GnRH Agonist

Trelstar® is the only gonadotropin-releasing hormone (GnRH) agonist approved for use in the United States for patients with prostate cancer that differs from natural GnRH by a single amino acid.1 Trelstar® has been engineered to deliver superagonist activity.2,3 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 GnRH.4

Trelstar® helps meet your and your patients’ needs with:

  • 3 different formulations – 3.75 mg, 11.25 mg, and 22.5 mg
  • Distinct dosing schedules4
  • MIXJECT® IM injection device4
  • Easy ordering

Important Safety Information

Contraindications

Indication

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.

Most Common Adverse Reactions

Specific Populations

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.

Nursing Mothers: TRELSTAR® is not indicated for use in women. It is not known if triptorelin is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from TRELSTAR®, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

Renal/Hepatic Impairment: Subjects with renal or hepatic impairment had higher exposure than young healthy males.

Please see full Prescribing Information.

Please call Allergan at 800-678-1605 for any product-related question. The prescribing information contains a phone number that is no longer associated with Allergan and the respective package insert is in the process of being updated.

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.
  • Pregnancy: TRELSTAR® may cause fetal harm when administered to a pregnant woman. Expected hormonal changes that occur with TRELSTAR® treatment increase the risk for pregnancy loss and fetal harm when administered to a pregnant woman. TRELSTAR® is contraindicated in women who are or may become pregnant. 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.

Indication

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.

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.

Specific Populations

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.

Nursing Mothers: TRELSTAR® is not indicated for use in women. It is not known if triptorelin is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from TRELSTAR®, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

Renal/Hepatic Impairment: Subjects with renal or hepatic impairment had higher exposure than young healthy males.

Please see full Prescribing Information.

Please call Allergan at 800-678-1605 for any product-related question. The prescribing information contains a phone number that is no longer associated with Allergan and the respective package insert is in the process of being updated.