Brand Name Choices
No generic medication is available for Rapamune (Sirolimus)
What Rapamune is and what it is used for
Rapamune contains the active substance sirolimus, which belongs to a group of medicines called immunosuppressants. It helps to control your body’s immune system after you have received a kidney transplant. Rapamune is used in adults to prevent your body from rejecting transplanted kidneys and is normally used with other immunosuppressant medicines called corticosteroids and initially (the first 2 to 3 months) with ciclosporin. Rapamune is also used for the treatment of patients with sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or declining lung function. S-LAM is a rare progressive lung disease that affects predominantly women of childbearing age. The most common symptom of S-LAM is shortness of breath.
How to take Rapamune
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide exactly what dose of Rapamune you must take and how often to take it. Follow your doctor’s instructions exactly, and never change the dose yourself. Rapamune is for oral use only. Do not crush, chew, or split the tablets. Inform your doctor if you have difficulty taking the tablet. Multiples of 0.5 mg tablets should not be used as a substitute for 1 mg and 2 mg tablets, as the different strengths are not directly interchangeable. Rapamune should be taken consistently, either with or without food. Kidney Transplant Your doctor will give you an initial dose of 6 mg as soon as possible after the kidney transplant operation. Then you will need to take 2 mg of Rapamune each day, until otherwise directed by your doctor. Your dose will be adjusted depending on the level of Rapamune in your blood. Your doctor will need to perform blood tests to measure Rapamune concentrations. If you are also taking ciclosporin, then you must take the two medicines approximately 4 hours apart. It is recommended that Rapamune be used first in combination with ciclosporin and corticosteroids. After 3 months, your doctor may discontinue either Rapamune or ciclosporin, as it is not recommended that these medicines be taken together beyond this period. Sporadic Lymphangioleiomyomatosis (S-LAM) Your doctor will give you 2 mg of Rapamune each day, until otherwise directed by your doctor. Your dose will be adjusted depending on the level of Rapamune in your blood. Your doctor will need to perform blood tests to measure Rapamune concentrations. If you take more Rapamune than you should If you have taken more medicine than you were told to, contact a doctor or go to the nearest hospital emergency department as soon as possible. Always take the labelled blister with you, even if it is empty. If you forget to take Rapamune If you forget to take Rapamune, take it as soon as you remember, but not within 4 hours of the next dose of ciclosporin. After that, continue to take your medicines as usual. Do not take a double dose to make up for a forgotten dose, and always take Rapamune and ciclosporin approximately 4 hours apart. If you miss a dose of Rapamune completely, you should inform your doctor. If you stop taking Rapamune Do not stop taking Rapamune unless your doctor tells you to, as you risk losing your transplant. If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should see your doctor immediately if you experience symptoms, such as swollen face, tongue
and/or back of the mouth (pharynx) and/or difficulties in breathing (angioedema), or a skin condition
whereby the skin can peel off (exfoliative dermatitis). These may be symptoms of a serious allergic
Kidney damage with low blood cell counts (thrombocytopaenic purpura/haemolytic uraemic
When taken with medicines called calcineurin inhibitors (ciclosporin or tacrolimus), Rapamune may
increase the risk of kidney damage with low blood platelets and low red blood cell counts, with or
without rash (thrombocytopaenic purpura/haemolytic uraemic syndrome). If you experience symptoms
such as bruising or rash, changes in your urine, or changes in behaviour or any others that are serious,
unusual or prolonged, contact your doctor.
Rapamune reduces your body’s own defence mechanisms. Consequently your body will not be as
good as normal at fighting infections. So if you are taking Rapamune, you may therefore catch more
infections than usual, such as infections of the skin, mouth, stomach and intestines, lungs and urinary
tract (see list below). You should contact your doctor if you experience symptoms that are serious,
unusual, or prolonged.
Side effect frequencies
Very common: may affect more than 1 in 10 people Fluid collection around the kidney Swelling of the body including hands and feet Pain Fever Headache Increased blood pressure Stomach pain, diarrhoea, constipation, nausea Low red blood cells, low blood platelets Increased fat in the blood (cholesterol and/or triglycerides), increased blood sugar, low blood potassium, low blood phosphorus, increased lactate dehydrogenase in the blood, increased creatinine in the blood Joint pain Acne Urinary tract infection Pneumonia and other bacterial, viral, and fungal infections A reduced number of infection-fighting cells in the blood (white blood cells) Diabetes Abnormal tests of liver function, elevated AST and/or ALT liver enzymes Rash Elevated protein in the urine Menstrual disorders (including absent, infrequent or heavy periods) Slow healing (this may include separation of the layers of a surgical wound or stitch line) Rapid heart rate There is a general tendency for fluid to collect in various tissues.
Common: may affect up to 1 in 10 people Infections (including life-threatening infections) Blood clots in the legs Blood clots in the lung Mouth sores Fluid collection in the abdomen Kidney damage with low blood platelets and low red blood cell counts, with or without rash (haemolytic uraemic syndrome) Low levels of a type of white blood cells called neutrophils Deterioration of bone Inflammation that may lead to lung damage, fluid around the lung Nose bleeds Skin cancer Kidney infection Ovarian cysts Fluid collection in the sac around the heart, that in some cases may decrease the heart's ability to pump blood Inflammation of the pancreas Allergic reactions Shingles Cytomegalovirus infection
Uncommon: may affect up to 1 in 100 people Cancer of the lymph tissue (lymphoma/post-transplant lympho-proliferative disorder), combined lowering of red blood cells, white blood cells and blood platelets Bleeding from the lung Protein in the urine, occasionally severe and associated with side effects, such as swelling Scarring in the kidney that may reduce kidney function Too much fluid collecting in the tissues due to irregular lymph function Low blood platelets, with or without rash (thrombocytopaenic purpura) Serious allergic reactions that can cause peeling of the skin Tuberculosis Epstein-Barr virus infection Infectious diarrhoea with Clostridium difficile Serious liver damage
Rare: may affect up to 1 in 1,000 people Protein build-up in the air sacs of the lungs that may interfere with breathing Serious allergic reactions that can affect blood vessels (see above paragraph on allergic reactions)
Not known: frequency cannot be estimated from the available data Posterior reversible encephalopathy syndrome (PRES), a serious nervous system syndrome that has the following symptoms: headache, nausea, vomiting, confusion, seizures, and visual loss. Should any of these occur together, please contact your physician. S-LAM patients experienced similar side effects to those of kidney transplant patients, with the addition of weight loss, which may affect up to 1 in 10 people.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax:+353 1 6762517 Website: www.hpra.ie E-mail: [email protected] Malta www.medicinesauthority.gov.mt/adrportal
How to Store Rapamune
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month. Do not store above 25˚C. Keep the blister in the outer carton in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
2 to 3 weeks on average
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