Description
Garadacimab-gxii injection is used to prevent attacks of hereditary angioedema (HAE). HAE is a rare disease that causes swelling of the face, hands, feet, throat, stomach, bowels, or genitals.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of garadacimab-gxii injection in children younger than 12 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of garadacimab-gxii injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use
This medicine is given as a shot under your skin in the upper arm, thigh, or stomach area (1 inch away from belly button). It may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.
This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have questions.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into the belly button, moles, scars, or bruises, or into skin areas that are bruised, red, tender, or hard.
This medicine is available in 2 forms: a prefilled autoinjector or a prefilled syringe.
Allow 30 minutes for the medicine to warm up to room temperature. Do not warm it by using a heat source (eg, hot water, microwave, direct sunlight) or in any other way.
Check the liquid in the prefilled autoinjector or syringe. It should be brownish-yellow to yellow and slightly opalescent to clear. Do not use it if it is discolored or has particles in it. Do not use it if it looks damaged, has cracks, leaking, or has been dropped. Do not shake.
To use the prefilled autoinjector:
- Wash your hands with soap and water before and after using this medicine.
- Do not remove the cap until your are ready to inject.
- Pull the cap straight off. Do not twist the clear cap. Do not put the cap back on. Do not touch the gray needle shield.
- Gently pinch the skin. Place the autoinjector at a 90 degree angle. Press the gray needle shield firmly against the skin, you will hear a "click" which means the injection has started. The yellow plunger will start moving in the viewing window. You will head a second "click" after the first one. Keep pressing down for 5 more seconds to make sure you get the full dose. Make sure the yellow plunger completely fills the window and has stopped moving before removing the autoinjector.
- The gray needle shield will return to its original position and will lock into place covering the needle.
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Do not remove the needle cap until your are ready to inject.
- Pull the needle cap straight off with one hand while holding the prefilled syringe with your other hand. Do not touch or hold the plunger. Do not recap the prefilled syringe. Do not touch the needle.
- Gently pinch the skin. Fully insert the needle at an angle between 45 and 90 degrees. Do not change the angle during injection. Do not hold or push the plunger while inserting the needle into the skin.
- Firmly push the plunger all the way down until it stops to get the full dose. Slowly remove the thumb from the plunger before removing the syringe from the skin. This will make the needle retract inside the syringe.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (solution):
- For hereditary angioedema:
- Adults and children 12 years of age and older—At first, 400 milligrams (mg) (two 200 mg injection) injected under the skin on the first day. Then a maintenance dose of 200 mg injected under the skin once a month.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For hereditary angioedema:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Keep it in its original container. Protect from light. Do not use it if it has been frozen or thawed.
Do not put it back in the refrigerator after it has reached room temperature.
Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that the medicine is working properly and to check for unwanted effects.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- fever
- headache
- muscle aches
- stomach pain
- stuffy or runny nose
- sore throat
- unusual tiredness or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80008474
