Important Safety Information
- Hypersensitivity: TRELSTAR® is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH.
Indications and Usage
TRELSTAR® is indicated for the palliative treatment of advanced prostate cancer.
Important Safety Information (cont’d)
Warnings and Precautions
Hypersensitivity Reactions: Anaphylactic shock, hypersensitivity, and angioedema related to triptorelin administration
have been reported. In the event of a hypersensitivity reaction, therapy with TRELSTAR® should be discontinued immediately and the appropriate
supportive and symptomatic care should be administered.
Transient Increase in Serum Testosterone: Initially, triptorelin, like other GnRH 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 GnRH agonists. Patients may experience worsening of symptoms or onset of new symptoms,
including bone pain, neuropathy, hematuria, or urethral or bladder outlet obstruction.
Metastatic Vertebral Lesions and Urinary Tract Obstruction: Cases of spinal cord compression, which may contribute to
weakness or paralysis with or without fatal complications, have been reported with GnRH 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.
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.
Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT/QTc interval. Providers should
consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long
QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT
interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.
Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men
receiving GnRH agonists. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH
agonist and manage with current practice for treatment of hyperglycemia or diabetes.
Cardiovascular Diseases: Increased risk of developing myocardial infarction, sudden cardiac death and stroke has
been reported in association with use of GnRH agonists in men. Patients receiving a GnRH agonist should be monitored for symptoms
and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice.
Laboratory Tests: Response to TRELSTAR® should be monitored by measuring serum levels of testosterone periodically
or as indicated.
Laboratory Test Interactions: Chronic or continuous administration of triptorelin in therapeutic doses
results in suppression of pituitary-gonadal axis. Diagnostic tests of the pituitary-gonadal function conducted during treatment
and after cessation of therapy may therefore be misleading.
TRELSTAR® can cause fetal harm when administered to a pregnant woman. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.
Most Common Adverse Reactions
3.75 mg: The most common adverse reactions (≥ 5%) during TRELSTAR® 3.75 mg therapy included hot flushes, skeletal pain,
impotence, and headache.
11.25 mg: The most common adverse reactions (≥ 5%) during TRELSTAR® 11.25 mg therapy included hot flushes, skeletal pain,
headache, edema in the legs, and leg pain.
22.5 mg: The most common adverse reactions (≥ 5%) during TRELSTAR® 22.5 mg therapy included hot flushes, erectile dysfunction,
and testicular atrophy.
Pregnancy: Pregnancy Category X. TRELSTAR® is contraindicated in women who are or may become pregnant while
receiving the drug. Expected hormonal changes that occur with TRELSTAR® treatment increase the risk for pregnancy loss. If this
drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential
hazard to the fetus.
Lactation: The safety and efficacy of TRELSTAR® have not been established in females. There are no data on the presence of triptorelin in human milk, the effects of the drug on milk production, or the effects of the drug on the breastfed child.
Because of the potential for serious adverse reactions in a breastfed child
from TRELSTAR®, a decision should be made to either discontinue breastfeeding, or discontinue the drug taking into account the importance
of the drug to the mother.
Females and Males of Reproductive Potential: TRELSTAR® may impair fertility in males of reproductive potential.
Renal/Hepatic Impairment: Subjects with renal or hepatic impairment had higher exposure than young healthy males.
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