ORSERDU- elacestrant tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

ELACESTRANT (UNII: FM6A2627A8) (ELACESTRANT - UNII:FM6A2627A8)

可用日期:

Stemline Therapeutics, Inc.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. None. Risk Summary Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available human data on ORSERDU use in pregnant women to inform the drug-associated risk. In an animal reproduction study, oral administration of elacestrant to pregnant rats during organogenesis caused embryo-fetal mortality and structural abnormalities at maternal exposures below the recommended dose based on AUC (see Data) . Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U

產品總結:

ORSERDU (elacestrant) film-coated tablets for oral use are supplied as follows: Storage and Handling Store at 20°C to 25°C (68°F to 77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F). [see USP controlled room temperature].

授权状态:

New Drug Application

产品特点

ORSERDU- ELACESTRANT TABLET, FILM COATED
STEMLINE THERAPEUTICS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ORSERDU SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ORSERDU.
ORSERDU™ (ELACESTRANT) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2023
INDICATIONS AND USAGE
ORSERDU is an estrogen receptor antagonist indicated for:
treatment of postmenopausal women or adult men, with ER-positive,
HER2-negative, _ESR1_-mutated
advanced or metastatic breast cancer with disease progression
following at least one line of endocrine
therapy (1)
DOSAGE AND ADMINISTRATION
Select patients for treatment with ORSERDU based on the presence of
_ESR1_ mutations. (2.1)
The recommended dosage of ORSERDU is one 345 mg tablet taken orally,
once daily, with food (2.2)
Dose interruption, reduction, or permanent discontinuation may be
required due to adverse reactions.
(2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 345 mg and 86 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Dyslipidemia: ORSERDU may cause hypercholesterolemia and
hypertriglyceridemia. Monitor lipid profile
prior to starting treatment and periodically thereafter. (5.1)
Embryo-Fetal Toxicity: ORSERDU can cause fetal harm. Advise of the
potential risk to a fetus and to use
effective contraception. (5.2, 8.1, 8.3)
ADVERSE REACTIONS
The most common (>10%) adverse reactions, including laboratory
abnormalities, of ORSERDU were
musculoskeletal pain, nausea, increased cholesterol, increased AST,
increased triglycerides, fatigue,
decreased hemoglobin, vomiting, increased ALT, decreased sodium,
increased creatinine, decreased
appetite, diarrhea, headache, constipation, abdominal pain, hot flush,
and dyspepsia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT STEMLINE THERAPEUTICS,
INC. AT 1-877-
332-7961 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Strong and Moderate CYP3A4 Inducers: Avoid concomitant use with
ORSERDU (7.1)
Strong and Moderate CYP3A4 Inhibitors