RAPAMUNE- sirolimus solution 
RAPAMUNE- sirolimus tablet, sugar coated 
Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.

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MEDICATION GUIDE

RAPAMUNE® (RAAP-a-mune) (sirolimus)Tablets

RAPAMUNE® (RAAP-a-mune) (sirolimus) Oral Solution

What is the most important information I should know about RAPAMUNE?

Rapamune can cause serious side effects, including:

1. increased risk of getting infections

2. increased risk of getting certain cancers

3. Increased risk of getting infections. Serious infections can happen including infections caused by viruses, bacteria, and fungi (yeast). Your doctor may put you on medicine to help prevent some of these infections.

Call your doctor right away if you have symptoms of infection including fever or chills while taking Rapamune.

4. Increased risk of getting certain cancers. 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.

RAPAMUNE has not been shown to be safe and effective in people who have had liver or lung transplants. Serious complications and death may happen in people who take RAPAMUNE after a liver or lung transplant. You should not take RAPAMUNE if you have had a liver or lung transplant without talking with your doctor.

See the section "What are the possible side effects of RAPAMUNE?" for information about other side effects of RAPAMUNE.

What is RAPAMUNE?

RAPAMUNE is a prescription medicine used to prevent rejection (anti-rejection medicine) in people 13 years of age and older who have received a kidney transplant. Rejection is when your body's immune system recognizes the new organ as a "foreign" threat and attacks it.

RAPAMUNE is used with other medicines called cyclosporine (Gengraf, Neoral, Sandimmune), and corticosteroids. Your doctor will decide:

It is not known if RAPAMUNE is safe and effective in children under 13 years of age.

RAPAMUNE is a prescription medicine also used to treat lymphangioleiomyomatosis (LAM). LAM is a rare progressive lung disease that affects predominantly women of childbearing age.

Who should not take RAPAMUNE?

Do not take RAPAMUNE if you are allergic to sirolimus or any of the other ingredients in RAPAMUNE. See the end of this leaflet for a complete list of ingredients in RAPAMUNE.

What should I tell my doctor before taking RAPAMUNE?

Before taking RAPAMUNE, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using RAPAMUNE with certain medicines may affect each other causing serious side effects.

RAPAMUNE may affect the way other medicines work, and other medicines may affect how RAPAMUNE works.

Especially tell your doctor if you take:

How should I take RAPAMUNE?

What should I avoid while taking RAPAMUNE?

What are the possible side effects of RAPAMUNE?

RAPAMUNE may cause serious side effects, including:

The most common side effects of RAPAMUNE in people with renal transplant include:

The most common side effects of RAPAMUNE in people with LAM include:

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of RAPAMUNE. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store RAPAMUNE?

RAPAMUNE tablets:

RAPAMUNE oral solution:

Do not use RAPAMUNE after the expiration date, which is located on the blister and carton. The expiration date refers to the last day of that month.

Safely throw away medicine that is out of date or no longer needed.

Keep RAPAMUNE and all medicines out of the reach of children.

General Information about the safe and effective use of RAPAMUNE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RAPAMUNE for a condition for which it was not prescribed. Do not give RAPAMUNE to other people even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about RAPAMUNE. If you would like more information talk to your doctor. You can ask your pharmacist or doctor for information about RAPAMUNE that is written for health professionals.

For more information, go to www.rapamune.com or call 1-800-934-5556.

What are the ingredients in RAPAMUNE?

Active ingredients: sirolimus

Inactive ingredients: RAPAMUNE Oral Solution: Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. RAPAMUNE Oral Solution contains 1.5%–2.5% ethanol.

Inactive ingredients: RAPAMUNE Tablets: sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.

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For Rapamune Oral Tablets and Oral Solution:

This Medication Guide has been approved by the U.S. Food and Drug Administration.

LAB-0578-4.0

May 2015

Revised: 9/2016
Document Id: 34f27616-dec7-4508-9cb7-452c492d58e4
Set id: 3275b824-3f82-4151-2ab2-0036a9ba0acc
Version: 48
Effective Time: 20160929
 
Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.