Source: FDA, National Drug Code (US) Revision Year: 2023
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 PIK3CA/AKT1/PTEN-alteration as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
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.
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)].
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* | 6* | 7* |
|---|---|---|---|---|---|---|---|
| Morning | 2 × 200 mg | 2 × 200 mg | 2 × 200 mg | 2 × 200 mg | |||
| Evening | 2 × 200 mg | 2 × 200 mg | 2 × 200 mg | 2 × 200 mg |
* No dosing on day 5, 6 and 7.
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.
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 |
|---|---|---|
| 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. |
* Severity grading according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
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.
Store TRUQAP in original bottle at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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