Afinitor (Everolimus) - Indications and Dosage

  INDICATIONS AND USAGE

AFINITOR^® is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.

  DOSAGE AND ADMINISTRATION

  Recommended D ose

The recommended dose of AFINITOR for treatment of advanced renal cell carcinoma is 10 mg, to be taken once daily at the same time every day, either with or without food  [see Clinical Pharmacology]. AFINITOR tablets should be swallowed whole with a glass of water. The tablets should not be chewed or crushed.

Continue treatment as long as clinical benefit is observed or until unacceptable toxicity occurs.

Dose M odifications

Management of severe and/or intolerable adverse reactions may require temporary dose reduction and/or interruption of AFINITOR therapy. If dose reduction is required, the suggested dose is 5 mg daily [see Warnings and Precautions].

Hepatic I mpairment:   For patients with moderate hepatic impairment (Child-Pugh class B), reduce the dose to 5 mg daily. AFINITOR has not been evaluated in patients with severe hepatic impairment (Child-Pugh class C) and should not be used in this patient population [se e Warnings and Precautions (5.6 ) and Use in Specific Populations].

Strong CYP3A4 I nducers: Avoid   the use of concomitant strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital). If patients require co-administration of a strong CYP3A4 inducer, consider increasing the AFINITOR dose from 10 mg daily up to 20 mg daily (based on pharmacokinetic data), using 5 mg increments. This dose of AFINITOR is predicted to adjust the AUC to the range observed without inducers. However, there are no clinical data with this dose adjustment in patients receiving strong CYP3A4 inducers. If the strong inducer is discontinued, the AFINITOR dose should be returned to the dose used prior to initiation of the strong CYP3A4 inducer   [see Drug   Interactions ] .

  DOSAGE FORMS AND STRENGTHS

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.

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.

HOW SUPPLIED/STORAGE AND HANDLING

5 mg   t ablets

White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other; available in:

Blisters of 28 tablets      NDC 0078-0566-51

Each carton contains 4 blister cards of 7 tablets each

10 mg   t ablets

White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other; available in:

Blisters of 28 tablets      NDC 0078-0567-51

Each carton contains 4 blister cards of 7 tablets each

Store AFINITOR (everolimus) tablets at 25° C (77°F); excursions permitted between 15°–30°C (59°–86°F). [See USP Controlled Room Temperature.] Store in the original container, protect from light and moisture. Keep this and all drugs out of the reach of children.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.^2-5 

AFINITOR tablets should not be crushed. Direct contact of crushed tablets with the skin or mucous membranes should be avoided. If such contact occurs, wash thoroughly as outlined in the references. Personnel should avoid exposure to crushed tablets.