See the DrugPatentWatch profile for Nplate
What does the FDA label for Nplate say?
Nplate (romiplostim) is a thrombopoietin receptor agonist used to treat certain patients with low platelet counts due to immune thrombocytopenia (ITP). The FDA label includes the approved indications, dosing instructions, contraindications/warnings, and monitoring requirements. [1]
Who is Nplate approved for (FDA indication)?
The FDA label specifies the patient populations for whom Nplate is indicated in immune thrombocytopenia, including adults and pediatric patients (age specified in the label), typically when ITP has not responded adequately to other treatments. [1]
How is Nplate dosed and adjusted on the FDA label?
The label describes how clinicians calculate the starting dose based on patient weight, how often Nplate is administered, and how the dose should be adjusted to maintain platelets within a target range. It also covers what to do if platelet counts rise too high or fail to rise sufficiently. [1]
What warnings and safety information are on the FDA label?
The FDA label includes boxed or prominent warnings (if applicable), along with risks such as thromboembolic events, bone marrow reticulin formation, and the possibility of platelet count overshoot. It also directs clinicians on platelet monitoring frequency and when to interrupt or reduce dosing. [1]
How often do patients need platelet monitoring (per the label)?
Nplate prescribing information specifies platelet monitoring during treatment and after dose changes, because dosing depends on platelet response. [1]
Where can I view the current FDA Nplate label?
You can access the FDA-approved prescribing information for Nplate through the FDA label (Drug Label Information) resource. [1]
Sources
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm