RAPAMUNE (Sirolimus)

RAPAMUNE (Sirolimus)

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prescription

What is this medication?

RAPAMUNE (Sirolimus)
Immunosuppressant Agent
mTOR Kinase Inhibitor

RAPAMUNE (Sirolimus) is indicated for the treatment of lymphangioleiomyomatosis, renal transplantation (rejection prophylaxis).      

ALERT: WARNING
Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression.

Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use RAPAMUNE (Sirolimus) for prophylaxis of organ rejection in patients receiving renal transplants. The safety and efficacy of RAPAMUNE (Sirolimus) as immunosuppressive therapy have not been established in liver or lung transplant patients, and therefore, such use is not recommended.

How does this medication work? 

RAPAMUNE (Sirolimus) has a mechanism that differs from other immunosuppressive agents.  It inhibits T-lymphocyte activation and proliferation in response to antigenic and cytokine stimulation and inhibits antibody production. It does this via binding FKBP-12, an intracellular protein, to form an immunosuppressive complex which inhibits the regulatory kinase, mTOR (mechanistic target of rapamycin). This inhibition suppresses cytokine mediated T-cell proliferation.  It prolongs graft survival and inhibits acute rejection of allografts.  In lymphangioleiomyomatosis, the mTOR signaling pathway is activated through loss of the tuberous sclerosis complex gene function.  By inhibiting the mTOR pathway, sirolimus prevents the proliferation of lymphangioleiomyomatosis cells.

How should I take this medication? 

Renal Transplant
Oral: Take once daily by mouth, consistently with or without food.  Take the initial dose as soon as possible after transplantation and 4 hours after CsA.  Adjust the maintenance dose to achieve sirolimus trough concentrations within the target-range.  

Renal Transplant at Low-to Moderate-Immunologic Risk
Oral: Take a loading dose of 6 mg on day 1, followed by daily maintenance doses of 2 mg.

Renal Transplant at High-Immunologic Risk
Oral: Take a loading dose of up to 15 mg on day 1, followed by daily maintenance doses of 5 mg.

Lymphangioleiomyomatosis
Oral: Take once daily by mouth, consistently with or without food (2). Recommended initial The dose is 2 mg/day.  Adjust the dose to achieve sirolimus trough concentrations between 5-15 ng/mL.

How to Take: Do not be crush, chew, or split tablets. Swallow whole.

What should I watch for while using this medication?

Before starting RAPAMUNE (Sirolimus) make sure your physician is aware of any allergies or medications you currently take, if you have hepatic impairment, are pregnant, or breastfeeding. Sirolimus use has been associated with adverse events such as anaphylaxis/ hypersensitivity reactions, angioedema, infections, interstitial lung disease, hyperlipidemia, lymphocele/fluid accumulation, malignancy, proteinuria, renal effects, and wound dehiscence.

What if I miss a dose?

If you miss a dose of medication, try to take it as soon as possible. However, if it is almost time for your next dose, take only that scheduled dose. Do not take double or extra doses.

How should I store this medication?

Keep out of the reach of children at all times. Store at room temperature, 59 to 86° F (15 to 30° C). Protect from light. Keep the container tightly closed.  Properly dispose of any unused medication after the expiration date.

What are the possible side effects of using this medication? 

Peripheral edema, hypertension, edema, deep vein thrombosis, pulmonary embolism, tachycardia, headache, pain, dizziness, acne vulgaris, skin rash, hypertriglyceridemia, hypercholesterolemia, amenorrhea, diabetes mellitus, hypermenorrhea, hypervolemia, hypokalemia, increased lactate dehydrogenase, menstrual disease, ovarian cyst, constipation, abdominal pain, diarrhea, nausea, stomatitis, urinary tract infection, anemia, thrombocytopenia, lymphoproliferative disorder, skin carcinoma, hemolytic-uremic syndrome, leukopenia, lymphocele, thrombotic thrombocytopenic purpura, herpes simplex infection, herpes zoster, sepsis, arthralgia, myalgia, osteonecrosis, increased serum creatinine, pyelonephritis, nasopharyngitis, epistaxis, pneumonia, upper respiratory tract infection, wound healing impairment.

Note this is not a complete list of side effects for RAPAMUNE (Sirolimus), only common ones.