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Empliciti

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Elotuzumab (elotuzumab) instruction manual

Common name: elotuzumab
Trade name: Empliciti
Full names: elotuzumab, elotuzumab, Empliciti


Indications:
Empliciti is suitable for the combined treatment of multiple myeloma patients who have received 1-3 treatments in combination with lenalidomide and dexamethasone.


Usage and Dosage:
The recommended dose is 10mg/kg. The first 1-2 courses of treatment (28 days is a course of treatment) are administered intravenously once a week, and the subsequent courses of treatment are administered once every 2 weeks.
On the day of Empliciti administration, 28 mg of dexamethasone was administered orally 3-24 hours before Empliciti administration, and 8 mg of dexamethasone was administered intravenously 45-90 minutes before Empliciti administration;
On days 8 and 22 of the third course of treatment and subsequent courses, 40 mg of dexamethasone was administered orally;
On days 1-21 of each course of treatment, 25 mg of lenalidomide was administered orally.


Adverse reactions:
Serious adverse reactions include: infusion reactions, infections, second primary malignancies, liver toxicity, and interference with determination of complete response.
Common Adverse Reactions: Blurred vision, body aches or pains, chest pain, chills, confusion, cough or hoarseness, dizziness when rising suddenly from a lying or sitting position, dizziness or lightheadedness, ear plugs, facial swelling, fever or chills, headache, hives, itching or rash, hoarseness, irritation


Contraindications:
There are no contraindications to Empliciti. However, u2002Empliciti is used in combination with lenalidomide and dexamethasone, so you need to check the contraindications to lenalidomide and dexamethasone before use.


Precautions:
Infusion reaction: Empliciti may cause infusion reaction. Infusion reactions were reported in approximately 10% of patients treated with Empliciti with lenalidomide and dexamethasone in randomized multiple myeloma trials. All reports of infusion reactions were grade 3 or less. Grade 3 infusion reactions occurred in 1% of patients. The most common symptoms of an infusion reaction include fever, chills, and hypertension. Bradycardia and hypotension also occurred during the infusion.
Infection: Monitor patients closely for the occurrence of infection and treat it promptly.
Second primary malignancy: Monitor patients closely for the occurrence of a second primary malignancy.
Hepatotoxicity: Discontinue Empliciti dosing for liver enzymes grade 3 or higher. When liver enzymes return to normal values, continued treatment can be considered.
Interfering with the determination of complete response: Empliciti is a humanized IgGu2002κ (Greek) monoclonal antibody that can be detected by serum protein electrophoresis (SPEP) and immunofixation (IFE) assays for clinical surveillance of endogenous M-protein. This interference may affect the determination of complete remission and possible relapse from complete remission in patients with IgGu2002κ myeloma protein.


Storage:
Store in refrigerator at 2°C to 8°C (36°F-46°F) in original packaging, protected from light, do not shake, do not freeze.


Mechanism of action:
Targeted signaling lymphocyte activating molecule family member 7 (SLAMF7, also known as CS1, CD2 subset-1, CRACC, CD319) is a cell surface glycoprotein that is highly expressed in myeloma cells and participates in regulating the mutual adhesion of myeloma cells and bone marrow stromal cells. Elotuzumab is a SLAMF7 monoclonal antibody with a dual mechanism of action. (1) Direct activation pathway: Through the SLAMF7 pathway, it directly acts on the highly expressed glycoprotein SLAMF7 on the surface of plasma cells, which can inhibit the adhesion between cells, thereby weakening the growth-stimulating effect of stromal cells on myeloma cells and directly activating the immune system through natural killer cells. (2) Antibody-dependent cell-mediated cytotoxicity (ADCC): Elotuzumab can target and bind to SLAMF7 on the surface of MM cells, label these malignant cells, and increase the activity of natural killer cells in killing malignant cells through antibody-dependent effects.


Safety and efficacy:
A phase II clinical trial of elotuzumab conducted in 2010 recruited 73 patients with refractory MM who were older than 18 years old. According to the periodic dosing method, the optimal dose of elotuzumab (10 mg·kg or 20 mg·kg), the results showed that elotuzumab 10 mg·kg was more effective than 20 mg·kg, and there was no significant difference in the incidence of adverse reactions.
The approval of EmplicitiTM is based on data from the randomized, open-label Phase III ELOQUENT-2 study. The study results show that compared with lenalidomide + low-dose dexamethasone combination therapy (Ld), elotuzumab + lenalidomide + dexamethasone combination therapy (E-Ld) can significantly prolong the progression-free survival (PFS) of patients with relapsed/refractory MM, with a median PFS of 14.9 months vs. 19.4 months (P < 0.001), significantly reducing the risk of disease progression or death by 30%. Data with more than 2 years of follow-up showed that the one-year progression-free survival rate of the E-Ld group was 68% (57% of the Ld group) and the two-year progression-free survival rate was 41% (27% of the Ld group). In addition, compared with the Ld group, the overall response rate (ORR) of the E-Ld group was significantly improved (79% vs. 66%, P < 0.001).