Trodelvy® (sacituzumab govitecan-hziy)
Incidence and Management of Rash
Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.
Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.
Trodelvy® (sacituzumab govitecan-hziy)
Incidence and Management of Rash
Gilead continually assesses safety data from all sources for unidentified drug reactions and updates the product label information accordingly to reflect the safety profile of SG. Because case reports of potential adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure. For this reason, Gilead does not provide information from post-marketing spontaneous reports.
Information summarized in this document includes data for SG monotherapy (10 mg/kg IV on Days 1 and 8 of a 21-day treatment cycle) from phase 2 and 3 clinical studies that constitute the largest pooled safety population of SG.
Some data may be outside of the US FDA-approved prescribing information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA-approved prescribing information.
The full indication, important safety information, and boxed warnings for neutropenia and diarrhea are available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.
Relevant Product Labeling1
Dosage and Administration
Recommended dosage
Premedication
Prior to each dose of SG, premedication for prevention of infusion reactions is recommended. Premedicate with antipyretics, H1 and H2 blockers prior to infusion, and corticosteroids may be used for patients who had prior infusion reactions.
Management of adverse reactions may require temporary interruption, dose reduction, or treatment discontinuation of SG as described in Tables 1 and 2. Do not re-escalate the SG dose after a dose reduction for adverse reactions has been made.
Table 1. Dosage Reduction Levels1
Dose Level | Dosage and Schedule |
Recommended starting dose | 10 mg/kg once weekly on Days 1 and 8 of 21-day treatment cycles |
First dose reduction | Reduce to 7.5 mg/kg |
Second dose reduction | Reduce to 5 mg/kg |
Requirement for further dose reduction | Permanently discontinue SG |
The recommended dosage modifications for adverse infusion-related reactions (IRRs) are provided in Table 2.
Table 2. Dose Modifications for IRRs1
Severity | Dose Modification |
Grade 1-3 IRRs | Slow infusion rate or interrupt the infusion |
Grade 4 IRRs | Discontinue SG |
Warnings and Precautions
Hypersensitivity and IRRs
SG can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions.
Incidence and Management of Rash in SG Clinical Studies
Pooled Safety Analysis
A pooled safety analysis (Figure 1) examined exposure to SG 10 mg/kg IV as monotherapy in 1063 patients from four studies of multiple epithelial tumors (IMMU-132-01,2 ASCENT,3 TROPiCS-02,4 and TROPHY-U-015-7). These studies included patients with metastatic triple negative breast cancer (mTNBC), hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (HR+/HER2- mBC), and metastatic urothelial cancer (mUC).8
The median treatment duration of SG in this population was 4.1 (range: 0–63) mo1; rash was not among the most common (≥15%) treatment-emergent adverse events (TEAEs) reported.8
Figure 1. Pooled Clinical Studies8
Abbreviations: CKD4/6i=cyclin-dependent 4/6 inhibitor; CPI=checkpoint inhibitor therapies; PLT=platinum; TNBC=triple-negative breast cancer.
Premedication and Management of SG-Related Toxicities
Premedication for the prevention of IRRs such as rash included antihistamines that were to be administered before each SG infusion. Corticosteroids (hydrocortisone 50 mg or equivalent [oral or IV]) could also be administered prior to subsequent infusions if the patient experienced an IRR with a previous infusion.2,9-11
SG-associated toxicities were assessed and managed in accordance with standard clinical/institutional practices and accepted treatment guidelines.2,9-11
Metastatic Breast Cancer Studies
Treatment durations and rash-related safety data for the ASCENT study in patients with mTNBC are shown in Table 3. No frequency data are available for pre-infusion medication use of corticosteroids or systemic antihistamines for the prevention of IRRs in either treatment group.3
Table 3. ASCENT: Treatment Duration and Rash-Related Safety Data in OSP3,12
| SG (n=258) | TPC (n=224) |
Treatment duration, median (range), mo | 4.4 (0.03–22.9) | 1–1.6a |
Any-grade TRAE of rash of any kind, n (%) | 22 (9) | 3 (1) |
Grade 3 TRAE of rash, n | 1 | 1 |
Any-grade TEAE of rash, n (%) | 32 (12) | 12 (5) |
Abbreviations: OSP=overall safety population; TPC=treatment of physicians’ choice; TRAE=treatment-related adverse event.
aTreatment durations for TPC agents: eribulin, 1.6 (0.03–15.3) mo; vinorelbine, 1 (0.03–11.5) mo; gemcitabine, 1.4 (0.2–8.1) mo; and capecitabine, 1.2 (0.3–10.6) mo. Data were unavailable for 6 patients who received capecitabine.
Within the TROPiCS-02 study in patients with HR+/HER2- mBC, IRRs were defined as symptoms, including rash, that occurred within the first 6 hours after SG administration and could occur at any cycle.10 Treatment durations and pre-infusion use of medications are shown in Table 4. Rash was not among the any-grade TRAEs with a reported incidence of ≥10%.13
Table 4. TROPiCS-02: Treatment Duration and Pre-Infusion Medications4,14-16
| SG (n=268) | TPC (n=249) | |
Treatment duration, median (range), mo | 4.1 (0.03–24.2) | 2.3 (0.03–22.3)a | |
Pre-infusion/concomitant use of medication,b % | Corticosteroids | 54 | 39 |
Systemic antihistamines | 72 | 21 | |
aTreatment durations for TPC agents: eribulin, 3.4 (0.03–18.3) mo; vinorelbine, 1.2 (0.03–8.1) mo; gemcitabine, 1.5 (0.03–22.3) mo; and capecitabine, 4.5 (0.2–12.9) mo.
bData are from the ITT population (N=543). Use of pre-infusion medication in the OSP was not reported.13
Metastatic Urothelial Cancer Study
Within the multi-cohort TROPHY-U-01 study in mUC, patients in Cohort 1 received a median of 6 SG cycles; treatment duration and rash-related TRAEs are shown in Table 5.17,18 All adverse events associated with rash were Grade ≤2.5
Table 5. TROPHY-U-01 Cohort 1: Treatment Duration and Rash‑Related TRAEs5,17
| SG (N=113) | |
Treatment duration, median (range), mo | 3.7 (0–20) | |
Rash-related TRAEs, % | Maculopapular rash | 7 |
Skin rash | 6 | |
In Cohort 2, patients treated with SG had median (range) follow-up duration of 9.3 (0.5–30.6) mo; median treatment duration was not provided for this cohort. Rash was not among the reports of any-grade TRAEs with an incidence of >20%.18
IRRs were defined as symptoms, including rash, that occurred within the first 6 hours after SG administration and could occur at any cycle.11 No frequency data are available for pre‑infusion medication use for the prevention of IRRs in the SG arms within these two cohorts.5,17,18
Metastatic Epithelial Cancer Study
Within IMMU-132-01, in patients with various advanced epithelial cancers (including mTNBC, HR+/HER2- mBC, or mUC), 402 of the 495 patients in the OSP received SG 10 mg/kg.2 Treatment duration, rash-related safety data, and pre-infusion medications are shown in Table 6.
Table 6. IMMU-132-01 (OSP): Treatment Duration, Treatment-Related Rash, and Pre‑Infusion Medications2,19
| SG (n=492) | |
Treatment duration, median (range), mo | 3.7 (0–55.2) | |
TRAE of rash, n (%) | 49 (12) | |
Pre-infusion medications, % | Systemic corticosteroids | 54.7 |
Antihistamines | 29.3 | |
References
Product Label
For the full indication, important safety information, and boxed warning(s), please refer to the Trodelvy US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.
Follow-Up
For any additional questions, please contact Trodelvy Medical Information at:
☎1‐888-983-4668 or www.askgileadmedical.com
Adverse Event Reporting
Please report all adverse events to:
Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
www.gilead.com/utility/contact/report-an-adverse-event
FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or www.accessdata.fda.gov/scripts/medwatch
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