Triptorelin pamoate

Triptorelin pamoate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

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Overview

Triptorelin pamoate is a gonadotropin releasing hormone (GnRH) agonist that is FDA approved for the {{{indicationType}}} of advanced prostate cancer. Common adverse reactions include hot flushes, skeletal pain, impotence and headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Triptorelin pamoate is indicated for the palliative treatment of advanced prostate cancer.
• Dosage:

• Triptorelin pamoate 3.75 mg, 1 injection every 4 weeks
• Triptorelin pamoate 11.25 mg, 1 injection every 12 weeks
• Triptorelin pamoate 22.5 mg, 1 injection every 24 weeks

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Triptorelin pamoate in adult patients.

Non–Guideline-Supported Use

• Central precocious puberty
• Endometrial hyperplasia
• Endometriosis
• Fibrocystic breast changes
• In vitro fertilization
• Uterine leiomyoma

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness not established in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Triptorelin pamoate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Triptorelin pamoate in pediatric patients.

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

Triptorelin pamoate 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. Triptorelin pamoate 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.

Warnings

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. 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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Triptorelin pamoate Clinical Trials Experience in the drug label.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of gonadotropin releasing hormone agonists. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

During postmarketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.

During postmarketing experience, convulsions, and thromboembolic events including, but not limited to, pulmonary emboli, cerebrovascular accident, myocardial infarction, deep venous thrombosis, transient ischemic attack, and thrombophlebitis have been reported.

Drug Interactions

No drug-drug interaction studies involving triptorelin have been conducted.

Human pharmacokinetic data with triptorelin suggest that C-terminal fragments produced by tissue degradation are either degraded completely within tissues or are rapidly degraded further in plasma, or cleared by the kidneys. Therefore, hepatic microsomal enzymes are unlikely to be involved in triptorelin metabolism. However, in the absence of relevant data and as a precaution, hyperprolactinemic drugs should not be used concomitantly with triptorelin since hyperprolactinemia reduces the number of pituitary GnRH receptors.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): X There is no FDA guidance on usage of Triptorelin pamoate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Triptorelin pamoate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Triptorelin pamoate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Triptorelin pamoate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Triptorelin pamoate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Triptorelin pamoate in geriatric settings.

Gender

There is no FDA guidance on the use of Triptorelin pamoate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Triptorelin pamoate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Triptorelin pamoate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Triptorelin pamoate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Triptorelin pamoate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Triptorelin pamoate in patients who are immunocompromised.

Administration and Monitoring

Administration

Intramuscular

Monitoring

There is limited information regarding Triptorelin pamoate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Triptorelin pamoate and IV administrations.

Overdosage

There is limited information regarding Triptorelin pamoate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Triptorelin pamoate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Triptorelin pamoate Mechanism of Action in the drug label.

Structure

There is limited information regarding Triptorelin pamoate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Triptorelin pamoate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Triptorelin pamoate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Triptorelin pamoate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Triptorelin pamoate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Triptorelin pamoate How Supplied in the drug label.

Storage

There is limited information regarding Triptorelin pamoate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Triptorelin pamoate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Triptorelin pamoate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Trelstar Depot
• Trelstar LA
• Trelstar

Look-Alike Drug Names

There is limited information regarding Triptorelin pamoate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.