Advagraf 1mg Capsule is used to:

• Prevent rejection after a kidney transplant: It helps stop the immune system from attacking a transplanted kidney in adults.

• Prevent rejection after a liver transplant: It helps stop the immune system from attacking a transplanted liver in adults.

• Treat resistant rejection: It may be used in adults when rejection of a transplanted organ has not responded to other immunosuppressive medicines.

• Provide long-term protection: Immunosuppression must be maintained to protect the transplanted organ, so there is no set limit to the duration of treatment.

Advagraf is not recommended for use in children and adolescents.

Advagraf 1mg Capsule contains tacrolimus, which enters immune cells called T-lymphocytes and blocks an enzyme called calcineurin. This reduces the activation and multiplication of T cells, which lowers the immune response against the transplanted organ and helps the body accept it.

The capsule is a prolonged-release formulation. It releases tacrolimus slowly over the day, which allows dosing once a day.

Tell your transplant specialist about all prescription medicines, over-the-counter medicines, supplements and herbal products you use before starting, stopping or changing any of them. Tacrolimus blood levels can change within a few days of a new medicine.

• Grapefruit and herbal products: Avoid grapefruit and grapefruit juice, which can raise tacrolimus levels. Avoid St. John’s wort and other herbal remedies unless your doctor agrees.

• Medicines that raise tacrolimus levels: These include azole antifungals (ketoconazole, itraconazole, voriconazole, fluconazole), macrolide antibiotics (clarithromycin, erythromycin), HIV and hepatitis C protease inhibitors (ritonavir), calcium channel blockers (diltiazem, verapamil, nifedipine) and omeprazole.

• Medicines that lower tacrolimus levels: Rifampicin, phenytoin, carbamazepine, phenobarbital and corticosteroids can lower levels and increase the risk of rejection.

• Ciclosporin and kidney-harming medicines: Do not combine ciclosporin with tacrolimus. Ibuprofen and other NSAIDs, aminoglycoside antibiotics, vancomycin, co-trimoxazole, amphotericin B, aciclovir and ganciclovir can add to kidney or nerve toxicity.

• Potassium: Avoid potassium supplements and potassium-sparing diuretics (spironolactone, amiloride, triamterene). Tacrolimus can raise blood potassium, and co-trimoxazole can add to this.

• Store Advagraf 1mg Capsule in its original pack to protect it from moisture, at room temperature.

• Keep the capsules in the blister, inside the foil wrapper, until you are ready to take them. The wrapper contains a drying sachet (desiccant). Do not swallow it.

• Use all capsules within 1 year of opening the aluminium wrapper.

• Do not use the capsules after the expiry date on the carton.

• Keep out of sight and reach of children. Ask your pharmacist how to dispose of unused medicine safely.

Take Advagraf 1mg Capsule exactly as prescribed by your transplant doctor. The dose depends on the type of transplant, your response and your tacrolimus blood levels. It is taken once a day in the morning. Take it on an empty stomach, or at least 1 hour before or 2 to 3 hours after a meal. Swallow the capsule whole with water. Do not open, crush or chew it. Take it immediately after removing it from the blister.

• Take the capsule at the same time every morning.

• If you forget the morning dose, take it as soon as possible on the same day. Do not take a double dose the next morning.

• Your doctor may ask you to have a blood test before your morning dose to check your tacrolimus level.

• Do not stop treatment, even if you feel well. Stopping can increase the risk of rejecting the transplanted organ.

• Do not change between tacrolimus products unless your transplant specialist tells you to.

Common side effects of Advagraf 1mg Capsule may include:

• Tremor (shaking)

• Headache

• Diarrhoea

• Nausea

• High blood pressure

• Difficulty sleeping

• High blood sugar or diabetes

• Raised potassium in the blood

• Kidney problems

Your doctor will monitor your blood tests for kidney function, blood sugar, potassium and liver function.

Serious side effects

Seek medical attention if you develop:

• Signs of infection, such as fever, sore throat, cough or feeling generally unwell. Memory loss, difficulty walking or loss of vision can be signs of a rare serious brain infection.

• Severe abdominal pain with or without chills, fever, nausea or vomiting, which can be a sign of a tear in the gut wall.

• Blurred vision, changes in colour vision or loss of vision.

• Fever, unexplained bruising under the skin, extreme tiredness, confusion, yellowing of the skin or eyes, or passing little or no urine, which can be signs of damage to small blood vessels.

• Severe headache, confusion, seizures or visual disturbance.

• New skin changes, lumps or discolouration, because immunosuppressants increase the risk of skin cancer and lymphoma.

• A fast or irregular heartbeat, palpitations or fainting.

• Take the same tacrolimus brand and formulation every time. Check the capsules when you collect your prescription and ask your pharmacist if they look different.

• Take Advagraf once daily in the morning, at the same time each day.

• Keep all appointments for blood tests so your dose can be adjusted.

• Avoid grapefruit, grapefruit juice and St. John’s wort.

• Tell every doctor, dentist and pharmacist that you take tacrolimus before starting any new medicine, including painkillers such as ibuprofen.

• Protect your skin from the sun and UV light with protective clothing and a high-SPF sunscreen.

• Avoid live vaccines and ask your doctor before any vaccination, including a flu shot.

• Contact your doctor if you have diarrhoea for more than a day, as it can change tacrolimus levels.

• Do not stop or change your dose without your transplant team, even if you feel well.