Medication Information Leaflet

What is this medication for?

It is used to treat rheumatoid arthritis (RA) for patients who cannot tolerate or do not respond to conventional disease-modifying antirheumatic drugs (DMARDs). It is also used to treat lupus nephritis, an inflammation of the kidney that is caused by systemic lupus erythematosus (SLE).

In rheumatoid arthritis, Tacrolimus suppresses your immune system and prevents it from attacking your joints and causing inflammation. This helps to reduce symptoms of joint swelling, pain and stiffness. In the long term, it also reduces joint deformity and bone erosion from the inflammatory condition.

In lupus nephritis, Tacrolimus suppresses your immune system and prevents it from attacking your kidney. This helps to reduce kidney damage and leakage of proteins in your urine (proteinuria).

This medication may also be used for other conditions as determined by your doctor.

How should I take or use this medication?

• Do not stop taking your medication without checking with your healthcare professional.

• This medicine should be taken on an empty stomach – either 1 hours before food, or 2 hours after. This is because food can reduce the absorption of this medication into the body.

• However, you may take it after food if you experience persistent gastric side effects. Take Tacrolimus consistently either with or without food.

• For capsules: Swallow the capsule whole, do not crush or chew.

• For suspension: Shake the suspension before taking.

What should I do if I forget to take or use this medication?

If you forget to take a dose, take it as soon as you remember. Then take your next dose at the usual time. Do not take two doses to make up for the missed dose.

What precautions should I take when taking or using this medication?

Inform your healthcare professional if:

• You are allergic to this medication or any of the other ingredients of this medication

• You are allergic to any antibiotic belonging to the subgroup of macrolide antibiotics (e.g. Erythromycin, Clarithromycin)

• You are pregnant, planning to become pregnant, or breastfeeding

• You are taking any other medications, including supplements, traditional medications and herbal remedies e.g. St John’s Wort.

• You have high blood pressure, diabetes, kidney or liver problems.

• You have an condition where there is alteration of the electrical activity of your heart, known as “QT prolongation”

• You are planning to receive any vaccines and you must avoid any live vaccinations.

What are some common side effects of this medication?

• Increased blood sugar

  • Your doctor may perform routine blood tests to monitor your blood sugar

  • If advised by your doctor, check your blood sugar using a home testing kit regularly and bring the readings to your doctor

  • Seek medical attention if you develop the following symptoms: increased thirst, frequent urination, blurred vision and/ or tiredness

• Increased potassium and/or reduced magnesium in your blood

  • Your doctor will perform routine blood tests to monitor the potassium and magnesium levels in your blood

  • Seek medical attention if you develop the following symptoms: chest pain, heart palpitations, irregular heartbeat, muscle weakness or cramps, nausea and vomiting

• Increased blood pressure

  • Your doctor will measure your blood pressure at each visit

  • (Where applicable) Check your blood pressure regularly and bring the readings to your doctor

• Increased uric acid in your blood, or gout

  • Your doctor will perform routine blood tests to monitor your uric acid, as well as monitor your gout symptoms

  • Seek medical attention if you develop the following symptoms: Intense joint pain and swelling (most commonly on the big toes) that comes on suddenly, especially in the middle of the night, redness and/or warmth of affected joint

• Tremors, headache, tingling/ numbness in fingers, insomnia

• Diarrhoea, nausea, vomiting, indigestion, heartburn and abdominal pain

  • Drink more water when having diarrhoea and vomiting

• Infections

  • Seek medical attention if you develop symptoms like prolonged diarrhoea, fever, chills, sore throat, mouth ulcers

• Kidney problems

  • Seek medical attention if you develop symptoms like swelling of hands and feet, inability to pass urine

• Hair loss

• Acne (pimples)

What are some rare but serious side-effects that I need to seek medical advice immediately?

The symptoms of a drug allergy include one or more of the following:

• Swollen face/eyes/lips/tongue

• Difficulty in breathing

• Itchy skin rashes over your whole body

Some of other rare but serious side effects include:

• Tear in your abdominal wall (perforation): Symptoms of pain or swelling in abdominal area, may or may not be accompanied with chills, fever, nausea or vomiting.

• Pure red cell aplasia (very severe reduction in red blood cell counts): Symptoms include tiredness, abnormal paleness of the skin, shortness of breath, dizziness, headache, chest pain and cold hands and feet

• Progressive Multifocal Leukoencephalopathy (viral infection of cells in the brain): Symptoms include memory loss, trouble thinking, difficulty walking or loss of vision

• Posterior Reversible Encephalopathy Syndrome (PRES) (a condition that causes swelling in the some parts of the brain): Symptoms include headache, confusion, mood changes, seizures, and visual disturbances

• Liver problem: Signs include dark urine or light coloured stools, nausea, vomiting, loss of appetite, stomach pain, yellowing of your eyes or skin

• QT prolongation or Torsade de Pointes (heart rhythm disturbances): Symptoms include heart palpitations, rapid pulse, dizziness, cold sweats, chest pain, shortness of breath, low blood pressure

• Cancer (blood or predominantly skin cancers) – limit or avoid sun and ultraviolet light exposure; use appropriate sunblock or protect your skin from the sun to reduce risk

If you experience any of these symptoms, you should stop your medication and see your healthcare professional immediately.

What food or medication should I avoid when I take or use this medication?

Avoid taking grapefruit and pomelo when you are taking this medicine as grapefruit may interact with your medicine and increase the risk of side-effects.

Inform your healthcare professional if you are taking other medications as they may interact with Tacrolimus.

How should I store this medication?

Store in a cool and dry place, away from direct sunlight. Keep this medication away from children.

Use all the capsules within 1 year of opening the aluminium wrapping. For suspension, do not use the suspension if passed the expiry stated on the bottle

How do I throw away this medication safely?

For general waste: Pack this medication into a black trash bag and seal it tightly before throwing it into the rubbish chute or bin.

Disclaimer

If you take more than the recommended dose, please seek medical advice immediately. The information provided on this page does not replace information from your healthcare professional. Please consult your healthcare professional for more information.

This article is jointly developed by members of the National Medication Information workgroup. The workgroup consists of cluster partners (National Healthcare Group, National University Health System and SingHealth), community pharmacies (Guardian, Unity and Watsons) and Pharmaceutical Society of Singapore. The content does not reflect drug availability and supply information in pharmacies and healthcare institutions. You are advised to check with the respective institutions for such information.

Last updated on Oct 2022