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POMALYST® (pomalidomide) is a prescription medicine, taken along with the medicine dexamethasone, used to treat people with multiple myeloma who have previously received at least 2 medicines to treat multiple myeloma, including a proteasome inhibitor and lenalidomide, and whose disease has become worse during treatment or within 60 days of finishing the last treatment. It is not known if POMALYST is safe and effective in children.

COMBINATION THERAPIES

POMALYST is used in FDA-approved
therapy combinations to treat multiple
myeloma

POMALYST + dexamethasone + elotuzumab

Information about POMALYST + dexamethasone + elotuzumab does not appear in the POMALYST full Prescribing Information. Please talk to your doctor and/or see the elotuzumab full Prescribing Information for a complete discussion of Important Safety Information at www.empliciti.com.

 

Indication and Usage

Elotuzumab is a prescription medicine used, in combination with POMALYST and dexamethasone, to treat multiple myeloma in adults who have received at least two prior treatments including lenalidomide and a proteasome inhibitor.

It is not known if elotuzumab is safe and effective in children.

 

Most common adverse reactions (20% or higher)

The most common side effects of POMALYST + dexamethasone + elotuzumab were constipation and high blood sugar.

The most common treatment-related changes to blood levels with POMALYST + dexamethasone + elotuzumab were low lymphocytes, low white blood cells, low platelets, low albumin, low calcium, high blood sugars, low sodium, and low potassium. The most common changes to vital signs with POMALYST + dexamethasone + elotuzumab (≥20%) were increased heart rate (≥100 beats per minute) and decreased heart rate (<60 beats per minute).*

 

These are not all of the possible side effects of POMALYST + dexamethasone + elotuzumab. Talk to your healthcare provider to learn more.

 

Serious side effects of elotuzumab

Elotuzumab may cause serious side effects, including infusion reactions, infections, developing new cancers (malignancies), and liver problems.

These are not all of the possible side effects of elotuzumab. If you have questions, talk to your healthcare provider to learn more.

 

Serious side effects of POMALYST + dexamethasone

Serious side effects include possible birth defects (deformed babies) or death of an unborn baby; blood clots in your arteries, veins and lungs; heart attack and stroke; low white blood cells, low platelets, and low red blood cells; severe liver problems, including liver failure and death; severe allergic reactions and severe skin reactions; dizziness and confusion; nerve damage; risk of new cancers (malignancies); tumor lysis syndrome (TLS).

*Patients experienced these side effects at a 5% or greater rate than patients who received POMALYST + dexamethasone alone.

Important Safety Information for elotuzumab

Elotuzumab in combination with POMALYST® (pomalidomide) and dexamethasone may cause the following serious side effects: Infusion reactions, infections, risk of developing new cancers (malignancies), and liver problems. There are also other serious risks associated with POMALYST to females and males of reproductive potential, including possible serious birth defects or death of an unborn baby, and specific requirements regarding birth control, pregnancy testing and blood and/or sperm donation. For more information, please read the Important Facts on www.empliciti.com. Your healthcare team will work with you to manage any side effects you may experience throughout your treatment with elotuzumab.

This is a summary of important information that you need to know about elotuzumab. Your healthcare team can work with you to help answer any questions you may have about elotuzumab.

What should I discuss with my healthcare team before starting elotuzumab?

Talk to your healthcare team about all of your medical conditions, including if you have an infection.

Let your healthcare team know as soon as possible if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if elotuzumab can harm an unborn baby. However, POMALYST may cause birth defects or death of an unborn baby. It is not known if elotuzumab passes into breastmilk. You should not breastfeed during treatment with elotuzumab + POMALYST + dexamethasone.

Before receiving elotuzumab + POMALYST + dexamethasone, females and males must agree to the instructions in the POMALYST REMS® program. The program has specific requirements about birth control (contraception), pregnancy testing, blood donation, and sperm donation that you need to know.

Talk to your healthcare team to learn more about POMALYST.

Interactions with other drugs may affect the way elotuzumab works in your body. Talk to your healthcare team about all the medicines you take, including:

  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements

Elotuzumab may cause serious side effects, including:

  • Infusion reactions. Infusion reactions can happen during your infusion or within 24 hours after your infusion of elotuzumab. Your healthcare provider will give you medicines before each infusion of elotuzumab to help reduce the risk of an infusion reaction. If you have an infusion reaction while receiving elotuzumab, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your healthcare provider may stop your treatment completely. Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with elotuzumab:
    • fever
    • chills
    • rash
    • chest pain
    • trouble breathing
    • dizziness
    • light-headedness
  • Infections. People with multiple myeloma who receive elotuzumab with POMALYST and dexamethasone may develop infections that can be serious. Tell your healthcare provider right away if you have any signs and symptoms of an infection, including:

    • fever
    • flu-like symptoms
    • cough
    • shortness of breath
    • burning with urination
    • a painful skin rash
  • Risk of new cancers (malignancies). People with multiple myeloma who receive elotuzumab with POMALYST and dexamethasone have a risk of developing new cancers. Talk with your healthcare provider about your risk of developing new cancers if you receive elotuzumab. Your healthcare provider will check you for new cancers during your treatment with elotuzumab.

  • Liver problems. Elotuzumab may cause liver problems. Your healthcare provider will do blood tests to check your liver during treatment with elotuzumab. Tell your healthcare provider if you have signs and symptoms of liver problems, including: tiredness, weakness, loss of appetite, yellowing of your skin or eyes, color changes in your stools, confusion, or swelling of the stomach area.

The most common side effects of elotuzumab when used with POMALYST + dexamethasone include:

  • constipation
  • high blood sugar

These are not all of the possible side effects of elotuzumab. You can report any side effects to the FDA by calling 1-800-FDA-1088.

POMALYST + dexamethasone + daratumumab

Information about POMALYST + dexamethasone + daratumumab does not appear in the POMALYST full Prescribing Information. Please talk to your doctor and/or see the daratumumab full Prescribing Information for a complete discussion of Important Safety Information at www.darzalex.com.

 

Indication and Usage

Daratumumab is a prescription medicine used, in combination with POMALYST and dexamethasone, to treat multiple myeloma in people who have received at least two prior medicines, including lenalidomide and a proteasome inhibitor.

It is not known if daratumumab is safe and effective in children.

Most common adverse reactions (20% or higher)

The most frequent adverse reactions with POMALYST + dexamethasone + daratumumab were low white blood cell count, low platelet count, low red blood cell count, infusion reactions, fatigue, upper respiratory tract infection, cough, diarrhea, constipation, shortness of breath, nausea, muscle spasms, fever, back pain, insomnia, joint pain, vomiting, dizziness, and chills.

 

The most common treatment-related changes to blood levels with POMALYST + dexamethasone + daratumumab were low red blood cells, low platelets, low neutrophils, and low lymphocytes.

 

Serious side effects of daratumumab

Daratumumab may cause serious side effects, including infusion reaction, changes in blood tests, and decreases in blood cell counts.

 

These are not all of the possible side effects of daratumumab. If you have questions, talk to your healthcare provider to learn more.

 

Serious side effects of POMALYST + dexamethasone

Serious side effects include possible birth defects (deformed babies) or death or an unborn baby; blood clots in your arteries, veins and lungs; heart attack and stroke; low white blood cells, low platelets, low red blood cells; severe liver problems, including liver failure and death; severe allergic reactions and severe skin reactions; dizziness and confusion; nerve damage; risk of new cancers (malignancies); tumor lysis syndrome (TLS).

Important Safety Information for daratumumab

Do not receive daratumumab if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in daratumumab.

What should I tell my healthcare provider before taking daratumumab?

Before you receive daratumumab, tell your healthcare provider about all of your medical conditions, including if you:

Before you receive daratumumab, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of breathing problems
  • have had shingles (herpes zoster)
  • are pregnant or plan to become pregnant. daratumumab may harm your unborn baby
    • Females who are able to become pregnant should use an effective method of birth control during treatment and for at least 3 months after your final dose of daratumumab. Talk to your healthcare provider about birth control methods that you can use during this time
  • are breastfeeding or plan to breastfeed. It is not known if daratumumab passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of daratumumab?

Daratumumab may cause serious reactions, including:

Infusion reactions. Infusion reactions are common with daratumumab and can be severe or serious. Your healthcare provider may temporarily stop your infusion or completely stop treatment with daratumumab if you have infusion reactions. Get medical help right away if you get any of the following symptoms:

    • shortness of breath or trouble breathing
    • dizziness or lightheadedness (hypotension)
    • cough
    • wheezing
    • throat tightness
    • runny or stuffy nose
    • headache
    • itching
    • nausea
    • vomiting
    • chills
    • fever
  • Changes in blood tests. daratumumab can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose of daratumumab. Your healthcare provider will do blood tests to match your blood type before you start treatment with daratumumab. Tell all of your healthcare providers that you are being treated with daratumumab before receiving blood transfusions.

  • Decreases in blood cell counts. daratumumab can decrease white blood cell counts, which help fight infections, and blood cells called platelets, which help to clot blood. Your healthcare provider will check your blood cell counts during treatment with daratumumab. Tell your healthcare provider if you develop fever or have signs of bruising or bleeding.

The most common side effects of daratumumab include:

  • tiredness
  • nausea
  • diarrhea
  • shortness of breath
  • trouble sleeping
  • feeling weak
  • decreased appetite
  • fever
  • cough
  • muscle spasms
  • back pain
  • joint pain
  • vomiting
  • bronchitis
  • cold-like symptoms (upper respiratory infection)
  • nerve damage causing tingling, numbness or pain
  • swollen hands, ankles or feet
  • constipation
  • chills
  • dizziness
  • lung infection (pneumonia)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of daratumumab. Call your doctor for medical advice about side effects. You can report any side effects to the FDA by calling 1-800-FDA-1088.

What is POMALYST® (pomalidomide)?

POMALYST® (pomalidomide) is a prescription medicine, taken along with the medicine dexamethasone, used to treat people with multiple myeloma who have previously received at least 2 medicines to treat multiple myeloma, including a proteasome inhibitor and lenalidomide, and whose disease has become worse during treatment or within 60 days of finishing the last treatment. It is not known if POMALYST is safe and effective in children.

WARNING: Risk to unborn babies, risk of low blood counts and blood clots
What is the most important information I should know about POMALYST?

Before you begin taking POMALYST, you must read and agree to all of the instructions in the POMALYST REMS® program. Before prescribing POMALYST, your healthcare provider (HCP) will explain the POMALYST REMS program to you and have you sign the Patient-Physician Agreement Form.

POMALYST can cause serious side effects, including:

  • Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or plan to become pregnant must not take POMALYST.
    • POMALYST is similar to the medicine thalidomide (THALOMID®), which is known to cause severe life-threatening birth defects. POMALYST has not been tested in pregnant females. POMALYST has harmed unborn animals in animal testing.
    • Females must not get pregnant:
      • For at least 4 weeks before starting POMALYST
      • While taking POMALYST
      • During any breaks (interruptions) in your treatment with POMALYST
      • For at least 4 weeks after stopping POMALYST
    • Females who can become pregnant:
      • Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.
      • Must agree to use 2 acceptable forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in treatment, and for at least 4 weeks after stopping POMALYST.
      • Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during and after treatment with POMALYST.
    • If you become pregnant while taking POMALYST, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Celgene Customer Care Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to:

      • FDA MedWatch at 1-800-FDA-1088
      • Celgene Corporation at 1-888-423-5436

      There is a pregnancy exposure registry that monitors the outcomes of females who take POMALYST during pregnancy, or if their male partner takes POMALYST and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation at the phone number listed above.

    • POMALYST can pass into human semen:

      • Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking POMALYST, during any breaks (interruptions) in your treatment with POMALYST, and for 4 weeks after stopping POMALYST.
      • Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.
      • Do not donate sperm while taking POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If a female becomes pregnant with your sperm, the baby may be exposed to POMALYST and may be born with birth defects.

      Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

    • Do not donate blood while you take POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If someone who is pregnant gets your donated blood, her baby may be exposed to POMALYST and may be born with birth defects.

  • Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take POMALYST.

    • Most people who take POMALYST will also take a blood thinner medicine to help prevent blood clots.
    • Before taking POMALYST, tell your healthcare provider:
      • If you have had a blood clot in the past.
      • If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia).
      • About all the medicines you take. Certain other medicines can also increase your risk for blood clots.

Call your healthcare provider or get medical help right away if you get any of the following during treatment with POMALYST:

    • Signs or symptoms of a blood clot in the lung, arm, or leg may include: shortness of breath, chest pain, or arm or leg swelling.

    • Signs or symptoms of a heart attack may include: chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen); feeling sweaty, shortness of breath, feeling sick, or vomiting.

    • Signs or symptoms of stroke may include: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance.

    • A red, itchy skin rash
    • Peeling of your skin or blisters
    • Severe itching
    • Fever

 

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with POMALYST:

  • swelling of your lips, mouth, tongue, or throat
  • trouble breathing or swallowing
  • raised red areas on your skin (hives)
  • a very fast heartbeat
  • You feel dizzy or faint
Who should not take POMALYST?

Do not take POMALYST if you:

  • Are pregnant, plan to become pregnant, or become pregnant during treatment with POMALYST. See “What is the most important information I should know about POMALYST?”
  • Are allergic to pomalidomide or any of the ingredients in POMALYST.
What should I tell my healthcare provider (HCP) before taking POMALYST?
  • If you smoke cigarettes (POMALYST may not work as well in people who smoke), have any other medical conditions, or are breastfeeding. Do not breastfeed during treatment with POMALYST—it is not known if POMALYST passes into breast milk and can harm the baby.
  • If you have liver problems
  • If you have kidney problems and are receiving hemodialysis treatment
  • Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. POMALYST and other medicines may affect each other, causing serious side effects. Talk with your HCP before taking any new medicines.
How should I take POMALYST?

Take POMALYST exactly as prescribed and follow all the instructions of the POMALYST REMS program.

  • Swallow POMALYST capsules whole with water 1 time a day. Do not break, chew, or open capsules.
  • Take POMALYST at the same time each day with or without food.
  • If you are on hemodialysis, take POMALYST after hemodialysis on hemodialysis days.
  • Do not open POMALYST capsules or handle them any more than needed. If you touch a broken POMALYST capsule or the medicine in the capsule, wash the area of your body right away with soap and water.
  • If you miss a dose of POMALYST and it has been less than 12 hours since your regular time, take POMALYST as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.
  • If you take too much POMALYST, call your healthcare provider (HCP) right away.
  • Do not share POMALYST with other people. It may cause birth defects and other serious problems.
What are the possible side effects of POMALYST?
  • See “What is the most important information I should know about POMALYST?”
  • POMALYST can cause serious side effects, including:
    • Low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia) are common with POMALYST, but can also be serious. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your blood counts should be checked by your healthcare provider (HCP) weekly for the first 8 weeks of treatment and monthly after that.
    • Severe liver problems, including liver failure and death. Your HCP should do blood tests to check your liver function during your treatment with POMALYST. Tell your HCP right away if you develop any of the following symptoms: yellowing of your skin or the white parts of your eyes (jaundice); dark or brown (tea-colored) urine; pain on the upper right side of your stomach area (abdomen); bleeding or bruising more easily than normal, or feeling very tired.
    • Severe allergic and severe skin reactions can happen with POMALYST and may cause death.
    • Dizziness and confusion. Avoid taking other medicines that may cause dizziness and confusion during treatment with POMALYST. Avoid situations that require you to be alert until you know how POMALYST affects you.
    • Nerve damage. Stop taking POMALYST and call your HCP if you develop numbness, tingling, pain, or a burning sensation in your hands, legs, or feet.
    • New cancers (malignancies). New cancers, including certain blood cancers (acute myelogenous leukemia or AML) have been seen in people who received POMALYST. Talk with your HCP about your risk.
    • Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your HCP may do blood tests to check you for TLS.
  • The most common side effects of POMALYST include tiredness, weakness, constipation, nausea, diarrhea, shortness of breath, upper respiratory tract infection, back pain, and fever.
  • These are not all the possible side effects of POMALYST. Your HCP may tell you to stop taking POMALYST if you develop certain serious side effects during treatment. Call your HCP for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.