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: PLGB 08829/0184.
Envarsus 0.75mg, 1mg & 4mg prolonged-release tablets
Envarsus 0.75 mg prolonged-release tablets
Envarsus 1 mg prolonged-release tablets
Envarsus 4 mg prolonged-release tablets
1. What Envarsus is and what it is used for
2. What you need to know before you take Envarsus
3. How to take Envarsus
4. Possible side effects
5. How to store Envarsus
6. Contents of the pack and other information
Envarsus contains the active substance tacrolimus. It is an immunosuppressant. Following your kidney or liver transplant, your body’s immune system will try to reject the new organ.
Envarsus is used to control your body’s immune response, enabling your body to accept the transplanted organ.
You may also be given Envarsus for an ongoing rejection of your transplanted liver, kidney, heart or other organ when any previous treatment you were taking was unable to control this immune response after your transplantation.
Envarsus is used in adults.
Envarsus contains the active substance tacrolimus presented in a prolonged release formulation. Envarsus is taken once daily and is not interchangeable with other existing medicines containing tacrolimus (immediate release or prolonged release) on an equal dose by dose basis.
Talk to your doctor or pharmacist before taking Envarsus:
Please avoid taking any herbal remedies, e.g., St. John’s wort (Hypericum perforatum) or any other herbal products as this may affect the effectiveness and the dose of Envarsus that you need to receive. If in doubt, please consult your doctor prior to taking any herbal products or remedies.
Your doctor may need to adjust your dose of Envarsus or will decide to stop treatment with tacrolimus.
You should keep in regular contact with your doctor.
From time to time, your doctor may need to do blood, urine, heart, or eye tests, to set the right dose of Envarsus.
You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Envarsus. This is because immunosuppressants could increase the risk of skin cancer. Wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
The use of Envarsus is not recommended in children and adolescents under 18 years.
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 preparations.
It is not recommended that Envarsus is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
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.
Envarsus blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Envarsus, which may require interruption, an increase or a decrease in Envarsus 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 Envarsus blood levels may occur very soon after starting the use of another medicine, therefore frequent continued monitoring of your Envarsus 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 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 adjustments to the dose after you start treatment for hepatitis C.
Tell your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation and pain), antibiotics (cotrimoxazole, vancomycin, or aminoglycoside antibiotics such as gentamicin), amphotericin B (used to treat fungal infections) or antivirals (used to treat viral infections, e.g. acyclovir, ganciclovir, cidofovir, foscarnet). These may worsen kidney or nervous system problems when taken together with Envarsus.
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).
While you take Envarsus your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, hypertension and kidney disease (e.g., amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim or cotrimoxazole that may increase levels of potassium in your blood, nonsteroidal anti-inflammatory substances (NSAIDs, e.g., ibuprofen) used for fever, inflammation and pain, anticoagulants (blood thinners), or oral medicines for diabetes.
If you need to have any vaccinations, please tell your doctor before.
Avoid grapefruit (also as juice) while on treatment with Envarsus, since it can affect its levels in the blood.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Tacrolimus passes into breast milk. Therefore, you should not breast-feed whilst taking Envarsus.
Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Envarsus. These effects are more frequent if you also drink alcohol.
Envarsus contains lactose (milk sugar).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
This medicine should only be prescribed for you by a doctor with experience in the treatment of transplant patients.
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.
This medicine should be taken once a day. If the appearance of this medicine is not the same as usual, or if dose instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
How much Envarsus do I have to take
The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
Initial daily doses just after transplantation will generally be in the range of:
0.11 - 0.17 mg per kg body weight per day depending on the transplanted organ. When treating rejection, the same doses may be used.
Your dose depends on your general condition and on which other immunosuppressive medicines you are taking. Following the initiation of your treatment with this medicine, frequent blood tests will be taken by your doctor to define the correct dose. Afterwards regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.
Your doctor will usually reduce your Envarsus dose once your condition has stabilised.
How should I take the Envarsus tablets
Envarsus is taken orally once daily, generally on an empty stomach.
Take the tablets immediately following removal from the blister. The tablets should be swallowed whole with a glass of water. Do not swallow the desiccant contained in the foil wrapper.
How long should I take the Envarsus tablets
You will need to take Envarsus every day as long as you need immunosuppression to prevent rejection of your transplanted organ. You should keep in regular contact with your doctor.
If you have accidentally taken too much Envarsus, contact your doctor or nearest hospital emergency department immediately.
Do not take a double dose to make up for a forgotten tablet. Take the tablet as soon as possible on the same day.
Stopping your treatment with Envarsus 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 medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tacrolimus reduces your body’s defence mechanism (immune system), which will not be as good at fighting infections. Therefore, you may be more prone to infections while you are taking Envarsus. 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:
Please contact your doctor immediately, should you experience severe effects.
Severe effects may occur, including allergic and anaphylactic reactions. Benign and malignant tumours have been reported following Envarsus treatment.
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):
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):
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via :
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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister and wrapper after ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original aluminium foil wrapper in order to protect from light.
Use all the prolonged-release tablets within 45 days of opening the aluminium wrapping.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Envarsus 0.75 mg prolonged-release tablets
Each prolonged-release tablet contains 0.75 mg tacrolimus (as monohydrate).
Envarsus 1 mg prolonged-release tablets
Each prolonged-release tablet contains 1.0 mg tacrolimus (as monohydrate).
Envarsus 4 mg prolonged-release tablets
Each prolonged-release tablet contains 4.0 mg tacrolimus (as monohydrate).
Envarsus 0.75 mg prolonged-release tablets are oval, white to off-white uncoated tablet, debossed with “0.75” on one side and “TCS” on the other side.
Envarsus 1 mg prolonged-release tablets are oval, white to off-white uncoated tablet, debossed with “1” on one side and “TCS” on the other side
Envarsus 4 mg prolonged-release tablets are oval, white to off-white uncoated tablet, debossed with “4” on one side and “TCS” on the other side.
Envarsus is supplied in PVC/alu blisters containing 10 tablets. 3 blisters are packed together within a protective aluminium foil wrapper, including a desiccant. Packs of 30, 60 and 90 prolonged-release tablets are available.
Not all pack sizes may be marketed.
United Kingdom (Northern Ireland) & Ireland:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in January 2023.
Other sources of information
Detailed information on this medicine is available on the