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In vitro studies. The clinical significance of this information is unknown.
INDICATION AND USAGE
TRELSTAR® (triptorelin pamoate for injectable suspension) is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
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.
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 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. Hyperglycemia may represent development of diabetes mellitus or worsening of glycemic control in patients with diabetes. 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. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. 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..
Embryo-Fetal Toxicity: Based on findings from animal studies and mechanism of action, 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.should be discontinued immediately and the appropriate supportive and symptomatic care should be administered. can cause fetal harm when administered to a pregnant woman. In animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.
MOST COMMON ADVERSE REACTIONS
• TRELSTAR® 3.75 mg: Most common adverse reactions (≥ 5%) included hot flushes, skeletal pain, impotence, and headache.
• TRELSTAR® 11.25 mg: Most common adverse reactions (≥ 5%) included hot flushes, skeletal pain, headache, edema in the legs, and leg pain.
• TRELSTAR® 22.5 mg: Most common adverse reactions (≥ 5%) included hot flushes, erectile dysfunction, and testicular atrophy.
SPECIFIC POPULATIONS
Pregnancy: Based on findings in animal studies and mechanism of action, TRELSTAR® can cause fetal harm when administered to a pregnant woman. Expected hormonal changes that occur with TRELSTAR® treatment increase the risk for pregnancy loss. In animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. Advise pregnant patients and females of reproductive potential of the potential risk 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: Based on mechanism of action, TRELSTAR® may impair fertility in males of reproductive potential.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Prostate cancer occurs primarily in an older population. Clinical studies with TRELSTAR® have been conducted primarily in patients ≥ 65 years.
Renal Impairment: Subjects with renal impairment had higher exposure than young healthy males.
Hepatic Impairment: Subjects with hepatic impairment had higher exposure than young healthy males.
To report SUSPECTED ADVERSE REACTIONS, contact Verity Pharma at 1-844-837-4891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information, visit www.Trelstar.com, or call 1-844-837-4891.
Please see the accompanying full Prescribing Information.
Trelstar® and its designs are licensed trademarks of Verity Pharmaceuticals, Inc.
MIXJECT® is a registered trademark of West Pharma. Services IL, Ltd.
Verity Pharmaceuticals, Verity Pharma, and their designs are trademarks of Verity Pharmaceuticals, Inc.
© 2023 Verity Pharmaceuticals, Inc. All rights reserved.
TSR-072 March 2023
TRELSTAR can be ordered directly from our national specialty distributor,
CuraScriptSD®, which provides next business day delivery and other convenient
benefits. Call CuraScriptSD® at 877.599.7748.
If you already have a TRELSTAR account with CuraScriptSD®, please click here or register at www.curascriptsd.com.
TRELSTAR can be ordered directly from our national specialty distributor, AndaMEDS, which provides next business day delivery and other convenient benefits. Call AndaMEDS at 1.855.468.5649, ext.74453.
If you already have a TRELSTAR account with AndaMEDS®, please click here or register at www.andameds.com.
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