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
Managing your patients’ treatment experiences
Together, we can work to help improve your patients’ treatment experiences with TRUQAP + fulvestrant. We have information and resources that can help your patients manage dosing schedules and prepare for adverse reactions.
Dosing
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 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.
Explore mechanism of
action
See TRUQAP results
AR Management
Monitoring your patients & management of adverse reactions
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Hyperglycemia in CAPItello-2911
Hyperglycemia in patients receiving TRUQAP + fulvestrant (n=355)
Severe hyperglycemia, including diabetic ketoacidosis and fatal outcomes, can occur in patients treated with TRUQAP.
CAPItello-291 allowed for patients with HbA1C <8% and diabetes not requiring insulin.
37%
experienced increase in FG from baseline
3.1%
experienced Grade 3 or 4
15
days (range: 1-367 days) median time to first occurrence of hyperglycemia
0.6%
discontinued TRUQAP due to hyperglycemia
0.6%
required dose reduction of TRUQAP
Counsel patients at treatment initiation1-3
- Evaluate FG, HbA1C, concurrent medications,* and your patients’ medical histories. Consider consulting an HCP with expertise in treating hyperglycemia and initiation of FG monitoring at home for patients who have risk factors for or who experience hyperglycemia
- Inform your patients to seek medical help if they experience signs and symptoms of hyperglycemia or ketoacidosis:
- Excessive thirst
- Dry mouth
- Increased urination
- Blurred vision
- Increased appetite with weight loss
- Abdominal pain
- Unusual tiredness
- Confusion
- Nausea or vomiting
- Fruity odor on breath
- Dry or flushed skin
- Difficulty breathing
- Sleepiness
- Advise patients on how changes to diet and lifestyle may help in the overall approach to managing treatment-related hyperglycemia: get regular exercise, limit use of alcohol, tobacco, and/or other substances, maintain a healthy diet (low in sugar and fat) and weight, and reduce/manage stress levels
Monitor patients periodically during therapy1
Test FG1
- Monitor or self-monitor FG on Day 3 or 4 of the dosing week during weeks 1, 2, 4, 6, and 8; then evaluate monthly while on TRUQAP and as clinically indicated
- Patients with a history of well-controlled type 2 diabetes mellitus may require intensified antihyperglycemic treatment and close monitoring of fasting glucose levels
- If hyperglycemia develops after initiating TRUQAP, monitor FG at least twice weekly, on days on and off TRUQAP, until FG decreases to baseline levels
- For patients on antihyperglycemic medication, monitor FG at least once a week for 2 months, followed by once every 2 weeks, or as clinically indicated
Test HbA1C1
- Every 3 months during treatment duration and as clinically indicated
Patients with the following characteristics may have a higher risk of hyperglycemia3,4:
- History of diabetes mellitus
- Obesity (BMI ≥30)
- Elevated FG and/or HbA1C levels
- Use of concomitant systemic corticosteroids
- Infections
Explore recommended dosage modifications
*Patients should avoid concomitant use of TRUQAP with strong or moderate CYP3A inducers.1
Diarrhea in CAPItello-2911
Diarrhea in patients receiving TRUQAP + fulvestrant (n=355)
72%
experienced any grade
9%
experienced Grade 3 or 4
8
days (range: 1-519 days) median time to first occurrence
4
days (range: 1-154 days) median time to at least 1 grade improvement (n=89)*
2%
discontinued TRUQAP due to diarrhea
8%
required dose reduction of TRUQAP
In CAPItello-291, primary prophylaxis for diarrhea was not administered prior to initiation of TRUQAP + fulvestrant5
Counsel patients at treatment initiation1,6-8
- Tell your patients that taking TRUQAP with food may reduce the risk of diarrhea†
- If diarrhea symptoms occur, instruct your patients to start antidiarrheal treatment and increase oral fluids to maintain hydration and electrolyte balance, and use skin barrier creams to prevent/reduce skin irritation
- Inform your patients to seek medical attention if they have:
- Dark urine
- Dry mouth and skin
- Moderate to severe abdominal pain
- Black stools
- Rapid/irregular heartbeat
- Fever (100.5 °F or higher)
- Dizziness
- Blood in stools
- Advise patients to consider dietary modifications, such as eliminating food with lactose, avoiding spicy foods, reducing intake of insoluble fiber, limiting caffeine and alcohol intake, and staying hydrated
Monitor patients periodically during therapy1,7
Monitor for:
- Loose, watery stools
- Frequent bowel movements
- Dehydration
How to grade diarrhea9
Grade 1:
- Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline
Grade 2:
- Increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL
Grade 3:
- Increase of ≥7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL
Grade 4:
- Life-threatening consequences; urgent intervention indicated
For persistent Grade 1 diarrhea, consider secondary prophylaxis with antidiarrheal treatment such as loperamide5
*In patients with Grade ≥2 diarrhea (n=93).1
†Results from a phase 1, single-center, open-label, randomized, crossover study designed to investigate the effect of food and acid-reducing agents on the pharmacokinetic profile of TRUQAP.6
CARs in CAPItello-2911
CARs in patients receiving TRUQAP + fulvestrant (n=355)
58%
experienced any grade
17%
experienced Grade 3 or 4
13
days (range: 1-575 days) median time to first occurrence
12
days (range: 2-544 days) median time to at least 1 grade improvement (n=104)†
7%
of patients required dose reductions
7%
of patients discontinued TRUQAP due to CARs
Examples of CARs you may see in your patients10:
- Rash maculopapular‡
- Pruritus‡
- Dry skin
- Erythema
- Erythema multiforme (EM)
- Drug eruption
- Rash erythematous
- Dermatitis
- Palmar-plantar erythrodysesthesia syndrome
- Dermatitis exfoliative generalized
- Rash pustular
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Rash follicular
- Toxic skin eruption
Rash, a cutaneous adverse reaction, in patients receiving TRUQAP + fulvestrant (n=355)4§
38%
experienced any grade
12%
experienced Grade 3 or 4
12
days (range: 10-15 days) median time to first occurrence for rash
4.5%
discontinued TRUQAP due to rash
4.5%
required dose reduction of TRUQAP
In CAPItello-291, primary prophylaxis for rash was not administered prior to initiation of TRUQAP + fulvestrant5
Counsel patients at treatment initiation
- Inform your patients to seek medical attention if they experience11:
- Itching, pain, or troubling symptoms accompanying rash
- Rash in the mouth or nose
- Fever (100.5 °F or higher)
- Unexplained skin worsening
- Blistering/peeling/open areas in the skin
- Signs of an allergic reaction (swelling, chest pain, or difficulty breathing)
- Advise your patients to report any signs or symptoms to their healthcare team as soon as they occur and to consider lifestyle changes to help prevent or avoid exacerbating CARs: Use mild soaps and lotions without perfumes, be gentle when washing and drying the skin, protect skin from the sun (sunscreen or protective clothing), and wear loose, nonirritating clothing1,11
- Consider an early consultation with a dermatologist1
Monitor patients periodically during therapy1
Monitor for:
- Reddening of the skin
- Skin peeling
- Blistering on skin, lips, eyes, or mouth
- Fever
- Dry skin
How to grade CARs
Grading will depend on the type of CARs.9
How to grade rash maculopapular:
Grade 1
Macules/papules covering <10% BSA with or without symptoms
Grade 2
Macules/papules covering 10%-30% BSA with or without symptoms; limiting instrumental ADL; rash covering >30% BSA with or without mild symptoms
Grade 3
Macules/papules covering >30% BSA with moderate or severe symptoms; limiting self-care ADL
Distribution of cutaneous adverse reactions on the body will vary by case.
For persistent rash, consider secondary prophylaxis with topical steroids and/or nonsedating oral antihistamines5
*CARs include butterfly rash, dermatitis, allergic dermatitis, dry skin, eczema, erythema multiforme, hand dermatitis, palmar-plantar erythrodysesthesia syndrome, pruritus, rash, erythematous rash, maculopapular rash, papular rash, skin discoloration, skin fissures, skin reaction, skin ulcer, urticaria, purpura, erythema, and drug eruption.1
†In patients with Grade ≥2 cutaneous adverse reaction (n=116).1
‡Occurred in >10%.10
§Rash includes rash macular, rash maculopapular, rash papular, and rash pruritic.4
Management of ARs for TRUQAP + fulvestrant
Learn about adverse reaction management, and understand the importance of identifying and addressing signs early.
KOL Video #2
Downloadable APP & Nurse Resources
The following resources are available for download.
Downloadable Patient Resources
The following resources are available for download.
Helping patients access the care they need
The AstraZeneca Access 360TM program provides personal support to help streamline access and reimbursement for TRUQAP. To learn more about the Access 360 program, please call 1-844-ASK-A360 (1-844-275-2360), Monday through Friday, 8 AM - 6 PM ET, or visit www.MyAccess360.com.
Learn how to enroll your patients in Access 360
aBC=locally advanced breast cancer not amenable to resection or radiation therapy with curative intent; ADL=activities of daily living; AKT1=serine/threonine protein kinase 1; AR=adverse reaction; BMI=body mass index; BSA=body surface area; CDK4/6i=cyclin-dependent kinase 4/6 inhibitor; ET=endocrine therapy; FG=fasting glucose; HbA1C=glycated hemoglobin; HER2−=human epidermal growth factor receptor 2 negative; HR+=hormone receptor positive; LHRH=luteinizing hormone-releasing hormone; mBC=metastatic breast cancer; PIK3CA=phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; PTEN=phosphatase and tensin homolog.
References: 1. TRUQAP® (capivasertib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 2. Sampayo V, Tofthagen C. Hyperglycemia and cancer: an algorithm to guide oncology nurses. Clin J Oncol Nurs. 2017;21(3):345-352. doi:10.1188/17.CJON.345-352 3. Yale Medicine. Hyperglycemia: Symptoms, Causes, and Treatments. Accessed May 8, 2024. https://www.yalemedicine.org/conditions/hyperglycemia-symptoms-causes-treatments 4. Rugo HS, Oliveira M, Howell SJ, et al. Capivasertib and fulvestrant for patients with hormone receptor-positive advanced breast cancer: characterization, time course, and management of frequent adverse events from the phase III CAPItello-291 study. ESMO Open. 2024;9(9):103697. doi: 10.1016/j.esmoop.2024.103697 5. Turner NC, Oliveira M, Howell SJ, et al. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med. 2023;388(22):2058-2070. doi:10.1056/NEJMoa2214131 6. Miller C, Sommavilla R, Murphy D, Morris T, Khatun M, Cullberg M. The effect of food and acid-reducing agents on the pharmacokinetic profile of capivasertib: results from a randomized, crossover study. Br J Clin Pharmacol. 2023;89(11):3330-3339. doi:10.1111/bcp.15831 7. ChemoCare. Diarrhea and Chemotherapy. Accessed October 9, 2025. https://dctd.cancer.gov/research/ctep-trials/for-sites/adverse-events/ctcae-v5-5x7.pdf 8. Benson AB 3rd, Ajani JA, Catalano RB, et al. Recommended guidelines for the treatment of cancer treatment-induced diarrhea. J Clin Oncol. 2004;22(14):2918-2926. doi:10.1200/JCO.2004.04.132 9. US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. November 27, 2017. Accessed December 12, 2025. https://dctd.cancer.gov/research/ctep-trials/for-sites/adverse-events/ctcae-v5-5x7.pdf 10. Data on file. REF-235937. AstraZeneca Pharmaceuticals LP. 11. ChemoCare. Rash and Chemotherapy. Accessed December 12, 2025. https://chemocare.com/sideeffect/rash
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.
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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.
