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NERLYNX is a brand name for Neratinib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NERLYNX (neratinib) is indicated: For the extended adjuvant treatment of women with early-stage hormone receptor positive and HER2-overexpressed/amplified breast cancer, within one year after completion of trastuzumab-based adjuvant therapy. In combination with capecitabine for the treatment of patients with…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations NERLYNX treatment can cause severe diarrhea (see 7 WARNINGS AND PRECAUTIONS). NERLYNX® (neratinib)- Product Monograph Page 5 of 47 Either a NERLYNX dose escalation or antidiarrheal prophylaxis with loperamide is recommended to lower the incidence and severity of diarrhea (see 8 ADVERSE REACTIONS and 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment). Prophylaxis Management of Diarrhea DOSE ESCALATION PROPHYLAXIS Initiate NERLYNX at 120 mg daily and increase the dose according to the treatment schedule described in Table 1. Table 1. NERLYNX Dose Escalation and Treatment Schedule Time on NERLYNX NERLYNX Dose Week 1 (days 1–7) 120 mg daily (three 40 mg tablets) Week 2 (days 8–14) 160 mg daily (four 40 mg tablets) Week 3 and onwards 240 mg daily (six 40 mg tablets, recommended dose) If diarrhea occurs with dose escalation, loperamide 4 mg should be initiated no later than with the first bout of diarrhea, and continued with loperamide 2 mg after every subsequent loose stool, up to 16 mg per day, until diarrhea-free for 12 hours.
Then, titrate loperamide to keep diarrhea controlled (1-2 bowel movements per day). ANTIDIARRHEAL PROPHYLAXIS WITH LOPERAMIDE Administer loperamide during the first 56 days of treatment, starting with the first dose of NERLYNX. For both indications, instruct patients to take loperamide as directed in Table 2, titrating to 1-2 bowel movements per day.
Additional antidiarrheal agents may be required to manage diarrhea in patients with loperamide-refractory diarrhea (see Tables 6 and 7 below). Table 2. 2 Recommended Dose and Dosage Adjustment Recommended Dose Extended Adjuvant Treatment of Early-Stage Breast Cancer: The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year at approximately the same time every day.
NERLYNX should be used in combination with endocrine therapy in patients with early -stage hormone receptor-positive and HER2 overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.
Metastatic Breast Cancer:
The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, at approximately the same time on Day 1 – 21 of a 21- day cycle in combination with capecitabine on Day 1 – 14 of a 21-day cycle until disease progression or unacceptable toxicities.
and 7 WARNINGS AND PRECAUTIONS). 2 Recommended Dose and Dosage Adjustment). Prophylaxis Management of Diarrhea DOSE ESCALATION PROPHYLAXIS Initiate NERLYNX at 120 mg daily and increase the dose according to the treatment schedule described in Table 1.
Table 1. NERLYNX Dose Escalation and Treatment Schedule Time on NERLYNX NERLYNX Dose Week 1 (days 1–7) 120 mg daily (three 40 mg tablets) Week 2 (days 8–14) 160 mg daily (four 40 mg tablets) Week 3 and onwards 240 mg daily (six 40 mg tablets, recommended dose) If diarrhea occurs with dose escalation, loperamide 4 mg should be initiated no later than with the first bout of diarrhea, and continued with loperamide 2 mg after every subsequent loose stool, up to 16 mg per day, until diarrhea-free for 12 hours.
Then, titrate loperamide to keep diarrhea controlled (1-2 bowel movements per day). ANTIDIARRHEAL PROPHYLAXIS WITH LOPERAMIDE Administer loperamide during the first 56 days of treatment, starting with the first dose of NERLYNX. For both indications, instruct patients to take loperamide as directed in Table 2, titrating to 1-2 bowel movements per day.
Additional antidiarrheal agents may be required to manage diarrhea in patients with loperamide-refractory diarrhea (see Tables 6 and 7 below). Table 2. 2 Recommended Dose and Dosage Adjustment Recommended Dose Extended Adjuvant Treatment of Early-Stage Breast Cancer: The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year at approximately the same time every day.
NERLYNX should be used in combination with endocrine therapy in patients with early -stage hormone receptor-positive and HER2 overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.
Metastatic Breast Cancer:
4 Geriatrics). 5% were ≥ 65 years of age. No overall differences of efficacy were observed between patients ≥ 65 years when compared to patients of < 65 years of age. 4 Geriatrics). 2 CONTRAINDICATIONS NERLYNX is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations NERLYNX treatment can cause severe diarrhea (see 7 WARNINGS AND PRECAUTIONS). NERLYNX® (neratinib)- Product Monograph Page 5 of 47 Either a NERLYNX dose escalation or antidiarrheal prophylaxis with loperamide is recommended to lower the incidence and severity of diarrhea (see
NERLYNX is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
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The recommended dose of capecitabine is 1500 mg/m2 total daily dose evenly divided into 2 doses of 750 mg/m2 each, starting on cycle 1 Day 1. Capecitabine should be taken with food or within 30 minutes after a meal. Dose Adjustment for Adverse Reactions NERLYNX dose modification is recommended based on individual safety and tolerability.
Management of some adverse reactions may require dose interruption and/or dose reduction of treatment with NERLYNX as shown in Tables 3 to 8 below. Discontinue NERLYNX in patients who fail to recover to Grade 0-1 from treatment-related toxicity, for toxicities that result in a treatment delay of > 3 weeks, or for patients who are unable to tolerate 120 mg NERLYNX daily.
). When NERLYNX is used in combination with capecitabine, refer to the product monograph for dose modifications to capecitabine. Table 3. NERLYNX Monotherapy Dose Modifications for Adverse Reactions Dose Level NERLYNX Dose Recommended starting dose 240 mg daily First dose reduction 200 mg daily Second dose reduction 160 mg daily Third dose reduction 120 mg daily NERLYNX® (neratinib)- Product Monograph Page 7 of 47 Table 4.
NERLYNX in Combination with Capecitabine Dose Modification for Adverse Reactions Dose Level NERLYNX Dose Recommended starting dose 240 mg daily First dose reduction 160 mg daily Second dose reduction 120 mg daily Table 5. NERLYNX Dose Modifications and Management–General Toxicities* Severity of Toxicity† Action Grade 3 Hold NERLYNX until recovery to Grade ≤ 1 or baseline within 3 weeks of stopping treatment.
Then resume NERLYNX at the next lower dose level. Grade 4 Discontinue NERLYNX permanently. 0 Dose Modifications for Diarrhea Diarrhea management requires the correct use of antidiarrheal medication, dietary changes , replacement of fluids and electrolytes and appropriate dose modifications of NERLYNX.
Guidelines for adjusting doses of NERLYNX in patients presenting with diarrhea are shown in Tables 6 and 7. Table 6. NERLYNX Monotherapy Dose Modifications for Diarrhea Severity of Diarrhea * Action Grade 1 diarrhea [increase of < 4 stools per day over baseline] Grade 2 diarrhea [increase of 4-6 stools per day over baseline] lasting < 5 days Grade 3 diarrhea [increase of ≥ 7 stools per day over baseline; incontinence; hospitalization indicated; limiting self-care activities of daily living] lasting ≤ 2 days Adjust antidiarrheal treatment Diet modifications Fluid intake of ~2 L should be maintained to avoid dehydration Once event resolves to ≤ Grade 1 or baseline, start loperamide 4 mg with each subsequent NERLYNX administration.
Any grade with complicated features† Grade 2 diarrhea lasting 5 days or longer‡ Interrupt NERLYNX treatment Diet modifications Fluid intake of ~2 L should be maintained to avoid dehydration NERLYNX® (neratinib)- Product Monograph Page 8 of 47 Severity of Diarrhea * Action […]
The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, at approximately the same time on Day 1 – 21 of a 21- day cycle in combination with capecitabine on Day 1 – 14 of a 21-day cycle until disease progression or unacceptable toxicities.
The recommended dose of capecitabine is 1500 mg/m2 total daily dose evenly divided into 2 doses of 750 mg/m2 each, starting on cycle 1 Day 1. Capecitabine should be taken with food or within 30 minutes after a meal. Dose Adjustment for Adverse Reactions NERLYNX dose modification is recommended based on individual safety and tolerability.
Management of some adverse reactions may require dose interruption and/or dose reduction of treatment with NERLYNX as shown in Tables 3 to 8 below. Discontinue NERLYNX in patients who fail to recover to Grade 0-1 from treatment-related toxicity, for toxicities that result in a treatment delay of > 3 weeks, or for patients who are unable to tolerate 120 mg NERLYNX daily.
). When NERLYNX is used in combination with capecitabine, refer to the product monograph for dose modifications to capecitabine. Table 3. NERLYNX Monotherapy Dose Modifications for Adverse Reactions Dose Level NERLYNX Dose Recommended starting dose 240 mg daily First dose reduction 200 mg daily Second dose reduction 160 mg daily Third dose reduction 120 mg daily NERLYNX® (neratinib)- Product Monograph Page 7 of 47 Table 4.
NERLYNX in Combination with Capecitabine Dose Modification for Adverse Reactions Dose Level NERLYNX Dose Recommended starting dose 240 mg daily First dose reduction 160 mg daily Second dose reduction 120 mg daily Table 5. NERLYNX Dose Modifications and Management–General Toxicities* Severity of Toxicity† Action Grade 3 Hold NERLYNX until recovery to Grade ≤ 1 or baseline within 3 weeks of stopping treatment.
Then resume NERLYNX at the next lower dose level. Grade 4 Discontinue NERLYNX permanently. 0 Dose Modifications for Diarrhea Diarrhea management requires the correct use of antidiarrheal medication, dietary changes , replacement of fluids and electrolytes and appropriate dose modifications of NERLYNX.
Guidelines for adjusting doses of NERLYNX in patients presenting with diarrhea are shown in Tables 6 and 7. Table 6. NERLYNX Monotherapy Dose Modifications for Diarrhea Severity of Diarrhea * Action Grade 1 diarrhea [increase of < 4 stools per day over baseline] Grade 2 diarrhea [increase of 4-6 stools per day over baseline] lasting < 5 days Grade 3 diarrhea [increase of ≥ 7 stools per day over baseline; incontinence; hospitalization indicated; limiting self-care activities of daily living] lasting ≤ 2 days Adjust antidiarrheal treatment Diet modifications Fluid intake of ~2 L should be maintained to avoid dehydration Once event resolves to ≤ Grade 1 or baseline, start loperamide 4 mg with each subsequent NERLYNX administration.
Any grade with complicated features† Grade 2 diarrhea lasting 5 days or longer‡ Interrupt NERLYNX treatment Diet modifications Fluid intake of ~2 L should be maintained to avoid dehydration NERLYNX® (neratinib)- Product Monograph Page 8 of 47 Severity of Diarrhea * Action Grade 3 diarrhea lasting longer than 2 days‡ If diarrhea resolves to Grade 0-1 in one week or less, then resume NERLYNX treatment at the same dose.
If diarrhea resolves to Grade 0-1 in longer than one week, then resume NERLYNX treatment at reduced dose (see Table 3). Once event resolves to ≤ Grade 1 or baseline, […]