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Generic name: sirolimus [sih-RO-lim-us]
Forms of dosage: oral solution (1 mg/ml) or oral tablets (0.5 mg, 1 mg, 2 mg).
Drug classes: MTOR inhibitors, selective immunosuppressants

What is Sirolimus?

Sirolimus helps to weaken your immune system so that it does not "reject" a transplanted kidney. When the immune system attacks the new organ, it is called "organ rejection". Sirolimus can be used in combination with other medications to prevent organ rejection following a renal transplant.

Sirolimus can also be given alone to treat lymphangioleiomyomatosis, a rare lung disorder (pronounced [lim-FAN-gee-oh LYE oh MYE ma TOE sis"). This condition is more common in women. It causes lung tumours, which are not cancerous. However, they can cause breathing problems. Sirolimus can be used in other ways not mentioned in this guide.

Side effects of Sirolimus

Sirolimus can cause a serious infection of the brain that may lead to death or disability. If you notice any changes in your mental health—reduced vision, weakness of one side, or difficulties with walking or speaking—call your doctor immediately. These symptoms can start slowly and then get worse very quickly.

If you experience any of the following symptoms, you should seek medical attention immediately: hives or rash; difficulty breathing; chest pain; feeling as if you may pass out; swelling on your face, lips, or tongue; or a tightening or pain in your chest.

Sirolimus may cause serious side effects. If you experience:

  • Redness, oozing, or slow healing in a skin injury;
  • A new lesion or mole that has changed size or colour
  • Unusual bleeding or bruises
  • Coughing, chest discomfort or pain, and feeling short of breath are all symptoms that may accompany sudden chest pain.
  • Tenderness around the transplanted renal
  • Signs of infection: fever, chills, and painful sores on the lips, mouth, or skin; symptoms of the cold or flu; or pain or burning while urinating.
  • Low red blood cells, or anaemia, can cause pale skin, unusual fatigue, feeling lightheaded, shortness of breath, and cold hands and/or feet.

Side effects of sirolimus include:

  • As well as fever and cold symptoms such as stuffy nose and sneezing, fever is also the source of cold symptoms like stuffy throat and coughing.
  • Mouth sores;
  • Nausea, stomach pain, diarrhoea;
  • Headaches, muscle pains;
  • Chest pain;
  • Dizziness;

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.


If you've ever had a lung transplant or a liver transplant, then sirolimus is not recommended. Sirolimus can cause an overproduction of white blood cells. This can cause cancer, brain infections that are severe enough to be fatal or severely disabled, or viral infections that result in kidney transplant failure.

If you experience any of the following symptoms, call your doctor immediately: fever, flu-like symptoms, burning in your urination, changes in your mental condition, reduced vision, weakness to one side, difficulty speaking or walking, or pain near your transplant

Before you take this drug

If you have had a liver or lung transplant or are allergic to the drug sirolimus, you should not take it.

Discuss with your physician both the potential advantages and drawbacks associated with taking this medication. Sirolimus may affect your immune system and cause an overproduction of white blood cells. This can cause cancer, severe brain infections resulting in disability or death, or viral infections causing kidney failure.

Tell your doctor about any of the following:

  • High cholesterol (or triglycerides);
  • Cytomegalovirus (CMV);
  • Liver disease
  • A family history of skin cancer (melanoma)

Do not use sirolimus if you are pregnant. Use birth control during your treatment with sirolimus and for 12 weeks following the last dose. Breastfeeding mothers should not use this medicine. Sirolimus is not recommended for children younger than 13 years of age.

How to take Sirolimus?

Read all the instructions or guides that come with your medication and follow the directions. Sometimes, your doctor will change the dose. You must take the medication exactly as prescribed. Sirolimus can be taken only once per day. Take sirolimus at least four hours after taking cyclosporine.

Take sirolimus the same way, whether you eat or not. Sirolimus tablets should not be crushed, chewed, or broken. If you are having trouble swallowing a tablet, tell your doctor. Please read and follow all instructions that accompany your medication, if they don't make sense to you, speak to either your physician or pharmacist for clarification. If necessary, seek guidance from either.

Sirolimus oral fluid must only be mixed with orange juice or water. No other liquids or juices are allowed. The liquid should be measured carefully. Use the provided dosing device or a dose-measuring tool (not a spoon) to measure the liquid.

Sirolimus alters the immune system's function, which can increase your chances of getting infected. You will have to undergo frequent medical testing. The results of the tests may affect your dosing schedule. Sirolimus should only be stopped with your doctor's approval. Your condition could worsen if you stop suddenly. Store sirolimus tablets at a temperature between 18 and 22 degrees Celsius, away from moisture, heat, and light.

Store sirolimus Liquid in the fridge. Don't freeze. The liquid may appear slightly hazy. The haze will disappear once the liquid reaches room temperature. You can store the syringe that you use to administer sirolimus orally in the case provided. Use the medicine within 24 hours, and keep the case at room temperature. Dispose of the disposable syringe after use.

What happens if I miss the dose?

If it is nearly time for your next dose, skip the one you missed. Never take two doses of the same medicine at once.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Avoid tanning beds or exposure to the sun. Sirolimus can increase your skin cancer risk. When venturing outdoors, wear protective clothing and apply an SPF 30 sunscreen product or higher for optimal sun protection. Stay away from people who appear sick. This will protect yourself and others around them from infection. If you notice any signs of an infection, tell your doctor immediately. Avoid getting sirolimus liquid or oral on the skin. If this occurs, wash the skin with soapy water. If you get sirolimus in your eyes, wash them with water.

Sirolimus can cause unwanted side effects if grapefruit is consumed. Use grapefruit juice when taking sirolimus. Avoid receiving a "live vaccine" while taking sirolimus. The vaccine might not work well and protect you as much during this period. Live vaccines are available for measles (MMR), mumps (MMR), rubella (R), polio (rotavirus), typhoid (rotavirus), yellow fever (typhoid), varicella (chickenpox), zoster (shingles), typhoid (rotavirus), syphilis (typhoid), syphilis (shingles), and a number of other diseases.

Interaction with other drug

Inform your doctor of all the medications you are taking. Sirolimus can be affected by many drugs, including:

  • Bromocriptine (Cycloset, Parlodel);
  • Cyclosporine;
  • Danazol;
  • John's Wort;
  • Tacrolimus;
  • Cholesterol-lowering medication;
  • Antibiotics or antifungal medicines;
  • Antiviral medication to treat HIV or hepatitis C
  • Heart or blood pressure medications;
  • Medicine to treat ulcers or reduce stomach acid;
  • Seizure medicine.

This list is incomplete, and sirolimus can be affected by many other medications. These include prescription and over-the-counter medicines, vitamins, and herbal products. This list does not include all possible drug interactions.