ADVERSE REACTIONS (≥10%) IN PATIENTS IN EMERALD1*
ORSERDU | SOC endocrine monotherapy† | |||
ARs | All grades (%) | Grade 3/4‡ (%) | All grades (%) | Grade 3/4‡ (%) |
Musculoskeletal and connective tissue disorders | ||||
Musculoskeletal pain§ | 41 | 7 | 39 | 1 |
Gastrointestinal disorders | ||||
Nausea | 35 | 2.5 | 19 | 0.9 |
Vomiting§ | 19 | 0.8 | 9 | 0 |
Diarrhea | 13 | 0 | 10 | 1 |
Constipation | 12 | 0 | 6 | 0 |
Abdominal pain§ | 11 | 1 | 10 | 0.9 |
Dyspepsia | 10 | 0 | 2.6 | 0 |
General disorders | ||||
Fatigue§ | 26 | 2 | 27 | 1 |
Metabolism and nutrition disorders | ||||
Decreased appetite | 15 | 0.8 | 10 | 0.4 |
Nervous system | ||||
Headache | 12 | 2 | 12 | 0 |
Vascular disorders | ||||
Hot flush | 11 | 0 | 8 | 0 |
Low discontinuation rate due to ARs: 6%1¶
Low dose reductions due to ARs: 3%1
Low dose interruptions due to ARs: 15%1
Serious ARs occurred in 12% of patients who received ORSERDU1
- Serious ARs in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%)1
Nausea was a common AR1:
- The majority had Grade 1 or 2; no Grade 41
- Low discontinuation rate due to nausea: 1.3%1
- Low antiemetic use across arms2:
8% with ORSERDU
4% with fulvestrant
10% with AIs
Taking ORSERDU with food can help reduce nausea1
Fatal ARs occurred in 1.7% of patients who received ORSERDU1||
*ARs were evaluated in patients with or without ESR1-mutated mBC (N=467) and were graded using NCI CTCAE version 5.0.1,3
†SOC endocrine monotherapy included either fulvestrant, anastrozole, letrozole, or exemestane.1
‡Only includes Grade 3 ARs.1
§Includes other related terms.1
||Fatal ARs included cardiac arrest, septic shock, diverticulitis, and unknown cause (1 patient each).1
¶ARs that resulted in permanent discontinuation of ORSERDU in >1% of patients were musculoskeletal pain (1.7%) and nausea (1.3%).1
SELECT LABORATORY ABNORMALITIES (≥10%) THAT WORSENED FROM BASELINE*
ORSERDU | SOC endocrine monotherapy† | |||
All grades (%) | Grade 3/4 (%) | All grades (%) | Grade 3/4 (%) | |
Chemistry | ||||
Cholesterol increased | 30 | 1 | 17 | 0 |
AST increased | 29 | 0 | 34 | 1 |
Triglycerides increased | 27 | 2 | 15 | 1 |
ALT increased | 17 | 0 | 24 | 1 |
Sodium decreased | 16 | 1 | 15 | 0 |
Creatinine increased | 16 | 0 | 6 | 0 |
Hematology | ||||
Hemoglobin decreased | 26 | 1 | 20 | 2 |
AI, aromatase inhibitor; ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; ER+, estrogen receptor-positive; ESR1, estrogen receptor 1; ET, endocrine therapy; HER2-, human epidermal growth factor receptor 2-negative; mBC, metastatic breast cancer; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; SOC, standard of care.
*The denominator used to calculate the rate varied from 29 to 236 for ORSERDU and from 37 to 225 for SOC endocrine monotherapy based on the number of patients with a baseline value and at least 1 post-treatment value.
†SOC endocrine monotherapy included either fulvestrant, anastrozole, letrozole, or exemestane.
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IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU.
Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ORSERDU 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 ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose.
Adverse Reactions
Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).
The most common adverse reactions (≥10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite (15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%).
Drug Interactions
Concomitant use with CYP3A4 inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU.
Use in Specific Populations
Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose.
Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).
The safety and effectiveness of ORSERDU in pediatric patients have not been established.
INDICATION
ORSERDU (elacestrant) 345 mg tablets are indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Patient Information.
References: 1. ORSERDU [prescribing information]. New York, NY: Stemline Therapeutics, Inc., a Menarini Group Company; 2023. 2. Data on file. Stemline Therapeutics, Inc., a Menarini Group Company. 3. Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: results from the randomized phase III EMERALD trial. J Clin Oncol. 2022;40(28):3246-3256.
ORSERDU is a trademark of the Menarini Group.
© 2023 Stemline Therapeutics, Inc., a Menarini Group Company. All rights reserved. 05/23 ELA-05033v3
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IMPORTANT SAFETY INFORMATION
+
Warnings and Precautions
Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU.
Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ORSERDU 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 ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose.
Adverse Reactions
Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).
The most common adverse reactions (≥10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite (15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%).
Drug Interactions
Concomitant use with CYP3A4 inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU.
Use in Specific Populations
Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose.
Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).
The safety and effectiveness of ORSERDU in pediatric patients have not been established.
INDICATION
ORSERDU (elacestrant) 345 mg tablets are indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Patient Information.
References: 1. ORSERDU [prescribing information]. New York, NY: Stemline Therapeutics, Inc., a Menarini Group Company; 2023. 2. Data on file. Stemline Therapeutics, Inc., a Menarini Group Company. 3. Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: results from the randomized phase III EMERALD trial. J Clin Oncol. 2022;40(28):3246-3256.