1. Indications and Usage
\nChemotherapy-Induced Neutropenia:
\nIndicated for the reduction of the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of febrile neutropenia.
\nContraindication for Mobilization:
\nIt is NOT indicated for the mobilization of peripheral blood progenitor cells into the peripheral blood for hematopoietic stem cell transplantation.
\n2. Dosage and Administration
\nRoute of Administration:
\nSubcutaneous Injection ONLY. Do not administer intravenously.
\nRecommended Dosage:
\nDose: 20 mg administered subcutaneously once per chemotherapy cycle.
\nTiming: Administer at least 24 hours after the completion of cytotoxic chemotherapy.
\nPreparation:
\nAllow the pre-filled syringe to reach room temperature for 30 minutes before use. Do not shake.
\n3. Mechanism of Action
\nFc Fusion Protein Technology:
\nEfbemalenograstim alfa is a recombinant fusion protein consisting of a dimer of human G-CSF and the Fc fragment of human IgG2.
\nNeutrophil Stimulation:
\nIt binds to G-CSF receptors on hematopoietic cells, stimulating the proliferation, differentiation, and activation of neutrophils. The Fc fusion extends the plasma half-life, allowing for once-per-cycle dosing.
\n4. Safety and Warnings
\nSplenic Rupture:
\nRare cases of splenic rupture have been reported. Evaluate spleen size if left upper abdominal pain is reported.
\nAcute Respiratory Distress Syndrome (ARDS):
\nMonitor patients for fever and lung infiltrates. Discontinue use if ARDS is suspected.
\nSevere Allergic Reactions:
\nHypersensitivity reactions, including anaphylaxis, can occur.
\nLatex Sensitivity:
\nThe needle cap of the pre-filled syringe contains natural rubber (latex). Do not use in patients with latex allergy.<\/p>\n
5. Adverse Reactions
\nBased on clinical trial data of 727 patients, the following adverse reactions were observed:
\nMost Common Adverse Reactions (\u2265 5%):
\nBone Pain: 11.1%
\nBack Pain: 5.0%
\nGeneral Adverse Reactions (by System Organ Class):
\nMusculoskeletal and Connective Tissue Disorders: Very Common (\u2265 1\/10): Bone pain, Back pain. Common (\u2265 1\/100 to < 1\/10): Arthralgia, Limb pain. Rare (\u2265 1\/10,000 to < 1\/1,000): Myalgia, Osteoarthrosis, Musculoskeletal discomfort, Neck pain.
\nGastrointestinal Disorders: Common: Nausea, Diarrhea, Vomiting. Rare: Stomatitis, Dry mouth, Dyspepsia, Abdominal pain, Dysphagia.
\nSkin and Subcutaneous Tissue Disorders: Common: Alopecia, Skin reactions (e.g., rash, pruritus). Rare: Angioedema, Cold sweat, Night sweats, Onychoclasis.
\nGeneral Disorders and Administration Site Conditions: Common: Malaise, Asthenia, Pyrexia. Rare: Peripheral edema, Injection site reactions (e.g., pain, swelling), Chills, Thirst.
\nBlood and Lymphatic System Disorders: Uncommon: Leukocytosis. Rare: Leukopenia, Neutropenia, Thrombocytopenia, Anemia, Splenomegaly.
\nNervous System Disorders: Common: Headache. Rare: Dizziness, Dysgeusia, Muscle spasms, Peripheral neuropathy, Somnolence.
\nRespiratory, Thoracic, and Mediastinal Disorders: Rare: Epistaxis, Oropharyngeal pain, Cough, Dyspnea, Nasal dryness.
\nMetabolism and Nutrition Disorders: Rare: Hyperglycemia, Anorexia.
\nVascular Disorders: Rare: Vasculitis, Hot flashes.
\nInfections and Infestations: Rare: Herpes virus infection.
\nSerious Adverse Reactions:
\nSplenic rupture, Acute Respiratory Distress Syndrome (ARDS), Severe hypersensitivity reactions (including anaphylaxis), Sickle cell crisis, Glomerulonephritis, Leukocytosis, Capillary leak syndrome, Potential stimulation of malignant tumor growth, Aortitis.
\n6. Drug Interactions
\nMyelosuppressive Chemotherapy Agents:
\nAvoid administration of Efbemalenograstim alfa within 24 hours following cytotoxic chemotherapy to prevent the stimulation of rapidly dividing myeloid cells which may be sensitive to chemotherapy toxicity.
\nLithium:
\nLithium may potentiate the release of neutrophils. Concomitant use should be monitored closely.
\n7. Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Recombinant fusion protein consisting of a dimer of human Granulocyte-Colony Stimulating Factor (G-CSF) and the Fc fragment of human Immunoglobulin G2 (IgG2) [expressed and purified from Chinese Hamster Ovary (CHO) cells].
\nMolecular Weight: Approximately 93.4 kDa.
\nExcipients: Glacial acetic acid, Sodium acetate, Sorbitol, Polysorbate 20, Disodium edetate.
\nStorage:
\nStore in a refrigerator at 2-8\u00b0C. Do not freeze or shake.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u4ebf\u7acb\u8212\u00ae\uff08Ryzneuta\u00ae)
\nGeneric Name: Efbemalenograstim alfa
\nStrength: 20mg (1.0mL) per pre-filled syringe
\nManufacturer: Evive Biotech (Beijing) Co., Ltd.
\nMarketing Authorization Holder: Evive Biotech (Beijing) Co., Ltd.
\nApproval Date in China: May 6, 2023
\nRegistration Number: \u56fd\u836f\u51c6\u5b57 S20230026
\nStorage: Store at 2\u2103\uff5e8\u2103, protected from light, do not freeze, avoid violent shaking. Do not freeze after taking out from refrigeration. Keep out of reach of children.<\/p>\n
Price&Cost:Contact Us now for the best price of Efbemalenograstim alfa\uff08Ryzneuta)<\/p>\n","protected":false},"featured_media":3406,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[25,73],"product_tag":[],"class_list":["post-3405","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