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ESR1 Mutations
Acquired ResistanceTesting
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ESR1 mutations are commonly acquired mutations associated with
endocrine resistance, leading to poorer prognosis.

In ER+/HER2- mBC following progression on initial ET +/- a CDK4/6i

ORSERDU is the first and only therapy
indicated for ESR1-mutated mBC

Discover
efficacy data1 Test for
ESR1 mutations Review safety
information

Test for ESR1 mutations. Treat with ORSERDU.

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.


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.


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.

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.

For Vermont Pricing Disclosures for ORSERDU® (elacestrant), please CLICK here:
VT Short Form.

For Colorado WAC Disclosures for ORSERDU® (elacestrant), please CLICK here:
Colorado Form.

Reference: 1. ORSERDU [prescribing information]. New York, NY: Stemline
Therapeutics, Inc., a Menarini Group Company; 2023.

ORSERDU is a registered trademark of the Menarini Group.

© 2023 Stemline Therapeutics, Inc., a Menarini Group Company. All rights
reserved. 07/23 ELA-05033v4

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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.

For Vermont Pricing Disclosures for ORSERDU® (elacestrant), please CLICK here:
VT Short Form.

For Colorado WAC Disclosures for ORSERDU® (elacestrant), please CLICK here:
Colorado Form.

Reference: 1. ORSERDU [prescribing information]. New York, NY: Stemline
Therapeutics, Inc., a Menarini Group Company; 2023.



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.

Please see Important Safety Information within.

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