Description
Sebelipase alfa injection is used to treat patients with Lysosomal acid lipase (LAL) deficiency.
This medicine is to be given 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 sebelipase alfa injection in children 1 month of age and older.
Geriatric
Appropriate studies on the relationship of age to the effects of sebelipase alfa injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
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:
- Allergy to eggs or egg products—May increase risk for allergic reactions to occur again.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through an IV catheter that is placed into one of your veins. The medicine must be injected slowly, so the IV will need to stay in place for at least 2 hours. It is usually given once a week or once every other week.
Precautions
Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood 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 or your child have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, 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 or nurse immediately if any of the following side effects occur:
More common
- Anxiety or agitation
- blurred vision
- chest tightness
- chills
- coughing
- diarrhea
- difficulty with breathing or swallowing
- dizziness
- dry mouth
- fever
- headache
- hives, itching, or rash
- hoarseness
- hyperventilation
- irregular heartbeats
- irritability
- nausea
- nervousness
- pale skin
- pounding in the ears
- reddening of the skin, especially around the ears
- restlessness
- shaking
- skin rash, encrusted, scaly, and oozing
- slow or fast heartbeat
- slow or irregular breathing
- stomach pain
- swelling of the eyes, face, inside of the nose, or throat
- vomiting
- trouble sleeping
- unusual tiredness or weakness
Less common
- Chest discomfort
- fast, pounding, or irregular heartbeat or pulse
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid shallow breathing
- redness of the skin
- redness of the white part of the eyes
- swelling of the eyelids
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
- Constipation
- difficulty having a bowel movement (stool)
- lack or loss of strength
- muscle aches
- pale skin
- sneezing
- sore throat
- stuffy or runny nose
- unusual bleeding or bruising
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-20168783
