desired total dose. Use one dosage form or the other.
Administer AFINITOR DISPERZ (everolimus tablets for oral suspension) as a suspension only.
Administer AFINITOR DISPERZ orally once daily at the same time every day. Administer either consistently with food or consistently without food [see Clinical Pharmacology (12.3)].
Administer suspension immediately after preparation. Discard suspension if not administered within 60 minutes after preparation.
Prepare suspension in water only.
Using an oral syringe:
•Place the prescribed dose of AFINITOR DISPERZ into a 10-mL syringe. Do not exceed a total of 10 mg per syringe. If higher doses are required, prepare an additional syringe. Do not break or crush tablets.
•Draw approximately 5 mL of water and 4 mL of air into the syringe.
•Place the filled syringe into a container (tip up) for 3 minutes, until the AFINITOR DISPERZ tablets are in suspension.
•Gently invert the syringe 5 times immediately prior to administration.
•After administration of the prepared suspension, draw approximately 5 mL of water and 4 mL of air into the same syringe, and swirl the contents to suspend remaining particles. Administer the entire contents of the syringe.
Using a small drinking glass:
•Place the prescribed dose of AFINITOR DISPERZ into a small drinking glass (maximum size 100 mL) containing approximately 25 mL of water. Do not exceed a total of 10 mg of AFINITOR DISPERZ per glass. If higher doses are required, prepare an additional glass. Do not break or crush tablets.
•Allow 3 minutes for suspension to occur.
•Stir the contents gently with a spoon, immediately prior to drinking.
•After administration of the prepared suspension, add 25 mL of water and stir with the same spoon to re-suspend remaining particles. Administer the entire contents of the glass.
3 DOSAGE FORMS AND STRENGTHS
3.1 AFINITOR (everolimus) Tablets
2.5 mg tablet
White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “LCL” on one side and “NVR” on the other.
5 mg tablet
White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other.
7.5 mg tablet
White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “7P5” on one side and “NVR” on the other.
10 mg tablet
White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other.
3.2 AFINITOR DISPERZ (everolimus tablets for oral suspension)
2 mg tablet for oral suspension
White to slightly yellowish, round, flat tablets with a bevelled edge and no score, engraved with “D2” on one side and “NVR” on the other.
3 mg tablet for oral suspension
White to slightly yellowish, round, flat tablets with a bevelled edge and no score, engraved with “D3” on one side and “NVR” on the other.
5 mg tablet for oral suspension
White to slightly yellowish, round, flat tablets with a bevelled edge and no score, engraved with “D5” on one side and “NVR” on the other.
4 CONTRAINDICATIONS
AFINITOR is contraindicated in patients w |
