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At Puma Biotechnology, the long-term health of our patients is our priority and therefore we recommend that all patients follow federal and state guidelines during the pandemic. In response to questions from patients, Puma wants to confirm that the available clinical and non-clinical data do not demonstrate any negative effect of NERLYNX® (neratinib) on the immune system. Treatment with NERLYNX does not place patients at greater risk of acquiring or responding to the COVID-19 virus. Patients starting or continuing treatment should follow the advice of their treating physician. Puma maintains significant stock of NERLYNX and does not anticipate any disruption of supply to existing or new patients. Our centers are dedicated to providing additional resources to patients and caregivers, 24 hours per day, 7 days per week. Healthcare Professionals with any questions should contact Puma at 1-844-NERLYNX (1-844-637-5969). Patients with any questions should call Puma’s Medical Inquiry line at 1-844-MED-PUMA (1-844-633-7862).
Now approved in metastatic HER2+ breast cancer
NERLYNX® (neratinib) tablets is now the first and only HER2-directed small molecule approved in both early and metastatic breast cancer. Based on positive results in the NALA trial,* the FDA has approved the use of NERLYNX, in combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2+ breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
IMPORTANT SAFETY INFORMATION
NERLYNX® (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:
- As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
- In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
WARNINGS AND PRECAUTIONS:
- Diarrhea: Aggressively manage diarrhea. If diarrhea occurs despite recommended prophylaxis, treat with additional anti-diarrheals, fluids, and electrolytes as clinically indicated. 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 indicated. 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 harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common adverse reactions (reported in ≥ 5% of patients) were:
- NERLYNX as a single agent: diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.
- NERLYNX in combination with capecitabine: diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.
To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. When patients require gastric acid reducing agents, use an H2-receptor antagonist or antacid. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists.
- Strong CYP3A4 inhibitors: Avoid concomitant use.
- Moderate CYP3A4 and P-glycoprotein (P-gp) dual inhibitors: Avoid concomitant use.
- Strong or moderate CYP3A4 inducers: Avoid concomitant use.
- P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:
- Lactation: Advise women not to breastfeed.
For Full Prescribing Information, please click here.