Rapamune

The active ingredient in Rapamune is sirolimus. It is an immunosuppressant that reduces the activity of your immune system. After an organ transplant, your immune system activity must be decreased for your body to accept the new kidney.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Rapamune. However, the following is a synopsis of the general guidelines for the use of Rapamune:

• Rapamune is normally taken once per day. If you are taking cyclosporine, take it at least 4 hours before taking this medication.
• Rapamune can be taken with or without food, but it should be taken the same way each time.
• Do not chew, crush, or break a Rapamune tablet. Tell your doctor if you have difficulty swallowing the tablet whole.
• Rapamune oral liquid can only be mixed with water or orange juice, not with any other juices or drinks. Carefully measure the liquid. Use the included dosing syringe or a pharmaceutical dose-measuring instrument (not a kitchen spoon).
• Sirolimus can raise your risk of infection by altering how your immune system functions and you may require frequent medical examinations.
• You should not discontinue using Rapamune without consulting your doctor. Stopping immediately could worsen your illness.

The most common side effects of Rapamune seen in clinical trials include:

• High cholesterol and fat in the blood.
• Swelling in arms and legs (edema).
• Constipation.
• Headache.
• Stomach pain and other body/muscle pain.
• Urinary tract infection (UTI).
• Change in kidney lab results.
• High blood pressure.
• Slow wound healing.
• Fever.
• Acne.
• Nausea.

Some individuals may experience serious side effects while using Rapamune. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Infections: fever, chills, tiredness, sore throat, and muscle aches.
• Serious lung difficulties (interstitial lung disease): breathing problems, chest pain, coughing, and fatigue.
• Severe allergic reactions: difficulty breathing, swelling of the face, constriction of the neck, rash, hives, welts, peeling or blistering skin.
• Low red blood cells (anemia): pale skin, unusual fatigue, lightheadedness, shortness of breath, or cold hands and feet.
• Increased risk of cancer, including skin cancer and lymphomas.

These are not all of the possible side effects of Rapamune. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Rapamune, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Rapamune should not be used if you are allergic to sirolimus or have previously had a lung or liver transplant.
• Rapamune can affect your immune system, potentially causing an overproduction of specific white blood cells. This can result in cancer, a serious brain infection that causes paralysis or death, or a viral infection that causes kidney transplant failure or transplanted organ failure.
• To ensure Rapamune's safety, notify your doctor if you have ever had excessive cholesterol or triglycerides, cytomegalovirus (CMV), liver illness, or a family history of skin cancer (melanoma).
• Call your doctor straight away if you have a fever, flu symptoms, burning when you urinate, a new skin lesion, a change in your mental state, impaired vision, weakness on one side of your body, speech or walking issues, or pain around your transplant.
• Don't get a "live" vaccine while taking Rapamune. During this time, the vaccine may not act as well and may not provide complete protection against disease. Live vaccinations include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and shingles.
• Rapamune has not been adequately studied in renal transplant patients at high immunological risk, therefore use is not recommended in this group of patients.
• People who take Rapamune have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Talk with your doctor about your risk for cancer and be sure to use sunscreen.

Rapamune has not been proven to be both safe and effective in persons who have received liver or lung transplants. People who use Rapamune after a liver or lung transplant may experience serious consequences, including death. If you have had a liver or lung transplant, do not use Rapamune without consulting your doctor. Patients allergic to peanuts or soya must not take Rapamune oral solution because the solution contains soya oil.

Rapamune is readily absorbed from the gastrointestinal system, reaching peak levels within 2 hours. However, the exact time it takes for this drug to start working will depend on several factors. You will need to take Rapamune for the rest of your life, or until your provider decides to change your immunosuppressive medication.

When Rapamune is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Bromocriptine (Cycloset; Parlodel).
• Cyclosporine.
• Danazol.
• St. John's wort.
• Tacrolimus.
• Cholesterol-lowering drugs.
• Certain antifungal medications.
• Some antiviral medications used to treat HIV or hepatitis C.
• Heart or blood pressure medication.
• Medicine for treating ulcers or lowering stomach acid.
• Azathioprine.
• Clarithromycin.
• Phenytoin.
• Rifabutin.
• Erythromycin.
• Grapefruit juice.

There are Rapamune or sirolimus tablets as well as a Rapamune oral solution.

To prevent a kidney transplant rejection, the recommended starting dose is 6 mg by mouth the day after the transplant, followed by 2 mg every day if you are at a low risk of rejection.

If you are at a higher risk of rejection, the typical starting dose is 15 mg by mouth the day after your transplant, followed by 5 mg every day.

Your provider will change your dosage based on the amount of medication in your blood and years of age.

For lymphangioleiomyomatosis, the recommended starting dose is 2 mg taken orally daily. Your provider will most likely measure the level of medication in your blood after a few weeks and modify your dose accordingly.

If you miss a dose, take it as soon as possible, but omit it if it's almost time for the following dose. Do not take two doses at the same time. Therapeutic drug monitoring is recommended for all patients receiving sirolimus.

Keep the pills at room temperature, away from heat, moisture, and light.

Store the oral liquid in the refrigerator. Don't freeze. You may see a tiny haze on the liquid. This haze should fade as the beverage reaches room temperature.

The pharmaceutical company that manufactures Rapamune is Pfizer.

Yes, there are several lower-cost generic versions available.

Do not change your dose or stop taking Rapamune without speaking to your healthcare provider as it could worsen your condition.

If you are pregnant, do not use Rapamune. Use effective birth control to avoid pregnancy while taking this medication and for at least 12 weeks following the final dosage.

Rapamune, like most immunosuppressive medications, is not recommended when nursing. Before breastfeeding your baby, seek advice from your doctor or pharmacist.