NERLYNX™ (NERATINIB) TABLETS:THE NEXT STEP IN EARLY-STAGE HER2+ BREAST CANCER
NOTE: No continuing nursing education contact hours will be awarded.
Massachusetts, Minnesota, Vermont, the Department of Defense, and the Department of Veterans Affairs have restrictions on receiving in-kind benefits (e.g., meals, paid parking) at company-sponsored events. For all attendees, please be advised that information such as your name and the value and purpose of any educational item, meal, or other items of value you receive may be publicly disclosed. You are accountable for understanding such restrictions and complying with them. If you are licensed in or affiliated with any of these states or federal agencies, Puma Biotechnology policies may restrict you from consuming any portion of the Puma Biotechnology-sponsored meal at this program or from receiving any other in-kind benefit from Puma Biotechnology (e.g., paid parking) in connection with the program.
This program is sponsored by Puma Biotechnology, Inc.
This is not an independent educational program, and no CME credits will be provided.
Please see Important Safety Information below and Full Prescribing Information including Patient Information here.
IMPORTANT SAFETY INFORMATION
NERLYNX™ (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
WARNINGS AND PRECAUTIONS:
- Diarrhea: Aggressively manage diarrhea occurring despite recommended prophylaxis with additional antidiarrheals, fluids, and electrolytes as clinically Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
- Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
- Embryo-Fetal Toxicity: NERLYNX can cause fetal Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3 hours after antacid
- Strong or moderate CYP3A4 inhibitors: Avoid concomitant
- Strong or moderate CYP3A4 inducers: Avoid concomitant
- P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with
USE IN SPECIFIC POPULATIONS:
- Lactation: Advise women not to breastfeed.