Nplate

[Chinese name]: Romiplostim

[Trade name]: Nplate

[English name]: Romiplostim

[Pharmaceutical manufacturer]: Agmen America

[Specification]: 250μg, 500μg; injection

[Romiplostim Nplate (Romiplostim) Introduction】

Romigrastim Nplate is a thrombopoietin (TPO) receptor agonist, which imitates the body's natural TPO and is designed to increase platelet counts in patients with immune thrombocytopenia (ITP).

Immune thrombocytopenia (ITP) is a rare, serious autoimmune disease characterized by a low count of platelets in the blood (thrombocytopenia) and impaired platelet production. In the United States, the annual incidence of ITP in children is estimated to be 5.3 per 100,000. Clinically, the treatment goals for pediatric patients with TIP are to increase platelet count and maintain it at a safe level, reduce the risk of bleeding, and improve symptoms.

[Romiplostim Nplate (Romiplostim) Indications]

(1) Romiplostim Nplate (Romiplostim) is a thrombopoietin receptor agonist and is suitable for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have an inadequate response to corticosteroids, immunoglobulins or splenectomy.

(2) Romigrastim Nplate should only be used in ITP patients with a degree of thrombocytopenia and clinical conditions that increase the risk of bleeding. Platelet count normalization should not be used with intent.

[Romiplostim Nplate (Romiplostim) usage and dosage]

(1) The initial dose is 1 μg/kg for subcutaneous injection once a week.

(2) Because of the need to reduce the risk of bleeding, adjust the weekly dose by increments of 1 μg/kg to achieve and maintain a platelet count of 50×109/L.

(3) The maximum dose should not exceed 10 μg/kg per week. If the platelet count reaches >400×109/L, do not administer the drug.

(4) If the platelet count does not increase after 4 weeks of the maximum dose, interrupt romiplostim Nplate.

(5) Do not shake during preparation; protect the prepared romigrastat Nplate from light; give the prepared romigrastim Nplate within 24 hours.

(6) The injection volume may be very small. Use a 0.01mL syringe.

(7) Discard the unused portion of single-use vials.

[Romiplostim Nplate (Romiplostim) Contraindications]

The most common adverse reactions (≥ 5% higher incidence in Nplate patients than placebo) are joint pain, dizziness, insomnia, myalgia, limb pain, abdominal pain, shoulder pain, dyspepsia, and paresthesia. Headache is most commonly reported.

[Romiplostim Nplate (Romiplostim) Warnings and Precautions]

(1) Romiplostim Nplate increases the risk of reticulin deposition in the bone marrow; clinical studies have not excluded the possibility of reticulin and other fiber deposition leading to myelofibrosis with cytopenias. Monitor peripheral blood for signs of myelofibrosis.

(2) Discontinuation of romiplostim Nplate may cause thrombocytopenia to be worse than before Nplate treatment. Monitor complete blood counts (CBCs), including platelet counts, for at least 2 weeks after discontinuation of Nplate.

(3) Excessive use of romiplostim Nplate may increase platelet count to a level that produces thrombosis/embolic complications.

(4) If the platelet count is severely reduced after the initial reaction to romiplostim Nplate, evaluate the formation of neutralizing antibodies in the patient.

(5) Romigrastim Nplate may increase the risk of hematological malignancies, especially in patients with myelodysplastic syndrome.

(6) Monitor CBCs, including platelet count and peripheral blood smears, weekly until a stable dose of romiplostim Nplate is reached. Thereafter, monitor CBCs, including platelet count and peripheral blood smear at least monthly.