ENVARSUS® 0.75 mg
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.
Tell your doctor if any of the following apply to you:
Your doctor may need to adjust your dose of Envarsus.
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).
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. In particular, you should tell your doctor if you are taking or have recently taken medicines like:
Tell your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation and pain), amphotericin B (used to treat fungal infections) or antivirals (used to treat viral infections, e.g. aciclovir). These may worsen kidney or nervous system problems when taken together with Envarsus.
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), 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.
Tacrolimus crosses the placenta. If you are pregnant, 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 dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
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.
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.
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.
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.
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.
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):
Unknown frequencies side effects (may affect less than 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
UK: Yellow Card Scheme at www.mhra.gov.uk/yellowcard .
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 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 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.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: