Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
ROMIPLOSTIM (UNII: GN5XU2DXKV) (ROMIPLOSTIM - UNII:GN5XU2DXKV)
Amgen Inc
ROMIPLOSTIM
ROMIPLOSTIM 500 ug in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
Nplate is indicated for the treatment of thrombocytopenia in: - Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. - Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation [see Clinical Studies (14.3)] . Limitations of Use: - Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP [see Warnings and Precautions ( 5.1 )] . - Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. - Nplate should not be used in an attempt to normalize platelet counts [see Warnings and Precautions ( 5.2 )]
Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, solid white lyophilized powder in single-dose vials of 125 mcg (NDC-55513-223-01), 250 mcg (NDC 55513-221-01) and 500 mcg (NDC 55513-222-01) of romiplostim. Store Nplate vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. If needed, unopened Nplate vials may be stored in the original carton at room temperature up to a maximum of 25°C (77°F) for a single period of up to 30 days. The new expiration date must be written in the space provided on the carton. Once stored at room temperature, do not place back in the refrigerator. If not used within the 30 days, discard Nplate.
Biologic Licensing Application
NPLATE- romiplostim injection, powder, lyophilized, for solution Amgen Inc ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 01/2021 MEDICATION GUIDE Nplate® (N-plāt) (romiplostim) for injection What is the most important information I should know about Nplate? Nplate can cause serious side effects, including: • Worsening of a precancerous blood condition to a blood cancer (leukemia). Nplate is not for use in people with a precancerous condition called myelodysplastic syndromes (MDS), or for any condition other than immune thrombocytopenia (ITP). If you have MDS and receive Nplate, your MDS condition may worsen and become an acute leukemia. If MDS worsens to become acute leukemia you may die sooner from the acute leukemia. • Higher risk for blood clots. ○ You may have a higher risk of getting a blood clot if your platelet count becomes high during treatment with Nplate. You may have severe complications or die from some forms of blood clots, such as clots that spread to the lungs or that cause heart attacks or strokes. ○ If you have a chronic liver disease, you may get blood clots in the veins of your liver. This may affect your liver function. • Injection of too much Nplate may cause a dangerous increase in your blood platelet count and serious side effects. Your healthcare provider may change your dose or stop Nplate depending upon the change in your blood platelet count. You must have blood platelet counts done before you start, during, and after Nplate therapy is stopped (see “How will I receive Nplate?”). See “What are the possible side effects of Nplate?” for other side effects of Nplate. What is Nplate? • Nplate is a prescription medicine used to treat low blood platelet counts (thrombocytopenia) in: • adults with immune thrombocytopenia (ITP) when certain medicines or surgery to remove your spleen have not worked well enough. • children 1 year of age and older with ITP for at least 6 months when certain medicines or surgery to r Leggi il documento completo
NPLATE- ROMIPLOSTIM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION AMGEN INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NPLATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NPLATE. NPLATE (ROMIPLOSTIM) FOR INJECTION, FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 2008 RECENT MAJOR CHANGES Dosage and Administration (2.3) 02/2022 INDICATIONS AND USAGE Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. (1.1) Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. (1.1) Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]). (1.2) Limitations of Use: Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts. (1) DOSAGE AND ADMINISTRATION Patients with Immune Thrombocytopenia (ITP) Recommended Initial Dose: 1 mcg/kg once weekly as a subcutaneous injection. Adjust dose based on platelet response. (2.1) Patients acutely exposed to myelosuppressive doses of radiation Recommended Dose: 10 mcg/kg administered once as a subcutaneous injection. Administer the dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation. (2.2) See Full Prescribing Information for instructions on reconstitution, preparation, and administration. (2.3) DOSAGE FORMS AND STRENGTHS For Leggi il documento completo