Empliciti 300mg Inj, 1 Vial

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 works by directly activating NK cells via SLAMF7 and by mediating antibody-dependent cell-mediated cytotoxicity (ADCC) against SLAMF7-expressing myeloma cells.

Serious Side Effects: Seek Medical Help Immediately

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 right away:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain, cramps, or spasms
+ Weakness
+ Shakiness
+ Balance changes
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ 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. However, many people experience no side effects or only mild ones. If you notice any of the following side effects or any others that concern you or don't go away, contact your doctor or seek medical attention:

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 about side effects, 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.

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 use, tell your doctor and pharmacist about:

All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

You may be at risk for severe allergic reactions or adverse effects during or within 24 hours of receiving this drug. Be sure to discuss any concerns with your doctor.

Taking this medication may increase your 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 individuals who have infections, colds, or the flu.

There is also a potential increased risk of developing certain types of cancer associated with this medication. Discuss this risk with your doctor to understand the benefits and risks.

Regular blood tests will be necessary to monitor your condition while taking this drug. Your doctor will provide guidance on the frequency of these tests. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests.

If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication.

If you become pregnant or suspect you may be pregnant while taking this drug, immediately contact your doctor to discuss the potential risks and necessary precautions.

• Infusion reactions (chills, fever, dyspnea, rash, hypotension, chest pain, wheezing, angioedema)
• Signs of infection (fever, cough, sore throat, fatigue, malaise)
• Fatigue
• Diarrhea
• Constipation
• Peripheral neuropathy (often related to combination therapy)

Based on its mechanism of action, Empliciti can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 4 months after the last dose.

It is not known whether elotuzumab is excreted in human milk. Human IgG is known to be excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 4 months after the last dose.

Safety and effectiveness in pediatric patients have not been established.

No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients (<65 years) in clinical trials. No dose adjustment is required based on age.

• Premedicate patients with dexamethasone, an H1-blocker (e.g., diphenhydramine), and acetaminophen prior to each Empliciti infusion to reduce the risk of infusion reactions.
• Infusion reactions are common, especially with the first dose. Monitor patients closely during and for at least 2 hours after the infusion.
• Empliciti is always administered in combination with other agents for multiple myeloma (e.g., lenalidomide and dexamethasone, or pomalidomide and dexamethasone).
• Patients may experience an increased risk of infections, particularly upper respiratory tract infections and pneumonia. Monitor for signs and symptoms of infection.
• Elotuzumab is an IgG kappa monoclonal antibody and may interfere with serological testing (e.g., serum protein electrophoresis, immunofixation) for multiple myeloma, potentially leading to false positive results. This interference should be considered when interpreting patient response assessments.

• Proteasome inhibitors (e.g., Bortezomib, Carfilzomib, Ixazomib)
• Immunomodulatory drugs (e.g., Lenalidomide, Pomalidomide, Thalidomide)
• 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, CAR T-cell therapies like Ide-cel, Cilta-cel)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. 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. 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. Additionally, some medications may come with a separate 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 amount, and the time it occurred.