Nplate Receives Expanded Indication

December 14, 2018 – The U.S. FDA has approved an expanded indication for Nplate® (romiplostim), manufactured by Amgen. It is now approved to treat children as young as one year of age who have chronic immune thrombocytopenic purpura (ITP). Nplate was previously approved only for use in adult patients.

Chronic ITP is characterized by abnormally low blood platelet counts and symptoms that last for at least six months. The low platelet counts can lead to easy or excessive bruising and bleeding, and patients require frequent follow-ups with a hematologist for treatment. While chronic ITP is more common in adults, pediatric cases do occur. In clinical studies, Nplate was found to be effective in patients at least one year of age.

The recommended dosing with Nplate is 1mcg/kg once weekly via subcutaneous injection, regardless of the patient’s age. The dose should be adjusted as needed based on the patient’s response. Nplate should only be used to treat patients whose ITP puts them at increased risk of bleeding. It is available in single-dose vials containing 250mcg or 500 mcg of lyophilized powder for reconstitution.