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RAPAMUNE

Transplantion

RAPAMUNE

Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants.

 

RAPAMUNE (Sirolimus) tablets, for oral use

 

Dosage forms and Strengths

Tablets: 1 mg

Indications and Usage

  • Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants.
  • Patients at low-moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation.
  • Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation. Safety and efficacy of CsA withdrawal has not been established in high risk patients. 
  • Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (LAM).

Dosage and Administration

  • Renal Transplant Patients:
  • Administer once daily by mouth, consistently with or without food.
  • Administer the initial dose as soon as possible after transplantation and 4 hours after CsA.
  • Adjust the Rapamune maintenance dose to achieve sirolimus trough concentrations within the target-range.
  • Hepatic impairment: Reduce maintenance dose in patients with hepatic impairment.
  • In renal transplant patients at low-moderate-immunologic risk:
  • Rapamune and CsA Combination Therapy: One loading dose of 6 mg on day 1, followed by daily maintenance doses of 2 mg.
  • Rapamune Following CsA Withdrawal: 2-4 months post-transplantation, withdraw CsA over 4-8 weeks
  • In renal transplant patients at high-immunologic risk:
  • Rapamune and CsA Combination Therapy (for the first 12 months post-transplantation): One loading dose of up to 15 mg on day 1, followed by daily maintenance doses of 5 mg.

 

  • Lymphangioleiomyomatosis Patients:
  • Administer once daily by mouth, consistently with or without food. 
  • Recommended initial Rapamune dose is 2 mg/day.
  • Adjust the Rapamune dose to achieve sirolimus trough concentrations between 5-15 ng/mL.
  • Hepatic impairment: Reduce maintenance dose in patients with hepatic impairment
  • Therapeutic drug monitoring is recommended for all patients

Contraindications

Hypersensitivity to Rapamune

Warnings and Precautions

  • Hypersensitivity Reactions
  • Angioedema
  • Fluid Accumulation and Impairment of Wound Healing
  • Hyperlipidemia
  • Decline in Renal Function
  • Proteinuria
  • Latent Viral Infections
  • Interstitial Lung Disease/Non-Infectious Pneumonitis
  • De Novo Use Without Cyclosporine
  • Increased Risk of Calcineurin Inhibitor-Induced Hemolytic Uremic Syndrome/ Thrombotic Thrombocytopenic Purpura/ Thrombotic Microangiopathy.

Adverse Reactions

  • Prophylaxis of organ rejection in patients receiving renal transplants: Most common adverse reactions (incidence ≥ 30%) are peripheral edema, hypertriglyceridemia, hypertension, hypercholesterolemia, creatinine increased, abdominal pain, diarrhea, headache, fever, urinary tract infection, anemia, nausea, arthralgia, pain, and thrombocytopenia.
  • Lymphangioleiomyomatosis: Most common adverse reactions (incidence ≥ 20%) are stomatitis, diarrhea, abdominal pain, nausea, nasopharyngitis, acne, chest pain, peripheral edema, upper respiratory tract infection, headache, dizziness, myalgia, and hypercholesterolemia.

Drug Interactions

  • Avoid concomitant use with strong CYP3A4/P-gp inducers or strong CYP3A4/P-gp inhibitors that decrease or increase sirolimus concentrations.
  • See full prescribing information for complete list of clinically significant drug interactions.

Pregnancy

Use only if the potential benefit outweighs the potential risk to the embryo/fetus

More Information

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