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
Trelstar Side Effects, and Drug Interactions - Triptorelin pamoate
Trelstar Side Effects, and Drug Interactions - Triptorelin pamoate
SIDE EFFECTS
In the majority of patients, testosterone levels increased
above baseline during the first week following the initial injection, declining
thereafter to baseline levels or below by the end of the second week of treatment.
The transient increase in testosterone levels may be associated with temporary
worsening of disease signs and symptoms, including bone pain, hematuria, and
bladder outlet obstruction. Isolated cases of spinal cord compression with weakness
or paralysis of the lower extremities have occurred (see WARNINGS).
In a controlled, comparative clinical trial, the following
adverse reactions were reported to have a possible or probable relationship
to therapy as ascribed by the treating physician in 1% or more of the patients
receiving triptorelin (Table 3). Often, causality is difficult to assess in
patients with metastatic prostate cancer. Reactions considered not drug-related
or unlikely to be related are excluded.
TABLE 3. TREATMENT-RELATED ADVERSE EVENTS REPORTED BY 1% OR
MORE OF PATIENTS DURING TREATMENT WITH TRELSTARTM LA
|
|
TRELSTARTM LA N=174
|
| |
N
|
%
|
|
Application Site
|
|
Injection site pain
|
7
|
4.0
|
|
Body As A Whole
|
|
Hot flushes*
|
127
|
73.0
|
|
Leg pain
|
9
|
5.2
|
|
Pain
|
6
|
3.4
|
|
Back pain
|
5
|
2.9
|
|
Fatigue
|
4
|
2.3
|
|
Chest pain
|
3
|
1.7
|
|
Asthenia
|
2
|
1.1
|
|
Peripheral edema
|
2
|
1.1
|
|
Cardiovascular
|
|
Hypertension
|
7
|
4.0
|
|
Dependent edema
|
4
|
2.3
|
|
Central and Peripheral Nervous System
|
|
Headache
|
12
|
6.9
|
|
Dizziness
|
5
|
2.9
|
|
Leg cramps
|
3
|
1.7
|
|
Endocrine
|
|
Breast pain
|
4
|
2.3
|
|
Gynecomastia
|
3
|
1.7
|
|
Gastrointestinal
|
|
Nausea
|
5
|
2.9
|
|
Constipation
|
3
|
1.7
|
|
Dyspepsia
|
3
|
1.7
|
|
Diarrhea
|
2
|
1.1
|
|
Abdominal pain
|
2
|
1.1
|
|
Liver and Biliary System
|
|
Abnormal hepatic function
|
2
|
1.1
|
|
Metabolic and Nutritional
|
|
Edema in legs
|
11
|
6.3
|
|
Increased alkaline phosphatase
|
3
|
1.7
|
|
Musculoskeletal System
|
|
Skeletal pain
|
23
|
13.2
|
|
Arthralgia
|
4
|
2.3
|
|
Myalgia
|
2
|
1.1
|
|
Psychiatric
|
|
Decreased libido*
|
4
|
2.3
|
|
Impotence*
|
4
|
2.3
|
|
Insomnia
|
3
|
1.7
|
|
Anorexia
|
3
|
1.7
|
|
Respiratory System
|
|
Coughing
|
3
|
1.7
|
|
Dyspnea
|
2
|
1.1
|
|
Pharyngitis
|
2
|
1.1
|
|
Skin and Appendages
|
|
Rash
|
3
|
1.7
|
|
Urinary System
|
|
Dysuria
|
8
|
4.6
|
|
Urinary retention
|
2
|
1.1
|
|
Vision Disorders
|
|
Eye pain
|
2
|
1.1
|
|
Conjunctivitis
|
2
|
1.1
|
* Expected pharmacologic consequences of testosterone suppression.
Changes in Laboratory Values During Treatment: The following
abnormalities in laboratory values not present at baseline were observed in
10% or more of patients at the Day 253 visit: decreased hemoglobin and RBC count
and increased glucose, BUN, SGOT, SGPT, and alkaline phosphatase. The relationship
of these changes to drug treatment is difficult to assess in this population.
DRUG INTERACTIONS
Drug Interactions: No drug-drug interaction studies involving triptorelin have been conducted. In the absence of relevant data and as a precaution, hyperprolactinemic drugs should not be prescribed concomitantly with TRELSTAR™ DEPOT since hyperprolactinemia reduces the number of pituitary GnRH receptors.
Drug/Laboratory Test Interactions: Chronic or continuous administration of triptorelin in therapeutic doses results in suppression of the pituitary-gonadal axis. Diagnostic tests of the pituitary-gonadal function conducted during treatment and after cessation of therapy may therefore be misleading.
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