Triptorelin

What it is and how it works

Mechanism of Action Triptorelin is a GnRH agonist.

Indications

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.

Dosage and administration (summary)

Must only be administered by a healthcare provider. Administer TRIPTODUR as a single intramuscular injection of 22.5 mg once every 24 weeks. 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. Measure height every 3-6 months and monitor bone age periodically. See FPI for complete reconstitution and administration instructions. Once TRIPTODUR is mixed, proceed to the next steps and administer without delay.

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 . Pregnancy: TRIPTODUR may cause fetal harm . Hypersensitivity reactions Pregnancy ( 4 , 8.1 )

Warnings and precautions

Initial Rise of Gonadotropins and Sex Steroid Levels: An increase in clinical signs and symptoms of puberty may be observed during the first 2-4 weeks of therapy since gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. Psychiatric events: Have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms.

Pregnancy

Pregnancy Risk Summary TRIPTODUR is contraindicated in women who are pregnant [ see Contraindications ] since expected hormonal changes that occur with TRIPTODUR treatment increase the risk for pregnancy loss.

Storage and supply

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,…

Source: Triptorelin (Triptodur) — US FDA prescribing information, 2025-09-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.