Rash

Patient Evaluation
Patient Counseling
Patient Monitoring
Medical Intervention

Patient Evaluation

Conduct a visual inspection of rash characteristics.

Color

Assess the hue, intensity, uniformity, blanching, and color changes in the rash.

Moisture

Check for dryness, moisture, fluid filled lesions, and texture.

Morphology

Identify the fundamental type of primary and secondary lesions, and assess their pattern.

Distribution

Assess characteristic distributions such as if the rash is localized or generalized, if there is symmetry, if the lesions have spread, or if the distribution correlates with any symptoms.

Patient Counseling

Educate patients on symptoms that require intervention, timely reporting of events, dietary adjustments, and stool monitoring.

Inform patients that the median time to onset of rash is 12 days (range, 10–15 days).

The potential for capivasertib-associated rash and symptoms requiring urgent care

Inform patients that capivasertib-associated rash is likely to occur within the first treatment cycle and instruct them to notify the healthcare team at the first occurrence. Emphasize that the patient should notify their HCP immediately with any of the following symptoms:

Swelling
Chest pain
Shortness of breath
Fever
Chills
Worsening rash
Blistering and peeling
Suspected infection

View Incidence

Remote assessment of rash

Encourage patients to capture photos of their rash and share via their electronic medical record or patient portal for real-time assessment.

Guidance for patient reporting

Instruct patients to notify the healthcare team at the first occurrence of capivasertib-associated rash.

Practical advice for skin protective measures

Advise patients to:

Avoid unprotected exposure to heat and sunlight

Refrain from using possible skin irritants

Use mild, fragrance-free soap

Regularly apply emollients

Rash – incidence

Frequency, time to occurrence, and dose modification of diarrhea under treatment with capivasertib+ fulvestrant in CAPItello-291
¹

1. Iyengar NM, O'Shaughnessy JA, Moore HN, et al. Optimizing clinical monitoring and management guidelines for capivasertib in HR-positive/HER2-negative advanced breast cancer: expert opinion. npj Breast Cancer. 2025;12(1):16. doi:10.1038/s41523-025-00864-2.

	Capivasertib + fulvestrant Overall population (n=355)
Rash of any grade %	38.0
Grade ≥3*	12.1
Median days to the onset of rash	12 (range 10–15)
Rash leading to dose modification %
Dose interruption	11.8
Dose reduction	4.5
Permanent discontinuation	4.5

Values in the PI may differ slightly from those reported in the Capivasertib Expert Opinion publication due to different cut-off dates and the inclusion of different preferred terms.

*No grade 4 diarrhea ARs were reported.

1. Iyengar NM, O'Shaughnessy JA, Moore HN, et al. Optimizing clinical monitoring and management guidelines for capivasertib in HR-positive/HER2-negative advanced breast cancer: expert opinion. npj Breast Cancer. 2025;12(1):16. doi:10.1038/s41523-025-00864-2.

Patient Monitoring

Estimate body surface area involved to select interventions.

Estimating BSA

Estimate the body surface area (BSA) involved using easy-to-remember tools like the palm method.

The palm method states that one palm, including fingers, equals ~1% BSA.

Medical Intervention

Consider treatment strategies based on grade, including antihistamines, topical corticosteroids, oral/systemic steroids (proactively intensify FG monitoring, introduce additional glucose testing 1–2 days after initiation of steroids, and closely follow-up thereafter), and capivasertib dose modifications.

Initiate rash prophylaxis with a non sedating H1 antihistamine

Initiate a prophylactic non sedating H1 antihistamine QD or BID, starting on day 1 of capivasertib treatment, for the first 8 weeks of treatment.

Examples of non sedating H1 antihistamines include:

Cetirizine 10 mg
Levocetirizine 5 mg
Loratadine 10 mg
Fexofenadine 180 mg

Maintain antihistamines throughout capivasertib treatment

If patients experience minimal/no rash during this 8 week period, antihistamines may be continued QD for the duration of capivasertib treatment.

Capivasertib dose modifications:

Maintain same dose

PI Recommendation

H1 Antihistamines

Initiate/escalate nonsedating H1 antihistamines in the morning and sedating H1 antihistamines at bedtime for pruritus.

Nonsedating agents include cetirizine 10 mg, levocetirizine 5 mg, loratadine 10 mg, or fexofenadine 180 mg
- Escalate as necessary up to cetirizine 40 mg/day, levocetirizine 15 mg/day, loratadine 20 mg/day, or fexofenadine 360 mg/day
Sedating agents include diphenhydramine 25–50 mg or hydroxyzine 25–50 mg

H2 receptor antagonists

Consider adding a H2 receptor antagonist, such as famotidine 40 mg daily, for symptomatic control of rash, including pruritus.

H2 receptor antagonists are not primarily used to treat rash, but they may provide symptomatic relief of pruritus when used adjunctively with H1 antihistamines

Topical corticosteroids

Topical corticosteroids can be used BID in patients not responding to oral medications, in patients with pruritus, or at patient’s request.

The choice of topical corticosteroids should be guided by the location of the rash. Steroid potency by location

Oral/systemic steroids

Consider a course of oral/systemic steroids, if rash/symptoms are not controlled with the therapies outlined above.

E.g. Prednisone 0.5 mg/kg/day or equivalent
Taper oral/systemic steroids over 7–10 days, depending on the severity of the rash or symptoms and time to improvement
Proactively intensify FG monitoring, introduce additional glucose testing 1–2 days after initiation of oral or systemic steroids, and closely follow-up thereafter

Capivasterib dosing

Consider a short delay in starting the next capivasertib dosing week.

Patients who experience low grade rash/other symptoms during the 4 days on capivasertib treatment may have significant recovery during the 3 days off

Capivasertib dose modifications:

Initial dose modification:

Withhold dose until grade ≤1

Dosing at recovery:

Recovery to grade ≤1 rash – resume at the same dose
Persistent or recurrent grade 2 rash – resume at one lower dose

PI Recommendation

H1 Antihistamines

Initiate/escalate nonsedating H1 antihistamines in the morning and sedating H1 antihistamines at bedtime for pruritus.

Nonsedating agents include cetirizine 10 mg, levocetirizine 5 mg, loratadine 10 mg, or fexofenadine 180 mg
- Escalate as necessary up to cetirizine 40 mg/day, levocetirizine 15 mg/day, loratadine 20 mg/day, or fexofenadine 360 mg/day
Sedating agents include diphenhydramine 25–50 mg or hydroxyzine 25–50 mg

H2 receptor antagonists

Consider adding a H2 receptor antagonist, such as famotidine 40 mg daily, for symptomatic control of rash, including pruritus.

H2 receptor antagonists are not primarily used to treat rash, but they may provide symptomatic relief of pruritus when used adjunctively with H1 antihistamines

Topical corticosteroids

Topical corticosteroids can be used BID in patients not responding to oral medications, in patients with pruritus, or at patient’s request.

The choice of topical corticosteroids should be guided by the location of the rash. Steroid potency by location

Oral/systemic steroids

Consider a course of oral/systemic steroids, if rash/symptoms are not controlled with the therapies outlined above.

E.g. Prednisone 1 mg/kg/day or equivalent
Taper oral/systemic steroids over 7–10 days, depending on the severity of the rash or symptoms and time to improvement
Proactively intensify FG monitoring, introduce additional glucose testing 1–2 days after initiation of oral or systemic steroids, and closely follow-up thereafter

Specialist consult

Consider a dermatology consultation for persistent or recurrent grade ≥2 rash

Capivasertib dose modifications:

Initial dose modification:

Withhold dose until grade ≤1

Dosing at recovery:

Recovery to grade ≤1 rash in ≤28 days – resume at the same dose
Recovery to grade ≤1 rash >28 days – resume at one lower dose
Recurrent grade 3 rash – permanently discontinue capivasertib

PI Recommendation

H1 Antihistamines

Nonsedating H1 antihistamines can be dosed up to:

Cetirizine 40 mg/day, levocetirizine 15 mg/day, loratadine 20 mg/day, or fexofenadine 360 mg/day

Sedating H1 antihistamines can be utilized at bedtime for pruritus, including:

Diphenhydramine 25–50 mg or hydroxyzine 25–50 mg

H2 receptor antagonists

Consider adding a H2 receptor antagonist, such as famotidine 40 mg daily, for symptomatic control of rash, including pruritus.

H2 receptor antagonists are not primarily used to treat rash, but they may provide symptomatic relief of pruritus when used adjunctively with H1 antihistamines

Topical corticosteroids

Topical corticosteroids can be used BID in patients not responding to oral medications, in patients with pruritus, or at patient’s request.

The choice of topical corticosteroids should be guided by the location of the rash. Steroid potency by location

Oral/systemic steroids

Consider a course of oral/systemic steroids, if rash/symptoms are not controlled with the therapies outlined above.

E.g. Prednisone 1 mg/kg/day or equivalent
Taper oral/systemic steroids over 7–10 days, depending on the severity of the rash or symptoms and time to improvement
Proactively intensify FG monitoring, introduce additional glucose testing 1–2 days after initiation of oral or systemic steroids, and closely follow-up thereafter

Specialist consult

Consider a dermatology consultation for persistent or recurrent grade ≥2 rash

Capivasertib dose modifications:

Permanently discontinue capivasertib and assess the need for hospitalization

PI Recommendation

H1 Antihistamines

Nonsedating H1 antihistamines can be dosed up to:

Cetirizine 40 mg/day, levocetirizine 15 mg/day, loratadine 20 mg/day, fexofenadine 360 mg/day

Consider utilizing sedating H1 antihistamines at bedtime for pruritus, including:

Diphenhydramine 25–50 mg or hydroxyzine 25–50 mg

H2 receptor antagonists

Consider adding a H2 receptor antagonist, such as famotidine 40 mg daily, for symptomatic control of rash, including pruritus.

H2 receptor antagonists are not primarily used to treat rash, but they may provide symptomatic relief of pruritus when used adjunctively with H1 antihistamines

Topical corticosteroids

Topical corticosteroids can be used BID in patients not responding to oral medications, in patients with pruritus, or at patient’s request.

The choice of topical corticosteroids should be guided by the location of the rash. Steroid potency by location

Oral/systemic steroids

Consider a course of oral/systemic steroids, if rash/symptoms are not controlled with the therapies outlined above.

E.g. Prednisone 1 mg/kg/day or equivalent
Taper oral/systemic steroids over 7–10 days, depending on the severity of the rash or symptoms and time to improvement
Proactively intensify FG monitoring, introduce additional glucose testing 1–2 days after initiation of oral or systemic steroids, and closely follow-up thereafter

Specialist consult

Consider a dermatology consultation for persistent or recurrent grade ≥2 rash

Monitoring patients treated with oral/systemic steroids

If the patient is being treated with oral/systemic steroids, proactively intensify fasting glucose (FG) monitoring:

Additional glucose testing 1–2 days after steroid initiation

Important Safety Information

TRUQAP is contraindicated in patients with severe hypersensitivity to TRUQAP or any of its components.

Hyperglycemia

TRUQAP can cause severe hyperglycemia, including diabetic ketoacidosis and fatal outcomes.

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 metabolic decompensation occurred in 0.6% of patients, including diabetic ketoacidosis in 0.3%.

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 1 diabetes or Type 2 diabetes that is uncontrolled or requiring insulin at baseline as these patients were excluded from clinical studies. 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. Withhold TRUQAP in clinical situations known to increase the risk of severe hyperglycemia or ketoacidosis (eg, suspected serious infection or acute illness). Based on the severity of hyperglycemia, withhold, reduce dose, or permanently discontinue TRUQAP.

Diarrhea

TRUQAP can cause severe diarrhea associated with dehydration.

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

TRUQAP can cause cutaneous adverse reactions, which can be severe, including erythema multiforme (EM), palmar-plantar erythrodysesthesia (PPE), and drug reaction with eosinophilia and systemic symptoms (DRESS).

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.

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.

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.

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-authorized 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.

Please see full Prescribing Information, including Patient Information for TRUQAP.

You may report side effects related to AstraZeneca products

ADL	activities of daily living
AE	adverse event
AKT1/2/3	serine/threonine protein kinase 1/2/3
BID	twice daily
BMI	body mass index
BSA	body surface area
CYP3A	cytochrome P450, family 3, subfamily A
DKA	diabetic ketoacidosis
DRESS	drug reaction with eosinophilia and systemic symptoms
eGFR	estimated glomerular filtration rate
EM	erythema multiforme
ET	endocrine therapy
FDA	US Food and Drug Administration
FG	fasting glucose
GI	gastrointestinal

GLP-1R	glucagon-like peptide-1 receptor
HbA1c	hemoglobin A1C
HCP	healthcare professional
IV	intravenous
mBC	metastatic breast cancer
PI3K	phosphoinositide 3-kinase
PIK3CA	phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha
PTEN	phosphatase and tensin homolog
QD	once daily
SGLT2i	sodium-glucose co-transporter-2 inhibitor
spp	species
T2D	type 2 diabetes
TID	three times daily
TZD	thiazolidinedione
ULN	upper limit of normal

2. 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.

3. TRUQAP. Prescribing information.

Rash

Summary PDF:

Patient Evaluation

Color

Moisture

Morphology

Distribution

Important Safety Information

IMPORTANT SAFETY INFORMATION ABOUT TRUQAP® (capivasertib) tablets

ADVERSE REACTIONS

DRUG INTERACTIONS

INDICATION AND USAGE

Abbreviations

References