Dawnzera (donidalorsen) instruction manual Chinese introduction

1. Name:Dawnzera, donidalorsen

2. Indications:

Dawnzera (donidalorsen) is indicated for preventing the onset of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older.

3. Usage and dosage:

1. Recommended dose: The recommended dose of Dawnzera is 80 mg subcutaneously every 4 weeks. A dose of 80 mg subcutaneously every 8 weeks may be considered.

2. Missed dose: If you miss a dose of Dawnzera, use it as soon as possible. Resume treatment at the recommended dosing frequency starting from the date of the most recent dose.

3. Administration instructions: Dawnzera is for subcutaneous injection. Dawnzera is for self-administration or administration by a caregiver. Before initiating treatment, educate the patient and/or caregiver on the proper preparation of the Dawnzera autoinjector and subcutaneous injection technique. 30 minutes before injection, remove the single-dose autoinjector from the refrigerator and allow it to warm to room temperature. Do not use other heating methods.

Before dosing, visually inspect DAWNZERA for particulate matter and discoloration The solution should be clear and colorless to yellow. Do not use if cloudiness, particulate matter, or discoloration is observed prior to administration. Dawnzera is injected subcutaneously into the abdomen or upper thigh area. If a caregiver or health care provider administers the injection, the back of the upper arm can also be used as the injection site.

4. Adverse reactions:

In clinical studies of Dawnzera, common adverse reactions included injection site reactions, upper respiratory tract infection, urinary tract infection and abdominal discomfort. There are also relevant warnings and precautions to follow when using Dawnzera. For example, hypersensitivity reactions, including anaphylaxis, may occur.

5. Supply and storage:

1. Supply: Dawnzera 80mg/0.8mL injection is a sterile, preservative-free, transparent, colorless to yellow solution, supplied in a single-dose automatic injector. Each Dawnzera autoinjector is filled to deliver 0.8 ml of a solution containing 80 mg of donidalorsen.

2. Storage: Store the Dawnzera Autosampler in the original carton in a refrigerator at 36°F to 46°F (2°C to 8°C). The Dawnzera Autosampler can be stored in the original carton for up to 6 weeks at room temperature up to 86°F (30°C); if not used within 6 weeks of storage at room temperature, discard Dawnzera. Do not freeze. Do not expose to high temperatures. Avoid direct sunlight.

6. Taboo:

Dawnzera is contraindicated in patients with a history of severe hypersensitivity reactions, including anaphylactic shock, and in patients with an allergic reaction to donidalorsen or any excipients in Dawnzera.

7. Mechanism of action:

The active ingredient in Dawnzera, donidalorsen, is an ASO-GalNAc conjugate that reduces PKK protein production by binding to PKK mRNA, causing H1 ribonuclease (RNase H1)-mediated degradation of PKK mRNA. PKK is the precursor enzyme of plasma kallikrein, which leads to the release of bradykinin, a potent vasodilator that causes the swelling and pain of HAE. In patients with HAE, C1 inhibitor (C1-INH) deficiency or dysfunction results in excessive plasma kallikrein activity, bradykinin production, and episodes of angioedema. Donilon reduces PKK concentrations and prevents excessive bradykinin production in HAE patients.

8. Treatment effect:

Dawnzera's safety and effectiveness were verified in large clinical trials. The U.S. Food and Drug Administration (FDA) approved the drug based on positive results from the OASIS-HAE study. The study is a global, multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial. The results showed that Dawnzera significantly reduced the monthly HAE attack rate by 81% over 24 weeks compared with the placebo group, demonstrating its therapeutic effect in preventing HAE attacks.

Reference materials:https://www.drugs.com/dawnzera.html