Herombopag Olamine(海曲泊帕乙醇胺片)

Introduction of Herombopag Olamine

Herombopag Olamine is a national Class 1 innovative drug independently developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd., and also the first non-peptide oral small-molecule thrombopoietin (TPO) receptor agonist in China with independent intellectual property rights. It was approved for marketing through priority review and approval by the National Medical Products Administration (NMPA) in 2021, and has benefited more than 350,000 patients to date.

Indications

Herombopag Olamine Tablets are indicated for adult patients with chronic primary immune thrombocytopenia (ITP) who have had an inadequate response to prior treatments such as corticosteroids and immunoglobulin, to increase the platelet count and reduce or prevent bleeding. This product is indicated only for ITP patients with an increased risk of bleeding due to thrombocytopenia and clinical conditions.

Herombopag Olamine Tablets are indicated for adult patients with severe aplastic anemia (SAA) who have had an inadequate response to immunosuppressive therapy (IST). This indication has been conditionally approved based on the results of a Phase I single-arm clinical trial. Full approval of this indication will be contingent upon the results of the ongoing confirmatory clinical trials.

Overview

Dosage and Administration

Herombopag Olamine Tablets should be taken orally on an empty stomach. No food shall be consumed for at least 2 hours after administration, and co-administration with meals is to be avoided. The following products should be used at least 2 hours after tablet intake, including dairy products (e.g., milk, yogurt, cheese, ice cream, etc.) or mineral supplements containing polyvalent cations (e.g., aluminum, calcium, magnesium, iron, selenium, zinc).

For adult patients with primary immune thrombocytopenia (ITP):

The lowest dose that achieves and maintains a platelet count of >50×10⁹/L should be administered. Individualized dose adjustment shall be made based on the platelet response after medication. This product must not be used for the purpose of normalizing the patient's platelet count. In clinical trials, the platelet count generally increases within 1 to 2 weeks after the initiation of treatment with this product and decreases within 1 to 2 weeks after treatment discontinuation.

Initial Dose:

The recommended initial dose of Herombopag Olamine Tablets for ITP patients is 2.5 mg once daily.

Monitoring and Dose Adjustment:

The platelet count should be monitored during treatment. Based on the platelet count, the lowest dose that achieves and maintains a platelet count of >50×10⁹/L should be used, with the maximum daily dose not exceeding 7.5 mg. Consult a physician for specific recommendations.

Contraindications

Contraindicated in patients with known hypersensitivity to herombopag olamine or any of its excipients.

Adverse Reactions

Common Adverse Reactions

Elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated platelet count, elevated blood lactate dehydrogenase, elevated blood bilirubin, elevated γ-glutamyl transferase, headache, and elevated blood alkaline phosphatase.

Severe Adverse Reactions

Elevated alanine aminotransferase, elevated platelet count, elevated aspartate aminotransferase, elevated blood bilirubin, elevated conjugated bilirubin, elevated unconjugated blood bilirubin, elevated γ-glutamyl transferase, hyperuricemia, acute myocardial infarction, and anemia.

Use in Special Populations

Use in Pregnant and Lactating Women

Contraception

Females of childbearing potential should use an effective method of contraception during treatment with this product and for at least 7 days after discontinuation of treatment.

Pregnancy

No data are available on the use of this product in pregnant women, and the effect of this product on human pregnancy is uncertain. This product should not be used during pregnancy unless the expected benefit outweighs the potential risk to the fetus. If a pregnant woman or a female of childbearing potential receives treatment with this product, the patient should be fully informed of the potential fetal risk of this product.

Lactation

It is unknown whether this product is excreted in human milk. Since many drugs are excreted in human milk, the benefit of breastfeeding to the infant and the benefit of treatment with this product to the mother must be considered before deciding whether to discontinue breastfeeding or continue/discontinue treatment with this product.

Fertility

No studies on the effects of herombopag olamine on fertility in either sex have been conducted. The impact of this product on fertility in both sexes is unknown.

Pediatric Use

No clinical trial data are available on the use of this product in patients under 18 years of age.

Geriatric Use

Experience with the use of this product in patients aged 65 years and older is limited. In clinical trials of this product, a total of 19 patients (3.1%) were aged 65 years and older. No clinically significant differences in the overall safety and efficacy of this product were observed when compared with younger patients.

No experience with the use of this product in patients aged 85 years and older is available.

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

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