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RAPAMUNE® (sirolimus) Instructions For Use

INSTRUCTIONS FOR USE

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

Be sure that you read and understand the following instructions for the correct way to dilute and take RAPAMUNE Oral Solution. Ask your pharmacist or doctor if you are not sure. Important:

  • Always keep the bottle in an upright position.
  • You may store RAPAMUNE Oral Solution that is in a syringe at room temperature up to 77°F (25°C) or in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 24 hours. See "How should I store RAPAMUNE?" at the end of this Instructions for Use.
  • RAPAMUNE Oral Solution can develop a slight haze when it is refrigerated. If this happens, bring the RAPAMUNE Oral Solution to room temperature and then gently shake the bottle until the haze goes away.
  • Only use a glass or plastic cup to dilute RAPAMUNE Oral Solution.
  • If you are a caregiver, do not let RAPAMUNE Oral Solution come in contact with your skin or eyes. If you get the oral solution on your skin, wash the area well with soap and water. If you get the oral solution in your eyes, rinse with plain water.
  • If you spill RAPAMUNE Oral Solution, dry the area with a dry paper towel and then wipe the area with a wet paper towel. Throw away the paper towels in the trash and wash your hands well with soap and water.

Each RAPAMUNE Oral Solution carton contains:

Figure
a)
a 2 oz. (60 mL fill) amber glass bottle of sirolimus (concentration of 1 mg/mL)
b)
1 oral syringe adapter for fitting into the neck of the bottle
c)
enough disposable amber oral syringes and caps for daily dosing
d)
1 carrying case

You will also need:

  • glass or plastic cup
  • 6 oz. of water or orange juice only
Figure 1: Opening the bottle
Figure 1 1. Open the solution bottle.
  • Remove the safety cap by squeezing the tabs on each side of the cap and twisting counterclockwise (Figure 1).
Figure 2: Inserting adapter
Figure 2
2. The first time you use a bottle of RAPAMUNE Oral Solution:
  • Insert the oral syringe adapter (plastic tube with stopper) tightly into the bottle until it is even with the top of the bottle (Figure 2).
  • Do not remove the oral syringe adapter from the bottle once inserted.
Figure 3: Inserting syringe 3. Use a new disposable amber oral syringe for each dose of RAPAMUNE Oral Solution.
Figure 3
  • Fully push down (depress) on the plunger of the disposable amber oral syringe.
  • Then, tightly insert the oral syringe into the opening in the adapter (Figure 3).
Figure 4: Withdrawing solution 4. Withdraw the prescribed amount of RAPAMUNE Oral Solution:
Figure 4
  • Gently pull back the plunger of the syringe until the level of the oral solution is even with the marking on the syringe for your prescribed dose.
  • Always keep the bottle in an upright position.
  • If bubbles form within the oral solution in the syringe, empty the syringe into the bottle and repeat step 4 (Figure 4).
  • You may need to repeat step 4 more than once to draw up your prescribed dose.
Figure 5: Capping syringe 5. If your doctor tells you to carry your medicine with you:
Figure 5
  • If you need to carry your RAPAMUNE Oral Solution in a filled syringe, place a cap securely on each syringe. The cap should snap into place (Figure 5).
  • Place the capped syringe in the enclosed carrying case (Figure 6). If you need more than 1 carrying case, talk with your doctor or pharmacist.
Figure 6: Placing syringe in carrying case
Figure 6
Figure 7: Emptying syringe into glass 6. Taking a dose of RAPAMUNE Oral Solution:
Figure 7
  • Choose a clean flat work surface. Place a clean paper towel on the work surface. Wash and dry your hands.
  • 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 1 minute and drink right away (Figure 7).
  • If more than 1 syringe is needed for your prescribed dose, empty the oral solution from each syringe into the same glass or plastic cup of water or orange juice.
  • 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. Do not mix RAPAMUNE Oral Solution with apple juice, grapefruit juice, or other liquids. Only glass or plastic cups should be used to mix RAPAMUNE Oral Solution.
  • The syringe and cap should be used only one time and then thrown away.
  • Throw away the paper towel and clean the work surface. Wash your hands.
7. Always store the bottles of medication in the refrigerator.

How should I store RAPAMUNE?

  • Store bottles of RAPAMUNE Oral Solution in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Protect from light.
  • Store RAPAMUNE Oral Solution that is in a syringe at room temperature up to 77°F (25°C) or in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 24 hours.
  • If necessary, bottles of RAPAMUNE Oral Solution can be stored at room temperature up to 77°F (25°C) for up to 15 days.
  • When a bottle of RAPAMUNE Oral Solution is opened, it should be used within 1 month.
  • Use any diluted RAPAMUNE Oral Solution right away.

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

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

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LAB-0579-3.0
Revised: April 2019

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