Truqap

Warnings and Precautions, Hyperglycemia (

TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more

• •Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with TRUQAP based on the presence of one or more of the following genetic alterations in tumor tissue:
  PIK3CA/AKT1/PTEN
  . (
  2.1 Patient Selection

  Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with TRUQAP, based on the presence of one or more of the following genetic alterations in tumor tissue:

  PIK3CA/AKT1/PTEN [see Clinical Studies (14)]

  .

  Information on FDA-approved tests for the detection of

  PIK3CA, AKT1

  , and

  PTEN

  alterations is available at:

  http://www.fda.gov/CompanionDiagnostics

  .
  )
• •
  Recommended Dosage:
  400 mg orally twice daily, with or without food, for 4 days followed by 3 days off. (
  2.3 Recommended Dosage and Administration

  The recommended dosage of TRUQAP, in combination with fulvestrant, is 400 mg orally twice daily (approximately 12 hours apart) with or without food, for 4 days followed by 3 days off. Continue TRUQAP until disease progression or unacceptable toxicity.

  TRUQAP dosing schedule for each week is provided in Table 1.

  Table 1: TRUQAP Dosing Schedule for Each Week

  Day	1	2	3	4	5 No dosing on day 5, 6 and 7.	6	7
  Morning	2 x 200 mg	2 x 200 mg	2 x 200 mg	2 x 200 mg
  Evening	2 x 200 mg	2 x 200 mg	2 x 200 mg	2 x 200 mg

  Swallow TRUQAP tablets whole. Do not chew, crush, or split tablets prior to swallowing. Do not take tablets that are broken, cracked, or otherwise not intact.

  If a patient misses a dose within 4 hours of the scheduled time, instruct the patient to take the missed dose. If a patient misses a dose more than 4 hours of the scheduled time, instruct the patient to skip the dose and take the next dose at its usual scheduled time.

  If a patient vomits a dose, instruct the patient not to take an additional dose and take the next dose at its usual scheduled time.

  Refer to the fulvestrant Full Prescribing Information for recommended fulvestrant dosing information.

  For premenopausal and perimenopausal women, administer a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards.

  For men, consider administering a LHRH agonist according to current clinical practice standards.
  )

Tablets:

• •160 mg: beige film-coated, round, biconvex tablets debossed with ‘CAV’ above ‘160’ on one side and plain on the reverse.
• •200 mg: beige film-coated, capsule-shaped, biconvex tablets debossed with ‘CAV 200’ on one side and plain on the reverse.