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RAPAMUNE® (sirolimus) How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

Since Rapamune is not absorbed through the skin, there are no special precautions. However, if direct contact of the oral solution occurs with the skin or eyes, wash skin thoroughly with soap and water; rinse eyes with plain water.

Do not use RAPAMUNE after the expiration date. The expiration date refers to the last day of that month.

16.1 Rapamune Oral Solution

Each Rapamune Oral Solution carton, NDC 0008-1030-06, contains one 2 oz (60 mL fill) amber glass bottle of sirolimus (concentration of 1 mg/mL), one oral syringe adapter for fitting into the neck of the bottle, sufficient disposable amber oral syringes and caps for daily dosing, and a carrying case.

Rapamune Oral Solution bottles should be stored protected from light and refrigerated at 2°C to 8°C (36°F to 46°F). Once the bottle is opened, the contents should be used within one month. If necessary, the patient may store the bottles at room temperatures up to 25°C (77°F) for a short period of time (e.g., not more than 15 days for the bottles).

An amber syringe and cap are provided for dosing, and the product may be kept in the syringe for a maximum of 24 hours at room temperatures up to 25°C (77°F) or refrigerated at 2°C to 8°C (36°F to 46°F). The syringe should be discarded after one use. After dilution, the preparation should be used immediately.

Rapamune Oral Solution provided in bottles may develop a slight haze when refrigerated. If such a haze occurs, allow the product to stand at room temperature and shake gently until the haze disappears. The presence of this haze does not affect the quality of the product.

16.2 Rapamune Tablets

Rapamune Tablets are available as follows:

  • NDC 0008-1040-05, 0.5 mg, tan, triangular-shaped tablets marked "RAPAMUNE 0.5 mg" on one side; bottle containing 100 tablets.
  • NDC 0008-1040-10, 0.5 mg, tan, triangular-shaped tablets marked "RAPAMUNE 0.5 mg" on one side; in Redipak® cartons of 100 tablets (10 blister cards of 10 tablets each).
  • NDC 0008-1041-05, 1 mg, white, triangular-shaped tablets marked "RAPAMUNE 1 mg" on one side; bottle containing 100 tablets.
  • NDC 0008-1041-10, 1 mg, white, triangular-shaped tablets marked "RAPAMUNE 1 mg" on one side; in Redipak® cartons of 100 tablets (10 blister cards of 10 tablets each).
  • NDC 0008-1042-05, 2 mg, yellow-to-beige triangular-shaped tablets marked "RAPAMUNE 2 mg" on one side; bottle containing 100 tablets.

Rapamune Tablets should be stored at 20°C to 25°C [USP Controlled Room Temperature] (68°F to 77°F). Use cartons to protect blister cards and strips from light. Dispense in a tight, light-resistant container as defined in the USP.

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