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
Plenaxis Side Effects, and Drug Interactions - Abarelix
Plenaxis Side Effects, and Drug Interactions - Abarelix
SIDE EFFECTS
Immediate-Onset Systemic Allergic Reactions: See BOXED
WARNINGS and WARNINGS
In the single study of Plenaxis™ conducted in men with
advanced symptomatic prostate cancer, adverse events reported by >10%
of patients are listed in Table 4. Adverse events are listed without regard
to causality. Causality is often difficult to assess in elderly patients with
multiple co-morbidities and prostate cancer.
|
Table 4. Adverse Events in > 10% of
Patients in the Advanced Symptomatic Prostate Cancer Study (without regard
for causality).
|
|
Preferred Term
|
Plenaxis™ N=81 n (%)
|
|
Hot flushes*
|
64 (79)
|
|
Sleep disturbance*
|
36 (44)
|
|
Pain
|
25 (31)
|
|
Breast enlargement*
|
24 (30)
|
|
Breast pain/nipple tenderness*
|
16 (20)
|
|
Back pain
|
14 (17)
|
|
Constipation
|
12 (15)
|
|
Peripheral edema
|
12 (15)
|
|
Dizziness
|
10 (12)
|
|
Headache
|
10 (12)
|
|
Upper respiratory tract infection
|
10 (12)
|
|
Diarrhea
|
9 (11)
|
|
Dysuria
|
8 (10)
|
|
Fatigue
|
8 (10)
|
|
Micturition frequency
|
8 (10)
|
|
Nausea
|
8 (10)
|
|
Urinary retention
|
8 (10)
|
|
Urinary tract infection
|
8 (10)
|
|
* Pharmacological consequence of androgen deprivation
|
Changes in Laboratory Values
Clinically meaningful increases in serum transaminases were
seen in a small percentage of patients in both treatment groups in each active-controlled
Plenaxis™ study. In Study 1 and Study 2 combined, the percentage
of Plenaxis™ patients reporting serum ALT >2.5 times upper limit of
normal or >200 U./L was 8.2% and 1.8%, respectively. The percentage reporting
serum AST >2.5 times upper limit of normal or >200 U/L was 3.1% and 0.8%,
respectively. Similar results were reported for active comparators.
Slight decrease in hemoglobin, a pharmacological consequence
of castration, were observed in patients receiving Plenaxis™ and active
comparator. Mean increases in serum triglycerides of approximately 10% were
seen in Plenaxis™-treated patients.
DRUG INTERACTIONS
No formal drug/drug interaction studies with Plenaxis™
were performed. Cytochrome P-450 is not known to be involved in the metabolism
of Plenaxis™. Plenaxis™ is highly bound to plasma proteins (96 to
99%).
Laboratory Tests
Response to Plenaxis™ should be monitored by measuring
serum total testosterone concentrations just prior to administration on Day
29 and every 8 weeks thereafter (see WARNINGS).
Serum transaminase levels should be obtained before starting treatment with
Plenaxis™ and periodically during treatment. Periodic measurement of serum
PSA levels may also be considered.
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