Description
Elapegademase-lvlr injection is used to treat severe immune deficiency due to adenosine deaminase deficiency, an inherited disorder that lacks all immune protection from bacteria, viruses, and fungi. Patients with this disorder are prone to repeated and persistent infections that can be very serious or life-threatening.
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of elapegademase-lvlr injection in children. Safety and efficacy have been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of elapegademase-lvlr 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:
- Infections (eg, bacteria, virus, or fungus)—May decrease your body's ability to fight an infection.
- Thrombocytopenia (low levels of platelets in the blood)—Use with caution. May increase risk of bleeding at the injection site.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles.
Precautions
It is very important that your doctor check your or your child's progress closely to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Protect yourself or your child from infections until your immune function is improved, usually after 2 to 6 months of treatment. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever, chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
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:
Rare
- Black, tarry, stools
- body aches or pain
- burning, dry or itching eyes
- change in hearing
- chest pain
- chills
- cough
- coughing or spitting up blood
- diarrhea
- difficulty in breathing
- discharge, excessive tearing
- ear congestion
- ear drainage
- earache
- fever
- general feeling of discomfort or illness
- headache
- itching in the genitals or other skin areas
- itching of the ears
- joint pain
- loss of appetite
- loss of voice
- lower back or side pain
- muscle aches and pains
- nasal congestion
- nausea
- painful or difficult urination
- pale skin
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- runny nose
- scaling
- seizures
- severe pain in the side and back
- shivering
- sneezing
- sore mouth or tongue
- sore throat
- stiff neck
- stomach cramps and pain
- sweating
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- thickening of bronchial secretions
- trouble sleeping
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- watery diarrhea
Incidence not known
- Back, leg, or stomach pains
- bleeding gums
- blood in the urine or stools
- dark urine
- dizziness
- general body swelling
- nosebleeds
- pain, warmth, or burning in the fingers, toes, and legs
- pinpoint red spots on the skin
- problems with vision or hearing
- weight loss
- yellowing of the eyes or skin
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:
Rare
- Change in walking and balance
- clumsiness or unsteadiness
- difficulty in moving
- ear canal irritation
- headache, severe and throbbing
- injection site discomfort
- lack or loss of strength
- mouth or throat pain
- muscle pain or stiffness
- rash
- swelling of the face or nose
- tearing of the skin
- tooth pain
- upper stomach pain
Incidence not known
- Redness and itching at the injection site
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-20444112
