Nerlynx (Neratinib) – HER2 | HongKong DengYue Medicine

Nerlynx Neratinib Application Scope

• Early-Stage HER2-Positive Breast Cancer: For adult patients with early-stage hormone receptor-positive HER2-overexpressed/amplified breast cancer who have completed adjuvant trastuzumab-based therapy within the past year.

• Advanced or Metastatic HER2-Positive Breast Cancer: In combination with capecitabine, for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 therapies in the metastatic setting.

  

Nerlynx Neratinib Characteristics

• Ingredients: Neratinib

• Properties:​ Film-coated tablets

• Packaging Specification:​ Bottles containing 180 tablets, 40 mg per tablet

• Storage:​ Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)

• Expiry Date: Refer to the packaging for the specific expiry date

• Executive Standard: ​Complies with the standards set by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA)

• Approval Number:

  • U.S. FDA Approval: NDA 208051

  • EU EMA Approval: EMEA/H/C/004420

• Date of Revision: Refer to the latest prescribing information for the most recent revision date

• Manufacturer: Puma Biotechnology, Inc.

Guidelines for the Use of Nerlynx Neratinib

• Dosage and Administration:

  • Recommended Dose: 240 mg (6 tablets of 40 mg) taken orally once daily with food.

  • Administration: Take the tablets whole; do not chew or crush.

  • Missed Dose:​ If a dose is missed, take it as soon as remembered on the same day. Do not take two doses on the same day to make up for a missed dose.

• Adverse Reactions:

  • Common Adverse Reactions: Diarrhea, nausea, vomiting, fatigue, abdominal pain, rash, decreased appetite, stomatitis, and muscle spasms.

  • Serious Adverse Reactions: Severe diarrhea, liver toxicity, dehydration, electrolyte imbalance.

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• Contraindications:

  • Hypersensitivity to neratinib or any excipients.

  • Pregnancy and breastfeeding.

• Precautions:

  • Diarrhea Management: Prophylactic antidiarrheal treatment is recommended during the first 56 days of therapy.

  • Liver Function Monitoring: Regular monitoring of liver enzymes is advised due to the risk of hepatotoxicity.

  • Pregnancy and Lactation: Not recommended during pregnancy or breastfeeding due to potential harm to the fetus or infant.

Nerlynx Interactions

• Antacids: Separate dosing of Nerlynx by 3 hours after antacids.

• H2-Receptor Antagonists: Take Nerlynx at least 2 hours before or 10 hours after H2-receptor antagonists.

• CYP3A4 Inhibitors: Concomitant use may increase neratinib plasma concentrations; monitor for adverse reactions.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.