Prograf 0.5 mg, 1 mg and 5 mg capsules (tacrolimus) – prevention of transplant rejection

Prograf is an immunosuppressant medicine containing tacrolimus (a calcineurin inhibitor). After an organ transplant, such as a liver, kidney or heart, the immune system tries to reject the new organ – Prograf suppresses this immune response and allows the body to accept the transplanted organ.

The medicine is available as hard capsules of 0.5 mg, 1 mg and 5 mg tacrolimus (immediate release) and is taken twice a day. It is often combined with other immunosuppressive medicines.

What is Prograf used for and how should it be taken correctly?

Basic information about the medicine

What is Prograf used for?

According to the summary of product characteristics, Prograf is used for:

• prevention of rejection of a transplanted liver, kidney or heart;
• treatment of transplant rejection when other immunosuppressive medicines have not been successful enough.

How is Prograf used and dosed?

The dose is determined and changed only by the transplant specialist, based on body weight, the transplanted organ, other medicines and regular blood tests. According to the leaflet:

• initial doses immediately after transplantation are usually 0.075–0.30 mg per kilogram of body weight per day, depending on the organ; once the condition stabilises, the doctor usually reduces the dose;
• the medicine is taken twice a day, usually in the morning and evening;
• it is taken on an empty stomach – 1 hour before or 2 to 3 hours after a meal;
• the capsules are swallowed whole with enough water, immediately after removal from the blister; the desiccant in the pouch must not be swallowed;
• if the appearance of the medicine or the dosing differs from usual, contact your doctor or pharmacist as soon as possible.

Special patient groups

• Liver impairment: a dose reduction may be needed to keep the blood level within the target range.
• Diarrhoea lasting more than one day: tell your doctor – a dose adjustment may be needed.
• Children: according to the SmPC, children generally need 1.5 to 2 times higher doses (per kg body weight) than adults to reach similar blood levels – the dose is set by the specialist.
• Older patients: according to the SmPC, there is no evidence that a dose adjustment is needed.

Contraindications – when the medicine must not be used

• allergy to tacrolimus or any of the excipients;
• allergy to macrolide antibiotics (e.g. erythromycin, clarithromycin, josamycin).

Precautions and warnings

• the medicine is taken every day for as long as immune suppression is needed; regular contact with your doctor and tests of blood, urine, heart, vision and nervous system are required;
• liver disease, severe abdominal pain (with chills, fever, nausea or vomiting), diarrhoea lasting more than one day, QT prolongation;
• limit exposure to sunlight and UV light (protective clothing, high protection factor) because of a possible risk of malignant skin changes;
• talk to your doctor before any vaccination;
• an increased risk of lymphoproliferative disorders has been reported;
• thrombotic microangiopathy – fever, bruising under the skin, unexplained tiredness, confusion, yellowing, reduced urine output, loss of vision or seizures; the risk is higher with sirolimus or everolimus;
• the medicine contains lactose; the printing ink on the 0.5 mg and 1 mg capsules contains soya lecithin – tell your doctor if you are allergic to peanut or soya.

Interactions with other medicines, food and drink

Prograf must not be used together with ciclosporin. Many medicines can increase or decrease tacrolimus blood levels (risk of serious side effects or organ rejection), so always tell your doctor about all medicines, especially:

• antifungals and antibiotics (ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, clotrimazole, erythromycin, clarithromycin, azithromycin, rifampicin, rifabutin, isoniazid, etc.), letermovir;
• medicines for HIV (ritonavir and other protease inhibitors, cobicistat, efavirenz, etravirine, nevirapine) and hepatitis C;
• certain cancer medicines (nilotinib, imatinib, crizotinib, enzalutamide, etc.), mycophenolic acid;
• omeprazole, lansoprazole, cimetidine, metoclopramide, magnesium-aluminium hydroxide;
• hormone therapy with ethinylestradiol (e.g. contraceptives), danazol;
• nifedipine, nicardipine, diltiazem, verapamil, amiodarone, statins;
• carbamazepine, phenytoin, phenobarbital, metamizole, prednisolone, methylprednisolone, nefazodone, cannabidiol;
• herbal preparations containing St John’s wort or Schisandra sphenanthera extract;
• ibuprofen, amphotericin B, co-trimoxazole, vancomycin, aminoglycosides, aciclovir, ganciclovir – may worsen kidney or nervous system disorders;
• potassium preparations, potassium-sparing diuretics, trimethoprim, NSAIDs, anticoagulants, oral diabetes medicines, sirolimus, everolimus.

The medicine is taken on an empty stomach; avoid grapefruit and grapefruit juice. Alcohol increases dizziness and drowsiness.

Pregnancy and breastfeeding

• Pregnancy: tacrolimus crosses the placenta. Use is considered only if there is no safer suitable alternative and the benefit justifies the risk to the baby; talk to your doctor before planning a pregnancy.
• Breastfeeding: the medicine passes into breast milk – do not breastfeed during treatment.

Driving and using machines

• Do not drive or use machines if you feel dizzy or drowsy or have blurred vision; these effects are more common with alcohol.

Possible side effects

• Infections: because the body’s defences are reduced, infections of the skin, mouth, stomach, bowel, lungs and urinary tract are more common; some can be serious. Report fever, cough, sore throat or general weakness immediately, as well as memory loss, difficulty thinking, walking problems or vision loss.
• Common serious: bowel perforation (severe abdominal pain), insufficient function of the transplanted organ, blurred vision.
• Uncommon and rare serious: thrombotic microangiopathy and thrombotic thrombocytopenic purpura, toxic epidermal necrolysis, blindness; very rarely Stevens-Johnson syndrome and torsades de pointes.
• Very common: increased blood sugar and diabetes, increased potassium, sleep problems, trembling, headache, high blood pressure, abnormal liver tests, diarrhoea, nausea, kidney problems.
• Common: blood count changes, electrolyte disturbances, reduced appetite, agitation, confusion, depression, nightmares, hallucinations, seizures, tingling in the hands and feet, eye disorders, ringing in the ears, fast heartbeat, low blood pressure, shortness of breath, cough, abdominal pain, constipation, mouth sores, jaundice, itching, rash, hair loss, acne, sweating, joint pain, muscle cramps, difficulty passing urine, fever, swelling.
• Frequency not known: opportunistic infections, benign and malignant tumours as a result of immunosuppression, severe blood disorders, allergic and anaphylactic reactions, posterior reversible encephalopathy syndrome, optic nerve disorder.

Overdose, missed dose and stopping treatment

• Overdose: if you accidentally take a higher dose, contact your doctor or the nearest emergency service immediately.
• Missed dose: do not take a double dose; wait until the time of the next regular dose and continue the usual dosing.
• Stopping treatment: stopping increases the risk of transplant rejection – treatment must not be stopped unless your doctor advises it.

Related information

Prograf is a specialist treatment managed by the transplant team. Ask your specialist all questions about the dose, blood tests and the use of other medicines or dietary supplements at the same time.

Composition, pack and manufacturer

• active substance: tacrolimus (as tacrolimus monohydrate) – 0.5 mg, 1 mg or 5 mg per capsule;
• capsule content: hypromellose, croscarmellose sodium, lactose monohydrate, magnesium stearate; shell: gelatin, titanium dioxide, iron oxides (depending on strength); the printing ink on 0.5 mg and 1 mg contains soya lecithin;
• appearance: 0.5 mg – light yellow capsules marked “0.5 mg” and “(f) 607”; 1 mg – white capsules marked “1 mg” and “(f) 617”; 5 mg – greyish-red capsules marked “5 mg” and “(f) 657”;
• pack: blisters of 10 capsules in an aluminium pouch with desiccant – 0.5 mg: 30 capsules; 1 mg: 60 capsules; 5 mg: 30 capsules;
• manufacturer: Astellas Ireland Co. Ltd., Killorglin, Co. Kerry, Ireland; marketing authorisation holder according to ALIMS lists from 2026: Evropa Lek Pharma d.o.o. Belgrade.

Storage

• the medicine does not require any special temperature storage conditions; store in the original package to protect from moisture;
• shelf life before opening the aluminium pouch: 3 years; after opening the pouch: 12 months below 30 °C;
• take the capsule immediately after removing it from the blister;
• keep out of the sight and reach of children; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

How should Prograf be taken correctly?

Twice a day, usually in the morning and evening, on an empty stomach – 1 hour before or 2 to 3 hours after a meal. The capsules are swallowed whole with water immediately after removal from the blister.

What if I miss a dose?

Do not take a double dose. Wait until the time of the next regular dose and continue with your usual dosing; if you are unsure, contact your doctor.

Can I take herbal preparations or eat grapefruit?

Not without your doctor’s advice. The leaflet advises avoiding herbal preparations (e.g. St John’s wort and Schisandra extract) and grapefruit, because they change tacrolimus blood levels and may lead to side effects or organ rejection.

Why must I not change the tacrolimus formulation?

Immediate-release and prolonged-release tacrolimus medicines give different blood levels. Switching without specialist supervision can lead to rejection of the transplanted organ or to stronger side effects.

Sources

• ALIMS – Patient information leaflet Prograf 1 mg (PIL)
• ALIMS – Summary of product characteristics Prograf 1 mg (SmPC)
• ALIMS – Patient information leaflet Prograf 0.5 mg (PIL)
• ALIMS – Patient information leaflet Prograf 5 mg (PIL)

Sources checked on: 25 October 2026.