Rapamune (Tablet, Sugar Coated)

dailymed-instance:drugs, http://www4.wiwiss.fu-berlin.de/drugbank/vocab/resource/class/Offer

dailymed-ingredient:sirolimus

BOX WARNING: IMMUNOSUPPRESSION, EXCESS MORTALITY IN DE NOVO LIVER TRANSPLANTATION, AND BRONCHIAL ANASTOMOTIC DEHISCENCE: Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use Rapamune. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions (5.1)]. The use of Rapamune in combination with tacrolimus was associated with excess mortality and graft loss in a study in de novo liver transplant patients. Many of these patients had evidence of infection at or near the time of death. In this and another study in de novo liver transplant patients, the use of Rapamune in combination with cyclosporine or tacrolimus was associated with an increase in HAT; most cases of HAT occurred within 30 days post-transplantation and most led to graft loss or death [see Warnings and Precautions (5.2)]. Cases of bronchial anastomotic dehiscence, most fatal, have been reported in de novo lung transplant patients when Rapamune has been used as part of an immunosuppressive regimen [see Warnings and Precautions (5.3)].

dailymed-ingredient:calcium_sulfate, dailymed-ingredient:carnauba_wax, dailymed-ingredient:dl-alpha_tocopherol, dailymed-ingredient:glyceryl_monooleate, dailymed-ingredient:lactose, dailymed-ingredient:magnesium_stearate, dailymed-ingredient:microcrystalline_cellulose, dailymed-ingredient:other_ingredients, dailymed-ingredient:pharmaceutical_glaze, dailymed-ingredient:poloxamer_188, dailymed-ingredient:polyethylene_glycol_20,000, dailymed-ingredient:polyethylene_glycol_8000, dailymed-ingredient:povidone, dailymed-ingredient:sucrose, dailymed-ingredient:talc, dailymed-ingredient:titanium_dioxide

Rapamune (Tablet, Sugar Coated)

http://www4.wiwiss.fu-berlin.de/dailymed/resource/routeOfAdministration/Oral