SIROLIMUS- sirolimus tablet, sugar coated 
Greenstone LLC

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MEDICATION GUIDE

Sirolimus Tablets

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

Sirolimus 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 sirolimus.

4. Increased risk of getting certain cancers. People who take sirolimus have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Talk with your doctor about your risk for cancer.

Sirolimus 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 sirolimus after a liver or lung transplant. You should not take sirolimus if you have had a liver or lung transplant without talking with your doctor.

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

What is sirolimus?

Sirolimus 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.

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

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

SIROLIMUS 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 sirolimus?

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

What should I tell my doctor before taking sirolimus?

Before taking sirolimus, 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 sirolimus with certain medicines may affect each other causing serious side effects.

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

Especially tell your doctor if you take:

How should I take sirolimus?

What should I avoid while taking sirolimus?

What are the possible side effects of sirolimus?

Sirolimus may cause serious side effects, including:

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

The most common side effects of SIROLIMUS 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 sirolimus. 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 sirolimus?

Sirolimus tablets:

Do not use sirolimus 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 sirolimus and all medicines out of the reach of children.

General information about the safe and effective use of sirolimus.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sirolimus for a condition for which it was not prescribed. Do not give sirolimus 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 sirolimus. If you would like more information talk to your doctor. You can ask your pharmacist or doctor for information about sirolimus that is written for health professionals.

For more information about sirolimus call 1-800-438-1985.

What are the ingredients in sirolimus?

Active ingredients: sirolimus

Inactive ingredients: sirolimus 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.

This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.

For sirolimus oral tablets:

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

LAB-0621-4.0

May 2017

Revised: 6/2017
Document Id: 62fa522f-54f1-40e7-af5c-2408ce9e7176
Set id: 5908cd1a-fc5a-462f-99ed-1d8983e253c9
Version: 11
Effective Time: 20170602
 
Greenstone LLC