Why is this medicine prescribed?
Donidalorsen injection is used to prevent attacks of hereditary angioedema (HAE; genetic condition causing recurrent episodes of severe swelling). Donidalorsen is in a class of medications called prekallikrein-directed antisense oligonucleotides. It works by blocking the production of the protein that causes the swelling in patients with HAE.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Donidalorsen injection comes as a solution in an autoinjector (a prefilled syringe designed to autoinject a single dose of medicine) to be given subcutaneously (under the skin) by yourself or a caregiver. Give every 4 to 8 weeks as prescribed by your doctor.
Use donidalorsen injection exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your healthcare provider will show you or your caregiver how to use the autoinjector. You will also be given instructions for use that come with step by step directions on how to give your injection. Ask your healthcare provider if you aren't sure on how to use the autoinjector.
Before injecting donidalorsen, remove the autoinjector from the refrigerator and let it warm to room temperature for 30 minutes. Do not try to warm by running under warm water, using a microwave, boiling or any other method. Inspect the autoinjector carefully to make sure the solution is clear and colorless to yellow. Do not use if there is cloudiness, particulate matter, or discoloration. Donidalorsen injection can be given into the abdomen or upper thigh. The back of the upper arm can be used if a caregiver is giving the injection.
What special precautions should I follow?
Before using donidalorsen,
- tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
- tell your doctor if you have or have ever had kidney or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using donidalorsen, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
Inject the missed dose as soon as you remember it and then schedule the next dose for 4 to 8 weeks later based on your prescribed dosing schedule.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
Donidalorsen injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- pain, redness, or swelling at the site of injection
- runny nose, congestion, or sneezing
- stomach pain or cramping
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
- hives; rash; difficulty breathing; swelling of lips, throat or face; feeling faint or loss of conciousness
- painful or frequent urination, fever, low back pain
Donidalorsen injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).What should I know about storage and disposal of this medication?
Store donidalorsen autoinjectors in the refrigerator in its original packaging. It can also be stored at room temperature in its original packaging for up to 6 weeks. Do not freeze or expose to hear. Protect from exposure to light.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to donidalorsen.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.