Brand Name
Triptodur
Generic Name
Triptorelin
View Brand Information FDA approval date: September 08, 2017
Form: Kit
What is Triptodur (Triptorelin)?
TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty . TRIPTODUR is a gonadotropin releasing hormone agonist indicated for the treatment of pediatric patients 2 years and older with central precocious puberty.
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Brand Information
TRIPTODUR (triptorelin)
1INDICATIONS AND USAGE
TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).
2DOSAGE FORMS AND STRENGTHS
For extended-release injectable suspension: 22.5 mg of triptorelin as a lyophilized white to slightly yellow powder cake in a single-dose vial for reconstitution with the co-packaged 2 mL of diluent (Sterile Water) for Injection.
3CONTRAINDICATIONS
- Hypersensitivity: TRIPTODUR is contraindicated in individuals with a known hypersensitivity to triptorelin, any other component of the product, or other GnRH agonists or GnRH
- Pregnancy: TRIPTODUR may cause fetal harm
4ADVERSE REACTIONS
The following serious adverse reactions are described here and elsewhere in the label:
- Initial Rise of Gonadotropins and Sex Steroid Levels [
- Psychiatric Events [
- Convulsions [
- Severe Cutaneous Adverse Reactions [
- Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
1Injection site reactions are presented separately
2Includes % of patients with vaginal bleeding or menstrual disorder (“menstrual cycle returned”) in 39 females out of N=44.
2Includes % of patients with vaginal bleeding or menstrual disorder (“menstrual cycle returned”) in 39 females out of N=44.
Other Selected Adverse Reactions:
Injection Site Reactions
Injection site reactions occurring in patients immediately and/or 2 hours after injection include pain (45%), redness (14%), pruritus (2.3%) and swelling (2.3%).
Psychiatric Disorders
Anxiety (2.3%) and mood altered (2.3%)
Injection Site Reactions
Injection site reactions occurring in patients immediately and/or 2 hours after injection include pain (45%), redness (14%), pruritus (2.3%) and swelling (2.3%).
Psychiatric Disorders
Anxiety (2.3%) and mood altered (2.3%)
4.2Post-marketing Experience
The following adverse reactions have been identified during post-approval use of triptorelin or GnRH 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.
Hypersensitivity Reactions:Anaphylactic shock, anaphylactoid reaction, angioedema, urticaria.
Cardiovascular:Hypertension.
Psychiatric:Emotional lability, such as crying, irritability, impatience, anger, and aggression .Depression, including rare reports of suicidal ideation and attempt. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression.
Nervous System:Convulsions ,pseudotumor cerebri (idiopathic intracranial hypertension)
Vision Disorders:Visual impairment, visual disturbance
Skin Reactions: erythema multiforme, bullous dermatitis, dermatitis exfoliative, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis, and acute generalized exanthematous pustulosis
5OVERDOSAGE
There is no experience with overdosage in clinical trials of triptorelin. If overdosage occurs, therapy should be discontinued and appropriate supportive and symptomatic treatment administered.
6DESCRIPTION
TRIPTODUR contains the pamoate salt of triptorelin, a synthetic decapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LHRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt). The molecular weight is 1699.9 and the structural formula is:
TRIPTODUR for extended release injectable suspension for intramuscular use is provided as a sterile, lyophilized, biodegradable microgranule formulation in a single-dose vial, co-packaged with a syringe containing 2 mL Sterile Water for Injection for reconstitution of the lyophilisate. The triptorelin formulation is comprised of 22.5 mg triptorelin (equivalent to 31 mg triptorelin pamoate), carboxymethylcellulose sodium (26 mg), mannitol (74 mg), poly-
7CLINICAL STUDIES
In a single-arm open-label study, 44 children 2 to 9 years of age with CPP, 39 females and 5 males, all naïve to previous GnRH agonist treatment, were administered TRIPTODUR 22.5 mg at a dosing interval of 24 weeks. Subjects were evaluated over two dosing intervals for a total of 12 months.
TRIPTODUR 22.5 mg suppressed pituitary release of LH and FSH and, consequently, gonadal secretion of estradiol in girls and testosterone in boys (Table 3). At all timepoints evaluated, ≥93% of children achieved LH suppression to prepubertal levels (i.e., serum LH ≤5 IU/L 30 minutes after GnRH agonist stimulation), ≥79% of girls achieved prepubertal levels of estradiol (i.e., <20 pg/mL), and ≥80% of boys achieved prepubertal levels of testosterone (i.e., <30 ng/dL). TRIPTODUR arrested or reversed progression of clinical signs of puberty with 95% of children showing no increase in the bone age/chronological age ratio, and 89% showing stabilization of sexual maturation at Month 12.
Table 3: Efficacy of TRIPTODUR 22.5 mg Administered Every 6 Months to Children with CPP
a-Intent-to-Treat population
b-Primary efficacy endpoint
c-Bone Age/Chronological Age
Following the second TRIPTODUR injection, 22 children (all girls) were assessed for evidence of an acute-on-chronic phenomenon (i.e., increase in basal LH >5 IU/L or serum estradiol level >20 pg/mL 48 hours after the second triptorelin injection). Of these, one girl who achieved prepubertal hormone levels prior to the second injection showed biochemical evidence of acute-on-chronic phenomenon
8HOW SUPPLIED/STORAGE AND HANDLING
Each TRIPTODUR 22.5 mg single-use kit (NDC 24338-150-20) contains:
- One single-dose vial of TRIPTODUR 22.5 mg (NDC 24338-150-01) with a Flip-Off seal containing sterile lyophilized white to slightly yellow powder cake
- One sterile, glass syringe with Luer Lock prefilled with 2 mL of Sterile Water for Injection (NDC 24338-150-02)
- Two sterile 21 gauge, 1½" needles (
- One Package Insert
Store at 20 to 25°C (68 to 77°F) excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Medication Guide).
Symptoms after Initial TRIPTODUR Administration
Inform caregivers that during the first weeks after the first TRIPTODUR injection, signs of puberty may occur such as vaginal bleeding [see Warnings and Precautions (]. Caregivers should notify the physician if these symptoms continue beyond the second month after TRIPTODUR administration.
Psychiatric Events
Inform caregivers that symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression have been observed in patients receiving GnRH agonists, including triptorelin. Alert caregivers to the possibility of development or worsening of psychiatric symptoms, including depression, during treatment with TRIPTODUR [see Warnings and Precautions (].
Convulsions
Inform caregivers that reports of convulsions have been observed in patients receiving GnRH agonists, including triptorelin. Patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions may be at increased risk [see Warnings and Precautions (].
Severe Cutaneous Adverse Reactions
Inform patients and/or caregivers that severe cutaneous adverse reactions (SCARs) may occur during treatment with TRIPTODUR. Advise patients and/or caregivers to stop TRIPTODUR and immediately contact their healthcare provider if they experience signs or symptoms of SCARs [see Warnings and Precautions (].
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Inform patients and caregivers that reports of pseudotumor cerebri (idiopathic intracranial hypertension) have been observed in pediatric patients receiving GnRH agonists, including triptorelin. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, and vision issues such as blurred vision, double vision, loss of vision, pain behind the eye or pain with eye movement, ringing in the ears, dizziness, and nausea. Advise patients and caregivers to contact their healthcare provider if the patient develops any of these symptoms. [see Warnings and Precautions (].
Pregnancy is Contraindicated
TRIPTODUR is contraindicated in pregnancy. If the patient becomes pregnant while taking the drug, the patient should be informed of the potential risk to fetus [see Use in Specific Populations (].
Compliance with the Dosing Schedule
Inform caregivers about the importance of adherence to the TRIPTODUR dosing schedule of one injection every 24 weeks. Patients should not miss or delay a scheduled dose.
Inform caregivers that during the first weeks after the first TRIPTODUR injection, signs of puberty may occur such as vaginal bleeding [see Warnings and Precautions (]. Caregivers should notify the physician if these symptoms continue beyond the second month after TRIPTODUR administration.
Psychiatric Events
Inform caregivers that symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression have been observed in patients receiving GnRH agonists, including triptorelin. Alert caregivers to the possibility of development or worsening of psychiatric symptoms, including depression, during treatment with TRIPTODUR [see Warnings and Precautions (].
Convulsions
Inform caregivers that reports of convulsions have been observed in patients receiving GnRH agonists, including triptorelin. Patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions may be at increased risk [see Warnings and Precautions (].
Severe Cutaneous Adverse Reactions
Inform patients and/or caregivers that severe cutaneous adverse reactions (SCARs) may occur during treatment with TRIPTODUR. Advise patients and/or caregivers to stop TRIPTODUR and immediately contact their healthcare provider if they experience signs or symptoms of SCARs [see Warnings and Precautions (].
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Inform patients and caregivers that reports of pseudotumor cerebri (idiopathic intracranial hypertension) have been observed in pediatric patients receiving GnRH agonists, including triptorelin. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, and vision issues such as blurred vision, double vision, loss of vision, pain behind the eye or pain with eye movement, ringing in the ears, dizziness, and nausea. Advise patients and caregivers to contact their healthcare provider if the patient develops any of these symptoms. [see Warnings and Precautions (].
Pregnancy is Contraindicated
TRIPTODUR is contraindicated in pregnancy. If the patient becomes pregnant while taking the drug, the patient should be informed of the potential risk to fetus [see Use in Specific Populations (].
Compliance with the Dosing Schedule
Inform caregivers about the importance of adherence to the TRIPTODUR dosing schedule of one injection every 24 weeks. Patients should not miss or delay a scheduled dose.
Manufactured for:
10MEDICATION GUIDE
This Medication Guide has been approved by the U.S. Food and Drug Administration Rev: 09/2025
11PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 24338-150-20
Triptodur
(triptorelin)
for extended-release injectable suspension
(triptorelin)
for extended-release injectable suspension
22.5 mg
KIT
FOR INTRAMUSCULAR USE
Must only be administered by a healthcare professional.
Give once every 24 weeks.
Contents:
–One Single-Dose Vial
–One Pre-filled Syringe of Diluent (sterile water) for Triptodur, 2 mL
–Two thin-walled, 21-gauge, 1½" Needles
Reconstitute With Accompanying Diluent Before Use.
After reconstitution, ensure there are no visible precipitates in the vial and administer immediately.
Dispense the accompanying Medication Guide to each patient.
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