Description
Donidalorsen 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 donidalorsen 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 donidalorsen 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.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Liver disease, moderate to severe—Use is not recommended in patients with this condition.
Proper Use
This medicine is given as a shot under your skin in the upper arm, thigh, or stomach area. 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 within 2 inches of the belly button, into scars, damaged skin, or into skin areas that are bruised, red, tender, or hard.
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) or in any other way.
Check the liquid in the autoinjector. It should be clear and colorless to yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not use it if it looks damaged or the clear cap is missing or not attached.
To use:
- Wash your hands with soap and water before and after using this medicine.
- Do not remove the cap until you are ready to inject.
- Pull the cap straight off. Do not twist the clear cap. Do not recap. Do not push the orange needle shield against the hand or finger.
- Place the autoinjector at a 90 degree angle against your skin. Push firmly and hold the autoinjector straight against your skin. You will hear a "click" which means the injection has started. You will hear a second "click" after the first one. Keep pressing down for 10 seconds to make sure you get the full dose. Make sure the orange plunger completely fills the window.
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—80 milligrams (mg) injected under the skin every 4 or 8 weeks.
- 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 freeze.
If needed, you may store the autoinjector at room temperature for up to 6 weeks. Throw away unused medicine within 6 weeks.
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 progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, dizziness, difficulty swallowing, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue, trouble breathing, or unusual tiredness or weakness.
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.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bladder pain
- 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
- bloody or cloudy urine
- body aches or pain
- chills
- cough
- difficult, burning, or painful urination
- ear congestion
- fever
- headache
- loss of voice
- lower back or side pain
- sore throat
- stuffy or runny nose
- trouble breathing
- unusual tiredness or weakness
Incidence not known
- Chest tightness
- cough
- difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
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
- Stomach discomfort
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-80008511
