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Drug overview for TRIPTODUR (triptorelin pamoate):
Generic name: TRIPTORELIN PAMOATE (TRIP-toe-REL-in)
Drug class: LHrH(GNrH) Agonist Analog Pituitary Suppressants
Therapeutic class: Endocrine
Triptorelin pamoate, a synthetic decapeptide analog of gonadotropin-releasing hormone (GnRH, luteinizing hormone-releasing hormone, gonadorelin), is used as an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: TRIPTORELIN PAMOATE (TRIP-toe-REL-in)
Drug class: LHrH(GNrH) Agonist Analog Pituitary Suppressants
Therapeutic class: Endocrine
Triptorelin pamoate, a synthetic decapeptide analog of gonadotropin-releasing hormone (GnRH, luteinizing hormone-releasing hormone, gonadorelin), is used as an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
TRIPTODUR 22.5 MG KIT
The following indications for TRIPTODUR (triptorelin pamoate) have been approved by the FDA:
Indications:
Precocious puberty
Professional Synonyms:
Accelerated sexual maturity
Indications:
Precocious puberty
Professional Synonyms:
Accelerated sexual maturity
The following dosing information is available for TRIPTODUR (triptorelin pamoate):
Dosage of triptorelin pamoate is expressed in terms of the base.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for TRIPTODUR (triptorelin pamoate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for TRIPTODUR (triptorelin pamoate):
Drug contraindication overview.
Known hypersensitivity to triptorelin or any other ingredient in the formulation, other gonadotropin-releasing hormone (GnRH) agonists, or GnRH. Known or suspected pregnancy. (See Fetal/Neonatal Morbidity and Mortality under Cautions: Warnings/Precautions.)
Known hypersensitivity to triptorelin or any other ingredient in the formulation, other gonadotropin-releasing hormone (GnRH) agonists, or GnRH. Known or suspected pregnancy. (See Fetal/Neonatal Morbidity and Mortality under Cautions: Warnings/Precautions.)
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Pregnancy |
There are 0 severe contraindications.
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Idiopathic intracranial hypertension |
| Lower seizure threshold |
| Seizure disorder |
The following adverse reaction information is available for TRIPTODUR (triptorelin pamoate):
Adverse reaction overview.
Initial (usually during the first week of therapy with the 3.75-, 11.25-, or 22.5-mg formulation of Trelstar(R)) transient increases in serum testosterone concentrations occur in most adults receiving triptorelin for prostate cancer and may be associated with temporary worsening of disease manifestations. (See Endocrine Effects under Cautions: Warnings/Precautions.) At least 10% of adults receiving the 11.25-mg formulation of triptorelin (Trelstar(R)) experienced abnormalities in laboratory values including decreased hemoglobin and erythrocyte count and increased serum concentrations of glucose, BUN, AST (SGOT), ALT (SGPT), and alkaline phosphatase.
At least 10% of adults receiving the 22.5-mg formulation of triptorelin (Trelstar(R)) experienced abnormalities in laboratory values including decreased hemoglobin concentration, increased serum glucose concentrations, and increased serum hepatic aminotransferase (transaminase) concentrations. Adverse effects occurring in 1% or more of adults receiving either the 3.75-
or 11.25-mg formulation (Trelstar(R)) include hot flushes (flashes), skeletal pain, headache, impotence, pain at injection site, hypertension, leg pain, generalized pain, insomnia, fatigue, dizziness, diarrhea, and urinary retention. Additional adverse effects occurring in 1% or more of adults include vomiting, anemia, pruritus, urinary tract infection, and emotional lability in those receiving the 3.75-mg
formulation. Additional adverse effects occurring in 1% or more of adults receiving the 11.25-mg formulation (Trelstar(R)) include leg edema, dysuria, back pain, nausea, dependent edema, breast pain, arthralgia, decreased libido, chest pain, leg cramps, gynecomastia, constipation, dyspepsia, increased alkaline phosphatase, anorexia, coughing, rash, asthenia, peripheral edema, abdominal pain, abnormal hepatic function, myalgia, dyspnea, pharyngitis, eye pain, and conjunctivitis.
Adverse effects occurring in 5% or more of adults receiving the 22.5-mg formulation (Trelstar(R)) include hot flushes (flashes), influenza, hypertension, urinary tract infection, back pain, erectile dysfunction, arthralgia, headache, pain in extremity, testicular atrophy, bronchitis, diabetes mellitus or hyperglycemia, insomnia, peripheral edema, and urinary retention. Adverse effects occurring in 5% or more of pediatric patients receiving the 22.5-mg
formulation (Triptodur(R)) include injection site reactions, vaginal bleeding, hot flush, headache, cough, and infection (i.e., bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, upper respiratory infection).
Initial (usually during the first week of therapy with the 3.75-, 11.25-, or 22.5-mg formulation of Trelstar(R)) transient increases in serum testosterone concentrations occur in most adults receiving triptorelin for prostate cancer and may be associated with temporary worsening of disease manifestations. (See Endocrine Effects under Cautions: Warnings/Precautions.) At least 10% of adults receiving the 11.25-mg formulation of triptorelin (Trelstar(R)) experienced abnormalities in laboratory values including decreased hemoglobin and erythrocyte count and increased serum concentrations of glucose, BUN, AST (SGOT), ALT (SGPT), and alkaline phosphatase.
At least 10% of adults receiving the 22.5-mg formulation of triptorelin (Trelstar(R)) experienced abnormalities in laboratory values including decreased hemoglobin concentration, increased serum glucose concentrations, and increased serum hepatic aminotransferase (transaminase) concentrations. Adverse effects occurring in 1% or more of adults receiving either the 3.75-
or 11.25-mg formulation (Trelstar(R)) include hot flushes (flashes), skeletal pain, headache, impotence, pain at injection site, hypertension, leg pain, generalized pain, insomnia, fatigue, dizziness, diarrhea, and urinary retention. Additional adverse effects occurring in 1% or more of adults include vomiting, anemia, pruritus, urinary tract infection, and emotional lability in those receiving the 3.75-mg
formulation. Additional adverse effects occurring in 1% or more of adults receiving the 11.25-mg formulation (Trelstar(R)) include leg edema, dysuria, back pain, nausea, dependent edema, breast pain, arthralgia, decreased libido, chest pain, leg cramps, gynecomastia, constipation, dyspepsia, increased alkaline phosphatase, anorexia, coughing, rash, asthenia, peripheral edema, abdominal pain, abnormal hepatic function, myalgia, dyspnea, pharyngitis, eye pain, and conjunctivitis.
Adverse effects occurring in 5% or more of adults receiving the 22.5-mg formulation (Trelstar(R)) include hot flushes (flashes), influenza, hypertension, urinary tract infection, back pain, erectile dysfunction, arthralgia, headache, pain in extremity, testicular atrophy, bronchitis, diabetes mellitus or hyperglycemia, insomnia, peripheral edema, and urinary retention. Adverse effects occurring in 5% or more of pediatric patients receiving the 22.5-mg
formulation (Triptodur(R)) include injection site reactions, vaginal bleeding, hot flush, headache, cough, and infection (i.e., bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, upper respiratory infection).
There are 22 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hypertension |
Anemia Chest pain Transient testosterone increase in male Urinary retention Urinary tract infection |
| Rare/Very Rare |
|---|
|
Acute myocardial infarction Anaphylaxis Angioedema Cancer-related spinal cord compression Cerebrovascular accident Deep venous thrombosis Diabetes mellitus Hematuria Idiopathic intracranial hypertension Interstitial lung disease Pituitary apoplexy Pulmonary thromboembolism Seizure disorder Steatosis of liver Thromboembolic disorder Transient cerebral ischemia |
There are 46 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bone pain Erectile dysfunction Injection site erythema Injection site pain Leg pain Testicular atrophy |
Abnormal hepatic function tests Abnormal vaginal bleeding Acute abdominal pain Anorexia Arthralgia Back pain Bronchitis Conjunctivitis Constipation Cough Cramps in legs Diarrhea Dizziness Drug-induced hot flash Dyspepsia Dyspnea Fatigue General weakness Gynecomastia Headache disorder Hyperglycemia Injection site inflammation Insomnia Mastalgia Mood changes Myalgia Ocular pain Pain Pain in extremities Peripheral edema Pharyngitis Pruritus of skin Skin rash Symptoms of anxiety Vomiting |
| Rare/Very Rare |
|---|
|
Aggressive behavior Depression Irritability Thrombophlebitis Visual changes |
The following precautions are available for TRIPTODUR (triptorelin pamoate):
Safety and efficacy of triptorelin pamoate have not been established in pediatric patients younger than 2 years of age. Safety and efficacy of triptorelin pamoate in pediatric patients with central precocious puberty (CPP) have been established in an open-label, noncomparative study that included 44 pediatric patients 2-9 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Triptorelin may cause fetal harm if administered to pregnant women based on its mechanism of action and animal findings. (See Fetal/Neonatal Morbidity and Mortality under Cautions: Warnings/Precautions.)
It is not known whether triptorelin is distributed into human milk or if the drug has any effect on milk production or the nursing infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for triptorelin and any potential adverse effects on the breastfed infant from triptorelin or from the underlying maternal condition.
Clinical studies evaluating triptorelin pamoate in patients with prostate cancer have been conducted principally in patients 65 years of age and older since prostate cancer occurs mainly in an older patient population.
The following prioritized warning is available for TRIPTODUR (triptorelin pamoate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for TRIPTODUR (triptorelin pamoate)'s list of indications:
| Precocious puberty | |
| E30.1 | Precocious puberty |
Formulary Reference Tool