Rapamune® (sirolimus) Off-Label Use
What Is Rapamune® Used For?
Rapamune® (sirolimus) is an immunosuppressant that is prescribed to prevent rejection of kidney transplants in patients 13 years of age and older. It is sometimes used with cyclosporine and a steroid medication such as prednisone.
Some physicians have been prescribing the medication for transplants of other organs besides kidneys, with unreliable results.
When the drug received U.S. Food and Drug Administration (FDA) approval in 1999, it was authorized only for preventing rejections of transplanted kidneys. But, Rapamune® has been used to transplant hearts, lungs, livers, pancreases and islet cells.
The label carries a distinct FDA warning not to prescribe the medication for off-label use; meaning for any use other than is recommended on the product label required by the FDA. Serious, sometimes fatal, results can occur when the product is used off label.
The label says in bold black letters, “Rapamune® has not been shown to be safe and effective in people who have liver or lung transplants. Serious complications and death may happen in people who take Rapamune® after a liver or lung transplant.”
Other warnings on the Rapamune® label include:
- It can make the patient susceptible to infection
- It can make the patient susceptible to certain cancers, especially lymphoma and skin cancer
- Only physicians who have experience in immunosuppressive therapy and management of kidney transplant patients should use Rapamune®.
- Patients who are treated with the drug should be in a facility that has appropriate laboratory and supportive medical resources
- The physician who follows up the patient should be thoroughly familiar with treating these types of patients
Because of the off-label use and its serious consequences, two former Wyeth sales representatives have filed a lawsuit against the company. The former employees charged that Wyeth was deliberately promoting Rapamune® for off-label uses by supplying its salespeople with marketing information to encourage off-label use.
It is illegal for a drug company to promote a product for off-label use.
The former Wyeth employees also charged that two hospitals with predominantly black patient populations were targeted for marketing Rapamune® off label — New York’s SUNY Downstate Medical Center and Einstein Medical Center in Philadelphia.
Wyeth, Rapamune®’s manufacturer, was acquired by Pfizer for $68 billion in dollars and stock in 2009.
Sirolimus, the generic name for Rapamune® was first approved as a solution Sept.15, 1999, as a new molecular entity. On Aug. 25, 2000, Rapamune® tablets were approved as a new formulation of the drug.
If you or a loved one was given Rapamune® for an off-label use treatment, you might be eligible for compensation if you were injured. For more information, contact a Rapamune® lawyer today.
