The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00166/0205.
Prograf 5mg/ml Concentrate for Solution for Infusion (UK)
Prograf 5 mg/ml concentrate for solution for infusion
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Prograf is and what it is used for
2. What you need to know before you use Prograf
3. How to use Prograf
4. Possible side effects
5. How to store Prograf
6. Contents of the pack and other information
Prograf belongs to a group of medicines called immunosuppressants. Following your organ transplant (e.g. liver, kidney, heart), your body’s immune system will try to reject the new organ. Prograf is used to control your body’s immune response enabling your body to accept the transplanted organ.
Prograf is often used in combination with other medicines that also suppress the immune system.
You may also be given Prograf for an ongoing rejection of your transplanted liver, kidney, heart or other organ or if any previous treatment you were taking was unable to control this immune response after your transplantation.
Talk to your doctor, pharmacist or nurse before using Prograf
Precaution for handling:
Direct contact with any part of your body like your skin or eyes, or breathing in of injection solutions, powder or granules contained in tacrolimus products should be avoided during preparation. If such contact occurs, wash the skin and eyes.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal remedies.
Prograf must not be used with ciclosporin.
If you need to attend a doctor other than your transplant specialist, tell the doctor that you are taking tacrolimus. Your doctor may need to consult your transplant specialist if you should use another medicine that could increase or decrease your tacrolimus blood level.
Prograf blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by using Prograf which may require interruption, an increase or a decrease in Prograf dose. Some patients have experienced increases in tacrolimus blood levels while taking other medicines. This could lead to serious side effects, such as kidney problems, nervous system problems, and heart rhythm disturbances (see section 4).
An effect on the Prograf blood levels may occur very soon after starting the use of another medicine, therefore frequent continued monitoring of your Prograf blood level may be needed within the first few days of starting another medicine and frequently while treatment with the other medicine continues. Some other medicines may cause tacrolimus blood levels to decrease, which could increase the risk of rejecting the transplanted organ. In particular, you should tell your doctor if you are taking or have recently taken medicines with active substances like:
Tell your doctor if you are receiving treatment for hepatitis C. The drug treatment for hepatitis C may change your liver function and may affect blood levels of tacrolimus. Tacrolimus blood levels may fall or may increase depending on the medicines prescribed for hepatitis C. Your doctor may need to closely monitor tacrolimus blood levels and make necessary adjustments of Prograf dose after you start treatment for hepatitis C.
Tell your doctor if you are taking or need to take ibuprofen, amphotericin B, antibiotics (cotrimoxazole, vancomycin, or so-called aminoglycoside antibiotics such as gentamicin), or antivirals (e.g. acyclovir, ganciclovir, cidofovir, or foscarnet). These may worsen kidney or nervous system problems when taken together with Prograf.
Tell your doctor if you are taking sirolimus or everolimus. When tacrolimus is taken together with sirolimus or everolimus, the risk of developing thrombotic microangiopathy, thrombotic thrombocytopenic purpura, and haemolytic uraemic syndrome may increase (see section 4).
Your doctor also needs to know if you are taking potassium supplements or potassium-sparing diuretics (e.g., amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim or cotrimoxazole that may increase levels of potassium in your blood, certain pain killers (so-called NSAIDs, e.g. ibuprofen), anticoagulants, or oral medication for diabetic treatment, while you receive Prograf.
If you need to have any vaccinations, please inform your doctor beforehand.
Grapefruit and grapefruit juice should be avoided while using Prograf.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Prograf is excreted into breast milk. Therefore you should not breast-feed whilst receiving Prograf.
The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight. Initial intravenous doses just after transplantation will generally be in the range of
0.01 – 0.10 mg per kg body weight per day
depending on the transplanted organ.
Prograf should be used for intravenous infusion only after it is diluted. You will receive Prograf as a continuous 24-hour infusion and never as a short injection.
Prograf may cause mild irritation if it is not infused directly into a vein.
Treatment with Prograf should not continue for more than 7 days. Your doctor will then prescribe Prograf capsules for you instead.
Your dose depends on your general condition and on which other immunosuppressive medication you are taking. Regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.
If you have received too much Prograf, your doctor will amend your next dose.
Stopping your treatment with Prograf may increase the risk of rejection of your transplanted organ. Do not stop your treatment unless your doctor tells you to do so.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Prograf can cause side effects, although not everybody gets them.
Prograf reduces your body’s own defense mechanism to stop you rejecting your transplanted organ. Consequently, your body will not be as good as usual at fighting infections. So if you are taking Prograf you may therefore catch more infections than usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.
Some infections could be serious or fatal and may include infections caused by bacteria, viruses, fungi, parasites, or other infections.
Tell your doctor immediately if you get signs of an infection including:
Severe side effects may occur, including the ones listed below.
Serious common side effects (may affect up to 1 in 10 people):
Serious uncommon side effects (may affect up to 1 in 100 people):
Serious rare side effects (may affect up to 1 in 1,000 people):
Serious very rare side effects (may affect up to 1 in 10,000 people):
Serious side effects - frequency not known (frequency cannot be estimated from the available data):
The side effects listed below may also occur after receiving Prograf and could be serious:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Very rare side effects (may affect up to 1 in 10,000 people):
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use Prograf after the expiry date which is stated on the carton and ampoule after EXP. The expiry date refers to the last day of that month.
Store ampoule in the original package in order to protect from light.
Do not store above 25 °C.
The concentrate is a clear colourless solution supplied in transparent glass ampoules. Each ampoule contains 1 ml of concentrate for solution for infusion, which must be diluted before use.
Each carton contains 10 ampoules.
Marketing Authorisation Holder:
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Cyprus, Czech Republic, Denmark, Germany, Greece, Spain, Finland, France, Hungary, Iceland, Ireland, Italy, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Sweden.
Belgium, Luxembourg, The Netherlands.
This leaflet was last revised in 12/2022