Why is this medicine prescribed?
Garadacimab-gxii is used to prevent hereditary angioedema (HAE) attacks (genetic condition causing recurring episodes of painful swelling in the face, limbs, airway and GI tract). Garadacimab-gxii is in a class of medications called monoclonal antibodies. It works by blocking certain substances in the body that are responsible for producing the symptoms of angioedema.
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?
Garadacimab-gxii comes as a solution in a prefilled autoinjector to be given subcutaneously (just under the skin). It is injected once a month.
Use garadacimab-gxii exactly as directed. Do not give 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 prepare and inject your medication so that the injections can be given at home. Carefully read the manufacturer's instructions for use that describe how to inject a dose of garadacimab-gxii injection. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.
To prepare to give your injection, remove the prefilled autoinjector from the refrigerator. Allow it to reach room temperature for 30 minutes before you are ready to inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water or in direct sunlight.
Always look at garadacimab-gxii solution before injecting it. Check that the expiration date has not passed and that the liquid is clear or slightly opalescent and brownish yellow to slightly yellow in color. The liquid should not contain visible particles. Do not use if it is expired or if the liquid is cloudy, discolored, or contains particles.
You can inject garadacimab-gxii injection under the skin on your thighs or stomach area, except for the 1-inch area around your navel (belly button). If a caregiver will be injecting the medication for you, that person can also inject it into your upper arm. Use a different spot for each injection. Do not inject garadacimab-gxii injection into a spot that is tender, bruised, red, or hard. Also, do not inject into areas with scars, moles, or stretch marks.
Use each autoinjector only once. Throw away used prefilled autoinjectors in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
What special precautions should I follow?
Before using garadacimab-gxii,
- 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 any medical conditions.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using garadacimab-gxii, 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?
Give the missed dose as soon as you remember it.
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?
Garadacimab-gxii may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- bruising, redness, itching at the site of injection
- abdominal pain
- runny nose, sneezing, sore throat
Garadacimab-gxii 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?
Keep this medication tightly closed in the container it came in. Store it in a refrigerator and protect from light. Do not freeze.
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.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving garadacimab-gxii.
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.