SIROLIMUS- sirolimus tablet 



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. 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.

2. 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.

Who should not take sirolimus?

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

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 tranplant 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:

Safely throw away medicine that is out of date or no longer needed.

Keep sirolimus tablets 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, call 1-855-361-3993.

What are the ingredients in sirolimus tablets?

Inactive ingredients: Sirolimus

The inactive ingredients: Sirolimus Tablets: carnauba wax, ethyl cellulose, hydroxypropyl methylcellulose 5 cps, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose (avicel pH 105), microcrystalline cellulose (avicel pH 200), poloxamer 188, polyethylene glycol 20000, polyethylene glycol 8000, sucrose, titanium dioxide, vitamin E preparation, seal coating agent opaglos clear NA 7150, and imprinting ink opacode red (S-1-15052). The 2 mg dosage strength also contains iron oxide red and iron oxide yellow.

Seal coating agent opaglos clear NA 7150 contains, acetylated monoglyceride, industrial methylated spirit 74 OP, povidone, and shellac.

Imprinting ink opacode red (S-1-15052) contains, ammonium hydroxide, FD&C Red # 40, propylene glycol, shellac glaze, and titanium dioxide.

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

Rx Only

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 02/18

AV 04/18 (P)

Revised: 3/2019