CAMCEVI- leuprolide injection, emulsion

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

LEUPROLIDE MESYLATE (UNII: 8E3C3C493W) (LEUPROLIDE - UNII:EFY6W0M8TG)

제공처:

Foresee Pharmaceuticals Co., Ltd.

관리 경로:

SUBCUTANEOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is contraindicated in patients known to be hypersensitive to GnRH, GnRH agonist analogs, or any of the excipients in CAMCEVI. Anaphylactic reactions to GnRH agonist analogs have been reported in the medical literature. Risk Summary Based on findings in animal studies and mechanism of action, CAMCEVI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data in pregnant women to inform the drug-associated risk. In animal developmental and reproductive toxicology studies, administration of a monthly formulation of leuprolide on day 6 of pregnancy (sustained exposure was expected throughout the period of organogenesis) caused adverse embryo-fetal toxicity in animals at doses less than the human dose based on body surface area using an estimated daily dose (see data) . Advise pregnant patients and females of reproductive potential of the potential risk to

제품 요약:

CAMCEVI is a sterile, off-white to pale yellow, viscous and opalescent injectable emulsion supplied in a kit as a single-dose, pre-filled syringe. CAMCEVI is available as follows: Store CAMCEVI at 2°C–8°C (36°F–46°F). Protect CAMCEVI from light by storing in the original package until time of use. Do not freeze or shake. The rubber used in syringe tip cap and plunger stopper is not made of natural rubber latex.

승인 상태:

New Drug Application

제품 특성 요약

CAMCEVI- LEUPROLIDE INJECTION, EMULSION
FORESEE PHARMACEUTICALS CO., LTD.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CAMCEVI™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CAMCEVI.
CAMCEVI (LEUPROLIDE) INJECTABLE EMULSION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2021
INDICATIONS AND USAGE
CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated
for the treatment of adult
patients with advanced prostate cancer. (1)
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for instructions on the preparation
and administration of the injectable
emulsion in a pre-filled syringe. (2)
Recommended Dosage: 42 mg subcutaneously every 6 months. (2)
DOSAGE FORMS AND STRENGTHS
Injectable emulsion: 42 mg (3)
CONTRAINDICATIONS
Hypersensitivity to GnRH, GnRH agonist analogs, or any of the
components of CAMCEVI. (4)
WARNINGS AND PRECAUTIONS
Tumor Flare: Transient worsening of bone pain, uretral obstruction,
spinal cord compression, or the
occurrence of additional signs and symptoms of prostate cancer may
develop during the first few weeks
of treatment. Monitor patients closely and manage symptoms. (5.1)
Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of
developing diabetes have been
reported in men receiving GnRH agonists. Monitor blood glucose level
and manage according to current
clinical practice. (5.2)
Cardiovascular Diseases: Increased risk of myocardial infarction,
sudden cardiac death, and stroke has
been reported in men receiving GnRH agonists. Monitor for
cardiovascular disease and manage
according to current clinical practice. (5.3)
QT/QTc Prolongation: Androgen deprivation therapy may prolong the QT
interval. Consider periodic
monitoring of electrocardiograms and electrolytes. (5.4)
Convulsions: Manage convulsions according to the current clinical
practice. (5.5)
Embryo-Fetal Toxicity: CAMCEVI may cause fetal harm. (5.7, 8.1)
ADVERSE REACTIONS
The most common (>10%) adverse reactions were hot flus