TRELSTAR triptorelin pamoate injection powder lyophilized for suspension

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Actavis Pharma, Inc.

INN (국제 이름):

TRIPTORELIN PAMOATE

구성:

TRIPTORELIN 3.75 mg in 2 mL

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

New Drug Application

제품 특성 요약

TRELSTAR- TRIPTORELIN PAMOATE INJECTION, POWDER, LYOPHILIZED, FOR
SUSPENSION
TRELSTAR- TRIPTORELIN PAMOATE
ACTAVIS PHARMA, INC.
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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)
INTRAMUSCULAR USE.
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions (5.4) 07/2014
INDICATIONS AND USAGE
TRELSTAR is a gonadotropin releasing hormone (GnRH) agonist indicated
for the palliative 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
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)
Pregnancy. (4.2 and 8.1)
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 and 5.3)
Effect on QT/QTc Interval: Androgen deprivation therapy may prolong
the QT interval. Consider risks and
benefits. (5.4)
Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of
developing diabetes have been reported in men
receiving GnRH analogs. Monitor blood glucose level and manage
according to current clinical pra