Empliciti is a brand-name prescription drug. It's used to treat a type of blood cancer called multiple myeloma in adults.

Empliciti is prescribed for people who fit into one of these two treatment situations:

  • Adults who have had one to three treatments in the past for their multiple myeloma. For these people, Empliciti is used in combination with lenalidomide (Revlimid) and dexamethasone.
  • Adults who have had at least two past multiple myeloma treatments that included lenalidomide (Revlimid) and a proteasome inhibitor, such as bortezomib (Velcade) or carfilzomib (Kyprolis). For these people, Empliciti is used in combination with pomalidomide (Pomalyst) and dexamethasone.

Empliciti belongs to a class of drugs called monoclonal antibodies. These drugs are made in a lab from immune system cells. Empliciti works by activating your immune system and making your immune cells stronger. The drug also helps show your immune system where multiple myeloma cells are in your body so that these cells can be destroyed.

Empliciti is available in two strengths: 300 mg and 400 mg. It comes as a powder that's made into a liquid solution and given to you by intravenous (IV) infusion (an injection into your vein over a period of time). The infusions are given at a healthcare facility and last about an hour or longer.

Effectiveness

Clinical studies have shown that Empliciti is effective at stopping the progression (worsening) of multiple myeloma. Results of some of these studies are described below.

Empliciti with lenalidomide (Revlimid) and dexamethasone

In clinical trials, people with multiple myeloma were given either Empliciti with lenalidomide and dexamethasone, or lenalidomide and dexamethasone alone.

The studies showed that people taking the Empliciti combination had a lower risk for their disease to progress. Over at least two years, those taking Empliciti with lenalidomide and dexamethasone had a 30% lower risk than people who were taking those drugs without Empliciti.

In another study lasting five years, people taking the Empliciti combination had a 27% lower risk of their disease worsening than people taking lenalidomide and dexamethasone alone.

Empliciti with pomalidomide (Pomalyst) and dexamethasone

In clinical trials, people with multiple myeloma were given either Empliciti with pomalidomide and dexamethasone, or pomalidomide and dexamethasone alone.

People taking the Empliciti combination had a 46% lower risk of their disease getting worse after at least nine months of treatment, compared to people taking pomalidomide and dexamethasone alone.

Empliciti is available only as a brand-name medication. It's not currently available in generic form.

Empliciti contains the active medication elotuzumab.

Empliciti can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Empliciti. This list does not include all possible side effects.

Your side effects can vary depending on whether you're taking Empliciti and dexamethasone with either lenalidomide (Revlimid) or pomalidomide (Pomalyst).

For more information on the possible side effects of Empliciti, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Empliciti when taken with lenalidomide and dexamethasone can include:

  • fatigue (lack of energy)
  • diarrhea
  • fever
  • constipation
  • cough
  • infections, such as sinus infections or pneumonia
  • decreased appetite or weight loss
  • peripheral nerve disease (damage to some of your nerves)
  • pain in your arms or legs
  • headache
  • vomiting
  • cataracts (cloudiness in the lens of your eye)
  • pain in your mouth and throat
  • changes in certain levels on your blood tests

The more common side effects of Empliciti when taken with pomalidomide and dexamethasone can include:

  • constipation
  • increased blood sugar level
  • infections, such as pneumonia or sinus infections
  • diarrhea
  • bone pain
  • trouble breathing
  • muscle spasms
  • swelling in your arms or legs
  • changes in certain levels on your blood tests

Most of these side effects may go away within a few days or a couple of weeks. If they're more severe or don't go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects can occur with Empliciti. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Serious side effects and their symptoms can include the following:

  • Other types of cancer, such as skin cancer. Symptoms can include:
    • weakness
    • feeling tired
    • changes in the appearance of your skin and moles
    • swollen lymph nodes
  • Liver problems. Symptoms can include:
    • feeling tired
    • weakness
    • yellowing of the whites of your eyes or your skin
    • decreased appetite
    • swelling in your belly area
    • feeling confused

Other serious side effects, which are discussed in more detail below, can include the following:

  • infusion reaction (can be caused by having an intravenous drug infusion)
  • severe allergic reaction
  • infections

Side effect details

You may wonder how often certain side effects occur with this drug. Here's some detail on some of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Empliciti. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Empliciti. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Infusion reactions

You may have an infusion reaction after receiving Empliciti. These are reactions that can happen up to 24 hours after you've received a drug through intravenous (IV) infusion.

In clinical trials, 10% of people taking Empliciti with lenalidomide and dexamethasone had an infusion reaction. Most of these people had an infusion reaction during their first Empliciti infusion. However, only 1% of people taking this treatment combination had to stop treatment due to severe infusion reactions.

Also in clinical trials, 3.3% of people taking Empliciti with pomalidomide and dexamethasone had infusion reactions. The only symptom of their infusion reactions was chest pain.

Symptoms of an infusion reaction can include:

  • fever
  • chills
  • increased or decreased blood pressure
  • slowed heart rate
  • trouble breathing
  • dizziness
  • skin rash
  • chest pain

Before your IV infusion of Empliciti, your doctor or nurse will give you certain medications to help prevent an infusion reaction from happening.

If you have any symptoms of an infusion reaction while you're receiving Empliciti, or up to 24 hours after your infusion, tell your doctor right away. In serious cases, your doctor may recommend that you stop Empliciti treatment.

Sometimes, Empliciti treatment can be restarted after an infusion reaction. But in some cases, choosing a different medication may be a better option for you.

Infections

You may have an increased risk of infections while you're taking Empliciti. This includes bacterial, viral, and fungal infections. Sometimes, these infections can be very serious if they're not treated. In some cases, they can lead to severe illness or even death.

In clinical trials, infection occurred in 81% of people taking Empliciti with lenalidomide and dexamethasone. Of people taking lenalidomide and dexamethasone alone, 74% had infections.

Also in clinical trials, infection occurred in 65% of people taking Empliciti with pomalidomide and dexamethasone. Infections occurred in the same percentage of people taking pomalidomide and dexamethasone alone.

Symptoms of infection can vary depending on what kind of infection you have. Examples of possible symptoms include:

  • fever
  • trouble breathing
  • flu-like symptoms, such as body aches and chills
  • cough
  • skin rash
  • burning feeling when you're urinating

If you have any symptoms of an infection, talk with your doctor right away. They may recommend that you stop taking Empliciti until your infection goes away. They'll also recommend if your infection needs to be treated.

Peripheral nerve disease

You may have nerve damage if you're taking Empliciti. Nerve damage can also be called peripheral nerve disease. This condition can cause weakness and pain that usually occurs in your hands or feet. Peripheral nerve disease usually doesn't go away, but it can be treated with certain medications.

In clinical trials, peripheral nerve disease occurred in 27% of people taking Empliciti with lenalidomide and dexamethasone. This condition occurred in 21% of people taking lenalidomide and dexamethasone alone.

Talk with your doctor if you have symptoms of peripheral nerve disease. They can recommend medical treatment if you need it.

Fatigue

You may have fatigue (lack of energy) while you're using Empliciti. This was a common side effect seen during studies in people taking Empliciti with lenalidomide and dexamethasone.

In studies, fatigue occurred in 62% of people taking Empliciti with lenalidomide and dexamethasone. Of people taking lenalidomide and dexamethasone alone, 52% had fatigue.

Talk with your doctor if you feel fatigued during your Empliciti treatment. They can recommend medical treatment if you need any and suggest ways to reduce your symptoms.

Diarrhea

You may have diarrhea while you're taking Empliciti. In clinical trials, diarrhea occurred in 47% of people taking Empliciti with lenalidomide and dexamethasone. Of people taking lenalidomide and dexamethasone alone, 36% had diarrhea.

Diarrhea was also a side effect seen in people taking Empliciti with pomalidomide and dexamethasone. In clinical trials, diarrhea occurred in 18% of people taking this combination of drugs. Of people taking pomalidomide and dexamethasone alone, 9% had diarrhea.

Talk with your doctor if you have diarrhea during your Empliciti treatment. They can recommend medical treatment if you need any and suggest ways to reduce your symptoms.

Changes in lab values or tests

You may have changes in certain blood test levels while you're taking Empliciti. Examples include changes in:

Your doctor may check blood tests more often than usual while you're taking Empliciti. This lets your doctor see whether there are any changes in your blood test levels. If such changes do occur, your doctor may monitor your blood tests even more frequently or recommend that you stop Empliciti treatment.

As with all medications, the cost of Empliciti can vary. This drug is given by intravenous (IV) infusion at healthcare clinics.

The actual price you'll pay depends on your insurance plan, your location, and the medical facility where you receive your treatments.

Financial and insurance assistance

If you need financial support to pay for Empliciti, or if you need help understanding your insurance coverage, help is available.

Bristol-Myers Squibb, the manufacturer of Empliciti, offers a program called BMS Access Support. For more information and to find out if you're eligible for support, call 800-861-0048 or visit the program website.

The Empliciti dosage your doctor prescribes will depend on a couple of factors. These include:

  • which medications you're taking with Empliciti
  • your body weight

Your dose may be adjusted over time to reach the amount that's right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Empliciti comes as a powder that's mixed with sterile water and made into a solution. It's given as an intravenous (IV) infusion (an injection into your vein over a period of time). The solution is made and the IV infusion is given to you at a healthcare facility.

Empliciti is available in two strengths: 300 mg and 400 mg.

Dosage for multiple myeloma

The dosage of Empliciti that you receive depends on your body weight and what medications you're taking with Empliciti.

If you're taking Empliciti with lenalidomide (Revlimid) and dexamethasone:

  • the typical dosage is 10 mg of Empliciti for every kilogram (about 2.2 pounds) of your body weight
  • you'll get weekly doses of Empliciti for the first eight weeks, which is considered two cycles, of treatment
  • after your first two cycles of treatment, Empliciti is given once every two weeks

If you're taking Empliciti with pomalidomide (Pomalyst) and dexamethasone:

  • the typical dosage is 10 mg of Empliciti for every kilogram (about 2.2 pounds) of your body weight
  • you'll get weekly doses of Empliciti for the first eight weeks, which is considered two cycles, of treatment
  • after your first two cycles of treatment, the dosage increases to 20 mg of Empliciti for every kilogram of your body weight, given once every four weeks

As an example of dose calculation, an adult who weighs 70 kilograms (about 154 pounds) would receive a 700 mg dose of Empliciti. This is calculated as 70 kilograms multiplied by 10 mg of the drug, which equals 700 mg of Empliciti.

With either dosage option, you'll usually continue taking Empliciti until your multiple myeloma gets worse or you have bothersome side effects from Empliciti.

What if I miss a dose?

If you miss an appointment for your Empliciti infusion, schedule another appointment as soon as possible. Talk with your doctor about the best way to schedule your future doses so that you're able to make it to your infusions.

Be sure to take your dexamethasone dose as directed by your doctor. If you miss a dose of dexamethasone, tell your doctor that you forgot to take it. Forgetting a dose of this drug can cause you to have a reaction to Empliciti. This can sometimes be very serious.

Will I need to use this drug long term?

Sometimes using medications can keep your multiple myeloma stable (not getting worse) for a long time. If you're taking Empliciti and your multiple myeloma isn't getting worse, your doctor may recommend that you stay on Empliciti treatment long term.

In clinical trials, over half of the people taking Empliciti didn't have worsening of their multiple myeloma for over 10 months. The length of time that you'll take Empliciti depends on how your body responds to the medication.

Other drugs or therapies are available that can treat multiple myeloma. Some may be better suited for you than others. If you're interested in finding an alternative to Empliciti, talk with your doctor. They can tell you about other medications or treatments that may work well for you.

Examples of other drugs that may be used to treat multiple myeloma include:

  • bortezomib (Velcade)
  • carfilzomib (Kyprolis)
  • ixazomib (Ninlaro)
  • daratumumab (Darzalex)
  • thalidomide (Thalomid)
  • lenalidomide (Revlimid)
  • pomalidomide (Pomalyst)
  • certain steroids, such as prednisone or dexamethasone

Other therapies that may be used to treat multiple myeloma include:

You may wonder how Empliciti compares to other medications that are prescribed for similar uses. Here we look at how Empliciti and Darzalex are alike and different.

Uses

Both Empliciti and Darzalex are approved by the Food and Drug Administration (FDA) to treat multiple myeloma in adults who:

  • have already tried at least two past treatments that included lenalidomide (Revlimid) and a proteasome inhibitor, such as bortezomib (Velcade) or carfilzomib (Kyprolis). For these people, either Empliciti or Darzalex is used with pomalidomide (Pomalyst) and dexamethasone.

Empliciti is also prescribed for adults who:

  • have had one to three treatments in the past for their multiple myeloma. For these people, Empliciti is used in combination with lenalidomide (Revlimid) and dexamethasone.

Darzalex is also FDA-approved to treat multiple myeloma in adults who have taken one or more treatments in the past. It's recommended for use on its own and in combination with other treatments, based on each person's treatment history.

Drug forms and administration

Empliciti comes as a powder. It's made into a solution and given to you as an intravenous (IV) infusion (an injection into your vein over a period of time). Empliciti is available in two strengths: 300 mg and 400 mg.

Your Empliciti dosage varies depending on your body weight and the other medications that you're taking with Empliciti. For more information on dosages, see the section "Empliciti dosage" above.

Empliciti is usually given weekly for first two cycles (a total of eight weeks) of treatment. After this, you'll get Empliciti every two to four weeks, depending on which drugs you're using with Empliciti. For more information, please see the section "Empliciti dosage" above.

Darzalex comes as a liquid solution. It's also given as an intravenous (IV) infusion. Darzalex is available in two strengths: 100 mg/5 mL and 400 mg/20 mL.

Your Darzalex dosage also depends on your body weight. However, the dosage schedule will differ based on which drugs you're taking with Darzalex.

Darzalex is usually given weekly for six to nine weeks. After this, you'll get Darzalex once every two to four weeks, depending on how long you've been using it.

Side effects and risks

Empliciti and Darzalex both contain medications that target multiple myeloma. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

Your side effects can vary depending on which medications you're taking with Empliciti or Darzalex. Your doctor can describe typical side effects that you may experience depending on which drugs you're taking.

More common side effects

These lists contain examples of more common side effects that can occur with Empliciti, with Darzalex, or with both drugs (when taken individually).

  • Can occur with Empliciti:
    • cataracts (cloudiness in the lens of your eye)
    • pain in your mouth or throat
    • bone pain
  • Can occur with Darzalex:
    • weakness
    • nausea
    • back pain
    • dizziness
    • insomnia (trouble sleeping)
    • increased blood pressure
    • joint pain
  • Can occur with both Empliciti and Darzalex:
    • fatigue (lack of energy)
    • diarrhea
    • constipation
    • decreased appetite
    • fever
    • cough
    • vomiting
    • trouble breathing
    • muscle spasms
    • swelling in your arms or legs
    • increased blood sugar level
    • headache

Serious side effects

These lists contain examples of serious side effects that can occur with Empliciti, with Darzalex, or with both drugs (when taken individually).

  • Can occur with Empliciti:
    • liver problems
    • developing other types of cancer, such as skin cancer
  • Can occur with Darzalex:
  • Can occur with both Empliciti and Darzalex:

Effectiveness

Empliciti and Darzalex are both approved to treat multiple myeloma in adults.

These drugs haven't been directly compared in clinical studies. But separate studies have found both Empliciti and Darzalex to be effective for treating multiple myeloma.

Costs

Empliciti and Darzalex are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Both Empliciti and Darzalex are given as intravenous (IV) infusions at a healthcare facility. The actual amount you'll pay for either medication will depend on your insurance, your location, and the clinic or hospital where you receive your treatments.

You may wonder how Empliciti compares to other medications that are prescribed for similar uses. Here we look at how Empliciti and Ninlaro are alike and different.

Uses

Both Empliciti and Ninlaro are approved by the Food and Drug Administration (FDA) to treat multiple myeloma.

Empliciti is prescribed for people who fit into one of these two treatment situations:

  • Adults who have had one to three treatments in the past for their multiple myeloma. For these people, Empliciti is used in combination with lenalidomide (Revlimid) and dexamethasone.
  • Adults who have had at least two past multiple myeloma treatments that included lenalidomide (Revlimid) and a proteasome inhibitor, such as bortezomib (Velcade) or carfilzomib (Kyprolis). For these people, Empliciti is used in combination with pomalidomide (Pomalyst) and dexamethasone.

Ninlaro is approved to treat multiple myeloma in adults who've tried at least one other treatment in the past. Ninlaro is approved for use in combination with lenalidomide (Revlimid) and dexamethasone.

Drug forms and administration

Empliciti comes as a powder. It's made into a solution and given to you as an intravenous (IV) infusion (an injection into your vein over a period of time). Empliciti is available in two strengths: 300 mg and 400 mg.

Your Empliciti dosage varies depending on your body weight and the other medications that you're taking with Empliciti. For more information on dosages, see the section "Empliciti dosage" above.

Empliciti is usually given weekly for the first two cycles (a total of eight weeks) of treatment. After this, you'll get Empliciti every two to four weeks, depending on which drugs you're using with Empliciti. For more information, please see the section "Empliciti dosage" above.

Ninlaro comes as capsules that are taken by mouth once each week. Ninlaro is available in three strengths:

  • 2.3 mg
  • 3 mg
  • 4 mg

Side effects and risks

Empliciti and Ninlaro both contain medications that help eliminate multiple myeloma cells. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

Ninlaro is only approved for use with lenalidomide (Revlimid) and dexamethasone. In this section, we're comparing the side effects of the Ninlaro treatment combination to the side effects of Empliciti also in combination with lenalidomide (Revlimid) and dexamethasone.

Your side effects can vary depending on which medications you're taking with Empliciti or Ninlaro. Your doctor can describe typical side effects that you may experience depending on which drugs you're taking.

More common side effects

These lists contain examples of more common side effects that can occur with Empliciti, with Ninlaro, or with both drugs (when taken individually).

  • Can occur with Empliciti treatment combination:
    • fatigue (lack of energy)
    • fever
    • cough
    • decreased appetite
    • headache
    • cataracts (cloudiness in the lens of your eye)
    • pain in your mouth
  • Can occur with Ninlaro treatment combination:
    • nausea
    • fluid retention, which may cause swelling
    • back pain
  • Can occur with both Empliciti and Ninlaro treatment combinations:
    • diarrhea
    • constipation
    • vomiting

Serious side effects

These lists contain examples of serious side effects that can occur with Empliciti, with Ninlaro, or with both drugs (when taken individually).

  • Can occur with Empliciti treatment combination:
    • infusion reactions
    • serious infections
    • developing other types of cancer
  • Can occur with Ninlaro treatment combination:
  • Can occur with both Empliciti and Ninlaro treatment combinations:

Effectiveness

Empliciti and Ninlaro are both approved to treat multiple myeloma in adults.

These drugs haven't been directly compared in clinical studies. But separate studies have found both Empliciti and Ninlaro to be effective for treating multiple myeloma.

Costs

Empliciti and Ninlaro are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Empliciti is given as an intravenous (IV) infusion at a healthcare facility. Ninlaro capsules are dispensed by specialty pharmacies. The actual amount you'll pay for either medication depends on your insurance, your location, and whether you receive your treatments at a clinic or hospital.

The Food and Drug Administration (FDA) approves prescription drugs such as Empliciti to treat multiple myeloma. This condition is a type of cancer that affects your plasma cells. These cells are a type of white blood cell that helps your body fight off germs and infections.

With multiple myeloma, your body makes abnormal plasma cells. The abnormal plasma cells, called myeloma cells, crowd out your healthy plasma cells. This means that you have fewer healthy plasma cells that can fight off germs. Myeloma cells also make a protein called M protein. This protein can build up in your body and damage some of your organs.

Empliciti is prescribed for people who fit into one of these two treatment situations:

  • Adults who have had one to three treatments in the past for their multiple myeloma. For these people, Empliciti is used in combination with lenalidomide (Revlimid) and dexamethasone.
  • Adults who have had at least two past multiple myeloma treatments that included lenalidomide (Revlimid) and a proteasome inhibitor, such as bortezomib (Velcade) or carfilzomib (Kyprolis). For these people, Empliciti is used in combination with pomalidomide (Pomalyst) and dexamethasone.

Effectiveness to treat multiple myeloma

Clinical studies have shown that Empliciti is effective at stopping the progression (worsening) of multiple myeloma. Results of some of these studies are described below.

Empliciti with lenalidomide (Revlimid) and dexamethasone

In clinical trials, people with multiple myeloma were given either Empliciti with lenalidomide and dexamethasone, or lenalidomide and dexamethasone alone.

The studies showed that people taking the Empliciti combination had a lower risk for their disease to progress. Over at least two years, those taking Empliciti with lenalidomide and dexamethasone had a 30% lower risk than people who were taking those drugs without Empliciti.

In another study lasting five years, people taking the Empliciti combination had a 27% lower risk of their disease worsening than people taking lenalidomide and dexamethasone alone.

Empliciti with pomalidomide (Pomalyst) and dexamethasone

In clinical trials, people with multiple myeloma were given either Empliciti with pomalidomide and dexamethasone, or pomalidomide and dexamethasone alone.

People taking the Empliciti combination had a 46% lower risk of their disease getting worse after at least nine months of treatment, compared to people taking pomalidomide and dexamethasone alone.

Empliciti is given with other medications when it's used to treat multiple myeloma.

Multiple myeloma medications used with Empliciti

Empliciti is always used in combination with a steroid called dexamethasone. It's also always used in combination with either lenalidomide (Revlimid) or pomalidomide (Pomalyst). Using these medications with Empliciti helps the drug to be more effective in treating multiple myeloma.

Pre-infusion medications used with Empliciti

Before you get your intravenous (IV) infusion of Empliciti, you'll take some drugs called pre-infusion medications. These drugs are used to help prevent side effects (including infusion reactions) caused by Empliciti treatment.

You'll receive the following pre-infusion medications about 45 to 90 minutes before your Empliciti treatment:

  • Dexamethasone. You'll receive 8 mg of dexamethasone by IV injection.
  • Ranitidine (Zantac). You'll receive 50 mg of ranitidine by IV injection or 150 mg of ranitidine by mouth.
  • Diphenhydramine (Benadryl). You'll take 25 mg to 50 mg of diphenhydramine before your Empliciti infusion. Diphenhydramine may be given by intravenous (IV) injection or as a tablet that's taken by mouth.
  • Acetaminophen (Tylenol). You'll also take 650 mg to 1,000 mg of acetaminophen by mouth.

Multiple myeloma is a type of cancer that affects certain white blood cells called plasma cells. These cells help your body fight off germs and infections. Plasma cells that are affected by multiple myeloma become cancerous and are called myeloma cells.

Empliciti works on a different type of white blood cell called a natural killer (NK) cell. NK cells work in your body to kill abnormal cells, such as cancer cells or cells infected with germs.

Empliciti works by activating (turning on) your NK cells. This helps your NK cells find abnormal plasma cells that are affected by multiple myeloma. The NK cells then destroy those abnormal cells. Empliciti also works by finding the myeloma cells for your NK cells.

Empliciti is called an immunotherapy drug. These drugs work with your immune system to help your body fight off certain conditions.

How long does it take to work?

Empliciti begins to work in your body after you've received your first infusion. However, you likely won't notice when Empliciti starts to work. Your doctor will be able to check if it's working by doing certain tests. If you have questions about how well Empliciti is working for you, talk with your doctor.

There aren't any known interactions between Empliciti and alcohol. However, Empliciti can cause liver problems. Drinking alcohol can also worsen your liver function.

Talk with your doctor before drinking alcohol while you're taking Empliciti. They can advise you whether it's safe for you to drink alcohol while you're using this drug.

Empliciti doesn't generally interact with other medications. However, medications that are used with Empliciti are known to interact with other drugs.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Empliciti treatment may also affect the results of certain lab tests.

Empliciti and laboratory tests

Empliciti can affect the results of certain tests that are used to check for M protein in your body. M protein is produced by multiple myeloma cells. A higher level of M protein means that your cancer is more advanced.

Your doctor will order tests to check for M protein in your body during Empliciti treatment. This lets your doctor see how well your body is responding to the drug.

However, Empliciti may alter the results of your M protein blood tests. This can make it difficult for your doctor to know if your multiple myeloma is improving or not. Empliciti may make it look like you have more M protein than you actually do. To work around this, your doctor may order lab tests that aren't affected by Empliciti to monitor your treatment.

Other drug interactions

Empliciti is always taken with dexamethasone and either pomalidomide (Pomalyst) or lenalidomide (Revlimid). While there aren't any known drug interactions with Empliciti, there are known interactions for the drugs it's used with.

Be sure to discuss with your doctor or pharmacist any possible interactions for the combination of drugs that you're taking.

You should take Empliciti according to your doctor or healthcare provider's instructions. Empliciti is given by intravenous (IV) infusion, usually through a vein in your arm. Drugs given by IV infusion are given slowly over a period of time. It may take an hour or more to receive your full dose of Empliciti.

Empliciti is only given at a doctor's office or healthcare clinic. While you're getting your infusion, you'll be monitored for an allergic reaction or infusion reaction.

When to take

Empliciti is given on a 28-day treatment cycle. How often you take the drug depends on the other medications you're taking with Empliciti. The typical schedule for when you'll take Empliciti is as follows:

  • If you're taking Empliciti with lenalidomide (Revlimid) and dexamethasone, you'll receive Empliciti once each week for the first two cycles (a total of eight weeks) of treatment. After that, you'll receive Empliciti once every other week.
  • If you're taking Empliciti with pomalidomide (Pomalyst) and dexamethasone, you'll also receive Empliciti once each week for the first two cycles (a total of eight weeks) of treatment. After that, you'll receive Empliciti once every cycle, which is one dose every four weeks.

Your doctor will monitor your treatment and determine how many total cycles of Empliciti you'll need.

There haven't been any studies of Empliciti in pregnant women. Animal studies in pregnancy also haven't been done yet for this drug.

However, lenalidomide (Revlimid) and pomalidomide (Pomalyst), which are each used with Empliciti, can cause serious harm to a growing fetus. These drugs should never be used during pregnancy. Using these drugs during pregnancy can cause major birth defects or miscarriage.

Because Empliciti is only approved to be used with either lenalidomide (Revlimid) or pomalidomide (Pomalyst), Empliciti should also be avoided during pregnancy. People taking Empliciti should use birth control if needed. See the next section, "Empliciti and birth control," for more details.

If you have questions about using Empliciti during pregnancy, talk with your doctor.

It's not known if Empliciti is safe to take during pregnancy.

However, lenalidomide (Revlimid) and pomalidomide (Pomalyst), which are each used with Empliciti, can cause serious harm to a growing fetus. These drugs should never be used during pregnancy. Because Empliciti is only approved to be used with either lenalidomide or pomalidomide, Empliciti should also be avoided during pregnancy.

Because of this, a special program has been developed to help prevent pregnancy in people using these medications. This program is called the Risk Evaluation and Mitigation Strategy (REMS) program.

Both females and males using Empliciti must agree to and follow the instructions for either the Revlimid REMS or Pomalyst REMS. You'll follow the REMS program for whichever medication you're taking with Empliciti. Each program has certain requirements that must be followed in order to continue taking lenalidomide or pomalidomide.

In addition to requiring people taking Empliciti to use birth control, the REMS program also requires that you:

  • have frequent testing for pregnancy, if you're a female using the drug
  • agree not to donate any blood or sperm while you're using the drug

Birth control for women

If you're a women who's able to become pregnant, you'll need to have two negative pregnancy tests before you start using either lenalidomide or pomalidomide.

While you're taking either of these drugs, you'll need to either use two forms of birth control or abstain from sex during treatment. You should continue using birth control or abstaining from sex for at least four weeks after you've stopped treatment.

Birth control for men

If you're a man taking Empliciti with either lenalidomide or pomalidomide, and you're sexually active with a women who's able to become pregnant, you'll need to use birth control (such as condoms) during treatment. This is important to do even if your partner is using birth control. You should continue using birth control for at least four weeks after you've stopped treatment.

There aren't any studies showing if Empliciti passes into human breast milk or if it causes any effects in a breastfeeding child.

It's also not known if lenalidomide (Revlimid) and pomalidomide (Pomalyst) can cause any effects in children. However, because of the risk of serious side effects in children, breastfeeding should be avoided while taking Empliciti.

Here are answers to some frequently asked questions about Empliciti.

Is Empliciti chemotherapy?

No, Empliciti isn't considered chemotherapy (traditional drugs used to treat cancer). Chemotherapy works by killing cells in your body that are quickly multiplying (making more cells). Although this kills the cancer cells, it can also kill other healthy cells.

Unlike typical chemotherapy, Empliciti is a targeted therapy. This type of drug works on specific cells (called natural killer cells), to target the cancer cells. Because Empliciti targets a special group of cells, it doesn't affect your healthy cells as much. This means it may cause fewer side effects than typical chemotherapy.

What will happen at my Empliciti treatments?

Empliciti is given as an intravenous (IV) infusion (an injection into your vein over a period of time). The IV is usually placed in your arm.

You'll typically receive one dose of Empliciti each week for the first two cycles of treatment. (Each cycle is 28 days.) Then, you might get an infusion once every two weeks or once every four weeks. This part of your dosing schedule depends on which medications you're taking with Empliciti.

The length of time each infusion takes depends on your body weight and how many doses of Empliciti you've already received.

After your second dose of Empliciti, your infusion shouldn't take longer than one hour. It might be helpful to bring something to do during your infusions to make the time pass by more quickly. For example, you might bring a book or magazine to read or music to listen to.

Before getting your Empliciti infusion, you'll get some other drugs to help prevent certain side effects, including an infusion reaction. These drugs are called pre-infusion medications.

The pre-infusion medications that you'll be given before your Empliciti infusion are:

  • diphenhydramine (Benadryl)
  • dexamethasone
  • acetaminophen (Tylenol)
  • ranitidine (Zantac)

How will I know if Empliciti is working for me?

Empliciti works by helping your immune system to fight off multiple myeloma cells. Your doctor can monitor how well your immune system is responding to treatment by ordering a test to check for M proteins.

M proteins are produced by multiple myeloma cells. These proteins can build up in your body and cause damage to some of your organs. A higher level of M protein is seen in people with more advanced multiple myeloma.

Your doctor may check your M protein levels to see how well you're responding to treatment. M protein levels can be tested by checking a blood or urine sample.

Your doctor may also monitor your response to treatment by ordering bone scans. These scans will show if you have certain bone changes caused by multiple myeloma.

Can using Empliciti cause me to have other types of cancer?

It possibly could. Using Empliciti to treat multiple myeloma can increase your risk of having other types of cancer.

In clinical trials, 9% of people taking Empliciti with lenalidomide (Revlimid) and dexamethasone developed another type of cancer. Of people taking only lenalidomide and dexamethasone, 6% had the same result. The types of cancer that developed were skin cancer and solid tumors, such as breast or prostate cancer.

Also in clinical trials, 1.8% of people taking Empliciti with pomalidomide (Pomalyst) and dexamethasone developed another type of cancer. Of people taking pomalidomide and dexamethasone alone, no one developed another type of cancer.

During treatment with Empliciti, your doctor may order extra blood tests or scans to monitor you for any new cancers developing.

Before taking Empliciti, talk with your doctor about your health history. Empliciti may not be right for you if you have certain medical conditions. These include:

  • Pregnancy. It's not known if Empliciti is harmful to a developing fetus. However, Empliciti is used with either lenalidomide (Revlimid) or pomalidomide (Pomalyst). Both of these drugs are known to cause birth defects. Because of this, people taking either lenalidomide or pomalidomide should use birth control to prevent pregnancy while they're using these medications. For more information, please see the section "Empliciti and pregnancy" above.
  • Breastfeeding. It's not known if Empliciti passes into human breastmilk. However, due to the risk of serious side effects in children, breastfeeding should be avoided while taking Empliciti. For more information, please see the section "Empliciti and breastfeeding" above.
  • Current infections. You shouldn't start taking Empliciti if you have an active infection. This includes the common cold, influenza, or other bacterial and viral infections. Your doctor may recommend that you start Empliciti after you've been treated for any infections. This is because Empliciti may weaken your immune system, which makes it harder to fight off the infection.

Note: For more information about the potential negative effects of Empliciti, see the "Empliciti side effects" section above.

The following information is provided for clinicians and other healthcare professionals.

Indications

Empliciti is indicated to treat multiple myeloma in people who fit into one of these two treatment situations:

  • Adults who have previously received one to three therapies. In these people, Empliciti is used with lenalidomide (Revlimid) and dexamethasone.
  • Adults who have already received at least two therapies that included lenalidomide (Revlimid) and any proteasome inhibitor. In these people, Empliciti is used with pomalidomide (Pomalyst) and dexamethasone.

Empliciti is not indicated for use in people younger than 18 years of age.

Mechanism of action

Empliciti is an IgG1 monoclonal antibody that is immunostimulatory. Empliciti works by targeting the Signaling Lymphocytic Activation Molecule Family member 7 (SLAMF7).

SLAMF7 is expressed not only on natural killer (NK) cells and plasma cells in the blood, but also on multiple myeloma cells. Empliciti works by facilitating the destruction of myeloma cells through antibody-dependent cellular cytotoxicity (ADCC). This mechanism works due to the interaction between NK cells and myeloma-infected cells. Some studies show that Empliciti may also help to activate NK cells, which then seek and destroy myeloma cells.

Pharmacokinetics and metabolism

Empliciti clearance increases as body weight increases. Empliciti showed nonlinear pharmacokinetics, where an increase in dose caused larger exposure to the drug than predicted.

Contraindications

Empliciti has no specific contraindications. However, it should be avoided in pregnant women when taken as indicated, which includes the use of pomalidomide or lenalidomide.

Storage

Empliciti is available as either a 300 mg or 400 mg lyophilized powder in a single-use vial. The powder must be reconstituted and diluted before it can be administered.

Empliciti powder should be stored in the refrigerator (at a temperature of 36°F to 46°F/2°C to 8°C) and protected from light. Don't freeze or shake the vials.

Once the powder is reconstituted, the solution must be infused within 24 hours. After mixing, if the infusion is not used right away, it should also be refrigerated protected from light. The Empliciti solution should be kept for a maximum of 8 hours (of the total 24 hours) at room temperature and room light.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.