Truqap Dosage

Generic name: CAPIVASERTIB 160mg
Dosage form: tablet, film coated
Drug class: Multikinase inhibitors

Medically reviewed by Drugs.com. Last updated on Nov 16, 2023.

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 Evaluation Before Initiating TRUQAP

Evaluate fasting blood glucose (FG) and hemoglobin A1C (HbA1C) prior to starting TRUQAP and at regular intervals during treatment [see Warnings and Precautions (5.1)].

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
* No dosing on day 5, 6 and 7.
Day	1	2	3	4	5*	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.

Dosage Modifications for Adverse Reactions

The recommended dose reductions for adverse reactions are listed in Table 2. Permanently discontinue TRUQAP if unable to tolerate the second dose reduction.

Table 2: Recommended Dose Reductions of TRUQAP for Adverse Reactions
TRUQAP	Dose and Schedule
First dose reduction	320 mg twice daily for 4 days followed by 3 days off
Second dose reduction	200 mg twice daily for 4 days followed by 3 days off

The recommended dosage modifications for adverse reactions are provided in Table 3.

Table 3: Recommended Dosage Modifications of TRUQAP for Adverse Reactions
Adverse Reaction	Severity*	TRUQAP Dosage Modification
* Severity grading according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Hyperglycemia (Fasting Glucose [FG]) [see Warnings and Precautions (5.1)]	FG > ULN‑160 mg/dL or FG > ULN‑8.9 mmol/L or HbA1C > 7%	Consider initiation or intensification of oral anti-diabetic treatment.
	FG 161‑250 mg/dL or FG 9‑13.9 mmol/L	Withhold TRUQAP until FG decrease ≤ 160 mg/dL (or ≤ 8.9 mmol/L). If recovery occurs in ≤ 28 days, resume TRUQAP at same dose. If recovery occurs in > 28 days, resume TRUQAP at one lower dose.
	FG 251‑500 mg/dL or FG 14‑27.8 mmol/L	Withhold TRUQAP until FG decrease ≤ 160 mg/dL (or ≤ 8.9 mmol/L). If recovery occurs in ≤ 28 days, resume TRUQAP at one lower dose. If recovery occurs in > 28 days, permanently discontinue TRUQAP.
	FG > 500 mg/dL or FG > 27.8 mmol/L or life-threatening sequelae of hyperglycemia at any FG level	For life-threatening sequelae of hyperglycemia or if FG persists at ≥ 500 mg/dL after 24 hours, permanently discontinue TRUQAP. If FG ≤ 500 mg/dL (or ≤ 27.8 mmol/L) within 24 hours, then follow the guidance in the table for the relevant grade.
Diarrhea [see Warnings and Precautions (5.2)]	Grade 2	Withhold TRUQAP until recovery to ≤ Grade 1. If recovery occurs in ≤ 28 days, resume TRUQAP at same dose or one lower dose as clinically indicated. If recovery occurs in > 28 days, resume at one lower dose as clinically indicated. For recurrence, reduce TRUQAP by one lower dose.
	Grade 3	Withhold TRUQAP until recovery to ≤ Grade 1. If recovery occurs in ≤ 28 days, resume TRUQAP at same dose or one lower dose as clinically indicated. If recovery occurs in > 28 days, permanently discontinue TRUQAP.
	Grade 4	Permanently discontinue TRUQAP.
Cutaneous Adverse Reactions [see Warnings and Precautions (5.3)]	Grade 2	Withhold TRUQAP until recovery to ≤ Grade 1. Resume TRUQAP at the same dose. Persistent or recurrent: reduce TRUQAP by one lower dose.
	Grade 3	Withhold TRUQAP until recovery to ≤ Grade 1. If recovery occurs in ≤ 28 days, resume TRUQAP at same dose. If recovery occurs in > 28 days, resume TRUQAP at one lower dose. For recurrent Grade 3, permanently discontinue TRUQAP.
	Grade 4	Permanently discontinue TRUQAP.
Other Adverse Reactions [see Adverse Reactions (6.1)]	Grade 2	Withhold TRUQAP until recovery to ≤ Grade 1. Resume TRUQAP at the same dose.
	Grade 3	Withhold TRUQAP until recovery to ≤ Grade 1. If recovery occurs in ≤ 28 days, resume TRUQAP at same dose. If recovery occurs in > 28 days, resume TRUQAP at one lower dose.
	Grade 4	Permanently discontinue TRUQAP.

Dosage Modifications for Strong and Moderate CYP3A Inhibitors

Avoid concomitant use with strong CYP3A inhibitors. If concomitant use with a strong CYP3A inhibitor cannot be avoided, reduce the dosage of TRUQAP to 320 mg orally twice daily for 4 days followed by 3 days off [see Drug Interactions (7.1)].

When concomitantly used with a moderate CYP3A inhibitor, reduce the dosage of TRUQAP to 320 mg orally twice daily for 4 days followed by 3 days off.

After discontinuation of a strong or moderate CYP3A inhibitor, resume the TRUQAP dosage (after 3 to 5 half-lives of the inhibitor) that was taken prior to initiating the strong or moderate CYP3A inhibitor.