Use of tacrolimus suppositories for inflammatory bowel disease (IBD) patients

Why am I prescribed tacrolimus suppositories?

A very few carefully selected patients with resistant proctitis (inflammation in the rectum or lower bowel) may be considered for treatment with tacrolimus suppositories when other more standard treatments have failed to give improvement in symptoms and/or have caused side effects.

How do I use tacrolimus suppositories?

Tacrolimus suppositories are to be inserted into the rectum following lubrication with a water based gel eg KY jelly once or twice daily (approximately 10 to 12 hours apart if used twice a day). The usual regime is one suppository (2mg) per rectum twice daily.

The suppositories should be inserted following completion of bowel openings in the morning and at bedtime. If you are concerned regarding urgency and frequency being a problem that might cause you to expel the suppository before it has had time to work, it might be better to wait until you feel more settled in the morning prior to administration and then sitting or lying quietly for an hour or so before resuming normal daily activities to give it a better chance of being retained.

A similar regime may need to be followed for the evening dose.

The suppositories have a short shelf life of 90 days and so may be issued in small supplies. These can only be obtained from the hospital pharmacy.

How should I store my suppositories?

The suppositories should be stored in cool conditions below 25°C, away from direct sunlight. If the suppositories become warm they can be difficult to remove from the moulds. If they become difficult to remove from the moulds or become too warm, they can be stored in the fridge.

How long will tacrolimus suppositories take to work?

A response to the treatment will usually be seen within a few days. If effective, it is likely to be continued for two to four weeks or possibly longer if clinically indicated.

Do I need any special checks/tests before starting tacrolimus suppositories?

You will need to have baseline blood tests carried out before starting tacrolimus suppositories. They will include full blood count (FBC), urea and electrolytes (U&Es), liver function tests (LFTs), blood glucose and immunity to the chicken pox virus (varicella). It is routine to check that you do not have certain infections, including hepatitis B and C and Epstein Barr virus (EBV, commonly known as glandular fever).

You will also need to have your blood pressure and weight recorded.

Do I need any special checks/tests during treatment?

It is important that your doctor can check to see if the treatment is working and to monitor for side effects of treatment. In order to do this you will need blood tests during the treatment. Within the first month, you will have blood tests that include FBC, U&Es, LFTs and trough tacrolimus levels (ie pre dose levels). The frequency of monitoring thereafter will depend on how long you remain on treatment.

There may be other tests you require during treatment but you will be informed of these if necessary.

Are there any side effects?

It is very important that you report promptly anything you feel to be unusual. As with all treatments the side effects need to be put into context considering the benefits and risks of treatment but there will be some instances that would indicate treatment should be stopped. These are less likely to occur with topical treatment compared to oral treatment but if they do occur to a significant extent then contact your specialist IBD nurse for further advice. If needs be, stop the medication pending receiving this advice.

Potential side effects

• Diarrhoea, indigestion, nausea or vomiting.
• Disturbed sleep pattern.
• Headaches, dizziness, blurred vision or increased sensitivity to lights.
• Tremor or muscle cramps/numbness.
• Skin rashes.
• Fever.

Special warnings/precautions

If you develop an infection, fever, unexplained bruising or bleeding at any time, report these to your GP or specialist IBD nurse via the helpline on 01223 257212 immediately.

• You should avoid live vaccinations while on tacrolimus due to the potential effect on the immune system.
• It is recommended that you have the annual flu and Covid-19 vaccines (neither are live vaccines).
• If you have not had chicken pox and come into contact with either chicken pox or shingles contact your GP or specialist IBD nurse.
• Tacrolimus may make your skin more sensitive to the sun. It is important to minimise exposure to the sun and use a high factor sunscreen.
• Tacrolimus should be avoided in pregnancy and by breastfeeding mothers.

Are there any problems taking tacrolimus suppositories with other medication?

• Tacrolimus may interact with some other drugs (including herbal medicines). It is important that you tell your GP practice, hospital doctor, specialist IBD nurse and pharmacist about any other medicines you are taking.
• Tacrolimus should not be taken with ciclosporin or if you have recently been treated with ciclosporin as there may be an interaction.
• If you are purchasing any drugs over the counter then please tell the pharmacist that you are on tacrolimus.

Further information

This leaflet is a guide only. Further information may be obtained from the manufacturer’s patient information leaflet that you will get with the medicine if available, or alternatively from speaking further with your hospital doctor/specialist nurse.

If you have side effects or problems with your medication you can contact the specialist IBD nurses via the helpline on 01223 257212.