Donanemab-azbt (Kisunla) represents a promising advancement in the treatment of Alzheimer's disease. The FDA approved it on 2nd July 2024.

As a monoclonal antibody specifically designed to target and reduce amyloid beta plaques in the brain, it offers a targeted approach to managing this debilitating condition.

By understanding how this drug works, its preparation, and its clinical benefits, patients and healthcare providers can better appreciate the potential of donanemab-azbt in the fight against Alzheimer's disease.

• Kisunla (Donanemab) Indications:

KISUNLA is a medication indicated for the treatment of Alzheimer's disease. It is intended for patients with mild cognitive impairment or mild dementia stages of the disease.

• Kisunla Dose:

The recommended dosage of KISUNLATM is 700 mg every four weeks for the first three doses, followed by 1400 mg every four weeks. It is administered via an intravenous infusion over approximately 30 minutes. If an infusion is missed, resume as soon as possible at the same dose.

• Use in Liver and Kidney Disease:

The document does not provide specific instructions regarding the use of KISUNLATM in patients with liver or kidney disease. Consult a healthcare provider for personalized advice.

• Use in Pregnancy and Lactation:

There are no adequate data on the use of KISUNLATM in pregnant women to determine the risk of major birth defects, miscarriage, or other adverse outcomes. The background risk in the general population is 2-4% for major birth defects and 15-20% for miscarriage.

There is no data on the presence of KISUNLATM in human milk, its effects on the breastfed infant, or its effects on milk production. Monoclonal antibodies typically have low passage into human milk and limited exposure to infants.

• Contraindications to Kisunla Use:

KISUNLATM is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or any of its excipients. This can include anaphylaxis.

• Side Effects of Kisunla:

KISUNLATM can cause amyloid-related imaging abnormalities (ARIA), including edema (ARIA-E) and hemosiderin deposition (ARIA-H), which can be observed on MRI.

Symptoms of ARIA may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Infusion-related reactions and hypersensitivity reactions, including anaphylaxis, have also been observed.

• Drug Interactions:

Patients should exercise caution when considering the use of antithrombotic or thrombolytic medications with KISUNLATM due to the increased risk of intracerebral hemorrhage and ARIA.

• How to Administer Kisunla?

KISUNLATM must be diluted with 0.9% sodium chloride injection before administration. Use aseptic technique, allow the solution to equilibrate to room temperature, and gently invert to mix. Administer intravenously over 30 minutes and monitor the patient for infusion reactions.

• Mechanism of Action

KISUNLATM is a monoclonal antibody that targets aggregated forms of beta-amyloid, a protein associated with Alzheimer's disease. By binding to beta-amyloid plaques, it helps reduce their presence in the brain.

For detailed information, please refer to the full document provided by the FDA.