1. Indications and Usage
\nChronic Immune Thrombocytopenia (ITP):
\nTreatment of adult patients (\u226518 years) who have had an inadequate response to corticosteroids, immunoglobulins, or splenectomy.
\nTherapeutic Goal:
\nUsed specifically to lower the risk of bleeding in patients with ITP and low platelet counts. It should not be used with the intent of restoring platelet counts to normal physiological levels.
\n2. Dosage and Administration
\nRoute of Administration:
\nSubcutaneous (SC) Injection ONLY.
\nRecommended Dosage:
\nInitial Dose: 1 \u00b5g\/kg based on actual body weight, administered once weekly.
\nTitration: Adjust weekly by 1 \u00b5g\/kg increments or decrements based on platelet response.
\nMaximum Dose: 10 \u00b5g\/kg once weekly.
\nCritical Administration Instructions:
\nPreparation: Reconstitute using ONLY preservative-free Sterile Water for Injection. Gently mix; do not shake.
\nAdministration Volume: A syringe with 0.01 mL graduations must be used for accuracy due to potentially small injection volumes.
\nSingle Use: The vial is for single use only. Do not mix contents from multiple vials. Do not store the reconstituted solution for more than 24 hours.
\n3. Mechanism of Action
\nTPO Receptor Agonism:
\nRomiplostim is a peptibody that mimics endogenous thrombopoietin (TPO).
\nMegakaryocyte Stimulation:
\nIt binds to and activates TPO receptors (c-Mpl) on hematopoietic megakaryocytes, stimulating the proliferation and differentiation of megakaryocytes to increase platelet production in the bone marrow.
\n4. Safety and Warnings
\nThrombotic\/Thromboembolic Complications:
\nTreatment may increase the risk of thrombosis. Platelet counts should be maintained at the minimum level required to prevent bleeding (typically \u226550 \u00d7 10\u2079\/L), avoiding normalization of counts.
\nBone Marrow Reticulin Fibrosis:
\nDose-dependent increases in bone marrow reticulin fibers and potential progression to myelofibrosis have been reported.
\nPost-Discontinuation Platelet Drop:
\nPlatelet counts may fall rapidly after discontinuation. Weekly monitoring of platelet counts is required for at least 2 weeks after stopping therapy.
\nMDS\/AML Progression:
\nIn patients with Myelodysplastic Syndromes (MDS)-associated thrombocytopenia, there is a risk of progression to acute myeloid leukemia (AML).
\n5. Adverse Reactions and Clinical Research
\nMost Common Adverse Reactions:
\nHeadache, arthralgia, dizziness, insomnia, myalgia, abdominal pain, extremity pain, shoulder pain, dyspepsia, and paresthesia.
\nClinical Research Highlights:
\nPhase 3 trials demonstrated significantly higher response rates (platelet count \u226550 \u00d7 10\u2079\/L) compared to placebo, with reduced risks of severe or life-threatening bleeding.
\n6. Drug Interactions
\nConcomitant ITP Therapies:
\nMay be used concurrently with corticosteroids, azathioprine, IVIG, or anti-D immunoglobulin. If platelet counts reach \u226550 \u00d7 10\u2079\/L, concomitant ITP therapies may be tapered or discontinued.
\nCYP450 System:
\nAs a recombinant fusion protein, it does not interact with CYP450 enzymes.
\n7. Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Romiplostim (Recombinant Fc-peptide fusion protein).
\nAppearance: White to off-white lyophilized cake or loose body.
\nPackaging: Single-use vial (250 \u00b5g or 500 \u00b5g).
\nStorage: Store in the original carton at 2\u00b0C to 8\u00b0C. Do not freeze.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name:\u60e0\u5c14\u51dd \u00ae\uff08Hui’erning\u00ae\uff09
\nGeneric Name: Romiplostim
\nStrength: Matching solvent volume 0.72 mL per vial
\nManufacturer: Kyowa Kirin Co.,Ltd., Takasaki Plant
\nMarketing Authorization Holder: Kyowa Kirin Co., Ltd.
\nApproval Date in China: January 7, 2022
\nRegistration Number: \u56fd\u836f\u51c6\u5b57SJ20220001
\nStorage: Store at 2\u00b0C\u20138\u00b0C, protected from light; do not freeze. Avoid violent shaking. Refer to the full package insert for storage requirements after reconstitution.<\/p>\n
Price&Cost:Contact Us now for the best price of Romiplostim\uff08Hui’erning\uff09<\/p>\n","protected":false},"featured_media":4405,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[25],"product_tag":[],"class_list":["post-4404","product","type-product","status-publish","has-post-thumbnail","product_cat-injection","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n