Our Therapies

EMPLICITI® Infusion Therapy

Violet Health Outpatient Specialty Infusion Care

About EMPLICITI® Infusion Therapy

EMPLICITI® (elotuzumab) is a SLAMF7-directed immunostimulatory antibody. SLAMF7 is a protein that sits on the surface of myeloma cells regardless of their genetic makeup, and it also sits on the surface of natural killer cells, the immune cells that destroy them. EMPLICITI® works on both ends of that encounter at once: it switches the natural killer cells on through the SLAMF7 pathway, and it coats the myeloma cells so those same natural killer cells recognize and kill them.

That dual action is unusual. Most antibody therapies either flag a target or stimulate an immune cell. This one does both through the same protein, which is why it is described as immunostimulatory rather than simply cytotoxic.

EMPLICITI® is never given on its own

This is the point that shapes everything else on this page. EMPLICITI® is approved only as part of a three-drug regimen, paired with either lenalidomide and dexamethasone or pomalidomide and dexamethasone. On its own it has limited activity. Combined with an immunomodulatory drug, the two reinforce each other and the effect is greater than either alone. Practically, that means your treatment has three moving parts: an infusion here, oral capsules you take at home, and a steroid that is split between the two settings. Which partner drug you are on decides your dose, your schedule, and how often you come in.

Dosing and administration

With lenalidomide and dexamethasone: 10 mg/kg intravenously every week for the first two 28-day cycles, then every 2 weeks thereafter, until the disease progresses or side effects make it unworkable.
With pomalidomide and dexamethasone: 10 mg/kg intravenously every week for the first two 28-day cycles, then 20 mg/kg every 4 weeks starting with cycle 3.

The pomalidomide schedule is worth pausing on. The dose doubles to 20 mg/kg while the interval stretches from weekly to monthly, so after the first two months you go from four visits a cycle down to one. The lenalidomide schedule settles at two visits a cycle instead. Either way, the first eight weeks are the busiest stretch of treatment and it eases considerably after that.

Premedication is required, not optional

Every single dose of EMPLICITI® is preceded by four medications. Dexamethasone is split in two, an oral dose taken at home 3 to 24 hours beforehand and an 8 mg intravenous dose given 45 to 90 minutes before the infusion. Alongside the IV steroid you receive an H1 blocker such as diphenhydramine, an H2 blocker, and 650 to 1,000 mg of acetaminophen. The split steroid dose is specific to this regimen and catches people out, so it is worth confirming with your care team exactly when to take the tablets at home.

EMPLICITI® comes as a 300 mg or 400 mg lyophilized powder that is reconstituted and diluted before use, then given through an infusion pump with an in-line filter. It is never mixed with or infused alongside another medication.

Liver enzymes are monitored periodically throughout treatment, and blood counts are followed closely because the partner drugs suppress them. Kidney function does not change the dose: no adjustment is needed at any degree of renal impairment, including end-stage disease on dialysis, and EMPLICITI® is not removed by dialysis.

Conditions treated by this therapy

EMPLICITI® is FDA approved for one disease, multiple myeloma, in two distinct settings. The difference between them is not the diagnosis but how much treatment has come before:

In combination with lenalidomide and dexamethasone

Adults with multiple myeloma who have received one to three prior therapies

In combination with pomalidomide and dexamethasone

Adults with multiple myeloma who have received at least two prior therapies, which must include lenalidomide and a proteasome inhibitor

Those prior-therapy counts are not background detail. They are the eligibility criteria, and they decide which of the two regimens applies. A patient with one prior line can only receive the lenalidomide combination. A patient who has already progressed through lenalidomide and a proteasome inhibitor moves to the pomalidomide combination. The referral has to state the number of prior lines and what they were.

What EMPLICITI® is not used for

Newly diagnosed multiple myeloma. There is no first-line indication.
Smoldering myeloma, MGUS, or amyloidosis.
Single-agent use. EMPLICITI® is not approved and not given on its own.
Children. Safety and effectiveness have not been established in patients under 18.

One note on how it sits alongside other myeloma antibodies. DARZALEX® targets CD38 and EMPLICITI® targets SLAMF7, so they work through different proteins and are not interchangeable. Prior exposure to one does not rule out the other, but it does need to be documented, since prior therapy history is what determines which EMPLICITI® regimen a patient qualifies for.

EMPLICITI® Price

The cost of prescription medications can vary depending on your insurance coverage. If you're concerned about the price of your medication:

Contact your insurance provider to understand your coverage
Ask your doctor or pharmacist about lower-cost alternatives
Check with the drug manufacturer about financial assistance programs
Explore patient assistance options if you're uninsured or underinsured

One thing specific to this therapy: EMPLICITI® is billed through your medical benefit as an infusion, while lenalidomide or pomalidomide is dispensed through a specialty pharmacy under your prescription benefit. Two separate approvals, two separate copays. It is worth sorting both out before the first visit. If you have questions about financial assistance opportunities, contact a member of our Violet Health team.

What to Expect During EMPLICITI® Infusion Therapy

EMPLICITI® is a prescription immunotherapy first approved by the FDA in 2015, with the pomalidomide combination added in 2018. At Violet Health we're proud to offer it in our spa-like infusion center, a comfortable alternative to traditional hospital settings.

Your first infusion is the longest one you will have

EMPLICITI® is started slowly and the rate is stepped up over the course of each visit, and over the first few visits, as long as you tolerate it. The first infusion begins at 0.5 mL per minute and increases in stages, so plan on a long morning. By the third or fourth dose the rate runs at its maximum from the start and the infusion itself is considerably shorter. Patients who move to the 20 mg/kg monthly dose step back down to a slower rate for that first larger infusion, then speed up again.

Here is what a typical visit looks like:

Take your oral dexamethasone at home as instructed, between 3 and 24 hours before the appointment. This is part of the premedication, not an optional extra, and the infusion may be delayed if it has been missed.
Labs are drawn before treatment, including a complete blood count, liver enzymes, kidney function, calcium, and glucose.
The remaining premedications are given 45 to 90 minutes before the infusion: intravenous dexamethasone, an antihistamine, an H2 blocker, and acetaminophen. The antihistamine makes many people drowsy.
The infusion runs through a standard peripheral IV using a pump. Vital signs are checked throughout, since blood pressure and heart rate can shift during the infusion.
Expect a long visit for the first two or three doses, with the premedication wait, the slow ramp, and observation afterwards. Later visits are meaningfully shorter.
Arrange a ride for the first few appointments. Between the antihistamine and the length of the day, most patients prefer not to drive until they know how they respond.

The part of treatment that happens at home

Lenalidomide or pomalidomide is taken by mouth on days 1 through 21 of each 28-day cycle, and dexamethasone continues on the weeks you do not come in. Those capsules come from a specialty pharmacy, not from us, and both are dispensed under a restricted program with its own enrollment, surveys, and pregnancy-prevention requirements. Keeping the oral schedule aligned with the infusion schedule is the most common source of confusion in this regimen, so a written calendar is genuinely useful.

If one part of the regimen has to be paused, the others often continue. A delay in your capsules does not automatically mean a delay in your infusion, and the reverse is also true. Your care team will tell you which parts to keep going.

How response is measured, and one thing that can look alarming

Myeloma response is tracked by blood and urine protein studies rather than scans, usually every cycle. EMPLICITI® is itself an antibody, and it can show up as a small band on those same tests. That band is the medication, not returning disease. It matters most for patients whose myeloma protein is IgG kappa, where it can make a complete response harder to confirm. Your care team knows to account for it, but it is worth understanding before you see a result that mentions a persistent small peak.

In the clinical trials, adding EMPLICITI® to lenalidomide and dexamethasone extended the median time before the disease progressed from 14.9 to 19.4 months and median overall survival from 39.6 to 48.3 months. In the pomalidomide trial, in patients who had already progressed through several lines, median time to progression went from 4.7 to 10.3 months and median survival from 17.4 to 29.8 months.

EMPLICITI® Side Effects

Because EMPLICITI® is always given with two other drugs, the side effects reported in trials belong to the regimen as a whole. The figures below compare the three-drug combination against the same two drugs without EMPLICITI®, which is the fairest way to see what EMPLICITI® itself adds.

With lenalidomide and dexamethasone

The most common reactions occurring in 20% or more of patients were:

Fatigue (62%)
Diarrhea (47%)
Fever (37%) and constipation (36%)
Cough (34%), nasopharyngitis (25%), and upper respiratory infection (23%)
Peripheral neuropathy (27%), meaning numbness, tingling, or burning in the hands and feet
Decreased appetite (21%) and pneumonia (20%)

Pain in the limbs, headache, vomiting, weight loss, low lymphocyte counts, and sore throat were also common. Cataracts were reported in 12% of patients, roughly twice the rate without EMPLICITI®, which is worth knowing because it develops gradually and is easy to attribute to age.

With pomalidomide and dexamethasone

This regimen produced a shorter list: constipation (22%), high blood sugar (20%), pneumonia (18%), diarrhea (18%), respiratory tract infection (17%), bone pain (15%), shortness of breath (15%), muscle spasms (13%), and swelling in the limbs (13%). Low lymphocyte counts were also more frequent.

High blood sugar deserves a mention of its own. Much of it comes from the dexamethasone rather than the EMPLICITI®, but it is common enough that patients with diabetes should expect their readings to move on treatment weeks and should have a plan for it.

Infusion reactions

Infusion reactions occurred in 10% of patients on the lenalidomide regimen and 3.3% on the pomalidomide regimen, and in the larger trial all of them were moderate or milder. The most common symptoms were fever, chills, and raised blood pressure, though slow heart rate and low blood pressure also occurred. The timing is predictable: about 70% of reactions happened with the very first dose. Where a reaction did interrupt treatment, the median pause was 25 minutes, after which the infusion was restarted at a slower rate and built back up. Only 1% of patients stopped treatment because of one.

Reactions can also appear within 24 hours of going home. Report fever, chills, rash, chest discomfort, dizziness, or trouble breathing after an infusion, not just during one.

Infections

Infection is the most clinically significant risk of this regimen. In the lenalidomide trial, infections occurred in 81% of patients receiving EMPLICITI® compared with 74% without it, and opportunistic infections in 22% compared with 13%. Shingles was reported in 14% of patients compared with 7%, and fungal infections in 10% compared with 5%. Fatal infections occurred in 2.5% of patients. Pneumonia was the single most frequent serious event in both trials.

Antiviral prophylaxis against shingles is standard practice with this regimen. Report fever, cough, shortness of breath, burning with urination, or a painful band of rash promptly rather than waiting to see if it settles.

Second primary malignancies

New cancers unrelated to the myeloma were observed in 9% of patients on the EMPLICITI® regimen compared with 6% without it, driven mainly by solid tumors and skin cancers rather than blood cancers. Skin checks and age-appropriate cancer screening continue throughout treatment.

Liver problems

Liver enzyme elevations consistent with hepatotoxicity occurred in 2.5% of patients. Treatment is stopped for significant elevations, and most patients were able to resume once values returned to baseline. Report yellowing of the skin or eyes, dark urine, pale stools, abdominal swelling, confusion, or unusual tiredness.

Get emergency help right away if you experience:

Trouble breathing, wheezing, or chest tightness
Swelling of the face, throat, or tongue
Fever above 100.4°F, shaking chills, or any sign of infection
Chest pain, fainting, or a heartbeat that feels unusually slow or irregular
Sudden leg swelling or pain, which can signal a clot, a known risk of the partner drugs
Yellowing of the skin or eyes

Important Safety Information

EMPLICITI® has no boxed warning and no contraindications on its label. That is genuinely unusual on this site. It does not mean the regimen is low risk, because the partner drugs carry substantial warnings of their own, and the most important safety requirements in this treatment come from them rather than from EMPLICITI®.

Interference with your myeloma blood tests

EMPLICITI® is a humanized IgG kappa antibody, and the serum protein electrophoresis and immunofixation assays used to track myeloma cannot tell it apart from your own myeloma protein. It appears as a small band in the early gamma region. This can make it look as though a trace of disease remains when it does not, which affects the determination of complete response and the assessment of relapse, particularly for patients whose own myeloma protein is IgG kappa. It is a known and expected finding, not a treatment failure.

Pregnancy, contraception, and the restricted programs

EMPLICITI® on its own has no defined contraception window, which sets it apart from nearly every other therapy on this site. The requirements instead come entirely from lenalidomide and pomalidomide, both of which cause severe birth defects and are available only through restricted distribution programs. Those programs set their own rules on pregnancy testing, contraception for both female and male patients, and prohibitions on donating blood or sperm. Enrollment is mandatory for the prescriber, the pharmacy, and the patient, and treatment cannot begin without it. Breastfeeding is not recommended during treatment.

Anti-drug antibodies

Antibodies against EMPLICITI® developed in 18.5% of patients across four studies and 36% in the pomalidomide trial. In nearly every case they appeared within the first two months and resolved within two to four months, and neutralizing antibodies were uncommon. This is monitored rather than acted on directly.

Kidney and liver function

No dose adjustment is needed for any degree of kidney impairment, including end-stage renal disease with or without dialysis. That matters in myeloma, where kidney involvement is common. Mild liver impairment also requires no adjustment, but EMPLICITI® has not been studied in moderate or severe liver impairment.

Age

Most patients in the trials were 65 or older, and no overall difference in how well the treatment worked or was tolerated was seen by age. The dexamethasone dose in the pomalidomide regimen is reduced for patients over 75, so age does change part of the regimen even though the EMPLICITI® dose stays the same.

Before you start, tell your care team if you

Have any current or recent infection, including shingles
Have liver disease or a history of hepatitis
Have diabetes or difficulty controlling blood sugar, given the steroid component
Have a history of blood clots, or a slow heart rate or low blood pressure
Have existing numbness or tingling in your hands or feet from previous treatment
Are taking any other medication, including over-the-counter products and supplements

Keep the Medication Guides for all three drugs in the regimen. If you need urgent care elsewhere, the treating clinician needs to know you are on an antibody therapy with an immunomodulatory drug, because both the infection risk and the blood test interference are easy to misread without that context.

What Your Referral Should Include

Eligibility for EMPLICITI® turns on treatment history more than on anything else, and the partner drug decides the entire schedule. A complete referral moves scheduling along considerably. Please include:

Number of prior lines of therapy, with the agents, dates, and best response for each. This is the single item that determines eligibility and which regimen applies.
Which regimen is intended, EMPLICITI® with lenalidomide and dexamethasone or with pomalidomide and dexamethasone, since it sets the dose, the interval, and the number of visits
For the pomalidomide regimen, explicit confirmation of prior lenalidomide and a proteasome inhibitor, and whether the disease is refractory to either
Prescriber and specialty pharmacy enrollment in the applicable restricted distribution program, since the oral agent cannot be dispensed without it and the infusion should not start ahead of it
The dexamethasone plan in writing, including the oral dose and timing on infusion days and the dose on non-infusion weeks, with the reduced dosing noted for patients over 75
Myeloma isotype and light chain restriction. Flag IgG kappa specifically, because of the assay interference.
Baseline disease markers: serum protein electrophoresis, immunofixation, serum free light chains, quantitative immunoglobulins, beta-2 microglobulin, and 24-hour urine studies where applicable
Cytogenetics and FISH results, ISS or R-ISS stage, and most recent bone marrow findings
Current weight with the date it was taken, since dosing is weight-based at both 10 mg/kg and 20 mg/kg
Baseline labs: CBC with differential, liver enzymes and bilirubin, creatinine with creatinine clearance, calcium, glucose or A1c, albumin, and electrolytes
Dialysis status and schedule if applicable, noting that no dose adjustment is required
Hepatitis B and C status, HIV status, varicella zoster history, and the antiviral prophylaxis plan
Infection history, particularly prior pneumonia or recurrent respiratory infection, and vaccination record
Baseline peripheral neuropathy grade, since many patients arrive with residual neuropathy from prior bortezomib
Thrombosis history and the planned anticoagulation or aspirin prophylaxis for the immunomodulatory drug
Autologous stem cell transplant history with dates, and whether transplant remains part of the plan
Bone disease status and current bisphosphonate or denosumab schedule, so it can be coordinated with infusion days
Cardiac history, baseline heart rate, and blood pressure, given the bradycardia and hypotension seen during infusions
ECOG performance status and any steroid intolerance
Pregnancy status and the contraception plan required by the partner drug's program
Venous access notes, including any history of difficult sticks or an existing port