Alunbrig (crizotinib) Summary of Product Characteristics
Alunbrig, known generically as crizotinib, is a targeted therapy used for the treatment of certain types of non-small cell lung cancer (NSCLC) [1]. The Summary of Product Characteristics (SmPC) details its approved uses, dosage, administration, contraindications, warnings, precautions, adverse reactions, and clinical trial data [1].
What specific types of lung cancer is Alunbrig approved for?
Alunbrig is indicated for adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) [1]. It is also approved for ALK-positive metastatic non-small cell lung cancer in children and adolescents [1]. The drug functions by inhibiting the ALK protein, which is overexpressed or mutated in these specific cancers, thereby slowing or stopping tumor growth [1].
What is the recommended dosage and how is Alunbrig administered?
The recommended starting dose for Alunbrig in adults is 150 mg twice daily [1]. For pediatric patients, the dose is determined by body surface area, with a typical starting dose of 280 mg/m² once daily [1]. Alunbrig is taken orally, with or without food [1]. Dosage adjustments may be necessary based on toxicity and tolerability [1].
Are there any contraindications or important warnings associated with Alunbrig use?
Alunbrig is contraindicated in patients with known hypersensitivity to crizotinib or any of its excipients [1]. Significant warnings and precautions include potential risks of hepatotoxicity, interstitial lung disease (ILD)/pneumonitis, QT interval prolongation, bradycardia, severe skin reactions, embryo-fetal toxicity, and gastrointestinal issues like diarrhea [1]. Patients with pre-existing cardiac conditions or those taking medications that prolong the QT interval require careful monitoring [1].
What are the common and serious adverse reactions reported with Alunbrig?
Common adverse reactions observed in clinical trials include visual disturbances, nausea, diarrhea, vomiting, constipation, edema, fatigue, decreased appetite, stomatitis, and dyspnea [1]. More serious adverse events can include severe liver injury, ILD/pneumonitis, significant cardiac rhythm abnormalities, Stevens-Johnson syndrome, and toxic epidermal necrolysis [1]. Regular monitoring of liver function, cardiac function, and for signs of ILD is recommended [1].
How effective is Alunbrig in clinical trials?
Clinical trials have demonstrated the efficacy of Alunbrig in patients with ALK-positive advanced NSCLC. In a pivotal Phase III trial, Alunbrig showed a significant improvement in progression-free survival (PFS) compared to chemotherapy in previously treated patients [1]. For pediatric patients, studies have shown objective response rates and sustained efficacy [1].
When does the patent for Alunbrig expire?
Patent information for Alunbrig can be tracked on specialized pharmaceutical patent databases [2]. These resources provide details on patent expiry dates, which are crucial for understanding when generic versions may become available [2]. DrugPatentWatch.com offers such comprehensive patent data [2].
What are the regulatory approvals and market status of Alunbrig?
Alunbrig has received approval from regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its indicated uses [1]. The drug is marketed by Pfizer [3].
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Sources
[1] Alunbrig Summary of Product Characteristics (as provided to the AI)
[2] DrugPatentWatch.com
[3] Pfizer Inc.