In combination with fulvestrant for patients with HR+/HER2− aBC or mBC with PIK3CA, AKT1, or PTEN alterations following progression on or after ET ± CDK4/6i
Select patients based on FDA-approved tests for detection of PIK3CA, AKT1, and PTEN.
Dosing Schedule
In combination with fulvestrant,
Benefit-risk balance achieved with 4 days on, 3 days off, every week1
The recommended starting dose of TRUQAP is 400 mg taken orally twice daily, approximately 12 hours apart, 4 consecutive days on, 3 days off, every week
Select patients based on an FDA-approved test for detection of PIK3CA, AKT1, and PTEN alterations.
Evaluate FG and HbA1C prior to starting TRUQAP and at regular intervals during treatment. Verify pregnancy status of females of reproductive potential prior to initiating TRUQAP.
See the full Prescribing Information for additional information related to hyperglycemia.
Advise patients on the following when taking TRUQAP:
Can be taken with or
without food
Swallow whole
Do not chew, crush, or split tablets prior to swallowing. Do not take tablets that are broken, cracked, or otherwise not intact
Do not consume
grapefruit products
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 by 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 to take the next dose at its usual scheduled time
For pre-/perimenopausal women, administer an LHRH agonist according to current clinical practice standards. For men, consider administering an LHRH agonist according to current clinical practice standards
Continue treatment until disease progression or unacceptable toxicity occurs.
Evaluate FG and HbA1C prior to starting TRUQAP and at regular intervals during treatment. Verify pregnancy status of females of reproductive potential prior to initiating TRUQAP.
Can be taken with or without food
Swallow whole with water
Do not chew, crush, or split tablets prior to swallowing. Do not take tablets that are broken, cracked, or otherwise not intact
Do not consume
grapefruit products
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 by 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 to take the next dose at its usual scheduled time
For pre-/perimenopausal women, administer an LHRH agonist according to current clinical practice standards. For men, consider administering an LHRH agonist according to current clinical practice standards
Continue treatment until disease progression or unacceptable toxicity occurs.
Evaluate FG and HbA1C prior to starting TRUQAP and at regular intervals during treatment. Verify pregnancy status of females of reproductive potential prior to initiating TRUQAP.
Blister pack for select doses helps patients keep track of their treatment with TRUQAP
Includes easy-to-use instructions that help patients follow their medication schedule.
400 mg twice daily
Two 200-mg tablets BID
|NDC 0310-9501-02
320 mg twice daily
Two 160-mg tablets BID
|NDC 0310-9500-02
Dose Modifications
In combination with fulvestrant,
Recommended dosage modification of TRUQAP for ARs
In the event of a dose reduction, the dosing schedule remains the same: 4 consecutive days on, 3 days off, every week
First dose reduction
320 mg twice daily for 4 consecutive days followed by 3 days off
Two 160-mg tablets BID
Not actual size.
Second dose reduction
200 mg twice daily for 4 consecutive days followed by 3 days off
One 200-mg tablet BID
Not actual size.
- Permanently discontinue TRUQAP if unable to tolerate the second dose reduction
- 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
- 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
- Avoid concomitant use of TRUQAP with strong or moderate CYP3A inducers
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FG >ULN-160 mg/dL
or
FG >ULN-8.9 mmol/L
or
HbA1C >7%
- Consider initiation or intensification of oral antidiabetic 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
- Withhold TRUQAP
- 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
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
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
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
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AKT1=serine/threonine protein kinase 1; AR=adverse reaction; CARs=cutaneous adverse reactions; CTCAE=Common Terminology Criteria for Adverse Events; FG=fasting glucose; HbA1C=glycated hemoglobin; LHRH=luteinizing hormone-releasing hormone; PIK3CA=phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; PTEN=phosphatase and tensin homolog; ULN=upper limit of normal.
References: 1. TRUQAP® (capivasertib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 2. Miller C, Sommavilla R, Murphy D, Morris T, Khatun M, Cullberg M. Br J Clin Pharmacol. 2023;89(11):3330-3339. doi:10.1111/bcp.15831 3. Turner NC, Oliveira M, Howell SJ, et al. N Engl J Med. 2023;388(22):2058-2070. doi:10.1056/NEJMoa2214131
IMPORTANT SAFETY INFORMATION ABOUT TRUQAP® (capivasertib) tablets
TRUQAP is contraindicated in patients with severe hypersensitivity to TRUQAP or any of its components.
Hyperglycemia
Severe hyperglycemia, including diabetic ketoacidosis and fatal outcomes, can occur in patients treated with TRUQAP (n=355).
Increased fasting glucose (FG) from baseline occurred in 37% of patients treated with TRUQAP, including 11% of patients with Grade 2 (FG >160 to 250 mg/dL), 2% with Grade 3 (FG >250 to 500 mg/dL), and 1.1% with Grade 4 (FG >500 mg/dL) events. The median time to first occurrence of hyperglycemia was 15 days (range: 1 to 367). Dose reduction for hyperglycemia was required in 0.6% of patients and permanent discontinuation was required in 0.6% of patients. Diabetic ketoacidosis occurred in 0.3% of patients and diabetic metabolic decompensation in 0.6% of patients.
In CAPItello-291, 12% (43/355) of patients who received TRUQAP had an anti-hyperglycemic medication either initiated or changed during the study, including treatment with insulin in 4.8% (17/355) of patients.
The safety of TRUQAP has not been established in patients with Type I diabetes or diabetes requiring insulin. Patients with insulin-dependent diabetes were excluded from CAPItello-291.
Before initiating treatment with TRUQAP, test fasting glucose levels (fasting plasma glucose or fasting blood glucose), hemoglobin A1C (HbA1C) levels, and optimize fasting glucose. After initiating treatment with TRUQAP, monitor or self-monitor FG levels on Day 3 or 4 of the dosing week during weeks 1, 2, 4, 6, and 8; then monthly while on treatment with TRUQAP; and as clinically indicated. Monitor HbA1C levels every 3 months during treatment with TRUQAP and as clinically indicated. Patients with a history of well-controlled Type 2 diabetes mellitus may require intensified anti-hyperglycemic treatment and close monitoring of FG levels.
For patients who experience hyperglycemia during treatment with TRUQAP, monitor FG at least twice weekly, on days on and off TRUQAP, until FG decreases to baseline levels. During treatment with anti-diabetic medications, monitor FG at least once a week for 2 months, followed by once every 2 weeks, or as clinically indicated. Consider consultation with a healthcare practitioner with expertise in the treatment of hyperglycemia and initiation of FG monitoring at home for patients who have risk factors for hyperglycemia or who experience hyperglycemia. Advise patients on the signs and symptoms of hyperglycemia and counsel patients on lifestyle changes.
Withhold TRUQAP immediately when ketoacidosis is suspected. If ketoacidosis is confirmed, permanently discontinue TRUQAP. Based on the severity of hyperglycemia, withhold, reduce dose, or permanently discontinue TRUQAP.
Diarrhea
Severe diarrhea associated with dehydration occurred in patients who received TRUQAP (n=355).
Diarrhea occurred in 72% of patients. Grade 3 or 4 diarrhea occurred in 9% of patients. The median time to first occurrence was 8 days (range: 1 to 519). In the 257 patients with diarrhea, 59% required antidiarrheal medications to manage symptoms. Dose reductions were required in 8% of patients and 2% of patients permanently discontinued TRUQAP due to diarrhea. In patients with Grade ≥2 diarrhea (n=93) with at least 1 grade improvement (n=89), median time to improvement from the first event was 4 days (range: 1 to 154).
Monitor patients for signs and symptoms of diarrhea. Advise patients to increase oral fluids and start antidiarrheal treatment at the first sign of diarrhea while taking TRUQAP. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity.
Cutaneous Adverse Reactions
Cutaneous adverse reactions, which can be severe, including erythema multiforme (EM), palmar-plantar erythrodysesthesia, and drug reaction with eosinophilia and systemic symptoms (DRESS), occurred in patients who received TRUQAP (n=355).
Cutaneous adverse reactions occurred in 58% of patients. Grade 3 or 4 cutaneous adverse reactions occurred in 17% of patients receiving TRUQAP. EM occurred in 1.7% of patients and DRESS occurred in 0.3% of patients. Dose reduction was required in 7% of patients and 7% of patients permanently discontinued TRUQAP due to cutaneous adverse reactions.
Monitor patients for signs and symptoms of cutaneous adverse reactions. Early consultation with a dermatologist is recommended. Withhold, dose reduce, or permanently discontinue TRUQAP based on severity.
Embryo-Fetal Toxicity
Based on findings from animals and mechanism of action, TRUQAP can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRUQAP and for 1 month after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRUQAP and for 4 months after the last dose.
TRUQAP is used in combination with fulvestrant. Refer to the full Prescribing Information of fulvestrant for pregnancy and contraception information.
ADVERSE REACTIONS
Among the 355 patients who received TRUQAP in CAPItello-291, the most common (≥20%) adverse reactions, including laboratory abnormalities, were diarrhea (72%), cutaneous adverse reactions (58%), increased random glucose (57%), decreased lymphocytes (47%), decreased hemoglobin (45%), increased fasting glucose (37%), nausea and fatigue (35% each), decreased leukocytes (32%), increased triglycerides (27%), decreased neutrophils (23%), increased creatinine (22%), vomiting (21%), and stomatitis (20%).
In the 155 patients with PIK3CA/AKT1/PTEN alterations treated with TRUQAP + fulvestrant, dose reductions due to adverse reactions were reported in 21% of patients. Permanent TRUQAP discontinuation due to an adverse reaction occurred in 10% of patients. Dose interruptions of TRUQAP occurred in 39% of patients.
DRUG INTERACTIONS
Strong CYP3A Inhibitors: Avoid concomitant use with a strong CYP3A inhibitor. If concomitant use cannot be avoided, reduce the dose of TRUQAP and monitor patients for adverse reactions.
Moderate CYP3A Inhibitors: When concomitantly used with a moderate CYP3A inhibitor, reduce the dose of TRUQAP and monitor patients for adverse reactions.
Strong or Moderate CYP3A Inducers: Avoid concomitant use of TRUQAP with strong or moderate CYP3A inducers.
INDICATION AND USAGE
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.
You may report side effects related to AstraZeneca products
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INDICATION AND USAGE
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.
