Sirolimus

corticosteroid therapy, Kidney Transplant, Lymphangioleiomyomatosis + 5 more

Treatment

3 FDA approvals

20 Active Studies for Sirolimus

What is Sirolimus

Sirolimus

The Generic name of this drug

Treatment Summary

Temsirolimus (brand name Torisel) is a medication used to treat renal cell carcinoma, a type of kidney cancer. It was approved by the FDA and EMEA in 2007. It is a derivative of sirolimus, a drug used to suppress the immune system.

Rapamune

is the brand name

image of different drug pills on a surface

Sirolimus Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Rapamune

Sirolimus

1999

43

Approved as Treatment by the FDA

Sirolimus, also known as Rapamune, is approved by the FDA for 3 uses such as corticosteroid therapy and Organ Transplantation .

corticosteroid therapy

Used to treat corticosteroid therapy in combination with Cyclosporine

Organ Transplantation

Used to treat Transplanted Organ Rejection in combination with Cyclosporine

Kidney Transplant

Used to treat Kidney Transplantation in combination with Cyclosporine

Effectiveness

How Sirolimus works in the body

Temsirolimus is a drug that stops a cell from dividing by targeting mTOR, a protein that controls cell division. When mTOR is blocked, the cell is unable to progress through the cell cycle and is instead forced to remain in a resting state. This drug also reduces the levels of two proteins, HIF-1 and HIF-2 alpha, which are linked to tumor growth. It also decreases the amount of a protein called vascular endothelial growth factor that can help tumors spread.

When to interrupt dosage

The recommended dose of Sirolimus is contingent upon the perceived condition. The amount of dosage fluctuates as per the delivery approach set out in the table beneath.

Condition

Dosage

Administration

Tuberous Sclerosis

, 2.0 mg, 1.0 mg, 0.5 mg, 5.0 mg, 1.0 mg/mL, 5.0 mg/mL, 0.002 mg/mg

Tablet - Oral, , Oral, Tablet, Tablet, sugar coated - Oral, Tablet, sugar coated, Tablet, film coated - Oral, Tablet, film coated, Solution - Oral, Solution, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Injection, powder, lyophilized, for suspension, Intravenous, Gel - Topical, Topical, Gel

Renal Angiomyolipomas

, 2.0 mg, 1.0 mg, 0.5 mg, 5.0 mg, 1.0 mg/mL, 5.0 mg/mL, 0.002 mg/mg

Tablet - Oral, , Oral, Tablet, Tablet, sugar coated - Oral, Tablet, sugar coated, Tablet, film coated - Oral, Tablet, film coated, Solution - Oral, Solution, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Injection, powder, lyophilized, for suspension, Intravenous, Gel - Topical, Topical, Gel

Chronic Graft Versus Host Disease

, 2.0 mg, 1.0 mg, 0.5 mg, 5.0 mg, 1.0 mg/mL, 5.0 mg/mL, 0.002 mg/mg

Tablet - Oral, , Oral, Tablet, Tablet, sugar coated - Oral, Tablet, sugar coated, Tablet, film coated - Oral, Tablet, film coated, Solution - Oral, Solution, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Injection, powder, lyophilized, for suspension, Intravenous, Gel - Topical, Topical, Gel

Organ Transplantation

, 2.0 mg, 1.0 mg, 0.5 mg, 5.0 mg, 1.0 mg/mL, 5.0 mg/mL, 0.002 mg/mg

Tablet - Oral, , Oral, Tablet, Tablet, sugar coated - Oral, Tablet, sugar coated, Tablet, film coated - Oral, Tablet, film coated, Solution - Oral, Solution, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Injection, powder, lyophilized, for suspension, Intravenous, Gel - Topical, Topical, Gel

corticosteroid therapy

, 2.0 mg, 1.0 mg, 0.5 mg, 5.0 mg, 1.0 mg/mL, 5.0 mg/mL, 0.002 mg/mg

Tablet - Oral, , Oral, Tablet, Tablet, sugar coated - Oral, Tablet, sugar coated, Tablet, film coated - Oral, Tablet, film coated, Solution - Oral, Solution, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Injection, powder, lyophilized, for suspension, Intravenous, Gel - Topical, Topical, Gel

Kidney Transplant

, 2.0 mg, 1.0 mg, 0.5 mg, 5.0 mg, 1.0 mg/mL, 5.0 mg/mL, 0.002 mg/mg

Tablet - Oral, , Oral, Tablet, Tablet, sugar coated - Oral, Tablet, sugar coated, Tablet, film coated - Oral, Tablet, film coated, Solution - Oral, Solution, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Injection, powder, lyophilized, for suspension, Intravenous, Gel - Topical, Topical, Gel

Lymphangioleiomyomatosis

, 2.0 mg, 1.0 mg, 0.5 mg, 5.0 mg, 1.0 mg/mL, 5.0 mg/mL, 0.002 mg/mg

Tablet - Oral, , Oral, Tablet, Tablet, sugar coated - Oral, Tablet, sugar coated, Tablet, film coated - Oral, Tablet, film coated, Solution - Oral, Solution, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Injection, powder, lyophilized, for suspension, Intravenous, Gel - Topical, Topical, Gel

Chordoma

, 2.0 mg, 1.0 mg, 0.5 mg, 5.0 mg, 1.0 mg/mL, 5.0 mg/mL, 0.002 mg/mg

Tablet - Oral, , Oral, Tablet, Tablet, sugar coated - Oral, Tablet, sugar coated, Tablet, film coated - Oral, Tablet, film coated, Solution - Oral, Solution, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Injection, powder, lyophilized, for suspension, Intravenous, Gel - Topical, Topical, Gel

Warnings

Sirolimus has a single contraindication and should not be utilized when encountering any of the conditions noted in the following table.

Sirolimus Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Sirolimus may interact with Pulse Frequency

Severe Hypersensitivity Reactions

Do Not Combine

Sirolimus may interact with Pulse Frequency

Severe Hypersensitivity Reactions

Do Not Combine

Sirolimus may interact with Pulse Frequency

There are 20 known major drug interactions with Sirolimus.

Common Sirolimus Drug Interactions

Drug Name

Risk Level

Description

2-Methoxyethanol

Major

The risk or severity of adverse effects can be increased when Sirolimus is combined with 2-Methoxyethanol.

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Sirolimus is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abetimus

Major

The risk or severity of adverse effects can be increased when Sirolimus is combined with Abetimus.

Acteoside

Major

The risk or severity of adverse effects can be increased when Sirolimus is combined with Acteoside.

Antilymphocyte immunoglobulin (horse)

Major

The risk or severity of adverse effects can be increased when Sirolimus is combined with Antilymphocyte immunoglobulin (horse).

Sirolimus Toxicity & Overdose Risk

Temsirolimus has been tested on cancer patients in early clinical trials with doses up to 220 mg/m2. Taking doses higher than 25 mg can increase the risk of potentially serious side effects, such as blood clots, punctured intestines, lung disease, seizures, and mental health issues.

image of a doctor in a lab doing drug, clinical research

Sirolimus Novel Uses: Which Conditions Have a Clinical Trial Featuring Sirolimus?

Fifteen active trials are actively investigating the potential of Sirolimus to treat Advanced Renal Cell Carcinoma (aRCC).

Condition

Clinical Trials

Trial Phases

Kidney Transplant

34 Actively Recruiting

Phase 2, Phase 1, Phase 4, Not Applicable, Phase 3

Organ Transplantation

0 Actively Recruiting

corticosteroid therapy

0 Actively Recruiting

Lymphangioleiomyomatosis

0 Actively Recruiting

Chordoma

0 Actively Recruiting

Chronic Graft Versus Host Disease

24 Actively Recruiting

Phase 4, Phase 1, Phase 2, Not Applicable, Phase 3

Renal Angiomyolipomas

0 Actively Recruiting

Tuberous Sclerosis

5 Actively Recruiting

Phase 3, Phase 4, Phase 2, Phase 1

Sirolimus Reviews: What are patients saying about Sirolimus?

4

Patient Review

11/10/2007

Sirolimus for Prevention of Cardiac Transplant Rejection

I've had a heart transplant five years ago and have been using this medication ever since to prevent rejection. So far, it's working great!

4

Patient Review

4/7/2009

Sirolimus for Prevent Kidney Transplant Rejection

I've had a new kidney for seven years now and have only had a few health issues since, none of which were serious.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about sirolimus

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is sirolimus a steroid?

"The usage of rapamycin as a means of reducing the amount of steroids needed to treat dermatomyositis."

Answered by AI

Is sirolimus chemotherapy?

"They are called "antineoplastic" drugs.

The use of sirolimus as an antineoplastic drug is based on the rationale that it prevents tumor cells from dividing, which in turn inhibits their growth or causes them to die."

Answered by AI

What is the drug sirolimus used for?

"Sirolimus is used in combination with other medications to prevent organ rejection in transplant patients. It is classified as an immunosuppressive agent. When a patient receives a transplanted organ, the body's white blood cells try to remove the transplanted organ."

Answered by AI

What are side effects of taking sirolimus?

"The most common side effects of this drug are swelling in the limbs, high levels of triglycerides in the blood, high blood pressure, high cholesterol, increased creatinine levels, constipation, abdominal pain, diarrhea, headache, fever, urinary tract infection, anemia, nausea, joint pain, and low platelet count."

Answered by AI

Clinical Trials for Sirolimus

Image of Ohio State University Comprehensive Cancer Center in Columbus, United States.

Ruxolitinib for T-Cell Lymphoma

18+
All Sexes
Columbus, OH

This phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. The "graft" is the donor blood cells that patients get during the transplant. The "host" is the person receiving the cells. GVHD is when the donor graft attacks and damages some of the transplant recipient's tissues. Ruxolitinib is a type of drug called a Janus kinase (JAK) inhibitor which works by decreasing the immune response of cells in the body. It is also a cancer growth blocker that blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene, called JAK2, that is important in the production of cancer cells.

Phase 2
Recruiting

Ohio State University Comprehensive Cancer Center

Jonathan Brammer, MD

Incyte Corporation

Image of University of California, Los Angeles in Los Angeles, United States.

Testosterone Replacement for Kidney Failure

18+
Male
Los Angeles, CA

This prospective study aims to evaluate the safety and efficacy of testosterone replacement therapy (TRT) as an adjunct to an enhanced recover after surgery (ERAS) protocol in men with end-stage renal disease (ESRD) undergoing kidney transplantation. Participants will be highly-listed hypogonadal men, defined as total testosterone level \<300 on two occasions with clinical symptoms of hypogonadism, with ESRD who are expected to receive a kidney transplant within 6 months. Participants will be started on TRT, ideally for at least 3 months prior transplantation. The investigators will perform a subset analysis to evaluate if there is a significant difference in our endpoints by comparing these two subgroups (Three months or more receiving TRT vs. Less than three months receiving TRT). There will be no cut-off time for pre-transplant TRT. Following the intervention period, a historical control cohort of age-matched and health-matched patients will be identified, who have followed a standard transplant protocol that does not incorporate TRT. The primary outcome will evaluate safety, including 30- and 90-day adverse events, 3, 6, and 12-month allograft survival, and overall patient survival. Secondary outcomes will focus on (1) qualitative assessments of symptoms using validated questionnaires, (2) quantitative improvements in the hormonal profile before and after initiation of TRT and surgery, and (3) allograft function and incidence of delayed graft function. The results of this study could provide novel insights into the benefits of TRT in improving surgical outcomes in men with ESRD undergoing kidney transplantation.

Phase 1 & 2
Waitlist Available

University of California, Los Angeles

Image of New York University Langone Health in New York, United States.

GGTA1 KO Thymokidney for Kidney Failure

40 - 70
All Sexes
New York, NY

The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow-up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant or for 52 weeks following nephrectomy, if required.

Phase 1 & 2
Recruiting

New York University Langone Health

United Therapeutics

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Trimethoprim-Sulfamethoxazole for Urinary Tract Infections

13 - 29
All Sexes
San Francisco, CA

The goal of this clinical trial is to learn if a common antibiotic called trimethoprim-sulfamethoxazole (TMP-SMX) can help prevent urinary tract infections (UTIs) in children and young adults who recently had a kidney transplant. Most people take TMP-SMX for about 6 months after getting a kidney transplant. In this study, researchers want to see what happens if people keep taking it for 6 more months. The main questions this study is asking are: * Does TMP-SMX lower the number of UTIs in the first year after transplant? * What side effects or problems do participants have while taking TMP-SMX? Researchers will compare TMP-SMX to a placebo (a look-alike pill that does not contain any medication) to see if TMP-SMX works to prevent UTIs. Participants will: * Take either TMP-SMX or a placebo pill by mouth every day for 6 months * Have three visits to touch base with the study team about any issues * Complete short monthly online surveys about any symptoms or side effects * Share blood and urine test results from their regular transplant clinic visits

Phase 4
Waitlist Available

University of California, San Francisco

Alexandra Bicki, MD

Image of City of Hope Medical Center in Duarte, United States.

Emapalumab for Graft-versus-Host Disease

18 - 75
All Sexes
Duarte, CA

This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT). Giving chemotherapy, such as fludarabine, melphalan, or busulfan, before a donor \[peripheral blood stem cell\] transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When healthy stem cells for a donor are infused into a patient (allogeneic HCT), they may help the patient's bone marrow make more healthy cells and platelets. Allogeneic HCT is an established treatment, however, GVHD continues to be a major problem of allogeneic HCT that can complicate therapy. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Emapalumab binds to an immune system protein called interferon gamma. This may help lower the body's immune response and reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Mycophenolate mofetil is a drug used to prevent GVHD after organ transplants. It is also being studied in the prevention of GVHD after stem cell transplants for cancer, and in the treatment of some autoimmune disorders. Mycophenolate mofetil is a type of immunosuppressive agent. Giving emapalumab with post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil may be safe, tolerable and/or effective in preventing GVHD in patients with AML or MDS after a reduced-intensity allogeneic HCT.

Phase 1
Waitlist Available

City of Hope Medical Center

Amandeep Salhotra

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Xenokidney for Kidney Failure

40 - 70
All Sexes
New York, NY

The purpose of this study is to evaluate the safety and efficacy of the 10 GE Xenokidney in patients with ESRD who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, 10 GE Xenokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant.

Phase 1 & 2
Recruiting

New York University Langone Health

United Therapeutics

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