- Patient Evaluation
- Patient Counseling
- Patient Monitoring
- Medical Intervention
Patient Evaluation
Conduct a visual inspection of rash characteristics.
1
Patient Counseling
Educate patients on symptoms that require intervention, timely reporting of events, dietary adjustments, and stool monitoring.
1
Inform patients that the median time to onset of rash is 12 days (range, 10–15 days).
2
Rash – incidence
Frequency, time to occurrence, and dose modification of diarrhea under treatment with capivasertib+ fulvestrant in CAPItello-291
1
| 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.
1
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.
1
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.
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
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
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
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
- 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
Important Safety Information