EMPLICITI- elotuzumab injection, powder, lyophilized, for solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

ELOTUZUMAB (UNII: 1351PE5UGS) (ELOTUZUMAB - UNII:1351PE5UGS)

থেকে পাওয়া:

E.R. Squibb & Sons, L.L.C.

INN (আন্তর্জাতিক নাম):

ELOTUZUMAB

রচনা:

ELOTUZUMAB 300 mg

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

None. There are no available data on EMPLICITI use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted with elotuzumab. EMPLICITI is administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone. Lenalidomide and pomalidomide can cause embryo-fetal harm and are contraindicated for use in pregnancy. Refer to the lenalidomide, pomalidomide and dexamethasone prescribing information for additional information. Lenalidomide and pomalidomide are only available through a REMS program. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. There are no data on the presence of EMPLICITI in hum

পণ্য সারাংশ:

EMPLICITI (elotuzumab) is white to off-white lyophilized powder available as follows: Carton Content NDC One 300 mg single-dose vial 0003-2291-11 One 400 mg single-dose vial 0003-4522-11 Store EMPLICITI under refrigeration at 2°C to 8°C (36°F-46°F). Protect EMPLICITI from light by storing in the original package until time of use. Do not freeze or shake.

অনুমোদন অবস্থা:

Biologic Licensing Application

পণ্য বৈশিষ্ট্য

EMPLICITI- ELOTUZUMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
E.R. SQUIBB & SONS, L.L.C.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EMPLICITI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EMPLICITI.
EMPLICITI (ELOTUZUMAB) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
For Injection: 300 mg or 400 mg lyophilized powder in a single-dose
vial for reconstitution. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (20% or higher)
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BRISTOL-MYERS SQUIBB AT
1-800-721-5072
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Pregnancy: Embryo-fetal toxicity in combination with lenalidomide and
dexamethasone or pomalidomide
and dexamethasone. (8.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 3/2022
®
combination with lenalidomide and dexamethasone for the treatment of
adult patients with multiple
myeloma who have received one to three prior therapies. (1)
combination with pomalidomide and dexamethasone for the treatment of
adult patients with multiple
myeloma who have received at least two prior therapies including
lenalidomide and a proteasome
inhibitor. (1)
With lenalidomide and dexamethasone: 10 mg/kg administered
intravenously every week for the first
two cycles and every 2 weeks thereafter until disease progression or
unacceptable toxicity. (2.1)
With pomalidomide and dexamethasone: 10 mg/kg administered
intravenously every week for the
first two cycles and 20 mg/kg every 4 weeks thereafter until disease
progression or unacceptable
toxicity. (2.2)
Premedicate with dexamethasone, diphenhydramine, ranitidine and
acetaminophen. (2.3)
Infusion reactions: Premedi