Donanemab-Azbt|Alzheimer’s disease|HongKong DengYue Medicine

  • Generic Name/Brand Name: Donanemab-azbt / Kisunla
  • Indications: Alzheimer’s disease
  • Dosage Form: Injection
  • Specification: 350 mg/20 mL (17.5 mg/mL) solution in a single-dose vial

Donanemab-azbt Application Scope

Kisunla (donanemab-azbt) is indicated for the treatment of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of the disease.

donanemab-azbt

Characteristics

  • Ingredients:

    • Active: Donanemab-azbt

    • Excipients: Anhydrous citric acid, polysorbate 80, sodium citrate, sucrose, Water for Injection, USP

  • Properties:
    Sterile, preservative-free, clear to opalescent, colorless to slightly yellow to slightly brown solution

  • Packaging Specification:
    Single-dose vial, one vial per carton

  • Storage:
    Store refrigerated at 2°C to 8°C (36°F to 46°F). Keep the vial in the outer carton to protect from light. Do not freeze or shake.

  • Expiry Date:
    Refer to the expiration date printed on the vial label and carton.

  • Executive Standard:
    FDA-approved labeling

  • Approval Number:
    Biologics License Application (BLA) 761248

  • Date of Revision:
    July 2, 2024

  • Manufacturer:
    Eli Lilly and Company

Guidelines for the Use of Donanemab-azbt

  • Dosage and Administration:
    Administer Kisunla as an intravenous infusion every four weeks. The recommended dosage is detailed in the prescribing information.

  • Adverse Reactions:
    Common adverse reactions include:

    • Amyloid-related imaging abnormalities (ARIA), such as brain swelling and bleeding

    • Headache

    • Infusion-related reactions (e.g., flu-like symptoms, nausea, vomiting)

    • Hypersensitivity reactions, including anaphylaxis and angioedema

  • Contraindications:
    Kisunla is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or any of its excipients.

  • Precautions:

    • Monitor patients for ARIA via MRI scans before and during treatment.

    • Observe patients during and after infusion for signs of hypersensitivity reactions.

    • Ensure appropriate patient selection based on clinical and imaging criteria.

Donanemab-azbt Interactions

  • Drug Interactions:
    No specific drug interaction studies have been conducted with donanemab-azbt. Caution is advised when co-administering with other medications that may increase the risk of bleeding or immune reactions.

 

Note:

  • If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
  • It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.
Contact Us
Contact Form Demo