Sirolimus Side Effects
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Sirolimus Safety Reports reported to FDA
Total Sirolimus reports: 168.Sirolimus FDA safety alerts: 2002 2003 2007 .
Reported deaths: 11 Reported hospitalizations: 118.
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Reported Sirolimus Side Effects: focal glomerulosclerosis, kidney transplant rejection, condition aggravated, proteinuria, anaemia, liver transplant rejection, pneumonia, asthenia, blood creatinine increased, haemodialysis, complications of transplanted kidney.
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Sirolimus Side Effects Report #5455341-6Physician from ARGENTINA reported SIROLIMUS problem on Sept 14, 2007. Female patient, weighting 194.4 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, septic shock. SIROLIMUS dosage: unknown. During the same period patient was treated with BEZAFIBRATE, AMFETAMINIL, GLIMEPIRIDE, OMEPRAZOLE, EPOGEN, ATENOLOL, FLUOXETINE. Patient was hospitalized. Patient died on 09/14/2007.
Sirolimus Side Effects Report #5456396-5
SIROLIMUS problem was reported by a Physician from GERMANY on Sept 10, 2007. Male patient, weighting 165.3 lb, was diagnosed with prophylaxis against transplant rejection, cardiac disorder, hyperlipidaemia, antiviral prophylaxis and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: hepatic cancer metastatic. SIROLIMUS dosage: 2 MG/FREQUENCY NOT PROVIDED. During the same period patient was treated with METOPROLOL SUCCINATE, FLUVASTATIN, RAMIPRIL, ASPIRIN, FAMCICLOVIR. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5458317-8
Health Professional from ITALY reported SIROLIMUS problem on Sept 10, 2007. Female patient, 54 years of age, was diagnosed with haemophilus infection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: renal impairment. SIROLIMUS dosage: unknown. During the same period patient was treated with PREDNISONE, OMEPRAZOLE, NITRGLYCERIN TRANSDERMAL SYSTEM, NITRGLYCERIN TRANSDERMAL SYSTEM, CLARITHROMYCIN. Patient recovered.
Sirolimus Side Effects Report #5458960-6
SIROLIMUS problem was reported by a Physician from GERMANY on Sept 10, 2007. Male patient, weighting 180.8 lb, was diagnosed with prophylaxis against transplant rejection, hypertension and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: liver transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with ENALAPRIL MALEATE, FUROSEMIDE, ASPIRIN, HUMULIN R, LEVOTHYROXINE. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5463324-5
Health Professional from EGYPT reported SIROLIMUS problem on Sept 10, 2007. Male patient, 36 years of age, was diagnosed with diabetes mellitus and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, INSULIN, BASILIXIMAB. Patient recovered.
Sirolimus Side Effects Report #5463325-7
SIROLIMUS problem was reported by a Health Professional from EGYPT on Sept 10, 2007. Male patient, 32 years of age, was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, BASILIXIMAB. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5463326-9
Health Professional from EGYPT reported SIROLIMUS problem on Sept 10, 2007. Male patient, 34 years of age, was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: 10 MG/DAY GRADUALLY ADJUSTED TO ACHIEVE TARGET LEVEL OF 6-12 NG/ML. During the same period patient was treated with MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, PREDNISONE, BASILIXIMAB. Patient recovered.
Sirolimus Side Effects Report #5463331-2
SIROLIMUS problem was reported by a Health Professional from EGYPT on Sept 10, 2007. Male patient, 32 years of age, was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: unknown. During the same period patient was treated with TACROLIMUS, PREDNISOLONE, BASILIXIMAB. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5463332-4
Health Professional from EGYPT reported SIROLIMUS problem on Sept 10, 2007. Female patient, 37 years of age, was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis, graft complication. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, BASILIXIMAB. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5465888-4
SIROLIMUS problem was reported by a Health Professional from UNITED KINGDOM on Sept 18, 2007. Male patient, child 10 years of age, weighting 66.14 lb, was diagnosed with kidney transplant rejection, bone disorder, hypertension, infection prophylaxis, acidosis, nephrogenic anaemia and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: malignant hypertension, reversible posterior leukoencephalopathy syndrome. SIROLIMUS dosage: unknown. During the same period patient was treated with ALFACALCIDOL, BENDROFLUAZIDE, BICARBONATE, NEORECORMON, NIFEDIPINE, NYSTATIN, PREDNISOLONE. Patient recovered.
Sirolimus Side Effects Report #5466060-4
Physician from UNITED KINGDOM reported SIROLIMUS problem on Sept 20, 2007. Male patient, weighting 192.5 lb, was diagnosed with renal transplant, prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with TACROLIMUS, METHYLPREDNISOLONE. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5466627-3
SIROLIMUS problem was reported by a Physician from BELGIUM on Sept 21, 2007. Male patient, weighting 194.0 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with CORTICOSTEROIDS, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5467402-6
Physician from GERMANY reported SIROLIMUS problem on Sept 14, 2007. Male patient, weighting 152.1 lb, was diagnosed with prophylaxis against transplant rejection, hypertension, immunosuppression, bile output abnormal and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: hepatitis c virus, liver transplant rejection. SIROLIMUS dosage: 2MG. During the same period patient was treated with METOPROLOL SUCCINATE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, URSODIOL. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5467464-6
SIROLIMUS problem was reported by a Physician from BELGIUM on Sept 21, 2007. Male patient, weighting 132.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with MEDROL. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5467890-5
Health Professional from INDIA reported SIROLIMUS problem on Sept 17, 2007. Male patient, 31 years of age, weighting 149.9 lb, was diagnosed with immunosuppression and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: escherichia urinary tract infection, hypokalaemia, renal tubular disorder. SIROLIMUS dosage: unknown. During the same period patient was treated with TACROLIMUS, PREDNISOLONE. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5468005-X
SIROLIMUS problem was reported by a Health Professional from UNITED STATES on Sept 17, 2007. Male patient, 55 years of age, was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: pulmonary alveolar haemorrhage. SIROLIMUS dosage: unknown. During the same period patient was treated with LISINOPRIL, DILTIAZEM, PAROXETINE, LEVOFLOXACIN, NIACIN, CALCITRIOL, NEORAL. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5468105-4
Physician from UNITED KINGDOM reported SIROLIMUS problem on Sept 20, 2007. Male patient, weighting 192.5 lb, was diagnosed with renal transplant, prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with TACROLIMUS, METHYLPREDNISOLONE. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5469406-6
SIROLIMUS problem was reported by a Physician from HONG KONG on Sept 19, 2007. Female patient, weighting 110.1 lb, was diagnosed with prophylaxis against transplant rejection, hypertension, antiviral prophylaxis, hepatitis b and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: oedema peripheral, proteinuria. SIROLIMUS dosage: unknown. During the same period patient was treated with NIFEDIPINE, LAMIVUDINE. Patient was hospitalized. Patient recovered.
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Drug Information: Sirolimus
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a602026.html
(sir oh' li mus)IMPORTANT WARNING:
| Sirolimus may increase the risk of infection and lymphoma. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, chills, frequent or painful urination, or other signs of infection.Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to sirolimus.Talk to your doctor about the risks of taking sirolimus. |
Why is this medication prescribed?
Sirolimus is used in combination with other medications to prevent rejection of kidney transplants. Sirolimus is in a class of medications called immunosuppressants. It works by suppressing the body's immune system.
How should this medicine be used?
Sirolimus comes as a tablet and a solution (liquid) to take by mouth. It is usually taken once a day, either always with food or always without food. To help you remember to take sirolimus, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sirolimus exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Continue to take sirolimus even if you feel well. Do not stop taking sirolimus without talking to your doctor.
To use the bottles of solution, follow these steps:
- Open the solution bottle. On first use, insert the plastic tube with stopper tightly into the bottle until it is even with the top of the bottle. Do not remove from the bottle.
- For each use, tightly insert one of the amber syringes with the plunger fully pushed in into the opening in the plastic tube.
- Draw up the amount of solution your doctor has prescribed by gently pulling out the plunger of the syringe until the bottom of the black line of the plunger is even with the correct mark on the syringe. Keep the bottle upright. If bubbles form in the syringe, empty the syringe into the bottle and repeat this step.
- Empty the syringe into a glass or plastic cup containing at least 2 ounces (1/4 cup) of water or orange juice. Do not use apple juice, grapefruit juice, or other liquids. Stir vigorously for 1 minute and drink immediately.
- Refill the cup with at least 4 ounces (1/2 cup) of water or orange juice. Stir vigorously and drink the rinse solution.
- Throw away the used syringe.
If you need to carry a filled syringe with you, snap a cap onto the syringe and put the syringe in the carrying case. Use the medication in the syringe within 24 hours.
To use the pouches of solution, follow these steps:
- Before opening the pouch, squeeze the pouch from the neck area to push the contents into the lower part of the pouch.
- Fold the marked area on the pouch and carefully cut with scissors.
- Squeeze the entire contents of the pouch into a glass or plastic cup containing at least 2 ounces (1/4 cup) of water or orange juice. Do not use apple juice, grapefruit juice, or other liquids. Stir vigorously for 1 minute and drink immediately.
- Refill the cup with at least 4 ounces (1/2 cup) of water or orange juice. Stir vigorously and drink the rinse solution.
Other uses for this medicine
Sirolimus also is used sometimes to treat psoriasis. Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking sirolimus,
- tell your doctor and pharmacist if you are allergic to sirolimus or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: amphotericin B (Abelcet, AmBisome, Amphocin, Fungizone); antifungals such as clotrimazole (Lotrimin), fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); bromocriptine (Parlodel); cimetidine (Tagamet); cisapride (Propulsid); clarithromycin (Biaxin); danazol (Danocrine); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), and phenytoin (Dilantin); metoclopramide (Reglan); nicardipine (Cardene); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); rifapentine (Priftin); troleandomycin (TAO); and verapamil (Calan, Covera, Isoptin, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking cyclosporine (Neoral) soft gelatin capsules or solution, take them 4 hours before sirolimus.
- tell your doctor what herbal products you are taking, especially St. John's wort.
- tell your doctor if you have or have ever had high cholesterol or triglycerides or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use an effective method of birth control before starting to take sirolimus, while taking sirolimus, and for 12 weeks after stopping sirolimus. If you become pregnant while taking sirolimus, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sirolimus.
- plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Sirolimus may increase your risk for skin cancer.
- do not have any vaccinations (e.g., measles or flu shots) without talking to your doctor.
What special dietary instructions should I follow?
Avoid drinking large amounts of grapefruit juice while taking this medicine.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Sirolimus may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- weakness
- back pain
- headache
- constipation
- diarrhea
- upset stomach
- vomiting
- swelling of the hands, feet, ankles, or lower legs
- weight gain
- joint pain
- difficulty falling asleep or staying asleep
- tremor
- rash
- fever
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- pale skin
- unusual bleeding or bruising
- cough
- shortness of breath
Sirolimus may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store tablets at room temperature and away from excess heat and moisture (not in the bathroom). Keep liquid medication in the refrigerator, closed tightly, and throw away any unused medication one month after the bottle is opened. Do not freeze. If needed, you may store the pouches for up to 24 hours and the bottles for up to 15 days at room temperature. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to sirolimus.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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