Description
Depemokimab-ulaa injection is used as an add-on maintenance treatment of severe asthma (eosinophilic phenotype) in patients whose asthma is not controlled with their current medicines. This medicine helps prevent asthma attacks (exacerbations). This medicine will not relieve an asthma attack that has already started.
This medicine is to be given only by or under the direct supervision of your doctor.
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 depemokimab-ulaa 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 depemokimab-ulaa injection in the elderly.
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:
- Parasitic (worm) infection—Use with caution. It is not known if this medicine may affect patients with this condition. The infection should be treated first before using this medicine.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the thigh, stomach area, or upper arm once every 6 months.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Missed Dose
Call your doctor or pharmacist for instructions.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have hives, itching, skin rash, lightheadedness, dizziness, fainting, swelling of the face, mouth, or tongue, or trouble breathing.
If you are using a steroid medicine for your asthma, do not suddenly stop taking it without first checking with your doctor. You may need to slowly decrease your dose before stopping it completely.
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 or nurse immediately if any of the following side effects occur:
More common
- Body aches or pain
- chills
- cough
- diarrhea
- ear congestion
- fever
- general feeling of discomfort or illness
- headache
- joint pain
- loss of voice
- muscle aches and pains
- nausea
- shivering
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- trouble breathing
- trouble sleeping
- unusual tiredness or weakness
- vomiting
Incidence not known
- Difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, or 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:
Less common
- Bleeding, blistering, burning, coldness, discoloration of the 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
- difficulty in moving
- dryness of the throat
- hoarseness
- joint pain
- muscle stiffness
- tender, swollen glands in the neck
- voice changes
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-80008583
