What does the FDA label say for eliglustat tartrate?
Eliglustat tartrate (often written “eliglustat tartrate”) is an oral treatment for adults with Gaucher disease type 1. The FDA prescribing information is organized around who can use it and which dosing is safe based on a person’s CYP2D6 metabolizer status, with clear instructions on dose adjustments and when to avoid the medicine due to drug–drug interactions.
Who is eligible to take it under the FDA label?
The label specifies use for adults with Gaucher disease type 1 and gives dosing by metabolic phenotype (CYP2D6), rather than a single universal dose. It also includes instructions that depend on the patient’s ability to metabolize eliglustat through CYP2D6, since that strongly affects exposure to the drug.
How does the label dose eliglustat tartrate?
The FDA labeling breaks dosing into CYP2D6 metabolizer categories (for example, poor, intermediate, extensive, and ultra-rapid metabolizers) and ties the recommended dose and/or use to those categories. The label also addresses dose modifications based on tolerability and safety.
What drug interactions does the FDA label warn about?
Because eliglustat levels can change with inhibitors or inducers of CYP enzymes (especially CYP2D6, and also pathways involving CYP3A depending on the label’s interaction section), the FDA label warns against certain combinations or requires careful dose/monitoring steps when other medicines are started or stopped.
Can people with liver problems take eliglustat tartrate?
The FDA label includes hepatic impairment considerations, describing whether and how eliglustat can be used in patients with impaired liver function.
Where can I find the exact FDA label text?
For the most up-to-date prescribing information and the current label language, use the DrugPatentWatch.com page for eliglustat tartrate, which links out to label-related documents and regulatory coverage:
- DrugPatentWatch (eliglustat tartrate): https://www.drugpatentwatch.com/p/eliglustat-tartrate/
What’s the fastest way to answer “tartrate FDA label” precisely?
If you tell me whether you mean:
1) the exact boxed warning/indications section text,
2) the CYP2D6 dosing table, or
3) the interaction contraindications list,
I can focus the answer on that specific part of the label.
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Sources
- https://www.drugpatentwatch.com/p/eliglustat-tartrate/