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Sirolimus

Immunosuppressant

Brand names:

Rapamune®

Other names:

Rapamycin

Often used for:

Graft versus host disease (GVHD) after stem cell transplant, prevent rejection after organ transplant

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What is sirolimus (rapamycin)?

Sirolimus is a medicine that suppresses the immune system (immunosuppressant). Sirolimus is also known as rapamycin (Rapamune®). It is used to decrease the body’s natural immune system response and prevent or treat GVHD after stem cell transplant. Sirolimus may also be given after an organ transplant to prevent the immune system from attacking or rejecting the transplanted organ. 

Your child will have regular blood draws to check blood counts, cholesterol and triglyceride levels, and to monitor kidney and liver function. Your care team will also measure sirolimus levels in the blood. The dose of sirolimus may change based on levels in the blood.

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May be given as a tablet by mouth

 
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May be given as a liquid by mouth

 
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Possible side effects

  • Nausea and vomiting
  • Headache
  • Diarrhea
  • Abdominal (belly) pain
  • Fever
  • Swelling of the arms and legs (edema)
  • Joint pain
  • High blood pressure
  • Kidney problems
  • Urinary tract infection (UTI)
  • Anemia
  • High cholesterol levels
  • High triglyceride levels
  • Increased risk of infection
  • Constipation
  • Shaking or tremors
  • Acne
  • Nose or throat irritation
  • Slowed wound healing
  • Changes in the menstrual cycle
  • High blood sugar levels
  • Lung problems

Not all patients who take sirolimus will have these side effects. Common side effects are in bold, but there may be others. Report any symptoms or side effects to your doctor or pharmacist. 

Find more information on side effects.

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Possible long-term or late effects

Sirolimus may cause medical problems that continue or develop months or years after treatment ends. These may include:

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Tips for patients and families

Be sure to discuss all questions and instructions with your doctor or pharmacist.

  • Your care team will let you know when they will do tests to measure sirolimus levels in the blood. On that day, your child should not take the medicine until instructed by the care team.
  • This medicine can weaken the immune system and increase the risk of infection. Wash hands often, keep patient areas clean, and avoid contact with people who are sick. 
  • Talk to your care team before your child gets any vaccine. This medicine can change how well some vaccines work or increase the risk of side effects.
  • Have your child drink plenty of fluids. Follow the care team’s instructions for fluid intake. This can lower the risk of kidney damage.
  • While taking this medicine, your child should not eat grapefruit or Seville (bitter) oranges. Patients also should not drink juice or beverages containing grapefruit or Seville orange.
  • If your child also takes cyclosporine, give sirolimus at least 4 hours after cyclosporine.
  • Certain medicines can interact with sirolimus or change the levels of the medicine in the blood. Tell your doctor and pharmacist about all medicines your child takes.
  • Your child may bleed more easily, and wounds may heal more slowly. Brush teeth gently with a soft toothbrush, use an electric razor to shave, and avoid activities that can cause injury.
  • This medicine may make the skin sensitive to the sun and increase risk of skin cancer. Take steps to protect the skin from the sun. Have your child wear sunscreen and protective clothing and avoid sun exposure when possible.
  • Sirolimus can affect your child’s ability to get pregnant or father a child. Talk to your doctor about the risk of fertility problems and options for protecting fertility. 
  • It is important that patients tell the care team if they are pregnant, breastfeeding, or sexually active. 
  • Sexually active patients should take steps to prevent pregnancy during treatment and for 3 months after treatment is complete. 

Sirolimus at home:

  • Give the medicine at the same time each day and in the same way in relation to meals. Sirolimus can be taken with or without food. But it is important to take this medicine the same way every day. This 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 1 dose, and empty into a cup with ¼ cup water or orange juice. (Do not eat grapefruit or bitter Seville oranges or drink juices containing these fruits). Mix well and give 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, give another dose.
  • 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 the skin or in the 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.

Learn more about sirolimus.

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Always check the medication label. Many medicines look the same. Do not take any new medicine, including over-the counter medicines or supplements, without checking with your doctor or pharmacist. Talk to your doctor or pharmacist about what to do in the case of a missed dose, allergic reaction, or medical emergency. 

This information is not intended to be a complete guide and is not a substitute for talking with your provider. Medicine names, appearance, formulas, or availability may vary by clinic location. Always follow the instructions given by your care team.