TRELSTAR- triptorelin pamoate kit

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

TRIPTORELIN PAMOATE (UNII: 08AN7WA2G0) (TRIPTORELIN - UNII:9081Y98W2V)

Disponible desde:

Verity Pharmaceuticals Inc.

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

TRELSTAR is indicated for the treatment of advanced prostate cancer [see  Clinical Studies (14) ]. TRELSTAR is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH [see Warnings and Precautions (5.1) ]. Risk Summary Based on findings in animal studies and mechanism of action, TRELSTAR can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . Expected hormonal changes that occur with TRELSTAR treatment increase the risk for pregnancy loss. In animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus. Data Animal Data Studies in pregnant rats administered triptorelin at doses of 2, 10, and 100 mcg/kg/day (approximately equivalent to 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area) during the period of organogenesis demonstrated maternal toxicity and embryo-fetal toxicities.  Embryo-fetal toxicities consisted of pre-implantation loss, increased resorption, and reduced mean number of viable fetuses at the high dose.  Teratogenic effects were not observed in viable fetuses in rats or mice.  Doses administered to mice were 2, 20, and 200 mcg/kg/day (approximately equivalent to 0.1, 0.7, and 7 times the estimated human daily dose based on body surface area).     The safety and efficacy of TRELSTAR have not been established in females. There are no data on the presence of triptorelin in human milk, the effects of the drug on milk production, or the effects of the drug on the breastfed child.  Because of the potential for serious adverse reactions in a breastfed child from TRELSTAR, a decision should be made to either discontinue breastfeeding, or discontinue the drug taking into account the importance of the drug to the mother. Infertility Males Based on mechanism of action, TRELSTAR may impair fertility in males of reproductive potential [see Clinical Pharmacology (12.1)] . The safety and effectiveness of TRELSTAR in pediatric patients have not been established. Prostate cancer occurs primarily in an older population.  Clinical studies with TRELSTAR have been conducted primarily in patients ≥ 65 years [see  Clinical Pharmacology (12.3) and Clinical Studies (14) ]. Subjects with renal impairment had higher exposure than young healthy males [see  Clinical Pharmacology (12.3) ]. Subjects with hepatic impairment had higher exposure than young healthy males [see  Clinical Pharmacology (12.3) ].

Resumen del producto:

TRELSTAR (triptorelin pamoate for injectable suspension) is supplied as a single dose vial with a Flip-Off cap containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, with injection kit consisting of a vial adapter, a 21 gauge 1 ½” injection needle, and a pre-filled syringe containing sterile water for injection, USP, 2 mL. TRELSTAR 3.75 mg – NDC 74676-5902-1: 3.75 mg of slightly yellow microgranules provided in a vial with a violet flip-off cap with injection kit. TRELSTAR 11.25 mg – NDC 74676-5904-1: 11.25 mg of slightly yellow microgranules provided in a vial with a yellow green flip-off cap with injection kit. TRELSTAR 22.5 mg – NDC 74676-5906-1: 22.5 mg of slightly yellow microgranules provided in a vial with a dark green flip-off cap with injection kit. Storage Store at 20-25°C (68-77°F).  [See USP Controlled Room Temperature.]  Do not freeze TRELSTAR.

Estado de Autorización:

New Drug Application

Ficha técnica

TRELSTAR- TRIPTORELIN PAMOATE
VERITY PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRELSTAR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRELSTAR.
TRELSTAR (TRIPTORELIN PAMOATE FOR INJECTABLE SUSPENSION), FOR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions (_5.3_, _5.4_)
11/2023
Warnings and Precautions (_5.5_)
04/2024
INDICATIONS AND USAGE
TRELSTAR is a gonadotropin releasing hormone (GnRH) agonist indicated
for the treatment of advanced
prostate cancer. (_1_)
DOSAGE AND ADMINISTRATION
TRELSTAR is administered as a single intramuscular injection in either
buttock. Due to different release
characteristics, the dosage strengths are not additive and must be
selected based upon the desired
dosing schedule. (_2.1_)
3.75 mg every 4 weeks. (_2.1_)
11.25 mg every 12 weeks. (_2.1_)
22.5 mg every 24 weeks. (_2.1_)
DOSAGE FORMS AND STRENGTHS
For injectable suspension: 3.75 mg, 11.25 mg, 22.5 mg. (_3_)
CONTRAINDICATIONS
Known hypersensitivity to triptorelin or any other component of the
product, or other GnRH agonists or
GnRH. (_4_)
WARNINGS AND PRECAUTIONS
Hypersensitivity: Anaphylactic shock, hypersensitivity, and angioedema
have been reported. In the
event of a reaction, discontinue TRELSTAR and initiate appropriate
medical management. (_5.1_)
Tumor Flare: Transient increase in serum testosterone levels can occur
within the first few weeks of
treatment. This may worsen prostate cancer and result in spinal cord
compression and urinary tract
obstruction. Monitor patients at risk and manage as appropriate.
(_5.2_)
Metabolic Syndrome: The use of GnRH agonists may lead to an increased
risk of metabolic changes
such as hyperglycemia, diabetes, hyperlipidemia, and non-alcoholic
fatty liver disease. Monitor for signs
and symptoms of metabolic syndrome including lipids, blood glucose
level and/or HbA1c and manage
according to institutional guidelines. (_5.3_)
Cardiovascular Diseases