Generic drug: neratinib
Brand name: Nerlynx
What is Nerlynx (neratinib), and how does it work?
- Nerlynx (neratinib) is a prescription medicine used alone to treat adults with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and who have previously been treated with trastuzumab-based therapy.
- Nerlynx is also used with a medicine called capecitabine to treat adults with HER2-positive breast cancer that has spread to other parts of the body (metastatic) and who have received 2 or more anti-HER2 therapy medicines for metastatic breast cancer.
It is not known if Nerlynx is safe and effective in children.
What are the side effects of Nerlynx?
Nerlynx may cause serious side effects, including:
- Liver problems. Changes in liver function tests are common with Nerlynx. Your healthcare provider should do blood tests before you begin treatment, monthly during the first 3 months, and then every 3 months as needed during treatment with Nerlynx. Your healthcare provider will stop your treatment with Nerlynx if your liver tests show severe problems. Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
The most common side effects of Nerlynx when used alone include:
- stomach-area (abdomen) pain
- dry or inflamed mouth, or mouth sores
- decreased appetite
- muscle spasms
- upset stomach
- nail problems including color change
- dry skin
- swelling of your stomach-area
- weight loss
- urinary tract infection
The most common side effects of Nerlynx when used with capecitabine include:
- decreased appetite
- weight loss
- back pain
- joint pain
- urinary tract infection
- upper respiratory tract infection
- swelling of your stomach-area
- kidney problems
- muscle spasms
These are not all of the possible side effects of Nerlynx. For more information, ask your Healthcare Provider.
Tell your doctor if you have any side effects that bother you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Nerlynx?
Administer antidiarrheal prophylaxis during the first 56 days of treatment and initiate with the first dose of Nerlynx. Instruct patients to take loperamide as directed in Table 1. Titrate loperamide to 1–2 bowel movements per day.
Table 1: Loperamide Prophylaxis
|Time on Nerlynx||Loperamide Dose and Frequency|
|Weeks 1-2 (days 1-14)||4 mg three times daily|
|Weeks 3-8 (days 15-56)||4 mg twice daily|
|Weeks 9-52 (days 57-365)||4 mg as needed, not to exceed 16 mg per day; titrate dosing to achieve 1-2 bowel movements per day|
If diarrhea occurs despite prophylaxis, treat with additional antidiarrheals, fluids and electrolytes as clinically indicated. Nerlynx dose interruptions and dose reductions may also be required to manage diarrhea.
Recommended Dose And Schedule
Extended Adjuvant Treatment Of Early Stage Breast Cancer
The recommended dose of Nerlynx is 240 mg (six tablets) given orally once daily, with food, continuously until disease recurrence or for up to one year.
Advanced Or Metastatic Breast Cancer
The recommended dose of Nerlynx is 240 mg (six tablets) given orally once daily with food on Days 1–21 of a 21-day cycle plus capecitabine (750 mg/m² given orally twice daily) on Days 1–14 of a 21-day cycle until disease progression or unacceptable toxicities.
Instruct patients to take Nerlynx at approximately the same time every day. Nerlynx tablets should be swallowed whole (tablets should not be chewed, crushed, or split prior to swallowing).
If a patient misses a dose, do not replace missed dose, and instruct the patient to resume Nerlynx with the next scheduled daily dose.
Dose Modifications 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 as shown in Table 2 to Table 7. Discontinue Nerlynx for patients with adverse reactions that fail to recover to Grade 0–1 or baseline, with toxicities that result in a treatment delay >3 weeks, or if unable to tolerate 120 mg daily. Additional clinical situations may result in dose adjustments as clinically indicated (e.g. intolerable toxicities, persistent Grade 2 adverse reactions, etc.).
When Nerlynx is used in combination with capecitabine, refer to the capecitabine prescribing information for dose modifications of capecitabine.
Table 2: Nerlynx Monotherapy Dose Modifications for Adverse Reactions
|Dose Level||Nerlynx Dose|
|Recommended starting dose||240 mg daily (six 40 mg tablets)|
|First dose reduction||200 mg daily (five 40 mg tablets)|
|Second dose reduction||160 mg daily (four 40 mg tablets)|
|Third dose reduction||120 mg daily (three 40 mg tablets)|
Table 3: Nerlynx in Combination with Capecitabine Dose Modifications for Adverse Reactions
|Dose Level||Nerlynx Dose|
|Recommended starting dose||240 mg daily (six 40 mg tablets)|
|First dose reduction||160 mg daily (four 40 mg tablets)|
|Second dose reduction||120 mg daily (three 40 mg tablets)|
Table 4: 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.|
|* Refer to Table 5, Table 6, and Table 7 below for management of diarrhea and hepatotoxicity
† Per CTCAE v4.0
Dose Modifications For Diarrhea
Guidelines for adjusting doses of Nerlynx in the setting of diarrhea are shown in Table 5 and Table 6. Diarrhea management may require use of antidiarrheal medications, dietary changes, replacement of fluids and electrolytes and appropriate dose modifications of Nerlynx as clinically indicated.
Table 5: Dose Modifications of Nerlynx Monotherapy for Diarrhea
|Severity of Diarrhea*||Action|
|* Per CTCAE v4.0
† Complicated features include dehydration, fever, hypotension, renal failure, or Grade 3 or 4 neutropenia
‡ Despite being treated with optimal medical therapy
Table 6: Dose Modifications of Nerlynx and Capecitabine for Diarrhea
|Severity of Diarrhea*||Actions|
|Abbreviations: L: liter
* NCI CTCAE v.4.0
a Since capecitabine is provided as 150 mg or 500 mg tablets, it is recommended that the capecitabine dose reduction(s) is rounded down to the nearest 500 mg or multiple of 150 mg for the twice daily dose. If the patientâ€™s body surface area is >2.0, the standard of care for the study center can be utilized for capecitabine mg/m² dosing.
Dose Modifications For Hepatic Impairment
Reduce the Nerlynx starting dose to 80 mg in patients with severe hepatic impairment (Child Pugh C). No dose modifications are recommended for patients with mild to moderate hepatic impairment (Child Pugh A or B).
Dose Modifications For Hepatotoxicity
Guidelines for dose adjustment of Nerlynx in the event of liver toxicity are shown in Table 7. Patients who experience =Grade 3 diarrhea requiring IV fluid treatment or any signs or symptoms of hepatotoxicity, such as worsening of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia, should be evaluated for changes in liver function tests. Fractionated bilirubin and prothrombin time should also be collected during hepatotoxicity evaluation.
Table 7: Dose Modifications for Hepatotoxicity
|Severity of Hepatotoxicity*||Action|
|ALT=Alanine Aminotransferase; AST=Aspartate Aminotransferase; ULN=Upper Limit Normal
* Per CTCAE v4.0
Concomitant Use With Gastric Acid Reducing Agents
Proton Pump Inhibitors (PPI)
Avoid concomitant use with Nerlynx. H2-receptor antagonists: Take Nerlynx at least 2 hours before the next dose of the H2-receptor antagonist or 10 hours after the H2-receptor antagonist.
Separate dosing of Nerlynx by 3 hours after antacids.
What drugs interact with Nerlynx?
Effect Of Other Drugs On Nerlynx
Table 10 includes drug interactions that affect the pharmacokinetics of neratinib.
Table 10: Drug Interactions That Affect Neratinib
|Gastric Acid Reducing Agents|
|Clinical Impact||Concomitant use of Nerlynx with a proton pump inhibitor, H2-receptor antagonist, or antacid may decrease neratinib plasma concentration. Decreased neratinib AUC may reduce Nerlynx activity. Lansoprazole (PPI) resulted in a decrease of neratinib Cmax by 71% and AUC by 65%.|
|Prevention or Management||Avoid concomitant use.|
|Take Nerlynx at least 2 hours before the next dose of the H2-receptor antagonist or 10 hours after the H2-receptor antagonist.|
|Separate Nerlynx dosing by 3 hours after antacids.|
|Strong CYP3A4 Inhibitors|
|Prevention or Management||Avoid concomitant use of Nerlynx with strong CYP3A4 inhibitors.|
|Moderate CYP3A4 and P-gp Dual Inhibitors|
|Prevention or Management||Avoid concomitant use of Nerlynx with other moderate CYP3A4 and P-gp dual inhibitors.|
|Strong or Moderate CYP3A4 Inducers|
|Prevention or Management||Avoid concomitant use of Nerlynx with strong or moderate CYP3A4 inducers.|
|AUC=Area Under Curve; Cmax=Maximum Concentration|
* These examples are a guide and not considered a comprehensive list of all possible drugs that may fit this category. The healthcare provider should consult appropriate references for comprehensive information.
Effect Of Nerlynx On Other Drugs
P-glycoprotein (P-gp) Substrates
- Concomitant use of Nerlynx with digoxin, a P-gp substrate, increased digoxin concentrations. Increased concentrations of digoxin may lead to increased risk of adverse reactions including cardiac toxicity.
- Refer to the digoxin prescribing information for dosage adjustment recommendations due to drug interactions. Nerlynx may inhibit the transport of other P-gp substrates (e.g., dabigatran, fexofenadine).
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Is Nerlynx safe to use while pregnant or breastfeeding?
- Based on findings from animal studies and the mechanism of action, Nerlynx can cause fetal harm when administered to a pregnant woman.
- There are no available data in pregnant women to inform the drug-associated risk.
- No data are available regarding the presence of neratinib or its metabolites in human milk or its effects on the breastfed infant or on milk production.
- Because of the potential for serious adverse reactions in breastfed infants from Nerlynx, advise lactating women not to breastfeed while taking Nerlynx and for at least 1 month after the last dose.
Nerlynx (neratinib) is a prescription medicine used alone to treat adults with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and HER2-positive breast cancer that has spread to other parts of the body (metastatic). Serious side effects of Nerlynx include liver problems.
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