Tacrolimus for the treatment of autoimmune liver disease

This leaflet will provide you with information about the drug and can answer any questions you may have.

What is tacrolimus used for?

Tacrolimus is used to suppress your immune system. It is given if you have had a liver transplant to stop your body rejecting the liver, or in autoimmune hepatitis to suppress your immune system from attacking your liver. We also prescribe tacrolimus if you are on steroid treatment to try and reduce your steroid dose and dependence on it.

When and how do I take tacrolimus?

Brands

There are different brands of tacrolimus. Some brands are taken once per day, others are taken twice per day.

It is very important that you know which brand you are taking and stay on the same brand that we start you on.

You must not switch between different brands unless we tell you to do so.

Dose

It is also very important to know what dose you are taking, as it can change regularly and the label on your box of medicine may only say “take as directed”.

Please check with us if you are not sure.

When you collect your prescription from your pharmacy, check you have received the correct brand.

1. Immediate-release tacrolimus (e.g. Adoport® / Prograf®).

This preparation is taken twice per day, about 12 hours apart. Choose times suitable to you e.g. 8.00 am and 8.00 pm or 10.00 am and 10.00 pm. Swallow the capsules whole with a glass of water, if possible, 1 hour before or 2 hours after food. Some patients find it easier to take with food. If you do this, it is important to take at the same time in relation to food each day.

What to do if you forget to take a dose:

If you remember within 6 hours of when you usually take a dose, then take the next dose as soon as you remember missing it and take your next dose at the usual time. If you remember over 6 hours from when you usually take a dose, forget this dose and take your next dose at the usual time. Never take a double dose to make up for missed doses.

2. Prolonged-released tacrolimus (e.g. Dailiport® and Advagraf®).

This preparation is taken once per day in the morning.

Swallow the capsules whole with a glass of water, if possible, 1 hour before or 2 hours after food. Some patients find it easier to take their tacrolimus with food. If you do this, it is important to take it at the same time in relation to food each day.

What to do if you forget to take a dose:
If you remember within 12 hours of when you usually take a dose, then take the next dose when you remember and take your next dose at the usual time. If you remember over 12 hours from when you usually take a dose, forget this dose and take your next dose at the usual time. Never take a double dose to make up for missed doses.

Receiving your tablets

This medication will not be supplied by your GP or local pharmacy, it will come from Addenbrooke’s hospital. We will be responsible for supplying and monitoring your treatment.

Storage

Most tacrolimus preparations come in an aluminium wrap. Once this has been opened, the capsules expire after 1 year. Store in the original package in order to protect from moisture.

If you are travelling and need to take tacrolimus with you during this time, you can store your medicine in the original package up to a maximum of 25°C.

If you require a larger delivery of medication to cover the period of being away, you need to contact the us at least three months in advance and we will assess if your request is possible.

Initial blood monitoring

When you start taking tacrolimus, you will need to take the following blood tests every 2 weeks for 2 months or until stable:

• Full blood count (FBC)
• Kidney function tests (U&Es)
• Liver function tests (LFTs)

For the blood tests you can attend the drive-through Phlebotomy (blood test taking facility) located in Newmarket Road Park and Ride in Cambridge (CB5 8AA). A leaflet and more information are available on the Outpatient phlebotomy/blood tests section of our website.

The drop-in service will be available between 09:30 and 16:30, Monday to Fridays. You must attend in a car, as the site is not suitable for walk-ins or bicycles.

You can also arrange an appointment to have bloods taken at Addenbrooke's Hospital by calling 01223 256998 (Monday to Friday, 09:00–17:00); some appointments are also available at Princess of Wales Hospital, Ely.

Ongoing blood monitoring

When the blood tests show that you are stable during treatment, we may ask your local GP surgery or hospital to take blood tests for us and send us back the results.

When you are stable on therapy, you will need full blood count (FBC) and liver function tests (LFTs) every 1-3 months.

There may be other tests you require in addition to these from time to time for general monitoring and management of your condition.

This may include a specialist blood test measuring how much tacrolimus is in your blood. We will provide you with more information on what to do when you require this. It is important to take the blood test before your take your tacrolimus that day.

If you are asked by your GP to change your dose or to stop your medication, please contact us and we will arrange further appointments with you.

Are there any side effects?

Tacrolimus has several side effects but not everyone will experience them. Some of the side effects disappear as the dose of tacrolimus is reduced over time.

Listed below are the most common side-effects:

• tremor (shaking) of the hands
• headache
• vivid dreams
• upset stomach
• hair loss on head
• numb, hot or tingly hands, feet or mouth
• diabetes mellitus
• high blood pressure
• reduced kidney function

You may notice some of these side effects yourself. Tell us if you do as there is often a solution.

As tacrolimus suppresses the immune system, it can make you more likely to develop infections. You should tell us straight away if you develop any of the following after starting tacrolimus:

• a sore throat, fever or any other signs of infection
• shortness of breath
• unexplained bruising or bleeding
• yellowing of the skin or eyes
• any other new symptoms or anything else that concerns you.

You should also see your doctor if you develop chickenpox or shingles or come into contact with someone who has chickenpox or shingles. You may need antiviral treatment, and you may be advised to stop taking tacrolimus until you are better.

There is an increased risk of skin cancer with all immunosuppressant medication. Therefore, we advise you to avoid excessive sun exposure, avoid sunbeds and to use high factor sunscreen.

Taking tacrolimus alongside other medicines and food

Some medicines can increase or decrease your tacrolimus level in the blood. Always check with your doctor or pharmacist if you are prescribed or if you buy any new medicines over the counter, including herbal medicines (e.g. St. John’s wort).

There are various medicines that you should NOT take whilst on tacrolimus. Some examples include:

• antibiotics called erythromycin and clarithromycin
• non-steroidal anti-inflammatory drugs such as ibuprofen or diclofenac (can affect your kidneys)
• some antifungals
• anti-epileptic medication

Always check with a doctor or pharmacist that any new medicine is safe for you to take. If you are in doubt, contact us.

You should avoid eating or drinking the following whilst you are taking tacrolimus because they contain a chemical that affects the level of tacrolimus in your blood. Other citrus fruits are safe to eat or drink.

• grapefruit
• grapefruit juice
• Seville oranges
• Seville orange products
• pomegranate
• pomelo

Cannabidiol (CBD) from cannabis alters blood levels of tacrolimus and should be avoided.

Vaccinations

Your body’s resistance to infection is likely to be reduced whilst taking tacrolimus. You are more likely to become unwell from certain infections. Therefore, if you are not already immune, we will recommend you get shingles (Shingrix® brand only) and pneumonia vaccines. We also recommended everyone to get their yearly influenza and SARS-CoV-2 (COVID-19) immunisations.

However, you should avoid live vaccines whilst on treatment and for 6 months after the last dose. Live vaccines include the live varicella/shingles immunisation (Zostavax® brand), oral polio, oral typhoid, BCG, MMR and yellow fever. We will be able to advise you if you need these.

Alcohol

You should only drink alcohol in small amounts, as both the alcohol and tacrolimus can affect your liver. It is also strongly recommended to have alcohol-free days and avoid saving units up to drink later in one go. If you are concerned, you should discuss your alcohol intake with us.

Pregnancy, breastfeeding and fertility

Please discuss with us if you wish to become pregnant or are pregnant/ breastfeeding.

Tacrolimus is one of the safer options in pregnancy; therefore, please do not stop taking tacrolimus if you discover you are pregnant without discussing with the team.

Follow-up

We will arrange telephone and face-to-face appointments regularly. At these appointments, we will check if you are responding to treatment, review your latest blood tests, order further blood tests, decide if you are to continue therapy and issue new prescriptions. If you have any problems or concerns before this date, please do not hesitate to contact us.

How to contact us

1. Autoimmune Hepatology Helpline: 01223 216109
2. Message via MyChart

Both of these methods are non-urgent services. If the issue is more urgent, you must use alternative services e.g. GP practice, NHS 111, or in the case of a clinical emergency, A&E.

Other information

• We encourage you to attend all NHS screening programs (that you are eligible for) including bowel cancer or cervical smear tests, as appropriate.
• Please notify us if you change your address, contact details or GP practice.

Useful websites

• British Liver Trust website on autoimmune hepatitis (opens in a new tab)