Velaglucerase alfa (Intravenous route)
- Powder for Solution
Uses of This Medicine:
Velaglucerase alfa injection is used to treat type 1 Gaucher's disease. This disease is caused by the lack of a certain enzyme, glucocerebrosidase, in the body. This enzyme is necessary for the body to use fats correctly, and fats will build up in certain areas of the body if the enzyme is not present. Velaglucerase alfa replaces the missing enzyme to help the body process fats.
This medicine is available only with your doctor's prescription.
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 velaglucerase alfa injection in children 4 to 17 years of age. However, safety and efficacy have not been established in children younger than 4 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of velaglucerase alfa injection in the elderly.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
Proper Use of This Medicine:
A nurse or other trained health professional will give you or your child this medicine in a hospital or clinic. This medicine is given through a needle placed in one of your veins.
You or your child may also receive medicines to help prevent unwanted effects from the injection.
Precautions While Using This Medicine:
It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.
This medicine may cause a rare but serious type of an allergic reaction called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have a cough, difficulty with swallowing, dizziness, fast heartbeat, headaches, wheezing, trouble with breathing, chest tightness, swelling in your face or hands, fever, chills, itching or hives, nausea, unusual tiredness or weakness, or lightheadedness or faintness while you are receiving this medicine.
Side Effects of This Medicine:
- More common
- Body aches or pain
- difficulty with breathing
- ear congestion
- facial swelling
- fever or chills
- loss of voice
- nasal congestion
- nausea or vomiting
- runny nose
- shortness of breath
- skin rash
- sore throat
- unusual tiredness or weakness
- Less common
- Blurred vision
- bone pain
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- pain, itching, burning, swelling, or a lump under your skin where the needle is placed
- pounding in the ears
- slow or fast heartbeat
- More common
- Abdominal or stomach pain
- back pain
- joint pain
- lack or loss of strength
- Less common
- Feeling of warmth
- hives or welts
- redness of the skin
- redness of the face, neck, arms, and occasionally, upper chest
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