BeiGene's BRUKINSA: Safety Information and Drug Interactions

authorIntellectia.AI2024-11-08
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BGNE.O
Illustration by Intellectia.AI

Title: BeiGene's BRUKINSA: Important Safety Information and Drug Interactions

Overview: BeiGene, a global oncology company, provides crucial information regarding the use of its medication, BRUKINSA, including potential risks during pregnancy, common side effects, drug interactions, and dosage recommendations for specific populations.

Content:

Pregnancy Warning: Men are advised not to father a child during treatment with BRUKINSA and for one week after the last dose. If the medication is used during pregnancy or if a patient becomes pregnant while taking this medication, they should be informed about the potential risk to the fetus.

Common Side Effects: Among patients receiving BRUKINSA (N=1729), the most frequent side effects (≥30%) include reduced neutrophil count (51%), reduced platelet count (41%), upper respiratory tract infections (38%), bleeding (32%), and musculoskeletal pain (31%).

Drug Interactions:

CYP3A Inhibitors: When BRUKINSA is administered with a strong CYP3A inhibitor, the dose should be reduced to 80 mg once daily. For moderate CYP3A inhibitors, the dose should be reduced to 80 mg twice daily.

CYP3A Inducers: Avoid co-administration with strong or moderate CYP3A inducers. Dose adjustment may be recommended for moderate CYP3A inducers.

Specific Populations: For patients with severe liver impairment, the recommended dose of BRUKINSA is 80 mg orally twice daily.

About BeiGene: BeiGene is committed to researching and developing innovative treatments that are more affordable and accessible for cancer patients worldwide. With a diverse portfolio, BeiGene advances its pipeline of novel therapeutics through internal capabilities and collaborations. The company is dedicated to significantly improving access to medications for more patients in need. BeiGene's growing global team comprises over 10,000 colleagues across five continents.

Forward-Looking Statements: This press release contains forward-looking statements regarding BeiGene's leadership in hematology and commitment to making innovative medicines accessible to many cancer patients. These statements involve risks and uncertainties, including the ability to demonstrate the efficacy and safety of its drug candidates, regulatory actions affecting clinical trials and market approval, and commercial success of its marketed drugs and drug candidates. Detailed risk factors are discussed in BeiGene's latest annual report on Form 10-Q and other filings with the U.S. Securities and Exchange Commission.

The original language of the text is the official and authorized version. Translations are provided for better understanding. Only the original language version of the text is legally valid, so translations should be compared with the original language version of the publication.

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