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 Warnings, Precautions, Pregnancy, Nursing, Abuse - Triptorelin pamoate
Trelstar Warnings, Precautions, Pregnancy, Nursing, Abuse - Triptorelin pamoate
WARNINGS
Rare reports of anaphylactic shock and angioedema related to
trip-torelin administration have been reported. In the event of a reaction,
therapy with TRELSTARTM LA should be discontinued immediately
and the appropriate supportive and symptomatic care should be administered.
Initially, triptorelin, like other LHRH agonists, causes a
transient increase in serum testosterone levels. As a result, isolated cases
of worsening of signs and symptoms of prostate cancer during the first weeks
of treatment have been reported with LHRH agonists. Patients may experience
worsening of symptoms or onset of new symptoms, including bone pain, neuropathy,
hematuria, or urethral or bladder outlet obstruction. Cases of spinal cord compression,
which may contribute to paralysis with or without fatal complications, have
been reported with LHRH agonists.
If spinal cord compression or renal impairment develops, standard
treatment of these complications should be instituted, and in extreme cases
an immediate orchiectomy considered.
PRECAUTIONS
General: Patients with metastatic vertebral lesions
and/or with upper or lower urinary tract obstruction should be closely observed
during the first few weeks of therapy (see WARNINGS
).
Hypersensitivity and anaphylactic reactions have been reported with triptorelin
as with other LHRH agonists (see CONTRAINDICATIONS
and WARNINGS
).
Laboratory Tests: Response to TRELSTARTM LA
should be monitored by measuring serum levels of testosterone and prostate-specific
antigen. Testosterone levels should be measured immediately prior to or immediately
after dosing.
Pregnancy, Teratogenic Effects: Pregnancy Category X (see
CONTRAINDICATIONS). TRELSTARTM LA
is contraindicated in women who are or may become pregnant while receiving
the drug. Studies in pregnant rats administered triptorelin at doses of 2, 10,
and 100 mcg/kg/day (approximately equivalent to 0.2, 0.8, and 8 times the recommended
human therapeutic dose based on body surface area) during the period of organogenesis
displayed maternal toxicity and embryotoxicity, but no fetotoxicity or teratogenicity.
Similarly, no teratogenic effects were observed when mice were administered
doses of 2, 20, and 200 mcg/kg/day (approximately equivalent to 0.1, 0.7, and
7 times the recommended human therapeutic dose based on body surface area).
If this drug is used during pregnancy or if the patient becomes pregnant while
taking this drug, she should be apprised of the potential hazard to the fetus
(see PRECAUTIONS
, and Pregnancy).
Carcinogenesis, Mutagenesis, Impairment of Fertility: In
rats, doses of 120, 600, and 3000 mcg/kg given every 28 days (approximately
0.3, 2, and 8 times the recommended human therapeutic dose based on body surface
area) resulted in increased mortality with a drug treatment period of 13-19
months. The incidence of benign and malignant pituitary tumors and histiosarcomas
were increased in a dose related manner. No oncogenic effect was observed in
mice administered triptorelin for 18 months at doses up to 6000 mcg/kg every
28 days (approximately 8 times the human therapeutic dose based on body surface
area).
Mutagenicity studies performed with triptorelin using bacterial
and mammalian systems (in vitro Ames test and chromosomal aberration test in
CHO cells and an in vivo mouse micronucleus test) provided no evidence of mutagenic
potential.
After 60 days of treatment followed by a minimum of four estrus
cycles prior to mating, triptorelin, at doses of 2, 20, and 200 mcg/kg/day in
saline (approximately 0.2, 2.0, and 16 times the recommended human therapeutic
dose based on body surface area) or 20 mcg/kg/day in slow release microspheres,
had no effect on the fertility or general reproductive performance of female
rats. Treatment did not elicit embryotoxicity, teratogenicity, or any effects
on the development of the offspring (F1 generation) or their reproductive performance.
No studies were conducted to assess the effect of triptorelin
on male fertility.
Geriatric Use: Prostate cancer occurs primarily in an
older patient population. Clinical studies with TRELSTARTM LA
have been conducted primarily in patients ³65
years old.
Use in Women: TRELSTARTM LA has not been
studied in women and is not indicated for use in women.
Nursing Mothers: It is not known whether TRELSTARTM
LA is excreted in human milk. Because many drugs are excreted in human
milk and because the effects of TRELSTARTM LA on lactation
and/or the breastfed child have not been determined, TRELSTARTM LA
should not be used by nursing mothers.
Pediatric Use: TRELSTARTM LA has not been
studied in pediatric patients and is not indicated for use in pediatric patients.
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