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
Somavert Side Effects, and Drug Interactions - Pegvisomant
Somavert Side Effects, and Drug Interactions - Pegvisomant
SIDE EFFECTS
Laboratory Changes
Elevations of serum concentrations of ALT and AST greater than
ten times the ULN were reported in two subjects (0.8%) exposed to SOMAVERT in
pre-approval clinical studies (see PRECAUTIONS,
Liver Tests [LTs]). General
Nine acromegalic patients (9.6%) withdrew from pre-marketing
clinical studies because of adverse events, including two patients with marked
transaminase elevations (see PRECAUTIONS,
Liver Tests [LTs]),one patient with lipohypertrophy at the injection sites,
and one patient with substantial weight gain. The majority of reported adverse
events were of mild to moderate intensity and limited duration. Most adverse
events did not appear to be dose dependent. Table 5 shows the incidence of treatment-emergent
adverse events that were reported in at least two patients treated with SOMAVERT
and at frequencies greater than placebo during the 12-week, placebo-controlled
study.
Immunogenicity
In pre-marketing clinical studies, approximately 17% of the
patients developed low titer, non-neutralizing anti-GH antibodies. Although
the presence of these antibodies did not appear to impact the efficacy of SOMAVERT,
the long-term clinical significance of these antibodies is not known. No assay
for antipegvisomant antibodies is commercially available for patients receiving
SOMAVERT.
|
Table 5. Number of Patients (%) with Acromegaly Reporting
Adverse Events in a 12-week Placebo-controlled Study with SOMAVERT*
|
|
Event
|
SOMAVERT
|
|
|
10 mg/day
|
15 mg/day
|
20 mg/day
|
Placebo n=32
|
|
n=26
|
n=26
|
n=28
|
|
|
Body as a whole
|
|
Infection†
|
6 (23%)
|
0
|
0
|
2 (6%)
|
|
Pain
|
2 (8%)
|
1 (4%)
|
4 (14%)
|
2 (6%)
|
|
Injection site reaction
|
2 (8%)
|
1 (4%)
|
3 (11%)
|
0
|
|
Accidental injury
|
2 (8%)
|
1 (4%)
|
0
|
1 (3%)
|
|
Back pain
|
2 (8%)
|
0
|
1 (4%)
|
1 (3%)
|
|
Flu syndrome
|
1 (4%)
|
3 (12%)
|
2 (7%)
|
0
|
|
Chest pain
|
1 (4%)
|
2 (8%)
|
0
|
0
|
|
Digestive
|
|
Abnormal liver function tests
|
3 (12%)
|
1 (4%)
|
1 (4%)
|
1 (3%)
|
|
Diarrhea
|
1 (4%)
|
0
|
4 (14%)
|
1 (3%)
|
|
Nausea
|
0
|
2 (8%)
|
4 (14%)
|
1 (3%)
|
|
Nervous
|
|
Dizziness
|
2 (8%)
|
1 (4%)
|
1 (4%)
|
2 (6%)
|
|
Paresthesia
|
0
|
0
|
2 (7%)
|
2 (6%)
|
|
Metabolic and nutritional disorders
|
|
Peripheral edema
|
2 (8%)
|
0
|
1 (4%)
|
0
|
|
Cardiovascular
|
|
Hypertension
|
0
|
2 (8%)
|
0
|
0
|
|
Respiratory
|
|
Sinusitis
|
2 (8%)
|
0
|
1 (4%)
|
1 (3%)
|
|
*Table includes only those events that were reported
in at least 2 patients and at a higher incidence in patients treated with
SOMAVERT than in patients treated with placebo.
|
|
† The 6 events coded as "infection" in the
group treated with SOMAVERT 10 mg were reported as cold symptoms (3),upper
respiratory infection (1),blister (1),and ear infection (1).The 2 events
in the placebo group were reported as cold symptoms (1) and chest infection
(1).
|
DRUG INTERACTIONS
Acromegalic patients with diabetes mellitus being treated with
insulin and/or oral hypoglycemic agents may require dose reductions of these
therapeutic agents after the initiation of therapy with SOMAVERT.
In clinical studies, patients on opioids often needed higher
serum pegvisomant concentrations to achieve appropriate IGF-I suppression compared
with patients not receiving opioids. The mechanism of this interaction is not
known.
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