|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised XXX 2021|
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:
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:
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?|
|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 LAM include:|
|Other side effects that may occur with RAPAMUNE: |
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?|
Safely throw away medicine that is out of date or no longer needed.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.
For Rapamune Oral Tablets and Oral Solution:
17 PATIENT COUNSELING INFORMATION
Advise patients, their families, and their caregivers to read the Medication Guide and Instructions for Use for the Oral Solution and assist them in understanding its contents. The complete text of the Medication Guide and Instructions for Use for the Oral Solution are reprinted at the end of the document.
See FDA-Approved Medication Guide and Instructions for Use for the Oral Solution.
Patients should be given complete dosage instructions [see FDA-Approved Medication Guide].
17.2 Skin Cancer Events
Advise patients that exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a broad spectrum sunscreen with a high protection factor because of the increased risk for skin cancer [see Warnings and Precautions (5.18)].
17.3 Pregnancy and Lactation
Advise female patients of reproductive potential to avoid becoming pregnant throughout treatment and for 12 weeks after Rapamune therapy has stopped. Rapamune can cause fetal harm if taken during pregnancy. Advise a pregnant woman of the potential risk to her fetus. Before making a decision to breastfeed, inform the patient that the effects of breastfeeding in infants while taking this drug are unknown, but there is potential for serious adverse effects [see Warnings and Precautions (5.15), Use in Specific Populations (8.1, 8.2, 8.3)].