ORSERDU™ (elacestrant) Logo
This site is intended for US Healthcare Professionals only.
Home
ESR1 Mutations
Acquired ResistanceTesting
Dosing
Access & Support
background
In ER+/HER2- mBC with identified ESR1 mutations following initial ET ± a CDK4/6iConvenient, once-daily oral dosing1
alt="ORSERDU™ (elacestrant) Tablet Icon
alt="Take ORSERDU™ (elacestrant) Tablet With Food Icon
alt="Take ORSERDU™ (elacestrant) at the Same Time Icon
Pill not actual size.
ONE 345-mg TABLET, ONCE DAILY1
WITH FOOD TO REDUCE NAUSEA1
AROUND THE SAME TIME EACH DAY1

Treat patients until disease progression or unacceptable toxicity.1

Tablets should be swallowed whole. Do not chew, crush, or split.1

If a dose is missed, continue regular dosing on the next day.1*

NO POTENTIALLY PAINFUL IM INJECTIONS1,2

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; IM, intramuscular; mBC, metastatic breast cancer.

*If a dose is missed for more than 6 hours or vomiting occurs, skip the dose and take the next dose the following day at its regularly scheduled time.1


In ER+/HER2- mBC with identified ESR1 mutations following initial ET ± a CDK4/6iDose modifications and reductions in patients receiving ORSERDU1

ORSERDU DOSAGE MODIFICATION GUIDELINES FOR ARs

Severity

Dosage modification

Grade 1

Continue ORSERDU at current dose level.

Grade 2

Consider interruption of ORSERDU until recovery to Grade ≤1 or baseline. Then resume ORSERDU at the same dose level.

Grade 3

Interrupt ORSERDU until recovery to Grade ≤1 or baseline. Then resume ORSERDU at the next lower dose level.

If the Grade 3 toxicity recurs, interrupt ORSERDU until recovery to Grade ≤1 or baseline. Then resume ORSERDU reduced by another dose level.

Grade 4

Interrupt ORSERDU until recovery to Grade ≤1 or baseline. Then resume ORSERDU reduced by 1 dose level.

If a Grade 4 or intolerable AR recurs, permanently discontinue ORSERDU.

ORSERDU DOSE REDUCTION LEVELS FOR ARs

Dose reduction

Dosage

Number and strength of tablets

First dose reduction

258 mg once daily

Three 86-mg tablets

Second dose reduction

172 mg once daily*

Two 86-mg tablets

Dose reductions were 3% with ORSERDU

AR, adverse reaction.

*If further dose reduction below 172 mg once daily is required, permanently discontinue ORSERDU.

Selected Important Safety Information

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).

Please see additional Important Safety Information below. Please see full Prescribing Information.

Learn more about Access & Support

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. Faslodex [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

ORSERDU is a trademark of the Menarini Group.

© 2023 Stemline Therapeutics, Inc., a Menarini Group Company. All rights reserved. 05/23 ELA-05033v3

Privacy Policy & Terms of Use

|

Cookies Settings

|

MENARINI Group Logo
Stemline® Logo

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. Faslodex [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.