Kisunla (donanemab-azbt) Injection Single-Dose Vial x 350 mg/20 mL (17.5 mg/mL)

Description

Kisunla (donanemab) is a prescription medicine used for the mild dementia stage of Alzheimer’s disease (AD) and mild cognitive impairment (MCI) due to Alzheimer’s disease. Kisunla is a plaque-targeting therapy that helps to slow down the decline in memory, thinking, and daily functioning. This slows the progression of Alzheimer’s disease so people can continue their daily activities and hobbies and live independently for a longer time. Kisunla is given as a once-monthly IV infusion.

How well does it work?

Kisunla (donanemab) significantly slowed Alzheimer’s disease progression by more than 20% at 76 weeks in the TRAILBLAZER-ALZ 2 clinical trial. This was measured using the Integrated Alzheimer’s Disease Rating Scale (iADRS) and Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score in patients with low/medium tau and in the combined low/medium and high tau populations.

Treatment with Kisunla benefited all groups of trial participants, but patients in earlier stages of the disease showed the most significant improvements.

Kisunla side effects

Common Kisunla side effects

Common Kisunla side effects include headache and swelling in areas of the brain with or without small spots of bleeding in or on the brain’s surface. These occurred in at least 10% of patients and at a higher incidence compared to placebo.

Serious Kisunla side effects

• Serious allergic reactions include swelling of the face, lips, mouth, or eyelids, difficulty breathing, and hives. Tell your healthcare provider if you have any symptoms of a serious allergic reaction during or after your infusion.
• Infusion-related reactions. If you have an infusion-related reaction, your infusion may be slowed down or stopped. Tell your healthcare provider right away if you have symptoms of sweating, irritation of the skin, headache, nausea, chest pain, vomiting, or problems breathing during an infusion chills. If you have had an infusion-related reaction while receiving Kisunla, your healthcare provider may give you an antihistamine, acetaminophen, or a steroid before your infusions to decrease your risk of having an infusion reaction.