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Reimbursement Support Services
Including benefits investigation and verification and prior authorization and medical necessity requirements.
ORSERDU Co-Pay Card
For eligible commercial patients, who could pay as little as $0 for their medication.*
ORSERDU Patient Assistance Program
For eligible, uninsured, or functionally uninsured patients, who may be able to access their medication at no cost.†
Getting assistance from Stemline ARC for your patients receiving ORSERDU is simple.
Learn more at StemlineARC.comER+, estrogen receptor-positive; ESR1, estrogen receptor 1; ET, endocrine therapy; HER2-, human epidermal growth factor receptor 2-negative; mBC, metastatic breast cancer.
*Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients who are enrolled in Medicare, Medicaid, or any other federal or state healthcare program. Stemline Therapeutics, Inc. reserves the right to rescind, revoke, or amend this program without notice. For full terms and conditions, visit ORSERDUcopay.com or call 1-800-519-2140.
†Terms and limitations requirements apply.
ORSERDU product information1
Dose: 345 mg | NDC: 72187-0102-03
Dose: 86 mg | NDC: 72187-0101-03
Pills not actual size.
ORSERDU is filled through specialty pharmacies and specialty distributors in the Stemline ARC® network. Ask your sales representative for a list of specialty pharmacies and distributors.
Specialty pharmacies
Biologics by McKesson
Phone: 1-800-850-4306
Fax: 1-800-823-4506
Website: https://biologics.mckesson.com/providers/#how-to-order
Onco360
Phone: 1-877-662-6633
Fax: 1-877-662-6355
Specialty distributors
AmerisourceBergen Oncology Supply
Phone: 1-800-633-7555
Fax: 1-800-248-8205
Email: service@oncologysupply.com
Cardinal Health Specialty Distribution
Phone: 1-800-926-3161
Fax: 1-866-633-7005
McKesson Specialty Health
Phone: 1-800-482-6700
Fax: 1-800-289-9285
Email: OncologyCustomerSupport@McKesson.com
NDC, National Drug Code.
View additional Resources
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.
ORSERDU is available as 345 mg tablets and 86 mg tablets.
INDICATION
ORSERDU (elacestrant) is 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.
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.
© 2024 Stemline Therapeutics, Inc., a Menarini Group Company. All rights reserved. 10/24 MAT-US-ELA-00146-v4
|
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.
ORSERDU is available as 345 mg tablets and 86 mg tablets.
INDICATION
ORSERDU (elacestrant) is 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.
Reference: 1. ORSERDU [prescribing information]. New York, NY: Stemline Therapeutics, Inc., a Menarini Group Company, 2023.