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
Geref Side Effects, and Drug Interactions - Sermorelin
Geref Side Effects, and Drug Interactions - Sermorelin
SIDE EFFECTS
A large proportion of patients develop anti-GRF antibodies at least once during
treatment with Geref® (sermorelin acetate for injection). The significance of
these antibodies is not clear and often a positive test at one growth assessment
will become negative by the next assessment. The presence of antibodies does
not appear to affect growth or appear to be related to a specific adverse reaction
profile. No generalized allergic reactions to Geref® have been reported.
The most common treatment-related adverse event (occurring in about 1 patient
in 6) is local injection reaction characterized by pain, swelling or redness.
Of 350 patients exposed to Geref® in clinical trials, three discontinued therapy
due to injection reactions. Other treatment-related adverse events had individual
occurrence rates of less than 1% and include: headache, flushing, dysphagia,
dizziness, hyperactivity, somnolence and urticaria.
When administered intravenously for diagnostic use, the following adverse reactions
have been noted: flushing of the face, injection site pain, redness and/or swelling,
nausea, headache, vomiting, dysgeusia, pallor and tightness in the chest.
DRUG ABUSE AND DEPENDENCE
The clinical pharmacology suggests that Geref® is very unlikely to be associated
with drug abuse or dependence and there have been no reports of this from clinical
trials.
DRUG INTERACTIONS
Concomitant glucocorticoid therapy may inhibit the response to Geref®. There was no evidence in the controlled studies
of Geref®'s interaction with drugs commonly used in the treatment of routine
pediatric problems/illnesses. However, formal drug interactions studies have
not been conducted.
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