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What is Rapamune
SirolimusThe Generic name of this drug
Treatment SummarySirolimus, also known as rapamycin, is a medication derived from bacteria found in the soil of Easter Island. It is used to suppress the immune system and treat tumors. It works by targeting and blocking the mammalian target of rapamycin (mTOR), a protein that regulates cell growth, proliferation and survival. This drug was approved by the FDA in 1999 for kidney transplants and in 2015 for lymphangioleiomyomatosis. In 2021, it was approved for the treatment of malignant perivascular epithelioid cell tumours. Sirolimus has also been investigated for use in treating
Rapamuneis the brand name
Rapamune 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 Kidney Transplant and corticosteroid therapy .Kidney Transplant
Used to treat Kidney Transplantation in combination with Cyclosporine
corticosteroid therapy
Used to treat corticosteroid therapy in combination with Cyclosporine
Organ Transplantation
Used to treat Transplanted Organ Rejection in combination with Cyclosporine
Effectiveness
How Rapamune Affects PatientsSirolimus is a drug that helps prevent organ rejection in transplant patients, as well as having anti-fungal and anti-tumor properties. In clinical studies, sirolimus was found to reduce the risk of organ rejection in low- to moderate-immunologic risk renal transplant patients when taken orally twice daily. Even after discontinuing the drug, its effects can last up to six months. It works by blocking the body’s immune response, and has been found to be effective in treating autoimmune diseases such as lupus, arthritis, diabetes, myocarditis, and uveoretinitis
How Rapamune works in the bodySirolimus prevents cells from growing and reproducing. It does this by blocking a protein kinase called mTOR from working, which stops signals from activating the growth of cells. In addition, sirolimus can prevent the body from producing antibodies and other growth factors. It is used to treat lymphangioleiomyomatosis, a disorder that affects the lungs, in people with tuberous sclerosis complex, which is an inherited condition caused by mutations in certain genes. Sirolimus works by blocking the mTOR pathway and preventing the abnormal growth of cells that occurs with this condition.
When to interrupt dosage
The measure of Rapamune is contingent upon the recognized disorder, including Kidney Transplantation, Chronic Graft Versus Host Disease and Rejection; Transplant, Liver. The quantity of dosage fluctuates as per the approach of delivery (e.g. Tablet or Tablet, coated) featured 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
, Oral, Tablet, Tablet - Oral, Tablet, sugar coated, Tablet, sugar coated - Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Intravenous, Injection, powder, lyophilized, for suspension, Gel - Topical, Topical, Gel
Chordomas
, 2.0 mg, 1.0 mg, 0.5 mg, 5.0 mg, 1.0 mg/mL, 5.0 mg/mL, 0.002 mg/mg
, Oral, Tablet, Tablet - Oral, Tablet, sugar coated, Tablet, sugar coated - Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Intravenous, Injection, powder, lyophilized, for suspension, 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
, Oral, Tablet, Tablet - Oral, Tablet, sugar coated, Tablet, sugar coated - Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Intravenous, Injection, powder, lyophilized, for suspension, 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
, Oral, Tablet, Tablet - Oral, Tablet, sugar coated, Tablet, sugar coated - Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Intravenous, Injection, powder, lyophilized, for suspension, 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
, Oral, Tablet, Tablet - Oral, Tablet, sugar coated, Tablet, sugar coated - Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Intravenous, Injection, powder, lyophilized, for suspension, 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
, Oral, Tablet, Tablet - Oral, Tablet, sugar coated, Tablet, sugar coated - Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Intravenous, Injection, powder, lyophilized, for suspension, 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
, Oral, Tablet, Tablet - Oral, Tablet, sugar coated, Tablet, sugar coated - Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Intravenous, Injection, powder, lyophilized, for suspension, 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
, Oral, Tablet, Tablet - Oral, Tablet, sugar coated, Tablet, sugar coated - Oral, Tablet, film coated, Tablet, film coated - Oral, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, Injection, powder, lyophilized, for suspension - Intravenous, Intravenous, Injection, powder, lyophilized, for suspension, Gel - Topical, Topical, Gel
Warnings
Rapamune ContraindicationsCondition
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
Common Rapamune 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).
Rapamune Toxicity & Overdose RiskThe lowest toxic dose of sirolimus in rats has been found to be 800 mg/kg and 2500 mg/kg in mice. Sirolimus is a drug with a small safe range, so overdoses can occur. Symptoms of an overdose may be similar to the usual side effects of sirolimus. Treatment usually involves general supportive care, since sirolimus is not likely to be removed from the blood by dialysis.
Rapamune Novel Uses: Which Conditions Have a Clinical Trial Featuring Rapamune?
80 active studies are examining the use of Rapamune in providing relief from Renal Angiomyolipomas, Lymphangioleiomyomatosis and Kidney Transplantation.Condition
Clinical Trials
Trial Phases
Chordomas
1 Actively Recruiting
Not Applicable
Organ Transplantation
0 Actively Recruiting
Lymphangioleiomyomatosis
0 Actively Recruiting
Tuberous Sclerosis
6 Actively Recruiting
Phase 3, Phase 4, Phase 2
corticosteroid therapy
0 Actively Recruiting
Renal Angiomyolipomas
0 Actively Recruiting
Chronic Graft Versus Host Disease
29 Actively Recruiting
Not Applicable, Phase 2, Phase 4, Phase 1, Phase 3, Early Phase 1
Kidney Transplant
26 Actively Recruiting
Not Applicable, Phase 1, Phase 2, Phase 4
Rapamune Reviews: What are patients saying about Rapamune?
5Patient Review
5/7/2010 I had a liver transplant in September 2008 and was placed on Prograft and Cellcept. Unfortunately, I had a stroke in November of that year as well; luckily, my liver MDs said this was a very rare side effect. They placed me on Rapamune and I've been doing much better since then. My only issues now are high cholesterol and blood pressure, but those are being treated with medication.
5Patient Review
10/6/2015 This has been a really great medication for me. I've had it for four years now and it's kept my lung function stable the whole time. The only downside is that I sometimes get mouth ulcers from it.
5Patient Review
3/21/2011 Six months ago, I had a kidney transplant. The Rapamune and Prograf have been working well for me with no side effects at the current dosage (1 mg/day and 4mg/day respectively).
5Patient Review
9/11/2011 I had a kidney transplant in April of 2009 and my son was the donor. I was on cellcept, prograf, and prednisone, but on July of 2010 I was diagnosed with central nervous system lymphoma. I had intense chemo for the last 14 months, but they switched me to 2mg.daily use of rapamune with no side effects. My cancer is in remission and the kidney is doing perfect.
5Patient Review
2/11/2012 The only downside is that it increases your cholesterol and triglicerides, so you need to take medication for them (statins). Otherwise, the drug does great things for your kidney health.
5Patient Review
8/12/2011 I've been on this medication for 3 years following my heart transplant. So far, I haven't had any issues with rejection.
4.7Patient Review
2/13/2011 I was very happy to start on this medication. It has a lot fewer side effects for me than the Cyclosporin I was taking before I started on the trial for it. I take 4mg per day and I have never had a rejection problem in the 7 years I have been on it.
4.3Patient Review
2/22/2012 I had a kidney transplant 19 years ago and have been on Rapamune for 10 years. It's really effective, with only minor side effects. The one downside is that now my cholesterol is high and I need to take Zetia every day.
3.7Patient Review
8/9/2011 I've had my transplant for ten years now, and Rapamune has been a part of my daily medication list. Recently, I developed severe edema and swelling in my right leg. For the past three and a half years, I've been wearing compression stockings to help manage the problem.
3Patient Review
2/20/2013 I had my transplant in 2007 and was switched from myfortic to rapamune in 2009. I developed lymphodemia in 2010 and am hoping to be taken off the medication soon.
1Patient Review
8/22/2014 I wasn't a fan of having to mix this medication with juice, and my cholesterol shot up to an unhealthy level as a result.
Patient Q&A Section about rapamune
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.What drug class is Rapamune?
"This medication belongs to a class of drugs that suppress the immune system. It does this by weakening the body's defenses to help the body accept a new organ as if it were the person's own."
Answered by AI
What is the drug Rapamune used for?
"After this, the corticosteroids can be tapered off by your doctor.
Rapamune is a medicine that helps to prevent the body from rejecting a newly transplanted kidney. It is most commonly used in adults who have a low to moderate risk of rejection. It is often recommended that Rapamune is used in combination with other rejection prevention medicines such as ciclosporin and corticosteroids for a period of two to three months. After this, the corticosteroids can be tapered off as decided by your doctor."
Answered by AI
Is Rapamune the same as rapamycin?
"The medication rapamycin was originally discovered by scientists from a soil sample on Easter Island. It was later given the generic name sirolimus by the U.S. pharmaceutical world."
Answered by AI