Indications  

Rapamune is a prescribed medication used to prevent organ rejection in patients aged 13 years and older who have undergone renal transplants. It may be administered alongside cyclosporine and steroid medication, like prednisone, in certain treatment regimens. 

Rapamune may also be used as a standalone treatment for lymphangioleiomyomatosis (LAM), a rare lung disorder primarily affecting women of childbearing age. 

As an mTOR inhibitor immunosuppressant, Rapamune functions by suppressing the body’s immune system to facilitate the acceptance of the transplanted organ as part of the recipient’s own body. In the case of LAM, this medication inhibits the activated mTOR pathway, thereby impeding the proliferation of LAM cells. 

Uses and Dosage 

Before taking Rapamune and with each prescription refill, carefully review its medication guide and patient information leaflet. Seek the guidance of your healthcare provider or pharmacist for any queries or concerns. 

The dosage of this medication is determined based on the patient’s weight, medical condition, laboratory tests (e.g., sirolimus trough levels), and response to the treatment. 

Typically, Rapamune is taken once daily as prescribed by the doctor, consistently either with or without food. Tablets must be swallowed whole, not cut, crushed, or chewed. 

For individuals concurrently using cyclosporine, ensure a minimum interval of 4 hours between its intake and this medication. 

For optimal results, take Rapamune exactly as directed at a regular time each day. Do not alter the prescribed dosage and frequency of intake, as it will not expedite improvement and may raise the risk of side effects. 

Consult your doctor before discontinuing this medication, as abruptly stopping could potentially exacerbate your condition. 

Side Effects 

Listed below are the potential adverse effects of Rapamune. If any of them last or worsen, tell your doctor right away. 

Common Side Effects 

• Fever or cold symptoms like stuffy nose, sneezing, sore throat 
• Mouth sores 
• Nausea, stomach pain, or diarrhea 
• Headache or muscle aches 
• Chest pain 
• Dizziness 
• Acne 

Serious Side Effects 

• Redness, oozing, or slow healing of a skin wound 
• New skin lesions or changes in the size/color of a mole 
• Unusual bleeding or bruising 
• Sudden chest pain, cough, or shortness of breath 
• Tenderness around the transplanted kidney 
• Signs of infection: 
  • Fever 
  • Chills 
  • Painful mouth or skin sores 
  • Cold or flu symptoms 
  • Painful/burning urination 
• Low red blood cells (anemia): 
  • Pale skin 
  • Unusual tiredness 
  • Feeling lightheaded 
  • Cold hands and feet 

Tell your doctor immediately if you experience any of the serious side effects above. 

The use of Rapamune may result in a severe brain infection leading to disability or death. If you experience any changes in mental state, reduced vision, weakness on one side of your body, or issues with speech or walking, contact your doctor immediately. These symptoms may develop gradually and worsen rapidly. 

Allergic Reactions 

Although rare, a severe allergic reaction to Rapamune may occur. Get immediate medical attention if you experience indications of an allergic reaction, such as: 

• Hives, rash, or peeling skin 
• Wheezing, difficulty breathing, chest pain, or tightness 
• Feeling like passing out or lightheaded 
• Swelling of the face, lips, tongue, or throat 

Not all side effects of Rapamune are included in this list. Tell your doctor right away if any unlisted effects are experienced. 

Cautions 

Before starting treatment with Rapamune, inform your doctor if you have any known allergies, particularly to sirolimus, temsirolimus, or other medications. 

Consult your pharmacist for more information about Rapamune, as it may contain inactive ingredients that could trigger allergic reactions or other complications. 

Individuals with a history of lung or liver transplants should not use Rapamune. 

Discuss the potential risks and benefits of using this medication with your doctor. Rapamune may impact the immune system, potentially leading to the overproduction of specific white blood cells, which can increase the risk of cancer, severe brain infection resulting in disability or death, or viral infection leading to kidney transplant failure. 

To ensure Rapamune is safe for you, disclose to your physician your medical background, especially if you have a history of: 

• Liver disease 
• High cholesterol or triglyceride levels 
• Cancer 
• Recent or current infections 

Inform all your healthcare providers of any current, newly started, or stopped medications, including prescription/nonprescription drugs, vitamins, and herbal supplements before taking Rapamune to reduce the risk of drug interactions. 

Some of the products that may interact with Rapamune include:  

• ACE inhibitors (e.g., benazepril, lisinopril) 
• Other drugs that weaken the immune system or increase infection risk (e.g., natalizumab, rituximab, tacrolimus) 

Sirolimus and temsirolimus are closely related. Avoid the use of medications containing temsirolimus while taking Rapamune. 

Certain medications can impact the elimination of Rapamune from the body, potentially altering its effectiveness. Some of them are: 

• Azole antifungals (e.g., itraconazole, ketoconazole, voriconazole) 
• Enzalutamide 
• Macrolide antibiotics (e.g., clarithromycin, erythromycin) 
• Mifepristone 
• HIV protease inhibitors (e.g., indinavir) 
• Rifamycins (e.g., rifampin, rifabutin) 
• Ritonavir 
• St. John’s wort 

Avoid receiving a live vaccine while taking Rapamune, as it may diminish the vaccine’s effectiveness and fail to provide complete protection against diseases. Examples of live vaccines include MMR, polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). 

Rapamune increases the risk of acquiring infections or exacerbating existing ones. Avoid contact with individuals who have easily transmissible infections like chickenpox, COVID-19, measles, or the flu. Consult your doctor if you have been exposed to an infection or require further information. 

Minimize sun exposure and avoid tanning beds while tsking Rapamune, as this medicine may heighten the risk of skin cancer. When outdoors, wear protective clothing and use sunscreen with SPF 30 or higher. 

Inform your doctor about your pregnancy status or plans. Use a reliable method of birth control before starting this medication, during its course, and for 12 weeks after discontinuation. If you become pregnant while on Rapamune treatment, contact your doctor promptly. 

Breastfeeding is not advised while taking Rapamune as its active ingredient can be transferred into the breastmilk, which may harm the nursing infant. Consult with your doctor before breastfeeding.