Nerlynx (Neratinib)

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Non-english packaging - English label and English insert included. Plan in advance - allow us 7 days to ship your medicine

Manufacturer for Europe: Pierre Fabre Médicament Production – Cahors Site de Cahors Le Payrat 46000 Cahors France

Information About Nerlynx (Neratinib)

Nerlynx is the brand name for neratinib, an oral, small molecule inhibitor designed to treat HER2-positive breast cancer. Neratinib works by irreversibly inhibiting the activity of the HER2 receptor, a protein that, when overexpressed or mutated, contributes to the growth of some breast cancer cells. HER2-positive breast cancers are more aggressive, and treatments targeting HER2 are critical for managing these types of cancers.

Nerlynx is specifically used after initial treatment with trastuzumab (Herceptin) and chemotherapy to reduce the risk of cancer recurrence. It is primarily indicated for early-stage, HER2-positive breast cancer but is also considered in other settings for advanced or metastatic disease.

Product Highlights

• Nerlynx is primarily used in the treatment of HER2-positive breast cancer, particularly for the following indications:
• Nerlynx is used after initial treatment with trastuzumab and chemotherapy for patients with early-stage HER2-positive breast cancer to reduce the risk of cancer recurrence.
• Nerlynx may be used in some cases of metastatic HER2-positive breast cancer, particularly when other HER2-targeted therapies are not effective.
• It is also prescribed as part of extended adjuvant therapy to help prevent recurrence after initial treatment, especially in patients who have completed primary treatment with other HER2 inhibitors.

Key Ingredient

• Neratinib

Key Benefits

• Nerlynx has been shown to lower the risk of cancer recurrence in patients with early-stage HER2-positive breast cancer who have completed initial treatment with chemotherapy and trastuzumab.
• As a HER2-targeted therapy, neratinib specifically inhibits the growth of HER2-positive cancer cells while having less impact on normal cells, potentially leading to fewer side effects compared to traditional chemotherapy.
• Clinical studies have demonstrated that treatment with neratinib can extend the disease-free survival (DFS) in patients with HER2-positive breast cancer, especially after initial therapy.
• Nerlynx is taken as an oral tablet, which offers a convenient alternative to intravenous (IV) therapies like trastuzumab.
• Nerlynx has been studied in combination with other cancer treatments, further supporting its role in multi-agent regimens to prevent recurrence and manage advanced disease.

Direction of Use

• The standard dosing regimen for Nerlynx is 240 mg (4 tablets of 60 mg) taken once daily with food. The medication should be taken at the same time each day without fail.
• It is recommended to take Nerlynx with a meal to improve its absorption and reduce the potential for gastrointestinal side effects (e.g., nausea, diarrhea).
• It is important to take the medication consistently, even if you feel well, to reduce the risk of cancer recurrence.
• The dose may need to be adjusted if side effects occur, particularly gastrointestinal issues, such as diarrhea. It’s important to follow your doctor’s instructions closely and consult them about any side effects or difficulties with the medication.

Safety Concerns

• One of the most common side effects of Nerlynx is diarrhea. It can be intense and may result in dehydration. Patients should be monitored for signs of diarrhea and treated promptly with anti-diarrheal medications, such as loperamide (Imodium). Hydration is crucial during treatment.
• Nerlynx can cause liver damage in some patients. Regular monitoring of liver function through blood tests is necessary, especially during the first few months of treatment.
• Nerlynx can cause QT interval prolongation on an ECG, which may increase the risk of arrhythmias. Patients with existing heart conditions should be closely observed.
• These are common side effects, though they are generally mild to moderate in severity.
• Some patients may experience fatigue or weakness while taking Nerlynx, which could impact daily activities.
• Rash and other skin-related issues may also occur, although these are usually mild.

Avoid Nerlynx (Neratinib) If

• Avoid Nerlynx if you are allergic to neratinib or any of its ingredients. Symptoms of an allergic reaction may include a rash, itching, swelling, and trouble breathing.
• Do not use Nerlynx if you have severe liver disease or impaired liver function. Liver function should be assessed before starting therapy and monitored regularly during treatment.
• Nerlynx is contraindicated during pregnancy, as it may harm a developing fetus. Women should avoid pregnancy during treatment and for at least 1 month after stopping the medication.
• Nerlynx should not be used while breastfeeding, as it may pass into breast milk and harm a nursing infant.
• If you are unable to control diarrhea despite treatment, or if you have ongoing severe diarrhea, you should avoid taking Nerlynx, as it can exacerbate dehydration and electrolyte imbalances.
• Patients with a history of arrhythmias or QT prolongation should avoid Nerlynx, or use it only under strict medical supervision with frequent monitoring.
• Nerlynx is metabolized by the CYP3A4 enzyme, so it should not be used with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) unless your healthcare provider adjusts the dose.