loader image
IMPORTANT SAFETY INFORMATION | PRESCRIBING INFORMATION

A POTENT GnRH AGONIST

TRELSTAR is a gonadotropin-releasing hormone (GnRH) agonist that differs from natural GnRH by a single amino acid.1 , 2

TRELSTAR has been engineered to deliver superagonist activity.3,4

  • TRELSTAR is a synthetic decapeptide analog of GnRH2
  • TRELSTAR differs from natural GnRH by a single amino acid substitution at position 62
  • In animal studies, TRELSTAR was found to have 13-fold higher luteinizing hormone-releasing activity and 21-fold higher follicle-stimulating hormone-releasing activity compared to natural GnRH1
  • 1 modified amino acid vs. 2 for leuprolide and goserelin7
  • High affinity in vitro for the LHRH receptor in the pituitary gland (6 x higher vs. leuprolide)7

In vitro studies. The clinical significance of this information is unknown.

LongER Half-Life 7,9
IncreaseD Receptor-Binding Affinity 7
Low Potential for Enzyme Cleavage 2,7
High Biologic ACTIVITY 7
131 TIMES MORE ACTIVE THAN NATIVE GnRH 2,7

Comparative Structure of GnRH Agonists: Amino Acid Sequences 8

  • The clinical significance of this information is unknown. Information is not to imply comparative efficacy/safety between the products; no head-to-head clinical trials have been conducted to compare the products.
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 reaction, discontinue TRELSTAR immediately and administer the appropriate supportive and symptomatic care.

Transient Increase in Serum Testosterone: Transient increase in serum testosterone levels can occur within the first few weeks of treatment. Worsening of signs and symptoms of prostate cancer or onset of new symptoms have been reported including bone pain, neuropathy, hematuria, or urethral or bladder outlet obstruction. Monitor patients at risk and manage as appropriate.

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. Closely observe patients with metastatic vertebral lesions and/or with upper or lower urinary tract obstruction during the first few weeks of therapy.

Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT/QTc interval. Consider risks and benefits 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. 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. Monitor 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: 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
  • 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: 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. 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. 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.

Renal/Hepatic Impairment: Subjects with renal or 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 full Prescribing Information.
Verity Logo

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

VerityPharma.com

Order TRELSTAR from CuraScriptSD®

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.

Order TRELSTAR from AndaMEDS®

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.

Thank you for visiting.

You are now leaving a Verity website. A link to a non-Verity website does not constitute an endorsement of the products or services offered by the non-Verity website, and Verity is not responsible for the content of any non-Verity website.
Continue

Healthcare Professionals

The information contained in this website is intended for US Healthcare professionals only.

Continue