Data from FDA - Curated by EPG Health - Last updated 29 September 2017

Indication(s)

1 INDICATIONS AND USAGE TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). TRIPTODUR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years and older with central precocious puberty. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS Hypersensitivity: TRIPTODUR is contraindicated in individuals with a known hypersensitivity to triptorelin, any other component of the product, or other GnRH agonists or GnRH [see Adverse Reactions (6.2)]. Pregnancy: TRIPTODUR may cause fetal harm [see Use in Specific Populations (8.1)]. Hypersensitivity reactions (4) Pregnancy (4, 8.1)
Adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described here and elsewhere in the label: Initial Rise of Gonadotropins and Sex Steroid Levels [see Warnings and Precautions (5.1)] Psychiatric Events [see Warnings and Precautions (5.2)] Convulsions [see Warnings and Precautions (5.3)] In clinical trials for TRIPTODUR, the most common adverse reactions (≥4.5%) are injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infection). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Arbor Pharmaceuticals, LLC at 1-866-516-4950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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. The safety of TRIPTODUR was evaluated in one uncontrolled, open-label single-arm clinical trial in which 44 children with central precocious puberty received two doses of TRIPTODUR and were observed for 12 months. The median age of the study population was 8 years (range 2-9 years) at treatment start; 88.6% of subjects were female, 59.1% were White, 27.3% were Black and 4.5% were Asian. Table 1 shows all the adverse reactions that occurred in at least 2 patients (≥4.5%) during the open-label single-arm trial. Table 1: Adverse ReactionsInjection site reactions are presented separately Occurring in ≥ 2 Patients Treated with TRIPTODUR in an Open-Label Single-Arm Trial Adverse Reactions Number of Patients Reporting Event (%) (Total N=44) Infections & Infestations Bronchitis 2 (4.5) Gastroenteritis 3 (6.8) Influenza 2 (4.5) Nasopharyngitis 6 (13.6) Otitis externa 2 (4.5) Pharyngitis 2 (4.5) Sinusitis 2 (4.5) Upper respiratory tract infection 4 (9.1) Nervous System Disorders Headache 6 (13.6) Reproductive System & Breast Disorders Menstrual (Vaginal bleeding)Includes % of patients with vaginal bleeding or menstrual disorder ("menstrual cycle returned") in 39 females out of N=44. 3 (7.7) Respiratory, Thoracic & Mediastinal Disorder Cough 3 (6.8) Vascular Disorders Hot flush 2 (4.5) 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%) 6.2 Postmarketing Experience 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. The following adverse reactions were reported from postmarketing experience of triptorelin in patients with CPP: Hypersenstivity Reactions: Anaphylactic shock, anaphylactoid reaction, angioedema, urticaria. Cardiovascular: Hypertension. Psychiatric: Emotional lability, such as crying, irritability, impatience, anger, and aggression, has been observed with GnRH agonists, including triptorelin [see Warnings and Precautions (5.2)]; Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists in children treated for CPP. 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 [see Warnings and Precautions (5.3)] Vision Disorders: Visual impairment, visual disturbance

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Must be administered under the supervision of a physician. (2.1) Administer TRIPTODUR as a single intramuscular injection of 22.5 mg once every 24 weeks. (2.1) Monitor response with LH levels after a GnRH or GnRH agonist stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1 to 2 months following initiation of therapy, during therapy as necessary to confirm maintenance of efficacy, and with each subsequent dose. (2.2) Measure height every 3-6 months and monitor bone age periodically. (2.2) See FPI for reconstitution and administration instructions. (2.3) 2.1 Dosing Information TRIPTODUR must be administered under the supervision of a physician. The dosage of TRIPTODUR is 22.5 mg reconstituted with accompanying diluent (Sterile Water) 2 mL, and administered as a single intramuscular injection once every 24 weeks. TRIPTODUR treatment should be discontinued at the appropriate age of onset of puberty at the discretion of the physician. 2.2 Monitoring Monitor response to TRIPTODUR with LH levels after a GnRH or GnRH agonist stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1 to 2 months following initiation of therapy, during therapy as necessary to confirm maintenance of efficacy, and with each subsequent dose. Measure height (for calculation of growth rate) every 3-6 months and monitor bone age periodically. Noncompliance with drug regimen or inadequate dosing may result in inadequate control of the pubertal process with gonadotropins and/or sex steroids increasing above prepubertal levels. If the dose of TRIPTODUR is not adequate switching to an alternative GnRH agonist for the treatment of CPP with the ability for dose adjustment may be necessary. 2.3 Reconstitution and Administration Instructions Please read these instructions completely before you begin. Use appropriate aseptic technique for preparation and administration. Screw the plunger rod into the barrel end of the prefilled sterile water diluent syringe. Remove the cap from the syringe barrel. Firmly attach one of the 21-gauge sterile safety needles onto the prefilled sterile water diluent syringe with a push and clockwise twist. This 21-gauge needle will only be used for reconstitution of the product. Pull back on the safety cover towards the syringe and away from the 21-gauge needle. Then pull the clear needle shield off. Insert the 21-gauge needle to inject the Sterile Water diluent into the vial. Do not release the plunger rod. Gently swirl the vial ensuring the diluent rinses the sides of the vial. The reconstituted solution is a milky suspension. Important: Once mixed, proceed to the next steps and administer without delay. Invert the vial and move back the syringe in order to position the end of the 21-gauge needle very near the level of the stopper, making sure the needle lumen is still completely in the vial. Pull back the plunger rod slowly to withdraw the reconstituted product into the syringe, withdrawing as much of the reconstituted product into the syringe as possible. Push the safety cover forward toward the needle until you hear and/or feel it lock. Then remove the first 21-gauge needle by grasping the needle hub to disconnect the needle from the syringe and discard it. This (first) 21-gauge needle will no longer be used. Firmly attach the second sterile needle onto the syringe and pull back the safety cover towards the syringe. This 21-gauge needle will be used for administration. Prime the 21-gauge needle to first remove air from the syringe, inspect the suspension visually for particulate matter and discoloration. If the suspension appears milky and homogenous without visible aggregates or precipitates then administer the suspension immediately. Inject the patient preferably in either buttock or thigh using the entire contents of the syringe. The injection of the suspension should be performed relatively rapidly and in a steady and uninterrupted manner in order to avoid any potential blockage of the needle. After administering the injection, immediately activate the safety cover: Center your thumb or forefinger on the textured finger pad area of the safety cover and push it forward over the needle until you hear or feel it lock. Use the one-handed technique and activate the mechanism away from yourself and others. Immediately discard the syringe assembly into a suitable sharps container. Image Image Image Image Image Image Image Image Image Image
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary TRIPTODUR is contraindicated in women who are pregnant [see Contraindications (4)] since expected hormonal changes that occur with TRIPTODUR treatment increase the risk for pregnancy loss. Available data with triptorelin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. Based on mechanism of action in humans and findings of increased pregnancy loss in animal studies, TRIPTODUR may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% -20%, respectively. Data Animal Data In pregnant rats administered triptorelin at doses of 2, 10, and 100 mcg/kg/day during the period of organogenesis, maternal toxicity (decrease in body weight) and embryo-fetal toxicities (pre-implantation loss, increased resorption, and reduced number of viable fetuses) were observed at 100 ug/kg, approximately 4 times the clinical dose based on body surface area. No embryonic and fetal developmental toxicities were observed in mice at doses up to 4 times the clinical dose. Teratogenic effects were not observed in viable fetuses in rats or mice. 8.2 Lactation Risk Summary There are no data on the presence of triptorelin in human milk, or the effects of the drug on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TRIPTODUR and any potential adverse effects on the breastfed child from TRIPTODUR or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of TRIPTODUR have been established in pediatric patients 2 years of age and older based on a single-arm open-label study of 44 children 2-9 years of age with CPP [see Clinical Studies (14)]. The safety and effectiveness of TRIPTODUR have not been established in pediatric patients less than 2 years old. 8.6 Renal Impairment TRIPTODUR has not been studied in children with renal impairment. Adult subjects with renal impairment had higher exposure than young healthy adult males [see Clinical Pharmacology (12.3)]. 8.7 Hepatic Impairment TRIPTODUR has not been studied in children with hepatic impairment. Adult subjects with hepatic impairment had higher exposure than young healthy adult males [see Clinical Pharmacology (12.3)].

Interactions

7 DRUG INTERACTIONS 7.1 Drug-Drug Interactions Results of in vitro studies show that drug-drug interactions with triptorelin are unlikely [see Clinical Pharmacology (12.3)]. 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. 7.2 Drug-Laboratory Test Interactions Administration of TRIPTODUR results in suppression of the pituitary-gonadal system. The effect of TRIPTODUR on pituitary and gonadal function is expected to disappear within six to twelve months after treatment discontinuation. Therefore, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment or after discontinuation of treatment may be affected.

More information

Category Value
Authorisation number NDA208956
Orphan designation No
Product NDC 24338-150
Date Last Revised 26-07-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 1944389
Storage and handling Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Do not freeze.
Marketing authorisation holder Arbor Pharmaceuticals, LLC