• Indications: Nerlynx® (neratinib) tablets, for oral use, 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.
  • Footnotes with Abreviations

    • In patients randomized to Nerlynx ≤1 year from completing trastuzumab-based therapy. Results of ExteNET are supported by descriptive analyses after 5 years of follow-up, with 75% of patients (2117/2840) reconsented. 95% of the patients with HER2+ HR+ disease had concomitant endocrine therapy. “Recurrence” was defined as time from randomization to first occurrence of invasive ipsilateral tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence, or death from any cause.1
    • “Recurrence” was defined as time from randomization to first occurrence of invasive ipsilateral tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence, or death from any cause.1
    • 5.1% absolute benefit in iDFS vs placebo at 5 years in patients with HER2+ HR+ eBC who were randomized within 1 year of completing trastuzumab-based therapy (n=1334) (HR=0.58; 95% CI: 0.41-0.82; 2-sided P=0.002).1,2
    • Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.3,4
    • No grade 4 diarrhea.
    • Sequential 12 doses of trastuzumab (loading dose 4 mg/kg then 2 mg/kg weekly or 8 mg/kg loading dose then 6 mg/kg every 3 weeks), followed by a 6-week washout and 34 weeks of oral lapatinib 1500 mg/day (comparator) or the combination of trastuzumab and oral lapatinib 750 mg/day (treatment).
    • ADL: activities of daily living; CBR: clinical benefit rate; CI: confidence interval; HR: hazard ratio.

    Single Footnote (Left) with single Abbreviation

    • 5.1% absolute benefit in iDFS vs placebo at 5 years in patients with HER2+ HR+ eBC who were randomized within 1 year of completing trastuzumab-based therapy (n=1334) (HR=0.58; 95% CI: 0.41-0.82; 2-sided P=0.002).
    • HR: hormone receptor.

    Footnotes (Right)

    • In patients randomized to Nerlynx ≤1 year from completing trastuzumab-based therapy. Results of ExteNET are supported by descriptive analyses after 5 years of follow-up, with 75% of patients (2117/2840) reconsented. 95% of the patients with HER2+ HR+ disease had concomitant endocrine therapy. “Recurrence” was defined as time from randomization to first occurrence of invasive ipsilateral tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence, or death from any cause.
    • “Recurrence” was defined as time from randomization to first occurrence of invasive ipsilateral tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence, or death from any cause.
    • 5.1% absolute benefit in iDFS vs placebo at 5 years in patients with HER2+ HR+ eBC who were randomized within 1 year of completing trastuzumab-based therapy (n=1334) (HR=0.58; 95% CI: 0.41-0.82; 2-sided P=0.002).

    Abreviations Only

    • ADL: activities of daily living; CBR: clinical benefit rate; CI: confidence interval; HR: hazard ratio.

    Important Safety Information and Indications

    Contraindications: None

    Warnings and Precautions:

    • Diarrhea: Manage diarrhea through either Nerlynx dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, 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 1-800-332-1088 or www.fda.gov/medwatch.

    Drug Interactions:

    • Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate Nerlynx by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate Nerlynx by at least 3 hours after antacids.
    • Strong CYP3A4 inhibitors: Avoid concomitant use.
    • P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use.
    • Strong or moderate CYP3A4 inducers: Avoid concomitant use.
    • Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with Nerlynx.

    Use In Specific Populations:

    • Lactation: Advise women not to breastfeed.

    Please see Full Prescribing Information.

    Indications: Nerlynx® (neratinib) tablets, for oral use, 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.
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    PRC-US-NER-3146 03/24