Empliciti 400mg Inj, 1 Vial
It is used to treat multiple myeloma. This drug is used with a steroid drug (dexamethasone) and either lenalidomide or pomalidomide. Talk with the doctor about the risks and side effects that may happen with those drugs.
Drug Class
Antineoplastic, Immunomodulator
Pharmacologic Class
Monoclonal antibody, SLAMF7-directed antibody
Pregnancy Category
Not available
FDA Approved
Nov 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Empliciti is a medicine used to treat multiple myeloma, a type of cancer that affects plasma cells in your bone marrow. It works by helping your immune system, specifically natural killer cells, find and kill the cancer cells. It is given as an infusion into your vein, usually along with other medications.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a period of time. Your healthcare team may also give you other medications to help manage any side effects that may occur during the infusion.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best way to store it.
Missing a Dose
If you miss a dose, contact your doctor to find out what to do next. If you miss a dose of the steroid medication dexamethasone or if it is discontinued, discuss this with your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a period of time. Your healthcare team may also give you other medications to help manage any side effects that may occur during the infusion.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best way to store it.
Missing a Dose
If you miss a dose, contact your doctor to find out what to do next. If you miss a dose of the steroid medication dexamethasone or if it is discontinued, discuss this with your doctor to determine the best course of action.
Lifestyle & Tips
- Report any signs of infection (fever, chills, cough) immediately to your doctor.
- Stay hydrated and maintain good nutrition.
- Follow your doctor's instructions for all medications, including those given with Empliciti.
- Attend all scheduled appointments for infusions and monitoring.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg/kg intravenously, administered weekly for the first 2 cycles (28-day cycles), then every 2 weeks thereafter. Administered in combination with lenalidomide and dexamethasone, or pomalidomide and dexamethasone.
Condition-Specific Dosing:
Multiple Myeloma:
10 mg/kg IV weekly for 8 doses (Cycles 1-2), then 10 mg/kg IV every 2 weeks (subsequent cycles). Administer in combination with lenalidomide and dexamethasone, or pomalidomide and dexamethasone.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary
Dialysis:
No specific recommendations; not renally cleared in the traditional sense.
Hepatic Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary
Pharmacology
Mechanism of Action
Elotuzumab is a humanized IgG1 monoclonal antibody that specifically targets the Signaling Lymphocytic Activation Molecule Family member 7 (SLAMF7), a glycoprotein expressed on multiple myeloma cells and natural killer (NK) cells. It directly activates NK cells via SLAMF7 and mediates antibody-dependent cellular cytotoxicity (ADCC) against SLAMF7-expressing multiple myeloma cells. It also has a direct effect on myeloma cells.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
End of infusion
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 5-7 L (central compartment)
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 21-22 days (terminal half-life)
Clearance:
Approximately 0.3-0.4 L/day
ExcretionRoute:
Not excreted as intact drug; catabolized
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Rapid (related to target binding and NK cell activation)
PeakEffect:
Achieved at the end of infusion and maintained with regular dosing due to long half-life and target saturation.
DurationOfAction:
Prolonged, consistent with its long half-life and sustained target engagement.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellowing of the skin or eyes
Signs of electrolyte problems: mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance changes, abnormal heartbeat, seizures, loss of appetite, or severe stomach upset or vomiting
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Dizziness or fainting
Abnormal heartbeat (fast or slow)
Changes in mole color or size
Skin lumps or growths
Changes in vision
Chest pain or pressure
Mood changes
Night sweats
Unexplained bruising or bleeding
Shortness of breath
Swelling in the arms or legs
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they don't go away, contact your doctor:
Feeling tired or weak
Diarrhea or constipation
Abnormal burning, numbness, or tingling sensations
Nose or throat irritation
Common cold symptoms
Decreased appetite
Arm or leg pain
Headache
Vomiting
Weight loss
Bone pain
* Muscle spasms
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellowing of the skin or eyes
Signs of electrolyte problems: mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance changes, abnormal heartbeat, seizures, loss of appetite, or severe stomach upset or vomiting
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Dizziness or fainting
Abnormal heartbeat (fast or slow)
Changes in mole color or size
Skin lumps or growths
Changes in vision
Chest pain or pressure
Mood changes
Night sweats
Unexplained bruising or bleeding
Shortness of breath
Swelling in the arms or legs
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they don't go away, contact your doctor:
Feeling tired or weak
Diarrhea or constipation
Abnormal burning, numbness, or tingling sensations
Nose or throat irritation
Common cold symptoms
Decreased appetite
Arm or leg pain
Headache
Vomiting
Weight loss
Bone pain
* Muscle spasms
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe infusion reactions (difficulty breathing, swelling of face/lips/tongue, hives, dizziness, chest pain)
- Signs of infection (fever, chills, persistent cough, unusual fatigue, pain during urination)
- Unusual bleeding or bruising
- Severe diarrhea or constipation
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are breastfeeding, as you should not breastfeed while taking this medication.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, consult with your doctor to confirm it is safe to:
Start taking a new medication
Stop taking a medication
* Change the dosage of any medication
Your doctor will help you determine if it is safe to take this medication with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are breastfeeding, as you should not breastfeed while taking this medication.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, consult with your doctor to confirm it is safe to:
Start taking a new medication
Stop taking a medication
* Change the dosage of any medication
Your doctor will help you determine if it is safe to take this medication with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Some individuals may experience severe allergic reactions or adverse effects during or within 24 hours of receiving this drug. It is crucial to discuss these potential risks with your doctor.
You may be at a higher risk of developing infections, some of which can be severe or life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with people who have infections, colds, or flu.
This medication may increase your risk of developing certain types of cancer. Be sure to discuss this potential risk with your doctor.
Regular blood tests will be necessary to monitor your condition, as directed by your doctor. Additionally, this medication may interfere with certain laboratory tests. Therefore, it is vital to inform all your healthcare providers and laboratory personnel that you are taking this drug.
If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication.
If you are pregnant or become pregnant while taking this drug, contact your doctor immediately to discuss the potential risks and necessary precautions.
Some individuals may experience severe allergic reactions or adverse effects during or within 24 hours of receiving this drug. It is crucial to discuss these potential risks with your doctor.
You may be at a higher risk of developing infections, some of which can be severe or life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with people who have infections, colds, or flu.
This medication may increase your risk of developing certain types of cancer. Be sure to discuss this potential risk with your doctor.
Regular blood tests will be necessary to monitor your condition, as directed by your doctor. Additionally, this medication may interfere with certain laboratory tests. Therefore, it is vital to inform all your healthcare providers and laboratory personnel that you are taking this drug.
If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication.
If you are pregnant or become pregnant while taking this drug, contact your doctor immediately to discuss the potential risks and necessary precautions.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are not well-established, but may include exaggerated adverse effects such as severe infusion reactions or increased risk of infection.
What to Do:
There is no specific antidote for Empliciti overdose. Management should consist of general supportive measures and treatment of symptoms. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline hematologic parameters and monitor for myelosuppression, especially in combination with other agents.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: To establish baseline liver function.
Timing: Prior to initiation of therapy
Renal Function Tests (e.g., creatinine, BUN)
Rationale: To establish baseline renal function.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening
Rationale: Although not directly linked to reactivation, general practice for patients receiving immunomodulatory therapy.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infusion reactions
Frequency: During and for at least 2 hours post-infusion
Target: Absence of symptoms
Action Threshold: Any signs of reaction (e.g., fever, chills, rash, dyspnea, hypotension) require interruption or discontinuation of infusion and management.
Signs and symptoms of infection
Frequency: Throughout therapy and for several months after
Target: Absence of infection
Action Threshold: Fever, cough, dyspnea, malaise, or other signs of infection warrant investigation and treatment.
Complete Blood Count (CBC)
Frequency: Periodically as clinically indicated, especially with combination therapy
Target: Within normal limits or acceptable range for patient's condition
Action Threshold: Significant cytopenias (e.g., neutropenia, thrombocytopenia) may require dose modification of concomitant agents or supportive care.
Symptom Monitoring
- Infusion reactions (fever, chills, rash, dyspnea, hypotension, chest tightness, wheezing, angioedema, flushing, pruritus)
- Signs of infection (fever, cough, sore throat, fatigue, malaise, localized pain/swelling)
- Fatigue
- Diarrhea
- Constipation
- Nausea
- Pneumonia symptoms (cough, fever, shortness of breath)
Special Patient Groups
Pregnancy
Empliciti may cause fetal harm when administered to a pregnant woman. IgG1 antibodies are known to cross the placental barrier. Advise pregnant women of the potential risk to a fetus. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, as IgG antibodies can cross the placenta early in pregnancy.
Second Trimester:
Increased placental transfer of IgG antibodies, potential for fetal harm.
Third Trimester:
Highest placental transfer of IgG antibodies, potential for fetal harm and effects on neonatal immune system.
Lactation
Human IgG is excreted in human milk. The effects of Empliciti on the breastfed infant or on milk production are unknown. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Empliciti and any potential adverse effects on the breastfed child from Empliciti or from the underlying maternal condition. Due to its large molecular weight, transfer into milk is likely low, and oral absorption by the infant is also low.
Infant Risk:
Low to moderate risk; monitor infant for adverse effects.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between patients ≥65 years and younger patients, but a higher incidence of certain adverse events (e.g., fatigue, pneumonia) was observed in older patients in clinical trials. No specific dose adjustment is required.
Clinical Information
Clinical Pearls
- Premedication with dexamethasone, an H1-blocker (e.g., diphenhydramine), and an H2-blocker (e.g., ranitidine or famotidine) is crucial prior to each Empliciti infusion to reduce the risk of infusion reactions.
- Empliciti is always administered in combination with an immunomodulatory agent (lenalidomide or pomalidomide) and dexamethasone for multiple myeloma.
- Infusion reactions are common, especially with the first dose. Monitor patients closely during and for at least 2 hours after the infusion.
- Patients should be advised of the increased risk of infection, particularly upper respiratory tract infections and pneumonia, and to report any signs of infection promptly.
Alternative Therapies
- Proteasome inhibitors (e.g., bortezomib, carfilzomib, ixazomib)
- Immunomodulatory drugs (e.g., thalidomide, lenalidomide, pomalidomide)
- Other monoclonal antibodies (e.g., daratumumab, isatuximab)
- Alkylating agents (e.g., melphalan, cyclophosphamide)
- Corticosteroids (e.g., dexamethasone)
- Histone deacetylase (HDAC) inhibitors (e.g., panobinostat)
- Nuclear export inhibitors (e.g., selinexor)
- BCMA-directed therapies (e.g., belantamab mafodotin, idecabtagene vicleucel, ciltacabtagene autoleucel)
- Stem cell transplantation
Cost & Coverage
Average Cost:
Highly variable, typically >$10,000 per vial per 400mg vial
Insurance Coverage:
Specialty Tier (Tier 4 or 5), requires prior authorization and may have step therapy requirements.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time it was taken to ensure prompt and effective treatment.