Sebelipase alfa (Intravenous route)
Uses of This Medicine:
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.
Before Using This Medicine:
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:
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.
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.
Although 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.
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.
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.
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 of This Medicine:
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. It is usually given for at least 2 hours once a week, or once every other week.
Precautions While Using This Medicine:
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. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, chest discomfort, or wheezing. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, itchy rash, running nose, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.
Side Effects of This Medicine:
- More common
- Abdominal or stomach pain
- anxiety or agitation
- blurred vision
- difficulty with breathing or swallowing
- dry mouth
- hives, itching, or rash
- irregular heartbeats
- paleness of the skin
- pounding in the ears
- reddening of the skin, especially around the ears
- skin rash, encrusted, scaly, and oozing
- slow or fast heartbeat
- slow or irregular breathing
- swelling of the eyes, face, inside of the nose, or throat
- tightness in the chest
- 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
- More common
- Difficulty having a bowel movement (stool)
- muscle aches
- pale skin
- sore throat
- stuffy or runny nose
- troubled breathing with exertion
- unusual bleeding or bruising
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:
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:
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.
Last Updated: 9/15/2016