Safety
Boxed warning: immunosuppression. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression (the label also warns against use in liver or lung transplant patients). The label warns about high cholesterol and triglycerides, slow wound healing, fluid build-up, lung inflammation, protein in the urine, skin cancer, reduced male fertility and harm in pregnancy, and says to avoid live vaccines. Strong CYP3A4 inhibitors and inducers (including some antibiotics and antifungals) and grapefruit juice change its blood levels. Mouth sores are common.
Talk to a licensed clinician about your health history and every medication you take before you start.
Legal status
Prescription only; FDA-approved. Sirolimus is FDA-approved and sold as a generic, so a clinician may prescribe it off-label for longevity. Compounded rapamycin is not FDA-approved, and one clinic reports it is roughly a third as bioavailable per milligram as commercial tablets, so the two aren’t interchangeable mg for mg.
What Rapamycin (sirolimus) is
Rapamycin (sirolimus) contains sirolimus, made by Rapamune (Pfizer) and generic manufacturers. Other sirolimus products are approved for a rare tumor (Fyarro) and facial angiofibroma in tuberous sclerosis (Hyftor gel). Prescribing it for longevity is off-label.
FDA-approved for
- Preventing organ rejection in kidney transplant patients 13 and older
- Lymphangioleiomyomatosis (LAM), a rare lung disease
Dosing
Tablet (generic) or compounded capsule, longevity clinics usually prescribe it once a week; the transplant dose on the label is daily. Set by your prescriber. The PEARL trial tested 5 mg or 10 mg of compounded rapamycin once a week, which its authors equate to about 1.43 mg or 2.86 mg of generic rapamycin.
How well it works
In mice, rapamycin started late in life extended lifespan by 14% in females and 9% in males, measured at 90% mortality (Harrison 2009). In people, the 48-week PEARL trial found weekly low-dose rapamycin relatively safe but did not change its main outcome, visceral fat; women on 10 mg gained lean mass and reported less pain. Six weeks of the related drug everolimus improved flu vaccine response by about 20% in older adults (Mannick 2014). No human trial has shown rapamycin extends lifespan. Individual results vary.
Rapamycin (sirolimus) cost
Prices vary by clinic. For the steps, read How to get a rapamycin prescription online.