Sirolimus
Sirolimus (sir OH li mus) is a generic medication prescribed to help prevent organ rejection after a kidney transplant. It’s also prescribed to treat a rare lung disorder. Sirolimus belongs to a group of drugs called immunosuppressants.
Sirolimus (sir OH li mus) is a generic medication prescribed to help prevent organ rejection after a kidney transplant. It’s also prescribed to treat a rare lung disorder. Sirolimus belongs to a group of drugs called immunosuppressants.
- Generic
- • Tablet
- • 1mg
- • 30 Tablets
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Intro
Introduction
Written by Patricia Weiser, PharmD
Medically reviewed by Christina Bookwalter PharmD, MS MEd, BCPS, BCACP
Updated on October 30, 2023
Sirolimus (sir OH li mus) is a generic medication prescribed to help prevent organ rejection after a kidney transplant. It’s also prescribed to treat a rare lung disorder. Sirolimus belongs to a group of drugs called immunosuppressants.
Boxed warnings
Sirolimus has boxed warnings about the risk of immunosuppression and how use of the drug isn’t recommended in people with liver or lung transplants. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).
For details, see the “Interactions and warnings for sirolimus” section.
Side effects
Side effects of sirolimus
Sirolimus may cause mild or serious side effects. More common mild side effects of sirolimus and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug.
To learn more about sirolimus’s side effects, see this article or ask your doctor or pharmacist. You can also refer to the prescribing information for sirolimus listed in the “Resources” section.
Mild side effects
More common mild side effects of sirolimus are listed below. These side effects may differ, depending on which condition you’re taking sirolimus to treat or help prevent.
This article doesn’t include all possible mild side effects of the drug. To learn more about sirolimus’s side effects, refer to the prescribing information for sirolimus listed in the “Resources” section.
With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.
Mild side effects of sirolimus oral tablet and sirolimus oral solution may include:
- pain in your joints or abdomen
- digestive side effects, such as diarrhea and nausea
- headache
- mouth sores
- mild allergic reaction*
* For details about this side effect, see the “Interactions and warnings for sirolimus” section.
Serious side effects
Serious side effects of sirolimus are listed below.
This article doesn’t include all possible serious side effects of the drug. To learn more about sirolimus’s side effects based on the form, refer to the prescribing information for sirolimus listed in the “Resources” section.
With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.
In general, sirolimus’s serious side effects include:
- risk of infections, including infections that are rare and serious
- high blood pressure
- high blood sugar, which may lead to diabetes
- lipid disorders, such as high cholesterol
- blood disorders, such as anemia (low level of red blood cells)
- edema (swelling due to fluid buildup) in your hands, feet, or around your heart or lungs
- decreased kidney function
- slowed healing of wounds
- infertility
- increased risk of certain cancers, such as lymphoma and skin cancer
- boxed warnings: risk of immunosuppression and use not recommended in people with liver or lung transplants*
- severe allergic reaction*
* For details about this side effect, see the “Interactions and warnings for sirolimus” section.
FAQ
Common questions about sirolimus
Below you’ll find answers to a few commonly asked questions about sirolimus.
What is the mechanism of action of sirolimus? How does the drug work?
Sirolimus works by reducing the activity of the immune system.
After a kidney transplant, the immune system recognizes the new kidney as foreign tissue. In response, certain immune cells are sent to attack the transplanted tissue (this is known as organ rejection). Sirolimus blocks this activation of immune cells. This helps prevent your body from rejecting the new kidney.
Sirolimus works by blocking a protein called mTOR. (mTOR stands for mammalian target of rapamycin. Rapamycin is another name for sirolimus.) mTOR is part of a pathway that affects many functions, including cell growth and multiplication.
With LAM, certain cells in the lungs grow too quickly. Taking sirolimus blocks mTOR, which stops or decreases this atypical growth. This helps treat the condition and slow its progression (worsening).
Sirolimus starts working within a couple of hours. It may take up to 6 days to reach its full effect. Your doctor will use blood tests to check the level of sirolimus in your blood. Based on the drug level, they’ll figure out whether dosage adjustments are necessary.
If you’d like to know more about this, talk with your doctor or pharmacist.
How does sirolimus compare with tacrolimus?
Sirolimus and tacrolimus are both immunosuppressants, but sirolimus works differently than tacrolimus. They treat similar conditions but some different ones as well. These drugs also come in different forms.
Oral forms of sirolimus and tacrolimus are prescribed to help prevent organ rejection after kidney transplants. For this use, tacrolimus is generally considered more effective than sirolimus. But sirolimus may be prescribed if someone can’t take tacrolimus.
Tacrolimus is also approved for preventing organ rejection after liver or heart transplants, while sirolimus isn’t. Sirolimus has a boxed warning about how the drug isn’t recommended for use in people with liver or lung transplants. For details, see the “Interactions and warnings for sirolimus” section.
Sirolimus is also approved to treat lymphangioleiomyomatosis (LAM), while tacrolimus isn’t.
Tacrolimus is available as a topical ointment that’s prescribed to treat atopic dermatitis (eczema). Sirolimus also is available as other dosage forms (Hyftor topical gel and Fyarro protein-bound particles for injectable suspension) to treat certain conditions. The Food and Drug Administration (FDA) has approved their use as “orphan drugs” because these conditions are relatively rare.
To learn more about how sirolimus compares with tacrolimus, talk with your doctor or pharmacist.
Uses
Uses of sirolimus
The Food and Drug Administration (FDA) approves prescription drugs such as sirolimus for certain conditions. Approved uses for sirolimus are described below.
Use for prevention of kidney transplant rejection
Doctors may prescribe sirolimus oral tablet or oral solution to help prevent organ rejection after a kidney transplant. It’s used for this purpose in children ages 13 years and older and adults. It’s usually prescribed as a long-term treatment.
After an organ transplant, the immune system’s natural response is to reject (attack) the transplanted tissue by activating certain immune cells. Sirolimus works by blocking this response, which helps keep your body from rejecting the organ.
Sirolimus is prescribed together with cyclosporine and corticosteroids (such as prednisone) for the first 2–12 months after a kidney transplant. After this timeline, which depends on your risk level for organ rejection, your doctor may have you stop taking the cyclosporine.
However, doctors may continue cyclosporine treatment with sirolimus longer in some people. This is because it isn’t known if sirolimus is effective without cyclosporine in:
- people who’ve experienced certain types of organ rejection
- people undergoing dialysis
- people with a blood creatinine level higher than 4.5
- Black people
- people who’ve had multiple organ transplants or secondary transplants
- people with high levels of certain antibodies
Because it’s not known whether it’s safe or effective, doctors may not prescribe sirolimus to help prevent kidney transplant rejection in certain situations, such as:
- when taken with cyclosporine and corticosteroids for more than 12 months in people at high risk of organ rejection
- in children younger than 13 years old
- in children younger than 18 years old at high risk of organ rejection
- if cyclosporine was not started after the kidney transplant
- in people who’ve previously taken a different type of medication called a calcineurin inhibitor (for example, tacrolimus) to help prevent kidney transplant rejection
Use for lymphangioleiomyomatosis
Doctors may prescribe sirolimus oral tablet or oral solution for treating lymphangioleiomyomatosis (LAM). It’s used for this purpose in adults. It’s usually prescribed as a long-term treatment.
With LAM, certain cells, mainly in the lungs, grow too quickly. This leads to the formation of fluid-filled cysts in the lungs, which can cause symptoms such as shortness of breath and fatigue. It’s a rare condition that’s more common in adult females* who haven’t been through menopause yet.
* Sex and gender exist on spectrums. In this article, we use the term “female” to refer to a person’s sex assigned at birth.
Interactions and warnings
Interactions and warnings for sirolimus
Below, you’ll find information about sirolimus’s possible interactions and warnings.
Interactions of sirolimus
Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.
Before you take sirolimus, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:
- prescription or over-the-counter drugs
- vitamins, herbs, or supplements
To learn about drug-condition interactions, see the “Warnings for sirolimus” section below.
Warnings for sirolimus
Some people should not take sirolimus, and others should take it cautiously.
Boxed warnings
Sirolimus has a boxed warning about the risk of immunosuppression. It also has a boxed warning that this drug isn’t recommended for use in people with liver or lung transplants. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).
Risk of immunosuppression. Sirolimus is an immunosuppressant drug that reduces the activity of your immune system. With immunosuppression, your immune system has a reduced ability to defend your body against infections and the development of certain cancers. So, taking sirolimus increases the risk of infections and cancer, including lymphoma.
Symptoms of an infection can vary but may include fever and cough. Symptoms of cancer can vary but may include growths or lumps on the skin and unexplained weight loss.
If you have symptoms of an infection or cancer during treatment with sirolimus, tell your doctor. They’ll recommend ways to treat the infection or cancer.
Use not recommended in people with liver or lung transplants. In studies, sirolimus has been shown to be effective for preventing organ rejection in people who’ve had kidney transplants. It isn’t known whether the drug is safe or effective for preventing organ rejection in people who’ve had liver or lung transplants. Harmful effects and deaths have been reported in some people who took sirolimus after liver or lung transplants. So, this drug isn’t recommended for use in people who’ve had liver or lung transplants.
To learn more, talk with your doctor or pharmacist.
Other warnings
Sirolimus could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether sirolimus is a safe option for you.
Ask your doctor about specific warnings for sirolimus, and be sure to tell your doctor about your:
- current health, including any allergies to medications
- past health conditions or surgeries
Allergic reaction
Sirolimus can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.
If you’ve had an allergic reaction to sirolimus or any of its ingredients, your doctor will likely not prescribe sirolimus. They can tell you about medications that are safer options for you.
A mild allergic reaction may cause the following symptoms:
A severe allergic reaction may cause the following symptoms:
- swelling under your skin, usually in your hands, feet, eyelids, or lips
- swelling of your mouth, throat, or tongue, which can cause breathing problems
If you have an allergic reaction to sirolimus, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.
Overdose of sirolimus
You should not take more sirolimus than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.
If you think you’ve taken too much sirolimus, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.
Pregnancy or breastfeeding and sirolimus
Information about sirolimus and pregnancy and breastfeeding is described below.
Sirolimus and pregnancy
Sirolimus should not be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. Your doctor may suggest birth control options to use during treatment with sirolimus. Females* should continue using birth control for an additional 12 weeks after their last dose of sirolimus.
* Sex and gender exist on spectrums. In this article, we use the term “female” to refer to a person’s sex assigned at birth.
Sirolimus and breastfeeding
It’s not known whether sirolimus should be taken while breastfeeding. Based on its mechanism of action, serious side effects in the breastfed infant are possible. If you’re currently breastfeeding or planning to do so, talk with your doctor. Your doctor may recommend other ways to feed your child.
Ask your doctor
What to ask your doctor
Let your doctor know if you have questions about sirolimus or would like more details about it.
Here’s a list of some possible questions you may want to ask your doctor:
- Will I need to take sirolimus for the rest of my life?
- Are there any over-the-counter products or dietary supplements I should avoid while taking sirolimus?
- Should I avoid cannabis or products containing CBD while taking sirolimus?
- What should I know about the effects of sirolimus on fertility?
Resources
Resources
- Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
- Lim MA, et al. (2016). Immunosuppression for kidney transplantation: Where are we now and where are we going? https://www.sciencedirect.com/science/article/abs/pii/S0955470X16300544
- Sirolimus oral solution. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/9f64692d-2a18-ffcb-c572-0f218a71ca67/spl-doc
- Sirolimus tablets, for oral use. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/fc81cb86-61e1-4622-b2ce-cde263143aa0/spl-doc
Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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