Indication
LUMIZYME® (alglucosidase alfa) is an enzyme
replacement therapy for patients with Pompe disease (acid α‑glucosidase
(GAA) deficiency).
Important Safety Information
WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND
IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE
- If you or your child is taking Lumizyme, you should know that severe
and potentially life-threatening allergic-type reactions known as
anaphylaxis, severe hypersensitivity reactions, and reactions
related to the immune system may occur during and after Lumizyme
treatment. These reactions may include extreme difficulty breathing,
shallow breathing, abnormal heart rate, low blood pressure, throat
tightness, face and tongue swelling, kidney dysfunction, and severe
skin lesions. You should seek immediate medical care if signs and
symptoms of anaphylaxis, hypersensitivity reactions, and immune
system reactions occur. If such a reaction is severe enough, your
doctor may decide to immediately discontinue the infusion and
provide immediate medical care. Appropriate medical support measures
may be administered during your infusion, and you may require close
observation during and after Lumizyme administration.
- If your child has compromised breathing or heart function due to
Pompe disease, there may be a risk of acute worsening of heart
and/or lung function with Lumizyme due to the fluid from the
infusion, and your doctor may decide that close observation during
and after Lumizyme administration may be necessary.
Warnings and Precautions
Anaphylaxis and Hypersensitivity Reactions: Life-threatening
anaphylaxis and hypersensitivity reactions have been observed in some patients
during and after treatment with alglucosidase alfa. If such a reaction is severe
enough, your doctor may decide to immediately discontinue the infusion and
provide you with immediate medical care. Appropriate medical support and
monitoring measures should be available during infusion.
Immune-Mediated Reactions: You or your child may be monitored
for the development of systemic immune-mediated reactions while receiving
Lumizyme. If these reactions occur, your doctor may discontinue the infusion and
initiate appropriate medical treatment.
Risk of Acute Cardiorespiratory Failure: Infant Pompe patients
with heart or breathing
problems who are experiencing an acute respiratory condition may be at risk for
increasing the seriousness of these problems as a result of Lumizyme
administration due to the infusion fluid, and your child’s doctor may
require additional monitoring for these infants.
Risk of Cardiac Arrhythmia and Sudden Cardiac Death during General
Anesthesia for Central Venous Catheter Placement: Caution should be
used when administering general anesthesia for the placement of a central venous
catheter intended for Lumizyme infusion. Ventricular arrhythmias and slow heart
rate resulting in cardiac arrest or death have been observed in infant Pompe
patients with cardiac hypertrophy during general anesthesia for central venous
catheter placement. Appropriate medical support and monitoring measures should
be available during infusion.
Risk of Antibody Development: Patients with infantile-onset
Pompe disease (IOPD) should be managed by a clinical specialist knowledgeable in
immune tolerance induction in Pompe disease to optimize treatment. Some patients
who develop high and sustained IgG antibody levels, including certain IOPD
patients, may have a reduced response to Lumizyme.
Monitoring: Laboratory Tests: Patients should be monitored for
IgG antibody formation every 3 months for 2 years and then annually thereafter.
Adverse Reactions
The most frequently reported adverse reactions during Lumizyme studies in
patients were allergy reactions and included: anaphylaxis, rash, fever,
flushing/feeling hot, hives, headache, excessive sweating, nausea, cough, less
oxygen in the blood, fast heart rate, rapid breathing, chest discomfort,
dizziness, muscle twitching, agitation, bluish or purple skin, redness of skin,
high blood pressure/increased blood pressure, facial paleness, chills, tremor,
vomiting, fatigue, and muscle pain.
Please see the Full Prescribing Information for complete details,
including boxed WARNING.
