A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Cerezyme Side Effects, and Drug Interactions - Imiglucerase
Cerezyme Side Effects, and Drug Interactions - Imiglucerase
SIDE EFFECTS
Experience in patients treated with Cerezyme ® (imiglucerase for injection)
has revealed that approximately 13.8% of patients experienced adverse events
which were judged to be related to Cerezyme ® administration and which
occurred with an increase in frequency. Some of the adverse events were related
to the route of administration. These include discomfort, pruritus, burning,
swelling or sterile abscess at the site of venipuncture. Each of these events
were found to occur in < 1% of the total patient population.
Symptoms suggestive of hypersensitivity have been noted in approximately 6.6%
of patients. Onset of such symptoms has occurred during or shortly after infusions;
these symptoms include pruritus, flushing, urticaria/angioedema, chest discomfort,
respiratory symptoms, cyanosis and hypotension. Anaphylactoid reaction has also
been reported. (see WARNINGS). Each
of these events were found to occur in < 1.5% of the total patient population.
Pre-treatment with antihistamines and/or corticosteroids and reduced rate of
infusion have allowed continued use of Cerezyme ® in most patients.
Additional adverse reactions that have been reported in approximately 6.5%
of patients treated with Cerezyme ® include: nausea, abdominal pain,
diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia.
Each of these events were found to occur in < 1.5% of the total patient population.
Incidence rates cannot be calculated from the spontaneously reported adverse
events in the post-marketing database. From this database, the most commonly
reported adverse events in children (defined as ages 2-12 years) included dyspnea,
fever, nausea, flushing, vomiting, and coughing, whereas in adolescents (>12
– 16 years) and in adults (>16 years) the most commonly reported events
included headache, pruritus, and rash.
In addition to the adverse reactions that have been observed in patients treated
with Cerezyme, transient peripheral edema and vomiting has been reported for
this therapeutic class of drug.
DRUG INTERACTIONS
No Information Provided.
top
