Donidalorsen sodium at a glance
Medicine class
Antisense oligonucleotide targeting prekallikrein production
Licensed use
Routine prevention of recurrent HAE attacks from 12 years of age
Administration
Injection under the skin using a single-use pre-filled pen after training
Acute attacks
Not a rescue treatment; prescribed acute-attack treatment is still required
Safety monitoring
Subject to additional monitoring; suspected side effects can be reported through the Yellow Card Scheme
What is Donidalorsen sodium used for?
Donidalorsen sodium is licensed for:
Routine prevention of recurrent HAE attacks in adults and adolescents aged 12 years and older.
How does Donidalorsen sodium work?
Donidalorsen binds to the messenger RNA used to make prekallikrein and promotes its breakdown. This lowers prekallikrein and plasma kallikrein activity, reducing production of bradykinin—the substance that drives fluid leakage and swelling during HAE attacks.
Donidalorsen sodium preparations and strengths
Injection
Route: Parenteral
Strengths: 80 mg
How to take Donidalorsen sodium
Use the pre-filled pen only after injection training from a healthcare professional, following its instructions for use.
Inject under the skin of the abdomen or front of the thigh; a trained caregiver may also use the back of the upper arm.
Rotate injection sites and avoid skin that is tender, bruised, red, hard, infected, discoloured, scarred or damaged.
Remove the pen from the refrigerator about 30 minutes before use; do not warm it another way.
The solution should be clear and colourless to yellow. Do not use it if frozen, cloudy, discoloured, particulate or if the pen is damaged.
Use each pen once only.
Donidalorsen sodium side effects
Common or expected effects
- Injection-site reactions, including redness, discolouration, pain, itching, hardening, bruising, scaling or swelling.
- Raised liver enzymes detected by blood tests.
Get urgent medical advice
- Hypersensitivity, including anaphylaxis, with symptoms such as rash, breathing difficulty, wheezing, chest tightness, swelling around the mouth or a rapid heartbeat.
Donidalorsen sodium in pregnancy
Human pregnancy information is limited. As a precaution, the product information advises avoiding donidalorsen during pregnancy. Anyone pregnant or planning pregnancy should discuss treatment and uncontrolled HAE with their specialist.
Donidalorsen sodium while breastfeeding
Transfer into breast milk cannot be excluded, and it is uncertain whether donidalorsen could affect a breastfed infant. A specialist should weigh the benefits of breastfeeding against the benefits of treatment when deciding whether either should be paused.
Donidalorsen sodium interactions
No specific clinically relevant medicine interactions are currently identified. Formal clinical interaction studies have not been performed, although laboratory data suggest interactions involving CYP enzymes, transporters or plasma-protein displacement are unlikely.
Common questions about Donidalorsen sodium
Answers are fully visible for fast scanning and source review.
Can donidalorsen sodium treat an HAE attack that has already started?
No. It is preventive treatment, not acute rescue treatment. Use the prescribed acute-attack plan and seek emergency help if breathing is affected.
Who can receive donidalorsen sodium?
It is licensed for routine prevention of recurrent HAE attacks in adults and adolescents aged 12 years and older.
Can donidalorsen sodium be self-injected?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.