Tacrolimus
Tacrolimus is a medication used in the treatment of systemic lupus erythematosus (also called ‘lupus’ or ‘SLE’), an inflammatory disease that affects a variety of different body systems.
Tacrolimus is a medication that works as a calcineurin inhibitor. By blocking calcineurin in the body, it reduces the amount of interleukin-2, a signalling molecule that increases the number of T-cells, which form part of the immune system.
In lupus, T-cell overactivity can cause the immune system to attack various tissues in the body. Tacrolimus helps to suppress this overactivity.
Important things to remember
- You must see your rheumatologist regularly to make sure the treatment is working and check for possible side effects.
- You should have regular blood tests as suggested by your rheumatologist.
- It is important to tell your rheumatologist if you have a new serious illness such as a serious infection, cancer or heart failure.
- If you are worried about any side effects, you should contact your rheumatologist as soon as possible.
- If you stop tacrolimus for any reason, you must contact your rheumatologist. Failure to do so may mean that your treatment may no longer be funded.
- If you plan to become pregnant, you must discuss the timing with your rheumatologist.
What benefit can you expect from your treatment?
It may take a number of weeks for you to notice a difference in your symptoms.
Tacrolimus can improve many different body systems that are affected by lupus and you may see improvement in your arthritis, with less joint swelling and pain, as well as improvement in your skin if you have a rash.
Tacrolimus may also improve how well your kidneys are working, as well as how well your bone marrow produces platelets (cell fragments that help bleeding to clot).
Stopping tacromlimus
If tacrolimus treatment is stopped or delayed there is a risk that your condition will get worse again. Continue with your treatment unless advised by your rheumatologist or unless side effects develop (see Side effects).
If you stop tacrolimus for any reason, you must contact your rheumatologist.
How will you be checked while on tacrolimus?
- Tacrolimus will only be given if your disease is active and if other treatments have not worked. It is not often used as a first-line treatment in Australia, unless you have lupus nephritis (kidney disease).
- Treatment will only continue if it helps your condition. This must be checked between 12 and 16 weeks after the start of treatment.
- Blood tests are needed during your treatment to monitor for side effects and to assess if the treatment is working. The amount of tacrolimus in the blood is important and will be checked regularly by your treating doctor to make sure it is in the therapeutic range.
- How often you have blood tests will depend on what other medications you are taking and what other illnesses you have. Your rheumatologist will advise on this.
How is tacrolimus given?
Tacrolimus is taken as an oral tablet, usually twice a day (morning and evening). It should be taken either 1 hour before or 2-3 hours after a meal (i.e. on an empty stomach) to maximise the absorption of the medication. Each tablet should be taken as soon as it is opened from the blister and it should be taken with water.
If your lupus primarily affects your skin, a topical preparation of tacrolimus is available which is used as a cream. This may reduce the risk of side effects.
What is the dosage?
The dose of tacrolimus differs between people, but can be up to 8mg daily, usually divided into two doses (morning and evening dose).
If you miss a dose of tacrolimus, just take your next dose as planned. Don’t double up the dose to make up for the missed dose.
Can other medicines be given while taking tacrolimus?
Tacrolimus can interact with a lot of other medications. Your prescriber will need to know a full list of the medications (including over-the-counter medications and supplements) you are currently taking. Some antibiotics and antifungals can change the amount of tacrolimus in your blood, so these will need to be checked before they are used.
Are there any side effects?
It is not uncommon to experience side effects with tacrolimus. The risk of side effects will be weighed against the potential benefit by your treating doctor.
Tell your doctor if you notice side effects that you think are caused by this medication. Many side effects disappear when tacrolimus treatment is reduced or stopped.
Common mild side effects
- Diarrhoea, cough, headache, hunger, thirst, joint pain, nausea, runny nose.
Serious side effects
- Hypertension (high blood pressure) is common in people taking tacrolimus. Your doctor will check your blood pressure regularly and may recommend that you check it yourself at home as well. In some people, medication to control the blood pressure may be required.
- Impaired kidney function can occur. Your treating doctor will test your blood and urine regularly to ensure that any reduction in your kidney function is detected early.
- High potassium or low magnesium in the blood. Your doctor will check for these regularly.
- Cardiomyopathy (enlarged heart) can occur in some people taking this medication. Should you notice any increase in fatigue, shortness of breath or begin coughing up clear sputum, it should be reviewed by your family doctor or the emergency department.
- Tacrolimus may increase your risk of diabetes mellitus (high blood sugar) which can result in damage to many different organs including your kidneys and eyes. Your doctor will test your blood sugar levels.
- Tacrolimus may increase your risk of skin cancer and lymphoma (cancer of the lymph nodes). It is important to have your skin checked regularly by your family doctor and have any suspicious skin changes looked at. If you notice any change to moles or other skin lesions, they should be checked by a health care professional. Using sunscreen, wearing hats and avoiding direct sunlight between 10am and 3pm can reduce chances of skin cancers. Avoid using tanning beds.
- This medication may increase your risk of infections, which may need treatment. Tacrolimus may need to be stopped for a while if you develop infection, so it is important to contact your doctor for advice.
- Taking general precautions against infections such as avoiding people who are unwell and washing hands is recommended.
- Tacrolimus can cause abnormalities in your blood count and the blood vessels. Symptoms such as tiredness, easily bruising, fever, sore throat, dark/bloody urine, stroke symptoms, yellowing to the skin/eyes should be reviewed urgently by your family doctor or the emergency department of your local hospital.
- PRES (posterior reversible encephalopathy syndrome) is a rare neurological event that may occur in people taking this medication, due to damage to the brain or nerves. If you notice any change in your vision, thinking, mood, personality, drowsiness, weakness etc, it must be reviewed by a medical professional.
- Tell your doctor or go to the hospital immediately if you have an allergic reaction as you need urgent medical attention.
Other side effects not listed in this leaflet may also occur. Tell your doctor if you notice any other side effects that you think might be caused by tacrolimus.
What precautions are necessary?
Infections
- If you have an active infection of any kind, treatment with tacrolimus will not be given until the infection is treated successfully.
Use with other medicines
- Tacrolimus can interact with a lot of other medications. Some of these medications can be continued, usually at a different dose. Other medications cannot be used together with tacrolimus. You should tell all your doctors about all medications you are taking or plan to take, especially if your family doctor starts any new medications. This includes over the counter or herbal/naturopathic medications
Vaccines
- While being treated with tacrolimus you should not be immunised with ‘live’ vaccines such as: MMR (measles, mumps and rubella), Varicella vaccines (Chicken pox/Shingles), OPV (oral polio virus), BCG (Bacillus Calmette Guerin), Japanese Encephalitis or Yellow Fever.
- Talk with your rheumatologist before receiving any vaccines.
- Pneumococcal, COVID-19 and the yearly seasonal flu vaccinations are encouraged.
- For more information on vaccination including the COVID-19 vaccination see: here
Surgery
- If you require surgery for any reason, you should discuss this with your rheumatologist as some people need to stop taking tacrolimus before surgery.
Alcohol
- Alcohol can interact with tacrolimus, causing the levels in the blood to be unstable. Whilst alcohol can be used while taking tacrolimus, it is important to let your doctor know if your use is increasing.
- It is important to be honest with your doctor about your use of alcohol in case dosage adjustment is required.
Use in pregnancy and when breastfeeding
- If you are pregnant or plan to become pregnant it is extremely important to discuss this with your rheumatologist before beginning this medication.
- Women of childbearing potential should use effective methods of contraception during treatment.
- Use of tacrolimus is not recommended in men who are trying to become fathers.
- Women who are breastfeeding should talk to their doctor about taking tacrolimus.
- More detailed information is available here.
How to store tacrolimus
- Store tacrolimus at room temperature (avoid freezing), in a closed container, away from heat, moisture and direct sunlight.
- Keep all medications out of reach of children.
- Return any out of date medication to your pharmacy.
For more information see the Tacrolimus- printable information sheet
This Information Sheet has been prepared using materials obtained from various sources which have been reviewed by the Australian Rheumatology Association (ARA). It contains general information only and does not contain a complete or definitive statement of all possible uses, actions, precautions, side effects or interactions of the medicines referenced. This information is not intended as medical advice for individual conditions nor for making an individual assessment of the risks and benefits of taking a particular medicine. Decisions regarding the assessment and treatment of patients are the sole responsibility of the treating medical professional, exercising their own clinical judgment and taking into account all of the circumstances and the medical history of the individual patient. ARA has used all reasonable endeavours to ensure the information on which this Information Sheet is based is accurate and up to date. However, the ARA accepts no responsibility or liability for the accuracy, currency, reliability and/or completeness of the information contained in this Information Sheet. To the maximum extent permitted by law, the ARA expressly disclaims any liability for any injury, loss, harm or damage arising from or in connection with use of and reliance on the information contained in this Information Sheet. This information sheet is copyright and may be reproduced in its entirety but may not be altered without prior written permission from the ARA.Page updated March 2024Discover more...
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