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Sirolimus

Immunosuppressant

Brand names:

Rapamune®

Other names:

Rapamycin

Often used for:

Graft vs. host disease (GVHD) after stem cell transplantation

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What is Sirolimus?

Sirolimus is a medicine that suppresses the immune system (immunosuppressant). It is used to decrease the body’s natural immune system and prevent or treat GVHD in hematopoietic cell transplant. Sirolimus may also be used to prevent rejection of organ transplants.

Patients will have regular blood draws to check blood counts, cholesterol and triglyceride levels, and to monitor kidney and liver function. Sirolimus levels in the blood will be monitored, and doses may change based on levels in the blood.

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May be taken as a tablet by mouth

 
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May be taken as a liquid by mouth

 
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Possible Side Effects

  • Hypertension
  • Kidney problems
  • Fever
  • UTI
  • Anemia
  • Nausea and vomiting
  • Headache
  • Diarrhea
  • Abdominal pain
  • Swelling of the arms and legs (edema)
  • Joint pain
  • High blood cholesterol or triglyceride levels
  • Increased risk of infection
  • Constipation
  • Tremors (shaking of the body)
  • Acne
  • Nose or throat irritation
  • Impaired wound healing
  • Changes in the menstrual cycle
  • High blood sugar levels
  • Lung problems

Not all patients who take sirolimus will experience these side effects. Common side effects are in bold, but there may be others. Please report all suspected side effects to your doctor or pharmacist.

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Possible Late Effects

Some patients may experience long-term or late effects of treatment that may continue or develop months or years after treatment ends. Possible late effects due to sirolimus include:

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Tips for Families

Be sure to discuss these and other recommendations with your doctor or pharmacist.

  • The staff will let patients know when tests will be performed to measure sirolimus levels in the blood. On that day, patients should not take the medicine until after the blood sample is obtained.
  • While taking sirolimus, it is important to drink plenty of fluids. Patients should follow the care team’s instructions for appropriate fluid intake.
  • While taking this medicine, patients should not eat grapefruit or Seville (bitter) oranges. Patients also should not drink juice or beverages containing grapefruit or Seville orange.
  • If patients are taking cyclosporine, give sirolimus at least 4 hours after cyclosporine.
  • This medicine may increase risk of skin cancer. Patients should take steps to protect skin from the sun. Wear sunscreen and protective clothing. Avoid sun exposure when possible.
  • Sexually active patients should take steps to prevent pregnancy during treatment and for 3 months after completion of therapy. 
  • Patients should tell their doctor if they are pregnant or breastfeeding.

Sirolimus at home:

  • Sirolimus can be taken with or without food. However, it is important to take this medicine the same way every day. Taking the medicine at the same time each day and in the same way in relation to meals will help keep a constant amount of sirolimus in the body.
  • Tablets:
    • Swallow tablets whole. Do not cut, crush, or chew.
    • Store sirolimus tablets at room temperature.
  • Oral liquid:
    • Shake liquid sirolimus well before use. Use the measuring device (oral syringe) that comes with the medicine. Measure one dose, and empty into a cup with ¼ cup water or orange juice (not from Seville bitter oranges). Mix well, and take the medicine right away. Then add a little more liquid to the cup, mix, and drink. Throw away the oral syringe used to measure the dose. Do not reuse.
    • Store liquid sirolimus in the refrigerator. The medicine may appear hazy after refrigeration. Liquid sirolimus may be kept at room temperature for up to 15 days. Throw away unused liquid medicine after 30 days.
  • If vomiting occurs within 20 minutes of taking sirolimus, another dose should be given.
  • Give a missed dose as soon as possible. If it is near the time of the next dose (within 4 hours), skip the dose. Do not give 2 doses at the same time.
  • Caregivers should wear gloves when handling this medicine. If the medicine gets on your skin or in eyes, wash the area right away.
  • Protect sirolimus from light.
  • Do not use the medicine past the expiration date.
  • Follow instructions for safe handling, storage, and disposal.