 |  |  |
ACCESS & REIMBURSEMENT SUPPORT | ADDITIONAL | FINANCIAL ASSISTANCE PROGRAMS & ORDERING |
Services that may assist you and your office staff, including:
| Available comprehensive access and reimbursement-related resources to help grant your patients access to treatment, including:
| Information on:
|
Getting assistance from Stemline ARC for your patients receiving ORSERDU is simple.
Learn more at StemlineARC.com*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.
 |  |  |
ORSERDU RAPID START PROGRAM* | ORSERDU CO-PAY CARD* | ORSERDU PATIENT ASSISTANCE PROGRAM† |
Patients waiting on a prior authorization or medical necessity approval may be able to begin treatment with ORSERDU at no cost to them. This program provides patients with a 15-day supply of ORSERDU 345 mg at no cost to them. | Eligible commercial patients could pay as little as $0 for their medication. For more information on the ORSERDU Co-pay Card, visit ORSERDUcopay.com. | Eligible, uninsured, or functionally uninsured‡ patients may be able to access their medication at no cost.§ |
*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.
†Criteria include patients who are uninsured or functionally uninsured, have an income requirement ≤500 federal poverty line (FPL) of gross household income, is a citizen of the United States, Puerto Rico, or other US territory, and is not currently receiving coverage through Puerto Rico's government health plan, Mi Salud.
‡Functionally insured is defined as having no prescription drug benefits through any insurer/payer/program; the drug not being medically necessary (payer has no review process); 2 denied claims; Medicare Part B, D, or Advantage plan (and not eligible for low-income subsidy (LIS)) and having spent at least $600 on out-of-pocket (OOP) prescription expenses during the calendar year; and a diagnosis and dosing consistent with the FDA indication and/or the National Comprehensive Cancer Network® Guidelines.
§To be eligible for this program, insured patients must have exhausted all other forms of patient assistance and meet financial criteria. Insured and uninsured patients must also meet certain eligibility criteria.
Learn more about Ordering
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.
ORSERDU is a trademark of the Menarini Group.
© 2023 Stemline Therapeutics, Inc., a Menarini Group Company. All rights reserved. 05/23 ELA-05033v3
|
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.