any other medicine, especially the antibiotics erythromycin, clarithromycin, azithromycin and telithromycin.
• If you have ever had an allergic reaction to any of the other ingredients in this medicine, for example polyoxyethylated hydrogenated castor oil or similar oils (Prograf® infusion contains polyoxyethylene hydrogenated castor oil).
• If you have an intolerance to some sugars (Advagraf® prolonged-release capsules contain lactose).
• If you are taking any other medicines, including those available to buy without a prescription, herbal and complementary medicines.

How to take tacrolimus

• Take your medication exactly as directed by your doctor.
• Take tacrolimus one hour before food or two to three hours after food.
• Try to take this medicine at the same time each day to avoid missing any doses. If you miss a dose speak to your doctor or pharmacist for advice. Do not take a double dose to make up for the missed dose.
• It is important that you do not change the formulation of tacrolimus that you are taking except on the advice of your transplant specialist. Different brands release different amounts of tacrolimus and if you swop brands this can either stop the medicine from working properly or lead to side-effects.
• If you are taking the granules for suspension your doctor will tell you the number of sachets that you need to open and the volume of water to use - follow these instructions carefully. Pour the correct amount of water into a glass or cup (do not use a PVC container). Open the correct number of sachets and pour the contents of each sachet into the glass or cup of water. Stir or swirl the granules gently in the water until all are suspended before drinking. Rinse the glass with the same amount of water as used to make up the suspension and drink this also.
• Do not stop taking tacrolimus without speaking to your doctor, even if you are feeling better.

Getting the most from your treatment

• Before taking any 'over-the-counter' medicines, check with your pharmacist which medicines are safe for you to take alongside tacrolimus.
• Keep your regular appointments with your doctor so your progress can be checked.
• Women must avoid getting pregnant while taking tacrolimus. Hormonal contraceptives such as the pill, injection, implant or intra-uterine progestogen-only system (IUS), may be less effective. Ask your doctor or pharmacist about suitable alternative methods of contraception.
• While you are taking tacrolimus, and for a while after you stop treatment, do not have any immunisations (vaccinations) without talking to your doctor first. Tacrolimus lowers the body's resistance to infection and there is a chance that you may get an infection from the vaccine.
• Avoid drinking grapefruit juice while you are taking this medicine as it can increase the levels of tacrolimus in the body.
• Tacrolimus may cause visual disturbances and slow your reactions. Make sure your reactions are normal before driving, operating machinery or doing other jobs which could be dangerous if you were not feeling well or fully alert. Alcohol may increase any visual disturbances and slow your reactions further.
• Tacrolimus may cause your skin to become more sensitive to sunlight than it is usually. Avoid strong sunlight and sun beds and use a sun protection cream higher than factor 15 .
• If you have diabetes this medicine may affect your blood sugar levels. Test your urine or blood regularly and report any extreme changes to your doctor.
• While you are taking tacrolimus, your doctor will carry out blood and urine tests. From the results of these, your doctor will decide whether you need to adjust the dose you are taking. Your blood pressure and heart function will also be checked.
• If you undergo surgery, including dental treatment and emergency treatment, tell the surgeon, dentist or doctor that you are taking tacrolimus.

Can tacrolimus cause problems

Along with their useful effects all medicines can cause unwanted side effects, which usually improve as your body adjusts to the new medicine. Speak with your doctor or pharmacist if any of the following side effects continue or become troublesome.

Other side-effects may include abdominal pain, abnormal dreams, agitation, anxiety, confusion, convulsions, indigestion, flatulence, bloating, fever, inflammation or ulcers in the mouth, flu-like symptoms, problems with urination (passing water), seeing or hearing things that are not there, headache, chest pain or tightness, fast or fluttering heartbeat, heart problems, itching, loss of appetite, weight loss or weight gain, loss of energy or weakness, kidney problems, tremor, increased or decreased blood pressure, blood sugar changes, feeling depressed, emotional changes, mental disorders, excess of body fluid, angina, trembling, joint pain, hair loss, acne, nervousness, sensitivity to light, loss of co-ordination, wheezing, shortness of breath, cough, swelling of feet or lower legs, tingling, excess hair growth, trouble sleeping, unusual bleeding or bruising, yellowing of skin, liver problems, unusual tiredness, pale skin, visual disturbances, muscle cramps and stiffness, numbness or pain in the legs, feet, arms or hands, ringing in ears and hearing changes, reduced consciousness, sweating, a general feeling of discomfort or illness, dehydration and thirst, speech and language problems, memory problems, menstrual disturbances and skin disorders. If you experience these or any other worrying symptoms, which you think may be due to this medicine, discuss them with your doctor or pharmacist.

How to store tacrolimus

• Keep all medicines out of the reach of children.
• Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

References

• British National Formulary; 54th Edition (September 2007) British Medical Association and Royal Pharmaceutical Society of Great Britain, London.
• Manufacturer's PIL, Prograf ® Capsules, Astellas Pharma Ltd, electronic Medicines Compendium. Text revised May 2007, accessed 21 January 2008.
• Manufacturer's PIL, Prograf® Concentrate for Infusion, Astellas Pharma Ltd, electronic Medicines Compendium. Text revised April 2007, accessed 21 January 2008.
• Manufacturer's PIL, Advagraf® Prolonged-release hard capsules, Astellas Pharma Ltd, electronic Medicines Compendium. Text revised April 2007, accessed 15 January 2008.
• Manufacturer's PIL, Modigraf® 0.2mg & 1mg granules for oral suspension, Astellas Pharma Ltd, electronic Medicines Compendium. Dated May 2009, accessed February 2010.