1. Indications and Usage
\nImmune Thrombocytopenia (ITP):
\nIndicated for the treatment of thrombocytopenia in patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
\nPopulations: Adults and pediatric patients aged 1 year and older .
\nAcute Radiation Syndromes:
\nIndicated to increase survival in adult and pediatric patients (including term neonates) with acute radiation syndromes resulting from acute exposure to myelosuppressive doses of radiation (hematopoietic syndrome) .
\n2. Dosage and Administration
\nRoute of Administration:
\nFor Subcutaneous Injection ONLY.
\nReconstitution:
\nReconstitute each vial with Sterile Water for Injection. Do not shake the vial vigorously .
\nRecommended Dosage (ITP):
\nStarting Dose: 1 mcg\/kg once weekly.
\nDose Adjustment: Adjust the weekly dose by 1 mcg\/kg increments to maintain the platelet count \u2265 50 \u00d7 10\u2079\/L.
\nMaximum Dose: 10 mcg\/kg once weekly .
\nAdministration Instructions:
\nMonitor platelet counts weekly until stable.
\nDose Holding: Withhold the dose if the platelet count exceeds 400 \u00d7 10\u2079\/L. Resume at a dose at least 1 mcg\/kg lower when platelet count decreases to < 200 \u00d7 10\u2079\/L .
\n3. Mechanism of Action
\nTPO Receptor Agonist:
\nRomiplostim is a peptibody that binds to the thrombopoietin receptor (c-Mpl) on the surface of hematopoietic stem cells .
\nMegakaryocyte Stimulation:
\nIt mimics the action of endogenous TPO, stimulating the proliferation and differentiation of megakaryocytes in the bone marrow, leading to increased platelet production .
\n4. Safety and Warnings
\nThrombotic\/Thromboembolic Complications:
\nOvercorrection of the platelet count may increase the risk of thrombotic\/thromboembolic complications.
\nLoss of Response:
\nSudden loss of response may occur, often associated with the development of neutralizing antibodies.
\nBone Marrow Reticulin Increase:
\nTreatment may be associated with increased bone marrow reticulin fibers. In rare cases, this can progress to myelofibrosis .
\nMalignancy Progression:
\nThere is a potential risk of progression of myelodysplastic syndromes (MDS) to acute myeloid leukemia (AML) .
\n5. Adverse Reactions
\nMost Common:
\nHeadache, arthralgia (joint pain), myalgia, insomnia, dizziness, nausea, vomiting, diarrhea, fatigue, and purpura .
\nOther Reported Reactions:
\nCataracts, bone marrow fibrosis, and secondary malignancies.
\n6. Drug Interactions
\nNo Specific Interactions:
\nNo formal drug-drug interaction studies have been conducted.
\nConcomitant Medications:
\nUse caution when administering with other drugs that may increase the risk of bleeding or thrombosis.
\n7. Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Romiplostim (a recombinant Fc-peptide fusion protein).
\nExcipients: Histidine, Histidine Hydrochloride, Sucrose, Polysorbate 80 .
\nStorage:
\nStore at 2\u00b0C to 8\u00b0C (36\u00b0F to 46\u00b0F) in the original carton to protect from light. Do not freeze .<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u745e\u7acb\u5347\u00ae(Ruilisheng\u00ae)
\nGeneric Name: Romiplostim N01
\nStrength: 250\u03bcg per vial, 1 vial per box
\nManufacturer: Qilu Pharmaceutical Co., Ltd.
\nMarketing Authorization Holder: Qilu Pharmaceutical Co., Ltd.
\nApproval Date in China: April 11, 2024
\nRegistration Number: \u56fd\u836f\u51c6\u5b57 S20240013
\nStorage: Store at 2\u2103\uff5e8\u2103, protected from light and avoid freezing; unopened product can be stored at \u226425\u2103 for a maximum of 30 days once out of refrigeration, keep away from children<\/p>\n
Price&Cost:Contact Us now for the best price of Romiplostim N01 (Ruilisheng\uff09<\/p>\n","protected":false},"featured_media":3561,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[25,73],"product_tag":[],"class_list":["post-3560","product","type-product","status-publish","has-post-thumbnail","product_cat-injection","product_cat-chinese-innovative-drug","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n