Rapamune 1 mg. 30 tablets
Rapamune contains the active substance sirolimus, which belongs to a group of medicines called immunosuppressants. It helps control the immune system of your body after you have received a kidney transplant.
It is used to prevent rejection of transplanted kidneys from your body and is normally used with other immunosuppressant medicines called corticosteroids and initially (the first 2 to 3 months) with ciclosporin.
2. What you need to know before you take Rapamune Do not take Rapamune?
- If you are allergic (hypersensitive) to sirolimus or any of the other ingredients of this medicine (listed in section 6) ..
- If you are allergic to peanuts or soya
Warnings and Precautions
Talk to your doctor or pharmacist before taking Rapamune
- If you have liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of Rapamune, you get, and you may need to give you make additional blood samples.
- Rapamune, like other immunosuppressive medicines, may decrease your body's ability to fight infection, and may increase the risk of developing cancer of the lymphoid tissues and skin.
- If you have a body mass index (BMI) greater than 30 kg / m, where you may have an increased risk of abnormal wound healing.
- If you believe that you are at high risk for rejection, such as if you have already lost their graft due to rejection.
Your doctor will perform tests to monitor the levels of Rapamune in your blood. During treatment with Rapamune, your doctor will also perform tests to monitor your kidney function, levels of blood fats (cholesterol and / or triglycerides) and possibly the liver.
Exposure to sunlight and UV light should be limited by covering your skin with clothing and using a sunscreen with a high protection factor because of the increased risk of skin cancer.
Children and adolescents
There is limited experience with the use of Rapamune in children and adolescents under 18 years of age. The use of Rapamune is not recommended in these patients.
Other medicines and Rapamune
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may interfere with the action of Rapamune and, therefore, may need a dose adjustment of Rapamune. In particular, you should tell your doctor or pharmacist if you are taking any of the following means:
- Any other immunosuppressive drugs
- Antibiotics or antifungal drugs used to treat infection, for example. clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole. Not recommended Rapamune be taken with rifampicin, ketoconazole or voriconazole
- Any medications for high blood pressure or heart problems, including nicardipine, verapamil and diltiazem
- Anti-epileptic drugs, including carbamazepine, phenobarbital, phenytoin.
- Drugs used to treat ulcers or other gastrointestinal disorders, such as cisapride, cimetidine, metoclopramide
- Bromocriptine (used in the treatment of Parkinson's disease and various hormonal disorders), danazol (used for the treatment of gynecological disorders), or protease inhibitors (eg. HIV and hepatitis C such as ritonavir, indinavir, boceprevir and telaprevir)
- St. John's wort (Hypericum perforatum)
The use of live vaccines should be avoided during treatment with Rapamune. Before vaccinations, please tell your doctor or pharmacist that you are taking Rapamune.
The use of Rapamune may lead to increased blood levels of cholesterol and triglycerides (blood fats), which may require treatment. Medicines known as "statins" and "fibrates" used to treat elevated cholesterol and triglycerides are associated with increased risk of muscle breakdown (rhabdomyolysis). Please tell your doctor if you are taking medication to reduce blood fats.
The concomitant use of Rapamune with angiotensin-converting enzyme (ASEinhibitori) (type of medicine used to lower blood pressure) may cause allergic reactions. Please tell your doctor if you are taking any of these medicines.
Rapamune with food and drink
Rapamune must always be taken in the same manner - regardless of whether with or without food. If you prefer to take Rapamune with food, you should always take it with food. If you prefer to take Rapamune without food, then you should always take it without food. Food can affect the amount of drug that falls in your blood, while taking the medicine in the same way means that the levels of Rapamune in your blood are kept stable.
Rapamune should not be taken with grapefruit juice.
Pregnancy, lactation and fertility
Rapamune should not be used during pregnancy unless clearly necessary. You should use effective method of contraception during treatment with Rapamune and for 12 weeks after discontinuation of treatment. If you are unsure, or think you may be pregnant, talk to your doctor.
It is not known whether Rapamune passes into breast milk. Patients taking Rapamune, should stop breastfeeding.
The use of Rapamune is associated with decreased sperm count, which usually returns to normal after discontinuation of treatment.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Although not expected Rapamune treatment affect your ability to drive, if you have any concerns, talk to your doctor.
Rapamune contains ethanol (alcohol)
Rapamune contains up to 2.5% by volume of ethanol (alcohol). An initial dose of 6 mg contains up to 150 mg of alcohol which is equivalent to 3 ml beer or wine 1,25 ml. This amount of alcohol may be harmful for people suffering from alcoholism, as well as for children and high-risk groups such as patients with liver disease or epilepsy. Alcohol may modify or increase the effects of other medicines.
Maintenance doses of 4 mg or less contain small amounts of ethanol (100 mg or less), are probably too low to be harmful.
3. How to take Rapamune?
Always take this medicine exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
Your doctor will decide exactly what dose of Rapamune you must take and how often to take it. Follow doctor's instructions exactly and never change the dose yourself.
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 Rapamune each day, until the doctor give you other instructions. Your dose will be adjusted depending on the level of Rapamune in your blood. Your doctor will need to take blood samples to measure the concentrations of Rapamune.
If you are also taking cyclosporine, you must take the two medicines approximately 4 hours apart.
It is recommended that Rapamune be applied first in combination with cyclosporine and corticosteroids. After 3 months, your doctor may stop or Rapamune, or ciclosporin, as it is not recommended that these medicines be taken together for a longer period.
Rapamune is intended for oral administration. Tell your doctor if you have difficulty taking the oral solution.
Rapamune must always be taken in the same way - or with food or without food. Instructions for dilution of Rapamune
1. Remove the safety cap from the bottle by squeezing the tabs on the cap and twisting. Insert the syringe adapter into the bottle until it is flush with the top of the bottle. Do not attempt to remove the syringe adapter from the bottle once you put it inside.
2. With the plunger fully depressed, insert one of the dosing syringes into the opening in the adapter.
3. Withdraw the exact amount of Rapamune oral solution as prescribed by your doctor by gently pulling out the plunger of the dosing syringe until the bottom of the black line of the plunger is level with the mark on the dosing syringe. The bottle should remain in an upright position when withdrawing the solution. If downloading dosing syringe bubbles, empty the Rapamune solution back into the bottle and repeat the withdrawal procedure.
4. You may have been instructed to take your Rapamune oral solution at a particular time of day. If you need to carry your medication with you, fill the dosing syringe to the appropriate mark and tighten the cap should snap into place. Then place the capped dosing syringe in the carrying case provided. Once in the syringe, the medicine can be kept at room temperature (not exceeding 25 ° C) or refrigerated and should be used within 24 hours.
5. Empty the contents of the dosing syringe just in glass or plastic container with at least 60 ml of water or orange juice. Stir well for one minute and drink immediately at once. Refill the glass with at least 120 ml of water or orange juice, stir well and drink immediately. No other liquids, including Grapefruit juice should not be used for reconstitution. The dosing syringe and the cap must be used once and then discarded.
When refrigerated the solution in the bottle may develop a slight haze. If this occurs, simply bring your Rapamune oral solution at room temperature and shake gently. This haze does not affect the quality of Rapamune.
If you take more Rapamune dose
If you take more medicine than you were told contact a doctor or go immediately to the emergency department of the nearest hospital. Always carry a medicine bottle with label, 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 if you stay less than 4 hours of the next dose of cyclosporine. Then continue to take your medicines as usual. Do not take a double dose to make up for forgotten and always take Rapamune and ciclosporin approximately 4 hours. If you miss a dose of Rapamune, you should tell your doctor.
If you stop taking Rapamune
Do not stop taking Rapamune, unless your doctor tells you to, as you risk losing your transplanted organ.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should call your doctor immediately if you experience symptoms such as swollen face, tongue and / or back of the mouth (pharynx) and / or difficulty breathing (angioedema), or a skin disease in which the skin can peel off (exfoliative dermatitis). These may be symptoms of a severe allergic reaction.
Kidney damage with low blood cell counts (thrombocytopenic purpura / haemolytic uraemic syndrome)
When taken with medicines called calcineurin inhibitors (cyclosporine or tacrolimus), Rapamune may increase the risk of kidney damage with low blood platelets and low red blood cell counts with or without rash (thrombocytopenic purpura / hemolytic uremic syndrome). If you experience symptoms such as
bruising or rash, changes in your urine, or changes in behavior or other symptoms that are serious, unusual or prolonged, contact your doctor.
Rapamune weakens own defense mechanisms your body to prevent rejection of your transplanted organ. Consequently your body will not fight infections as well as usual. So if you are taking Rapamune, you may receive more infections than usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract (see given below list). You should call your doctor if you experience symptoms that are serious, unusual or prolonged.
Frequency of adverse reactions
The frequency of adverse reactions listed below is defined using the following convention:
very common (affects more than 1 patient in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 patients in 10,000) not known (from the available data can not be estimated)
- Fluid collection around the kidney
- Swelling of the extremities (eg. Arms, legs)
- Increased blood pressure
- Pain in the stomach, diarrhea, constipation, nausea
- Low red blood cell count, low platelet count
- Increased content of blood fat (cholesterol and / or triglycerides), increased blood sugar, low blood potassium, low blood phosphorus, increased blood lactate dehydrogenase, increased blood creatinine
- Joint pain
- Urinary tract infection Common:
- Slow healing (this may include separation of the layers of a surgical wound or seam)
- Infections (including life-threatening infections)
- Fast heart beat
- Blood clots in the legs
- Mouth sores
- Collection of fluid in the abdomen
- Damage to the kidneys, accompanied by a low platelet count and low red blood cell counts with or without rash (thrombocytopenic purpura / haemolytic uraemic syndrome)
- Reduced number of blood cells that fight infection (white blood cells), low levels of a type of white blood cells called neutrophils
- Abnormal tests of liver function, elevated liver enzymes AST and / or ALT
- Deterioration of bone
- Pneumonia and other causes of inflammation that can lead to lung damage, fluid around the lungs
- Skin cancer
- Kidney infection; protein in the urine
- Ovarian cysts, menstrual disorders (including lack of cycle or a severe irregular cycle)
- Collection of fluid in the sac around the heart, which in some cases may decrease the heart's ability to pump blood
- Inflammation of the pancreas
- Blood clots in the lungs
- Cancer of the lymph tissue (lymphoma / post-transplant lymphoproliferative disorder), combined lowering of red blood cells, white blood cells and platelets in the blood
- Bleeding from the lung
- Protein in the urine, occasionally severe and associated with side effects such as swelling Rare:
- Protein build-up in the air sacs of the lungs, which can affect breathing
- Collection of too much fluid in the tissues due to irregular lymph function
- Serious allergic reactions (see above paragraph on allergic reactions) Not known:
- Serious liver damage and scarring in the kidney that may reduce renal function
- There is a general tendency for fluid accumulation in different tissues.
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.
5. How to store Rapamune?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Store in the refrigerator at 2 ° C - 8 ° C.
Keep Rapamune oral solution in its original bottle in order to protect from light.
Once the bottle has been opened, the contents should be kept refrigerated and used within 30 days. If necessary, you may store the bottles at room temperature up to 25 ° C for a short period of time, but not more than 24 hours.
After dosing syringe is filled with Rapamune oral solution, it must be kept at room temperature, but not above 25 ° C, for up to 24 hours.
After the contents of the dosing syringe is diluted with water or orange juice, the preparation should be drunk immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
The active substance is sirolimus. Each ml Rapamune oral solution contains 1 mg of sirolimus.
The other ingredients are Polysorbate 80 (E433) and phosal 50 PG (phosphatidylcholine, propylene glycol, mono- and diglycerides, ethanol, soya fatty acids and ascorbyl palmitate).