Generic Name: sirolimus (Oral route)
Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should prescribe sirolimus and they should have complete information requisite for the follow-up of the patient. The use of sirolimus in combination with cyclosporine or tacrolimus was associated with excess mortality, graft loss, and hepatic artery thrombosis in studies in de novo liver transplant patients. Cases of bronchial anastomotic dehiscence, most fatal, have been reported in de novo lung transplant patients when sirolimus has been used as part of an immunosuppressive regimen. The safety and efficacy of sirolimus as immunosuppressive therapy have not been established in liver or lung transplant patients, and therefore, such use is not recommended .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Immune Suppressant
Sirolimus belongs to a group of medicines known as immunosuppressive agents. It is used to lower the body's natural immunity in patients who receive kidney transplants.
When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Sirolimus works by preventing the white blood cells from getting rid of the transplanted organ.
Sirolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also reduce the body's ability to fight infections. You and your doctor should talk about the good this medicine will do as well as the risks of using it.
Sirolimus is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of sirolimus in children below 13 years of age or in children considered to be at high immunologic risk. Safety and efficacy have not been established .
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of sirolimus in the elderly. However, elderly patients are more likely to have liver and heart problems which may require caution in patients receiving sirolimus .
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This medicine usually comes with patient information or directions. Read them carefully and make sure you understand them before taking this medicine. If you have any questions, ask your doctor .
Take this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk of side effects, while using too little may lead to rejection of your transplanted kidney.
To help you remember to take your medicine, try to get into the habit of taking it at the same time each day. This will help sirolimus work better by keeping a constant amount in the blood.
Absorption of this medicine may be changed if you change your diet. This medicine should be taken consistently with respect to meals. You should not change the type or amount of food you eat unless you discuss it with your doctor .
Grapefruits and grapefruit juice may increase the effects of sirolimus by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.
Do not stop taking this medicine without first checking with your doctor. You may have to take this medicine for the rest of your life to prevent your body from rejecting the transplant.
Sirolimus usually is used along with a corticosteroid (cortisone-like medicine) and cyclosporine (another immunosuppressive agent). Sirolimus should be taken 4 hours after cyclosporine modified oral solution (Neoral®) or cyclosporine modified capsules (Neoral®). If you have any questions about this, ask your doctor .
If you have been taking sirolimus together with cyclosporine for 2 to 4 months after your transplant, your doctor may want you to stop using cyclosporine and increase the dose of sirolimus. However, some patients (e.g., black patients or those with transplant rejection in the past) may need to continue using cyclosporine for up to one year after the transplant. Your doctor will tell you if you need to keep taking cyclosporine .
Sirolimus tablets should not be crushed, chewed, or split. If you are unable to take the tablet form, your doctor will give you an oral solution of sirolimus and be given instructions on how to take it .
Mix sirolimus oral solution with at least 2 ounces (¼ cup, 60 milliliters [mL]) of water or orange juice in a glass or plastic container. Stir the mixture well and drink it immediately. Then, rinse the container with at least 4 ounces (½ cup, 120 mL) of additional water or orange juice, stir it well, and drink it to make sure that all of the medicine is taken.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store tablets at room temperature. Store the oral liquid form in the refrigerator.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
While you are taking sirolimus, it is important to maintain good dental hygiene and see a dentist regularly for teeth cleaning.
Raw oysters or other shellfish may contain bacteria that can cause serious illness and possibly death. This is more likely to be a problem if these foods are eaten by patients with certain medical conditions. Even eating oysters from “clean” water or good restaurants does not guarantee that the oysters do not contain the bacteria. Eating raw shellfish is not a problem for most healthy people; however, patients with the following conditions may be at greater risk: cancer, immune disorders, organ transplantation, long-term corticosteroid use (as for asthma, arthritis, or organ transplantation), liver disease (including viral hepatitis), excess alcohol intake (2 to 3 drinks or more per day), diabetes, stomach problems (including stomach surgery and low stomach acid), and hemochromatosis (an iron disorder). Do not eat raw oysters or other shellfish while you are taking sirolimus. Be sure oysters and shellfish are fully cooked.
While you are being treated with sirolimus, and after you stop treatment with it, it is important to see your doctor about the immunizations (vaccinations) you should receive. Do not get any immunizations without your doctor's approval. Sirolimus may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken the oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Treatment with sirolimus may increase the chance of getting other infections. If you can, avoid people with colds or other infections. If you think you are getting a cold or other infection, check with your doctor .
This medicine may also increase your risk of bleeding. Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin .
Sirolimus may cause serious types of allergic reactions, especially when used with certain medicines. Tell your doctor right away if you have a rash; itching; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using this medicine .
Sirolimus may cause you to have a greater risk for getting cancer, especially skin cancer. When you begin taking this medicine:
Check with your doctor right away if you notice a new mole; a change in size, shape or color of an existing mole; or a mole that leaks fluid or bleeds.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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