EMPLICITI 300 mg/1
elotuzumab · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · E.R. Squibb & Sons, L.L.C.
EMPLICITI is a injection, powder, lyophilized, for solution containing elotuzumab at 300 mg/1, taken intravenous. Manufactured by E.R. Squibb & Sons, L.L.C..
Key Facts
- Brand Name
- EMPLICITI
- Generic Name
- elotuzumab
- NDC Code (Product)
0003-2291- Manufacturer
- E.R. Squibb & Sons, L.L.C.
- Strength
- 300 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761035
- Drug Class
- SLAMF7-directed Immunostimulatory Antibody [EPC]
- Marketing Start
- 11/30/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE • EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. • EMPLICITI is indicated in 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. EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in • 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)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • 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) 2.1 Recommended Dosing when EMPLICITI Is Used in Combination with Lenalidomide and Dexamethasone The recommended dosage of EMPLICITI is 10 mg/kg administered intravenously every week for the first two cycles (28-day cycle) and every 2 weeks thereafter in conjunction with the recommended dosing of lenalidomide and low-dose dexamethasone as described below. Continue treatment until disease progression or unacceptable toxicity. Refer to the dexamethasone and lenalidomide prescribing information for additional information. Administer premedications before each dose of EMPLICITI [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ] . Administer dexamethason…
Contraindications
4 CONTRAINDICATIONS None. None (4)
Drug Interactions
7 DRUG INTERACTIONS 7.1 Drug Interactions For important drug interactions involving lenalidomide, pomalidomide and dexamethasone, refer to their respective prescribing information. 7.2 Laboratory Test Interference EMPLICITI may be detected in the SPEP and serum immunofixation assays of myeloma patients and could interfere with correct response classification. A small peak in the early gamma region on SPEP that is IgGƙ on serum immunofixation may potentially be attributed to EMPLICITI, particularly in patients whose endogenous myeloma protein is IgA, IgM, IgD, or lambda light chain restricted. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein [see Warnings and Precautions (5.5) ].
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in detail in other sections of the label: • Infusion reaction [see Warnings and Precautions (5.1) ] . • Infections [see Warnings and Precautions (5.2) ] . • Second Primary Malignancies [ see Warnings and Precautions (5.3) ] . • Hepatotoxicity [see Warnings and Precautions (5.4) ] . • Interference with determination of complete response [see Warnings and Precautions (5.5) ] . Most common adverse reactions (20% or higher) • with lenalidomide and dexamethasone are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia. (6.1) • with pomalidomide and dexamethasone are constipation and hyperglycemia. (6.1) 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the r…
Frequently Asked Questions
What is EMPLICITI used for?
EMPLICITI contains elotuzumab. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is EMPLICITI a controlled substance?
EMPLICITI is not classified as a controlled substance by the DEA.
What is the generic name for EMPLICITI?
The generic name for EMPLICITI is elotuzumab. There are no other listed brand versions of elotuzumab.
What is the NDC code for EMPLICITI 300 mg/1?
The NDC (National Drug Code) for EMPLICITI 300 mg/1 is 0003-2291, listed by E.R. Squibb & Sons, L.L.C..
Other EMPLICITI Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)