New Approaches for HR+/HER2- Advanced or Metastatic Breast Cancer and Best Practices for Utilizing FASLODEX

This is an AstraZeneca promotional activity.

Presentation Objectives:

1. Highlight the importance of the estrogen receptor as a critical driver of hormone receptor-positive (HR+) advanced or metastatic breast cancer
2. Evaluate the clinical evidence that supports the use of FASLODEX^® (fulvestrant) injection for the:
   • Treatment of HR+, HER2- advanced breast cancer (ABC) in postmenopausal women not previously treated with endocrine therapy
   • Treatment of HR+ ABC in postmenopausal women with disease progression following endocrine therapy
   • Treatment of HR+, HER2- advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy
3. To review best practices and potential injection-related adverse reactions associated with large-volume IM injections

Please see Important Safety Information for FASLODEX below.

Note: No continuing education (CE) credit will be awarded.

This program is intended for US healthcare professionals only.

AstraZeneca will comply with any and all federal or state reporting requirements regarding any value or expense associated with this event.

AstraZeneca fully supports and abides by the PhRMA Code on Interactions With Health Care Professionals (HCPs). This program is open only to HCP invitees. AstraZeneca will not accommodate attendance of a spouse or other guest of any HCP attendee, nor will AstraZeneca pay for transportation or parking costs of attendees. If you are a prescriber and/or a Federal, State, or institution employee, you may be subject to laws, regulations, or rules that prohibit or limit your receipt of gifts, meals, or items of value. We ask that you comply with any such restrictions. AstraZeneca will not recommend, endorse, or support the submission of this promotional program for CE credits. This is an AstraZeneca promotional activity.

Indications for FASLODEX

Monotherapy

FASLODEX is an estrogen receptor antagonist indicated for the:

• Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy
• Treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy

Combination Therapy

• FASLODEX in combination with palbociclib or abemaciclib is indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy

Important Safety Information About FASLODEX

Contraindications

• FASLODEX is contraindicated in patients with known hypersensitivity to the drug or to any of its components. Hypersensitivity reactions, including urticaria and angioedema, have been reported in association with FASLODEX

Risk of Bleeding

• Because FASLODEX is administered intramuscularly, it should be used with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use

Hepatic Impairment

• FASLODEX is metabolized primarily in the liver. A 250 mg dose is recommended in patients with moderate hepatic impairment (Child-Pugh class B). FASLODEX has not been evaluated in patients with severe hepatic impairment (Child-Pugh class C)

Injection Site Reaction

• Use caution while administering FASLODEX at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve. Injection site–related events, including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy, have been reported with FASLODEX injection

Embryo-Fetal Toxicity and Lactation

• Advise pregnant women of the potential risk to a fetus. Advise women of reproductive potential to use effective contraception during FASLODEX treatment and for 1 year after the final dose. Advise lactating women not to breastfeed during treatment with FASLODEX and for 1 year after the final dose because of the potential risk to the infant

Immunoassay Measurement of Serum Estradiol

• Due to structural similarity of fulvestrant and estradiol, FASLODEX can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels

Adverse Reactions

Monotherapy

• The most common adverse reactions occurring in ≥5% of patients receiving FASLODEX 500 mg were injection site pain, nausea, bone pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot flash, myalgia, vomiting, anorexia, diarrhea, asthenia, musculoskeletal pain, cough, dyspnea, and constipation
• Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of FASLODEX patients and were not dose-dependent

Combination Therapy—FASLODEX plus palbociclib

• The most frequently reported Grade ≥3 adverse reactions in patients receiving FASLODEX plus palbociclib in descending frequency were neutropenia and leukopenia
• Adverse reactions (≥10%) of any grade reported in patients receiving FASLODEX 500 mg plus palbociclib 125 mg/day by descending frequency were neutropenia, leukopenia, infections, fatigue, nausea, anemia, stomatitis, diarrhea, thrombocytopenia, vomiting, alopecia, rash, decreased appetite, and pyrexia
• Additional adverse reactions occurring at an overall incidence of <10% of patients receiving FASLODEX plus palbociclib included asthenia, aspartate aminotransferase increased, dysgeusia, epistaxis, lacrimation increased, dry skin, alanine aminotransferase increased, vision blurred, dry eye, and febrile neutropenia

Combination Therapy—FASLODEX plus abemaciclib

• The most frequently reported (≥5%) Grade 3 or 4 adverse reactions in patients receiving FASLODEX plus abemaciclib were neutropenia, diarrhea, leukopenia, anemia, and infections
• The most common adverse reactions (≥20%) of any grade reported in patients receiving FASLODEX 500 mg plus abemaciclib 150 mg twice daily were diarrhea, fatigue, neutropenia, nausea, infections, abdominal pain, anemia, leukopenia, decreased appetite, vomiting, and headache

Please see accompanying full Prescribing Information with Patient Information for FASLODEX. 

FASLODEX is a registered trademark of the AstraZeneca group of companies.

©2018 AstraZeneca. All rights reserved.

US-24394 Last Updated 10/18