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
Factrel Indications, Dosage, Storage, Stability - gonadorelin
Factrel Indications, Dosage, Storage, Stability - gonadorelin
INDICATIONS
AND USES
Factrel as a single injection is indicated for evaluating the functional capacity
and response of the gonadotropes of the anterior pituitary. This single-injection
test does not measure pituitary gonadotropic reserve, for which more prolonged
or repeated administration may be required. The LH response is useful in testing
patients with suspected gonadotropin deficiency, whether due to the hypothalamus
alone or in combination with anterior pituitary failure. Factrel is also indicated
for evaluating residual gonadotropic function of the pituitary following removal
of a pituitary tumor by surgery and/or irradiation. In clinical studies to date,
however, the single-injection test has not been useful in differentiating pituitary
disorders from hypothalamic disorders. The Factrel test can be performed concomitantly
with other post-treatment evaluations. The results of the Factrel test complement
the clinical examination and other laboratory tests used to confirm or substantiate
hypogonadotropic hypogonadism.
In cases where there is a normal response, it indicates the presence of functional
pituitary gonadotropes. The single-injection test does not measure pituitary
gonadotropic reserve.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container permit.
Adults: 100 mcg dose, subcutaneously or intravenously. In females
for whom the phase of the menstrual cycle can be established, the test should
be performed in the early follicular phase (Days 1-7).
TEST METHODOLOGY
To determine the status of the gonadotropin secretory capacity of the anterior
pituitary, a test procedure requiring seven venous blood samples for LH is recommended.
Procedure:
- Venous blood samples should be drawn at -15 minutes and immediately prior
to Factrel administration. The LH baseline is obtained by averaging the LH
values of the two samples.
- Administer a bolus of 100 mcg of Factrel subcutaneously or intravenously.
- Draw venous blood samples at 15, 30, 45, 60, and 120 minutes after administration.
- Blood samples should be handled as recommended by the laboratory that will
determine the LH content. It must be emphasized that the reliability of the
test is directly related to the inter-assay and intra-assay reliability of
the laboratory performing the assay.
INTERPRETATION OF TEST RESULTS
Interpretation of the LH response to Factrel requires an understanding of the
hypothalamic-pituitary physiology, knowledge of the clinical status of the individual
patient, and familiarity with the normal ranges and the standards used in the
laboratory performing the LH assays.
The Factrel test complements the clinical assessment of patients with a variety
of endocrine disorders involving the hypothalamic-pituitary axis. In cases where
there is a normal response, it indicates the presence of functional pituitary
gonadotropes. The single-injection test does not determine the pathophysiological
cause for the subnormal response and does not measure pituitary gonadotropic
reserve.
HOW SUPPLIED
Lyophilized Powder in single-dose Secule® vials containing 100 mcg (NDC 0046-0507-05)
and 500 mcg (NDC 0046-0509-05) gonadorelin as the hydrochloride with 100 mg
lactose, USP. Each Secule vial is accompanied by one ampul containing 2 mL sterile
diluent of 2% benzyl alcohol in sterile water.
DIRECTIONS
Store at room temperature (approximately 25°C).
Reconstitute 100 mcg Secule® vial with 1.0 mL of the accompanying sterile diluent.
Reconstitute 500 mcg Secule® vial with 2.0 mL of the accompanying sterile diluent.
Prepare solution immediately before use. After reconstitution, store at room
temperature and use within 1 day.
Discard unused reconstituted solution and diluent.
Secule® Registered trademark to designate a vial containing an injectable
preparation in dry form.
Manufactured by:
Ayerst Laboratories Inc.
A Wyeth-Ayerst Company
Philadelphia, PA 19101
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