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Pyrotinib
Pyrotinib

Pyrotinib(马来酸吡咯替尼片)

Its mainly indicated for the targeted therapy of HER2-positive breast cancer, featuring remarkable efficacy and convenient administration.

  • 80mg*14tablets
  • 80mg*100tablets

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Introduction of Pyrotinib

As China’s first independently developed anti-HER1/HER2/HER4 targeted drug, Pyrotinib’s approval and clinical application mark a major breakthrough for domestically innovative oncology drugs.

Indications

Recurrent/Metastatic Breast Cancer

In combination with capecitabine, this product is indicated for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer who have not received trastuzumab or have received prior trastuzumab therapy. Patients should have received prior anthracycline or taxane-based chemotherapy before administration of this product.

In combination with trastuzumab and docetaxel, this product is indicated for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer who have not received anti-HER2 therapy in the advanced stage.

Early or Locally Advanced Breast Cancer

In combination with trastuzumab and docetaxel, this product is indicated for the neoadjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive early or locally advanced breast cancer.

This indication is granted conditional approval based on the improvement of pathological complete response rate, which is a surrogate endpoint. The full approval of this indication is contingent upon the confirmation of long-term clinical benefits of this product in patients with early or locally advanced breast cancer by the ongoing adjuvant therapy studies.

Overview

Generic Name
Pyrotinib Maleate Tablets,马来酸吡咯替尼片
Brand Name
艾瑞妮
Drug Type
Rx Drug,targeted drug
Approval No.
80mg:国药准字H20180013;160mg:国药准字H20180012
Active Ingredient
Pyrotinib Maleate
Dosage Form
80mg*14tablets;80mg*100tablets
Specification
Tablet
Description
Pyrotinib is a film-coated tablet that appears yellow after the coating is removed.
Expiry Date
24 months
Manufacturer
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Storage
Store in a sealed container, in a dry place below 25℃. The shelf life after opening shall not exceed one month.

Dosage and Administration

HER2 Testing

Prior to treatment with this product, HER2 status should be determined using a fully validated detection method. Pyrotinib is indicated only for breast cancer patients with positive HER2 expression.

Recommended Dosage and Administration Method

The recommended dose of Pyrotinib is 400 mg, administered once daily. It should be taken orally within 30 minutes after a meal, at the same time each day.

Treatment is given continuously, with a 21-day treatment cycle. If a patient misses a daily dose of Pyrotinib, no make-up dose is required; the next dose should be taken as scheduled.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to Pyrotinib or any of the excipients of this product.

Adverse Reactions

Adverse Reactions of Pyrotinib Combined with Capecitabine in the Treatment of Recurrent/Metastatic Breast Cancer

Most Common Adverse Reactions (Incidence ≥20%)

Gastrointestinal reactions: Diarrhea, vomiting, nausea, oral mucositis.

Cutaneous reactions: Hand-foot syndrome, dyschromia.

Metabolic and nutritional disorders: Hypertriglyceridemia, decreased appetite, hypokalemia, weight loss.

Hepatobiliary system disorders: Increased aspartate aminotransferase (AST), increased blood bilirubin, increased alanine aminotransferase (ALT).

Hematological system disorders: Leukopenia, neutropenia, hemoglobin decrease.

Grade 3 or Higher Adverse Reactions (Incidence >2%)

Diarrhea,hand-foot syndrome,neutropenia,leukopenia,hypertriglyceridemia,vomiting,hemoglobin decrease,hypokalemia,increased alanine aminotransferase (ALT).

For more detailed drug information, please consult the official package leaflet.

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Contact Information

If any issues arise, please contact us immediately.

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Pharmacy Purchase Notes

What Kind of Drug is Pyrotinib? +

Pyrotinib is a small-molecule tyrosine kinase inhibitor (TKI) categorized as a targeted antineoplastic agent, primarily indicated for the treatment of HER2-positive breast cancer.

​Where can Pyrotinib Maleate Tablets be purchased? +

You can buy Pyrotinib Maleate Tablets at qualified hospitals or pharmacies. If physical pharmacies in your area do not stock this medication, you may also purchase it from online pharmacies.

Who is strictly prohibited from using Pyrotinib Maleate? +

Patients with hypersensitivity to pyrotinib or any of the components in the drug are prohibited from its use.

​Does Pyrotinib need to be taken with meals? +

Pyrotinib should be administered within 30 minutes after a meal. It is recommended to take the medication at a fixed time every day, as this helps maintain a stable drug concentration in the blood.

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