Trelstar

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 TRELSTAR administration have been reported. In the event of a reaction, discontinue TRELSTAR immediately and administer the appropriate supportive and symptomatic care.

Tumor Flare: 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. Closely monitor patients with metastatic vertebral lesions and/or with urinary tract obstruction during the first few weeks of therapy.

Metabolic Syndrome: The use of GnRH agonists (including TRELSTAR) may lead to metabolic changes such as hyperglycemia, diabetes mellitus, and hyperlipidemia. Non-alcoholic fatty liver disease, including cirrhosis, occurred in the post-marketing setting. Monitor for changes in serum lipids, blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving TRELSTAR and manage according to institutional guidelines.

Cardiovascular Diseases: Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists (including TRELSTAR) 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 patients recieving TRESTAR for symptoms and signs suggestive of development of cardiovascular disease and manage according to current institutional guidelines.

Convulsions: Convulsions have occurred in patients treated with GnRH analog (including TRELSTAR). These events included patients with risk factors for seizures such as a history of epilepsy, intracranial tumors or co-medication with other drugs known to present a risk of seizure reactions. Convulsions have also been reported in patients in the absence of known risk factors. Manage patients receiving TRELSTAR who experience convulsion according to institutional guidelines.

Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), occurred in patients treated with TRELSTAR, including cases with visceral involvement and/or requiring skin grafts. Monitor and advise patients of the signs and symptoms of SCARs. Interrupt TRELSTAR if signs or symptoms of a SCAR develop. Permanently discontinue if a SCAR is confirmed.

Effect on QT/QTc Interval: Androgen deprivation therapy with TRELSTAR 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.

Laboratory Tests: Monitor serum levels of testosterone following injection of TRELSTAR. In the majority of patients, testosterone levels increased above baseline, and then declined thereafter to castrate levels (< 50 ng/dL) within four weeks.

Laboratory Test Interactions: Chronic or continuous administration of TRELSTAR 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.

Pediatric Use: The safety and effectiveness of TRELSTAR in pediatric patients have not been established.

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.

IMPORTANT SAFETY INFORMATION | PRESCRIBING INFORMATION

RELIABLE TESTOSTERONE
SUPPRESSION

TRELSTAR can minimize agonist deficiency²

Flexible Dosing

LEARN HOW TO PREPARE TRELSTAR

EVALUATE EFFECTIVE T SUPPRESSION IN YOUR PATIENTS’ GnRH THERAPY

Measuring testosterone levels helps to ensure biochemical castration has been achieved and maintained.⁵

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