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ORSERDU ordering and distribution

ORSERDU product information1

Dose: 345 mg | NDC: 72187-0102-03

Dose: 86 mg | NDC: 72187-0101-03

ORSREDU™ Product Bottles

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

Website: https://onco360.com/how-to-order/overview/

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

Portal: specialtyonline.cardinalhealth.com

Email: gmb-b-cs-ind@cardinalhealth.com

McKesson Specialty Health

Phone: 1-800-482-6700

Fax: 1-800-289-9285

Email: OncologyCustomerSupport@McKesson.com

NDC, National Drug Code.

Learn more at StemlineARC.com

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 is a registered trademark of the Menarini Group.

© 2023 Stemline Therapeutics, Inc., a Menarini Group Company. All rights reserved. 08/23 ELA-05033v5

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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.