TRELSTAR- triptorelin pamoate kit

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Allergan, Inc.

INN (Tên quốc tế):

TRIPTORELIN PAMOATE

Thành phần:

TRIPTORELIN 3.75 mg in 2 mL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

TRELSTAR is indicated for the palliative 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. Dat

Tóm tắt sản phẩm:

TRELSTAR is supplied in the TRELSTAR MIXJECT single-dose delivery system consisting of a vial with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, a MIXJECT vial adapter, and a pre-filled syringe containing sterile water for injection, USP, 2 mL, pH 6 to 8.5. TRELSTAR 3.75 mg –NDC 0023-5902-04 (TRELSTAR 3.75 mg with MIXJECT single-dose delivery system) TRELSTAR 11.25 mg –NDC 0023-5904-12 (TRELSTAR 11.25 mg with MIXJECT single-dose delivery system) TRELSTAR 22.5 mg –NDC 0023-5906-23 (TRELSTAR 22.5 mg with MIXJECT single-dose delivery system) Storage Store at 20-25°C (68-77°F).  [See USP Controlled Room Temperature.]  Do not freeze TRELSTAR with MIXJECT.

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

TRELSTAR- TRIPTORELIN PAMOATE
ALLERGAN, 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), FOR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions, Embryo-Fetal Toxicity (5.9) 12/2018
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)
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 practice. (5.5)
Cardiovascular Diseases: Increased risk of myocardial infarction,
sudd