Danyelza Application Scope

Danyelza is indicated for the treatment of pediatric patients aged 1 year and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.

Danyelza Characteristics

Ingredients: Naxitamab
Properties: Humanized monoclonal antibody targeting GD2, a disialoganglioside expressed on neuroblastoma cells
Packaging Specification: Single-dose vial containing 40 mg of Naxitamab in 10 mL (4 mg/mL) solution
Storage: Store at 2–8°C (36–46°F). Do not freeze
Expiry Date: 12 months from the date of manufacture when stored at 2–8°C
Executive Standard: FDA-approved under Biologics License Application
Approval Number: BLA 761171
Date of Revision: Please refer to the latest prescribing information for the most recent revision date
Manufacturer: Y-mAbs Therapeutics, Inc.

Guidelines for the Use of Danyelza

Dosage and Administration:
- Recommended Dose: 3 mg/kg/day (up to 150 mg/day) administered intravenously on Days 1, 3, and 5 of each treatment cycle.
- Administration: Administer as an intravenous infusion after dilution.
- Missed Dose: If a dose is missed, administer the missed dose as soon as possible within the same treatment cycle.
Adverse Reactions:
- Common Adverse Reactions: Infusion-related reactions, pain, fatigue, nausea, vomiting, diarrhea, decreased appetite, hypertension, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, injection site reaction, edema, anxiety, localized edema, and irritability.
- Serious Adverse Reactions: Serious infusion-related reactions and neurotoxicity.
Contraindications: Danyelza is contraindicated in patients with a history of severe hypersensitivity reactions to naxitamab.
Precautions:
- Monitor for infusion-related reactions and neurotoxicity during and after administration.
- Administer pre-infusion medications as appropriate to mitigate infusion-related reactions.
- Discontinue Danyelza and GM-CSF for disease progression or unacceptable toxicity.

Danyelza Interactions

Formal drug interaction studies have not been conducted. As a monoclonal antibody, the potential for cytochrome P450-mediated interactions is considered low.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.