1. Indications and Usage
\nHigh-Risk Neuroblastoma:
\nTreatment of patients aged \u226512 months with high-risk neuroblastoma:
\nWho have responded at least to induction chemotherapy, followed by myeloablative therapy and stem cell transplantation.
\nWith relapsed or refractory neuroblastoma (with or without residual disease).
\nNote: Active progressive disease should be stabilized before initiating treatment.
\n2. Dosage and Administration
\nRoute of Administration:
\nFor Intravenous (IV) Infusion ONLY. Must be administered in a hospital setting with immediate access to resuscitation equipment.
\nRecommended Dosage:
\nTreatment typically consists of 5 consecutive cycles (each cycle is 35 days).
\nStandard Dose: Total dose of 100 mg\/m\u00b2 per cycle.
\nOption A (Continuous Infusion): 10 mg\/m\u00b2\/day continuously for 10 days (240 hours).
\nOption B (Short Infusion): 20 mg\/m\u00b2\/day for 5 days, infused over 8 hours each day.
\nCritical Administration Instructions (Premedication):
\nAnalgesics (Mandatory): Opioids (e.g., IV Morphine) and non-opioid analgesics (e.g., Acetaminophen\/Ibuprofen) must be administered. Gabapentin is recommended starting 3 days prior to infusion.
\nAntihistamines: To prevent allergic reactions.
\nDilution: Dilute in 0.9% Sodium Chloride containing 1% Human Albumin.
\n3. Mechanism of Action
\nGD2 Targeting:
\nDinutuximab beta binds specifically to Disialoganglioside 2 (GD2), a cell surface glycolipid highly expressed on neuroblastoma cells.
\nImmune Activation:
\nADCC (Antibody-Dependent Cellular Cytotoxicity): Recruits immune effector cells (NK cells, macrophages) to kill the tumor.
\nCDC (Complement-Dependent Cytotoxicity): Activates the complement system to lyse the tumor cell.
\n4. Safety and Warnings
\nSevere Infusion-Related Reactions:
\nMay occur (e.g., hypotension, bronchospasm, fever). Requires close monitoring during administration.
\nSevere Pain (Neuropathic):
\nExtremely common. Often requires continuous IV opioids throughout the infusion.
\nCapillary Leak Syndrome (CLS):
\nCan cause leakage of fluids and proteins from blood vessels.
\nOcular\/Neurological Toxicity:
\nMay cause blurred vision, mydriasis (dilated pupils), or other visual changes.
\n5. Adverse Reactions & Clinical Research
\nMost Common Adverse Reactions:
\nSevere pain (neuropathic), pyrexia (fever), thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, nausea, vomiting, diarrhea, rash, and acute kidney injury.
\nClinical Research Highlights:
\nSurvival Benefit: In a pivotal Phase 3 trial involving high-risk neuroblastoma patients, the addition of dinutuximab beta (plus IL-2 and GM-CSF) significantly improved survival rates compared to standard therapy alone.
\nEfficacy Data: The study showed a 3-year survival rate of approximately 71% in the dinutuximab beta group, compared to roughly 54-58% in the control groups.
\nSafety Profile: In clinical studies, severe infusion reactions occurred in approximately 26% of patients. Severe neuropathic pain was observed in up to 9% of patients.
\n6. Drug Interactions
\nImmunosuppressants: Use with caution with other immunosuppressive agents.
\nNephrotoxic Drugs: Caution advised with drugs that may affect renal function (e.g., NSAIDs), as Dinutuximab beta can cause nephrotoxicity.
\nNo CYP Interactions: As a monoclonal antibody, it is not metabolized by CYP450 enzymes.
\n7. Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Dinutuximab beta (Recombinant chimeric monoclonal antibody).
\nAppearance: Clear, colorless to slightly yellowish liquid.
\nPackaging: Single-use vial (20 mg\/4.5 mL).
\nStorage: Store in a refrigerator at 2\u00b0C to 8\u00b0C (36\u00b0F to 46\u00b0F). Do not freeze or shake.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name:\u00a0 \u51ef\u6cfd\u767e \u00ae\uff08Qarziba\u00ae\uff09
\nGeneric Name: Dinutuximab beta
\nStrength: 20 mg per vial (4.5 mL per vial)
\nManufacturer: EUSA Pharma (Netherlands) B.V.
\nMarketing Authorization Holder: EUSA Pharma (Netherlands) B.V.
\nDomestic Responsible Entity: EUSA Pharma Trading (Shanghai) Co., Ltd.
\nApproval Date in China: November 25, 2021
\nRegistration Number: \u56fd\u836f\u51c6\u5b57SJ20210036
\nStorage: Store refrigerated at 2\u00b0C\u20138\u00b0C, protect from light, do not freeze or shake violently. Once diluted, use the infusion solution immediately. Refer to the full package insert for detailed storage and handling specifications.<\/p>\n
Price&Cost:Contact Us now for the best price of Dinutuximab beta\uff08Qarziba\uff09<\/p>\n","protected":false},"featured_media":4277,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[25],"product_tag":[],"class_list":["post-4276","product","type-product","status-publish","has-post-thumbnail","product_cat-injection","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n