INDICATIONS AND USAGE
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.
• 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.
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.
• 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.
• Premedicate with dexamethasone, diphenhydramine, H2 blocker and acetaminophen.
DOSAGE FORMS AND STRENGTHS
For Injection: 300 mg or 400 mg lyophilized powder in a single-dose vial for reconstitution.
WARNINGS AND PRECAUTIONS
• Infusion reactions: Premedication is required. Interrupt EMPLICITI (elotuzumab) for Grade 2 or higher and permanently discontinue for severe infusion reaction.
• Infections: Monitor for fever and other signs of infection and treat promptly.
• Second Primary Malignancies (SPM): Higher incidences of SPM were observed in a controlled clinical trial of patients with multiple myeloma receiving EMPLICITI.
• Hepatotoxicity: Monitor liver function and stop EMPLICITI if hepatotoxicity is suspected.
• Interference with determination of complete response: EMPLICITI can interfere with assays used to monitor M-protein. This interference can impact the determination of complete response.
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.
• with pomalidomide and dexamethasone are constipation and hyperglycemia.
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.
EMPLICITI® and its associated logo are registered trademarks of Bristol-Myers Squibb Company.
POMALYST®, its associated logo, and POMALYST REMS® are registered trademarks of Celgene Corporation, a Bristol Myers Squibb company.
© 2022 Bristol-Myers Squibb Company. 689-US-2200031 05/22
EMPLICITI® (elotuzumab) is indicated in combination with POMALYST 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.
POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with MM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
IMPORTANT SAFETY INFORMATION FOR POMALYST & EMPLICITI
POMALYST Boxed WARNINGS
WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM
EMBRYO-FETAL TOXICITY: POMALYST is a thalidomide analogue and is contraindicated in pregnancy. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting treatment and use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping treatment. To avoid embryo-fetal exposure, POMALYST is only available through its restricted distribution program, POMALYST REMS® .
Information about the POMALYST REMS programs is available at www.celgeneriskmanagement.com or by calling 1-888-423-5436.
VENOUS AND ARTERIAL THROMBOEMBOLISM: POMALYST has demonstrated a significantly increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with MM. Thromboprophylaxis is recommended and the choice of regimen should be based on assessment of the patient’s underlying risk factors. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling.
Pregnancy: See Boxed WARNINGS. POMALYST can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If the patient becomes pregnant while taking POMALYST, the patient should be apprised of the potential risk to the fetus.
Severe Hypersensitivity Reactions: POMALYST is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide, or any of the excipients.
POMALYST & EMPLICITI WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity & Females of Reproductive Potential: See Boxed WARNINGS. Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning POMALYST.
REMS Program: See Boxed WARNINGS.
-Prescribers and pharmacies must be certified with the POMALYST REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive POMALYST. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.
-Further information about the POMALYST REMS program is available at www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436.
Hematologic Toxicity: POMALYST can cause significant neutropenia (46%) and thrombocytopenia. Neutropenia, anemia, and thrombocytopenia were the most frequently reported Grade 3 or 4 adverse reactions in patients taking POMALYST in clinical trials. Patients may require dose interruption and/or modification. For POMALYST, monitor CBC weekly for the first 8 weeks and monthly thereafter.
Venous & Arterial Thromboembolism: See Boxed WARNINGS. Venous thromboembolic events (DVT and PE) and arterial thromboses (myocardial infarction [MI] and stroke [CVA]) are increased in patients treated with POMALYST. Thromboprophylaxis is recommended and the regimen should be based on the patient’s underlying risks. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking).
Second Primary Malignancies (SPM): In patients receiving POMALYST as an investigational therapy outside of MM, cases of AML have been reported.
In the ELOQUENT-3 trial (N=115), invasive SPMs were 0% (EPd) and 1.8% (Pd). Monitor patients for the development of SPMs.
Increased Mortality With Pembrolizumab: In clinical trials in patients with MM, the addition of pembrolizumab to a thalidomide analogue (POMALYST) plus dexamethasone resulted in increased mortality. Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
Hepatotoxicity: Hepatic failure, including fatal cases, have occurred in patients treated with POMALYST. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST. Monitor liver function tests monthly for POMALYST. Stop POMALYST upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered. Stop EMPLICITI upon ≥ Grade 3 elevation of liver enzymes. Continuation of treatment may be considered after return to baseline values.
Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with POMALYST. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. These reactions can be fatal. Consider POMALYST interruption or discontinuation for Grade 2 or 3 skin rash. Permanently discontinue POMALYST for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS.
Tumor Lysis Syndrome (TLS): TLS may occur in patients treated with POMALYST. Patients at risk are those with high tumor burden prior to treatment. Closely monitor patients at risk and take appropriate preventive approaches.
Hypersensitivity: Hypersensitivity including angioedema, anaphylaxis, and anaphylactic reactions to POMALYST have been reported. Permanently discontinue POMALYST for angioedema or anaphylaxis.
Dizziness & Confusional State: In patients taking POMALYST in clinical trials, 14% experienced dizziness (1% Grade 3 or 4) and 7% a confusional state (3%Grade 3 or 4). Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice.
Neuropathy: In patients taking POMALYST in clinical trials, 18% experienced neuropathy (2% Grade 3 in one trial) and 12% peripheral neuropathy.
Interference with Determination of Complete Response: EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
USE IN SPECIFIC POPULATIONS