Sirolimus

• Immunosuppressive Agents
• Antifungals
• ATC:L04AA10

• Antibiotic AY 22989
• Rapamune
• Rapamycin

Patients should be given complete dosage instructions. Women of childbearing potential should be informed of the potential risks during pregnancy and that they should use effective contraception prior to initiation of Rapamune therapy, during Rapamune therapy and for 12 weeks after Rapamune therapy has been stopped.

Patients should be told that exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor because of the increased risk for skin cancer.

PATIENT INSTRUCTIONS FOR RAPAMUNE™ (SIROLIMUS) ORAL SOLUTION Bottles

1. Open the solution bottle. Remove the safety cap by squeezing the tabs on the cap and twisting counterclockwise.
2. On first use, insert the adapter assembly (plastic tube with stopper) tightly into the bottle until it is even with the top of the bottle. Do not remove the adapter assembly from the bottle once inserted.
3. For each use, tightly insert one of the amber syringes with the plunger fully depressed into the opening in the adapter.
4. Withdraw the prescribed amount of Rapamune™ Oral Solution by gently pulling out the plunger of the syringe until the bottom of the black line of the plunger is even with the appropriate mark on the syringe. Always keep the bottle in an upright position. If bubbles form in the syringe, empty the syringe into the bottle and repeat the procedure.
5. You may have been instructed to carry your medication with you. If it is necessary to carry the filled syringe, place a cap securely on the syringe ¾ the cap should snap into place.
6. Then place the capped syringe in the enclosed carrying case. Once in the syringe, the medication may be kept at room temperature or refrigerated and should be used within 24 hours. Extreme temperatures (below 36°F and above 86°F) should be avoided. Remember to keep this medication out of the reach of children.
7. Empty the syringe into a glass or plastic cup containing at least 2 ounces (1/4 cup, 60 mL) of water or orange juice, stir vigorously for one (1) minute and drink immediately. Refill the container with at least 4 ounces (1/2 cup, 120 mL) of water or orange juice, stir vigorously again and drink the rinse solution. Apple juice, grapefruit juice, or other liquids are NOT to be used. Only glass or plastic cups should be used to dilute Rapamune™ Oral Solution. The syringe and cap should be used once and then discarded.
8. Always store the bottles of medication in the refrigerator. When refrigerated, a slight haze may develop in the solution. The presence of a haze does not affect the quality of the product. If this happens, bring the Rapamune™ Oral Solution to room temperature and shake until the haze disappears. If it is necessary to wipe clean the mouth of the bottle before returning the product to the refrigerator, wipe with a dry cloth to avoid introducing water, or any other liquid, into the bottle.