Pomalyst is a brand-name prescription medication. It’s FDA-approved to treat the following types of cancer in certain situations:*

MM is a kind of cancer that affects blood cells known as plasma cells. KS is a form of cancer that causes growths under your skin, in your mouth, or in other areas of your body.

* For details on these uses, see the “Pomalyst for multiple myeloma” and “Other uses for Pomalyst” sections below.

Drug details

Pomalyst contains the active ingredient pomalidomide. Pomalyst is an immunomodulatory drug. This means that it works to treat cancer by improving your immune system’s ability to fight the growth of cancer. Pomalyst also targets and kills the cancer cells and cuts off their blood supply.

Pomalyst comes as a capsule that you swallow. You’ll likely take it once a day. Pomalyst is available in these strengths: 1 milligram (mg), 2 mg, 3 mg, and 4 mg.

FDA approval

In 2013, the Food and Drug Administration (FDA) first approved Pomalyst to treat MM in certain situations.

Then in 2020, the FDA approved Pomalyst to treat KS in certain situations. For this use, Pomalyst was granted an accelerated approval. This means that the FDA approved the drug before all of the clinical trials had been completed. Accelerated approvals are usually given only to drugs that effectively treat a disease that doesn’t have a lot of other treatment options.

Pomalyst was granted an accelerated approval due to the high overall response rate of people who took the drug in clinical trials. The overall response rate is how many people had either fewer and less severe symptoms of KS after taking Pomalyst, or no symptoms after taking it.

When more clinical trials have been done on Pomalyst and KS, the FDA may give the drug full approval.

Effectiveness

For information on the effectiveness of Pomalyst, see the “Pomalyst for multiple myeloma” and “Other uses for Pomalyst” sections below.

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

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Pomalyst contains the active ingredient pomalidomide.

Pomalyst can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Pomalyst. These lists don’t include all possible side effects.

Pomalyst can be used in certain people with multiple myeloma or Kaposi sarcoma. The side effects listed below may vary depending on what condition you’re taking the drug to treat.

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

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Pomalyst, you can do so through MedWatch.

Mild side effects

Mild side effects of Pomalyst can include:*

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Pomalyst. To learn about other mild side effects, talk with your doctor or pharmacist, or see the Pomalyst Medication Guide.
† For more information on this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Pomalyst aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* For more information on this side effect, see “Side effect details” below.
† Pomalyst has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. For more information on blood clots, see “Blood clots” in the “Side effect details” section below. For more information on birth defects, see the “Pomalyst and pregnancy” section below.)

Side effect details

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

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Pomalyst. 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

Allergic reactions, some of which were serious, have been reported in people taking Pomalyst. However, it’s not known how many people taking Pomalyst had an allergic reaction in clinical studies.

Call your doctor right away if you have a severe allergic reaction to Pomalyst. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Rash

Rash may occur with Pomalyst use. Sometimes the rash can be serious, and in rare cases, even fatal.

Examples of serious rashes that may develop during Pomalyst treatment include:

These conditions can cause fever and peeling or blistering skin. When the skin peels, it can become raw and painful.

If you develop any type of rash while you’re taking Pomalyst, talk with your doctor. They can see if the rash is mild or serious and whether the medication is the cause. Your doctor can also recommend treatments and determine if you should keep taking Pomalyst.

Rash in clinical trials

It’s not known how many people developed SJS, TEN, or DRESS in clinical trials. However, many people did develop rashes while taking this drug, although most weren’t severe.

In clinical trials of people taking Pomalyst, rash occurred in:

Serious rash occurred in:

  • 0% of people taking Pomalyst alone for MM
  • 3.6% of people taking Pomalyst alone for KS
  • 1% to 5% of people taking Pomalyst with low-dose dexamethasone for MM
  • 0% of people taking high-dose dexamethasone alone for MM

In the studies, Pomalyst wasn’t compared with a different drug or a placebo (treatment with no active drug in it).

Blood disorders

Pomalyst may affect the levels of blood cells, causing certain blood disorders, including:

Neutropenia

Neutropenia is the most common blood disorder that occurs in people taking Pomalyst. In clinical trials, neutropenia occurred in:

  • between 53% and 96% of people taking Pomalyst for either multiple myeloma (MM) or Kaposi sarcoma (KS)
  • between 49% and 51% of people taking Pomalyst with low-dose dexamethasone for MM
  • 21% of people taking high-dose dexamethasone alone for MM

In some cases, neutropenia can be severe. In clinical trials, severe neutropenia occurred in:

  • between 48% and 50% of people taking Pomalyst for either MM or KS
  • between 41% and 48% of people taking Pomalyst with low-dose dexamethasone for MM
  • 16% of people taking high-dose dexamethasone alone for MM

Neutropenia is a low level of certain white blood cells known as neutrophils. In some cases, the condition can be dangerous. Your white blood cells are responsible for fighting infections. If the level of white blood cells gets too low, your body may not be able to fight bacteria or viruses that enter it. This means you may have an increased risk for infections. You may also be more tired than usual, or have a fever, sore throat, or diarrhea.

Neutropenia sometimes occurs with a fever. In that case, it’s called febrile neutropenia.

If you develop neutropenia while you’re taking Pomalyst, your doctor may decrease your dose or have you stop taking the medication. Talk with your doctor about the best options for you.

Thrombocytopenia

Thrombocytopenia is another blood disorder that may occur in some people while taking Pomalyst.

In clinical trials, thrombocytopenia occurred in:

  • between 26% and 54% of people taking Pomalyst for either MM or KS
  • between 23% and 30% of people taking Pomalyst along with low-dose dexamethasone for MM
  • 29% of people taking high-dose dexamethasone alone for MM

In clinical trials, severe thrombocytopenia occurred in:

  • 22% of people taking Pomalyst for MM
  • 0% of people taking Pomalyst for KS
  • between 19% and 22% of people taking Pomalyst along with low-dose dexamethasone for MM
  • 26% of people taking high-dose dexamethasone alone for MM

Thrombocytopenia is a low level of platelets in the blood. Platelets are the cells that help your blood clot. If you don’t have enough platelets, you may bleed more easily than usual. You may also develop symptoms such as bruising easily, having frequent nosebleeds, or having blood in your vomit.

If you notice symptoms of thrombocytopenia while taking Pomalyst, talk with your doctor. They’ll probably give you a blood test to see if your platelet levels are too low. Based on the results, they may decrease your dose of Pomalyst or switch your medication.

Anemia

Anemia is another blood disorder that may occur with Pomalyst use. Anemia is low level of red blood cells. A specific part of your red blood cells, called hemoglobin, is responsible for carrying oxygen throughout your body.

In clinical trials, anemia or low hemoglobin levels occurred in:

  • between 38% and 54% of people taking Pomalyst for either MM or KS
  • between less than 5% and 42% of people taking Pomalyst along with low-dose dexamethasone for MM
  • less than 5% of people taking high-dose dexamethasone alone for MM

Anemia was considered severe in:

  • 23% of people taking Pomalyst alone to treat MM
  • 21% of people taking Pomalyst and low-dose dexamethasone for MM

If you have anemia, you may have symptoms such as feeling tired or weak, having a headache or feeling dizzy, and having pale gums or skin.

If you develop symptoms of anemia while you’re taking Pomalyst, talk with your doctor. They may give you a blood test to determine what your blood levels are. Depending on the results, they may decrease your dose or have you stop treatment.

Monitoring your blood levels

Your doctor will monitor your blood levels while you take Pomalyst to see if the medication is affecting them. Your doctor will likely check your levels every week or every 2 weeks for the first 8 to 12 weeks of treatment. After that, you’ll likely be monitored once a month.

Blood clots

Pomalyst can increase the risk of blood clots if you take the drug for multiple myeloma (MM). In fact, Pomalyst has a boxed warning for blood clots. A boxed warning is the most serious warning from the FDA.

In general, having cancer can put you at a higher risk for a blood clot compared with people who don’t have cancer. And there are certain cancers, such as MM, that naturally carry an even greater risk of blood clots than other cancers.

Blood clots that can develop with Pomalyst use include:

  • Deep vein thrombosis. A deep vein thrombosis (DVT) is a blood clot in a leg. Symptoms of a DVT can include pain, redness, and swelling of your leg.
  • Pulmonary embolism. A pulmonary embolism (PE) is a clot in a lung. Symptoms of a PE can include chest pain, trouble breathing, and heart palpitations.
  • Blood clot in the brain. This type of clot may cause a stroke. Symptoms of a stroke can include drooping of one side of the face and sudden numbness or weakness on one side of the body. Another possible symptom is a loss of balance.
  • Blood clot in the heart. This kind of blood clot may cause a heart attack. Symptoms of a heart attack can include chest pain, dizziness, and trouble breathing.

How often blood clots occurred with multiple myeloma

In clinical trials for MM, people took either Pomalyst and low-dose dexamethasone or high-dose dexamethasone alone. The results showed that blood clots occurred in:

  • 8% of people taking Pomalyst and low-dose dexamethasone
  • 3.3% of people taking high-dose dexamethasone

DVTs or PEs occurred in:

  • 4.7% of people taking Pomalyst and low-dose dexamethasone
  • 1.3% of people taking high-dose dexamethasone

Heart attacks or strokes occurred in:

  • 3% of people taking Pomalyst and low-dose dexamethasone
  • 1.3% of people taking high-dose dexamethasone

How often blood clots occurred with Kaposi sarcoma

In a clinical trial of 28 people with Kaposi sarcoma (KS), there were no reports of blood clots. This may be because people with a known risk for blood clots weren’t included. The study was also much smaller than the MM studies. The more people in a study, the more side effects that are likely to be reported.

Even though blood clots weren’t seen in the KS clinical trial, there’s still a risk of developing a clot if you have KS and you take Pomalyst. As more clinical trials are done on Pomalyst and KS, there will be additional information on the risk of developing blood clots.

Risk factors for blood clots

Certain factors can increase your risk for blood clots. These include having high blood pressure, high cholesterol, or a history of blood clots. To learn more, see the “Pomalyst precautions” section below.

When to talk with your doctor

If you develop any symptoms of a blood clot (see above) while taking Pomalyst, call 911 or your local emergency number, or go to the nearest emergency room. A blood clot can be very serious, and in some cases, life threatening. During your Pomalyst treatment, your doctor may have you take a medication to help prevent blood clots.

Due to the many risks involved with the use of Pomalyst, do not donate blood or sperm while taking the drug.

The Pomalyst dosage your doctor prescribes will depend on several factors. These include:

  • the type of the condition you’re using Pomalyst to treat
  • other medical conditions you may have
  • your body’s response to treatment

Typically, your doctor will start you on the usual dosage to treat multiple myeloma (MM) or Kaposi sarcoma (KS). Then they may adjust it over time if you develop side effects from the medication. 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 fit your needs.

Drug forms and strengths

Pomalyst comes as a capsule that you swallow. It’s available in these strengths: 1 milligram (mg), 2 mg, 3 mg, and 4 mg.

Dosage for multiple myeloma

The usual dose of Pomalyst for multiple myeloma (MM) is 4 mg once a day. You’ll likely take this dose on days 1 through 21 of your 28-day treatment cycle. You’ll use Pomalyst along with dexamethasone. Your doctor may have you stop taking Pomalyst if your MM gets worse or if side effects become too bothersome.

Dosage for Kaposi sarcoma

The usual dose of Pomalyst to treat Kaposi sarcoma (KS) is 5 mg once a day. You’ll likely take this dose on days 1 through 21 of your 28 day treatment cycle. Your doctor may have you stop taking Pomalyst if your KS gets worse or if side effects become too bothersome.

If you have AIDS-related KS, you should keep taking your HIV medication while you’re using Pomalyst.

What if I miss a dose?

If you miss a dose of Pomalyst and it’s been less than 12 hours since your missed dose, take the capsule that you missed as soon as possible.

If it’s been more than 12 hours since your missed dose, skip that dose and take your next dose as scheduled. You shouldn’t take two Pomalyst capsules at once to make up for a missed dose.

If you have any questions about when to take your next dose, talk with your doctor or pharmacist.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Pomalyst is meant to be used as a long-term treatment. Your doctor may have you stop taking Pomalyst if your cancer gets worse or you have serious side effects from the drug. (For information on side effects, see the “Pomalyst side effects” section above.)

If you and your doctor determine that Pomalyst is safe and effective for you, you’ll likely take it long term.

The Food and Drug Administration (FDA) approves prescription drugs such as Pomalyst to treat certain conditions.

Pomalyst is approved for use with dexamethasone in certain adults with multiple myeloma (MM). They must have tried at least two other treatments, including:

  • lenalidomide (Revlimid) and
  • a type of medication called a proteasome inhibitor

Before they can take Pomalyst, their MM must have gotten worse while using these drugs or within 60 days of stopping their use.

MM is a type of type of cancer that affects blood cells called plasma cells. These plasma cells are created in bone marrow. Symptoms of MM can include bleeding more easily than usual and having a weakened immune system. (Your immune system is your body’s defense against infection.)

Effectiveness for multiple myeloma

Pomalyst is an effective medication to treat MM.

In clinical trials, people with MM were given Pomalyst alone, Pomalyst with low-dose dexamethasone, or high-dose dexamethasone alone. At the end of the study, researchers looked at the overall response rate. This rate was the percentage of people who had either fewer and less severe symptoms of MM, or no symptoms of MM.

The results showed that the overall response rates were:

  • 7.4% of people who took Pomalyst alone
  • 23.5% to 29.2% in people who took Pomalyst with low-dose dexamethasone
  • 3.9% of people who took high-dose dexamethasone alone

In addition to the use listed above, Pomalyst may be used for other purposes. Below is information on other possible uses for Pomalyst.

Pomalyst for AIDS-related Kaposi sarcoma

Pomalyst is FDA-approved to treat AIDS-related Kaposi sarcoma (KS) in certain adults.* They must have already tried highly active antiretroviral therapy that didn’t work to treat KS.

KS is a kind of cancer that causes growths to occur under the skin, in the mouth, or in other areas of the body. KS occurs only in people who have a virus called human herpesvirus-8. However, most people who have this virus won’t develop KS.

KS typically affects people with weakened immune systems. This can include people with HIV or AIDS, people who have had an organ transplant, and people with another disease that can weaken the immune system.

* Based on early clinical trials, Pomalyst was granted accelerated approval from the FDA for this use. When more clinical trials have been done on Pomalyst and KS, the FDA may give the drug full approval. To learn more, see “FDA approval” in the “What is Pomalyst?” section above.

Effectiveness for AIDS-related Kaposi sarcoma

Pomalyst is an effective medication to treat AIDS-related Kaposi sarcoma.

In clinical trials, an overall response rate was used to determine if Pomalyst was an effective treatment for KS. The overall response rate was the percentage of people who had either fewer and less severe symptoms of KS or no symptoms at all after taking Pomalyst.

The overall response rate was 67% of people who took Pomalyst. Everyone in the study used Pomalyst, which means it wasn’t compared with a different drug or a placebo (treatment with no active drug in it).

Pomalyst for Kaposi sarcoma in people who are HIV-negative

Pomalyst is FDA-approved to treat Kaposi sarcoma (KS) in people who don’t have HIV.* They must have already tried highly active antiretroviral therapy that didn’t work to treat the KS.

KS is a kind of cancer that causes growths to occur under the skin, in the mouth, or in other areas of the body. KS occurs only in people who have a virus called human herpesvirus-8. However, most people who have this virus won’t develop KS.

KS typically affects people with weakened immune systems. This can include people with HIV or AIDS, people who have had an organ transplant, and people with another disease that can weaken the immune system.

* Based on early clinical trials, Pomalyst was granted accelerated approval from the FDA for this use. When more clinical trials have been done on Pomalyst and KS, the FDA may give the drug full approval. To learn more, see “FDA approval” in the “What is Pomalyst?” section above.

Effectiveness for Kaposi sarcoma in people who are HIV-negative

Pomalyst is an effective medication to treat KS in people who are HIV-negative.

In clinical trials, an overall response rate was used to determine if Pomalyst was an effective treatment for KS. The overall response rate was the percentage of people who had either fewer and less severe symptoms of KS or no symptoms at all after taking Pomalyst.

The overall response rate was 80% of people who took Pomalyst. Everyone in the study used Pomalyst, which means it wasn’t compared with a different drug or a placebo (treatment with no active drug in it).

There are no known interactions between Pomalyst and alcohol. However, Pomalyst may cause liver problems, such increased levels of liver enzymes. (For symptoms, see the “Pomalyst side effects” section above.) Alcohol can also cause liver problems, so drinking alcohol while taking Pomalyst may further increase the risk of liver problems.

Before you start Pomalyst treatment, talk with your doctor about how much alcohol is safe for you to drink.

Other drugs are available that can treat your multiple myeloma (MM) or Kaposi sarcoma. Some may be a better fit for you than others. If you’re interested in finding an alternative to Pomalyst, talk with your doctor. They can tell you about other medications that may work well for you.

Alternatives for multiple myeloma

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

Alternatives for Kaposi sarcoma

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

  • paclitaxel
  • doxorubicin liposome (Doxil)
  • vinblastine
  • interferon alfa-2B (Intron A)

You should take Pomalyst according to your doctor’s or healthcare provider’s instructions.

Pomalyst comes as a capsule that you swallow with water.

If you have any questions about the best way to take your medication, talk with your doctor or pharmacist.

When to take

You’ll likely take Pomalyst once a day. Try to take the medication at about the same time each day. This helps make sure that you have the same level of medication in your body at all times.

With a consistent level of Pomalyst in your body, the drug gives your immune system a steadier and more long-lasting boost to fight the cancer cells. This means Pomalyst is more likely to be effective.

In addition, if you take the drug regularly as your doctor prescribes, your body has a better chance of getting used to some side effects more quickly. (For information on side effects, see the “Pomalyst side effects” section above.)

If you don’t take Pomalyst regularly and it looks like the medication isn’t working, your doctor may think it’s due to Pomalyst itself. In this case, they may switch your medication when a change isn’t actually needed.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Pomalyst with food

You can take Pomalyst with or without food.

Can Pomalyst be crushed, split, or chewed?

You should swallow Pomalyst capsules whole. Be sure not to open, crush, split, or chew them. If a capsule does open up and the contents get on your skin, wash the area right away with soap and water. It’s important to avoid touching your eyes and face after coming into contact with a broken capsule. If Pomalyst capsule contents get in your nose or eyes, flush them with water.

There’s no known risk of withdrawal or dependence occurring with Pomalyst use.

Dependence is when you require a drug to live normally. Withdrawal happens when you have dependence on a drug and you stop taking it. Since your body needs the drug to function normally, after you stop taking it, you may have withdrawal symptoms, such as nausea, vomiting, or headache.

Here’s some information on other drugs that Pomalyst may be used with.

Dexamethasone

Pomalyst is approved to treat multiple myeloma (MM) only when it’s used with dexamethasone, a type of steroid.

Clinical trials show that Pomalyst is much more effective when taken with dexamethasone than when taken alone. Researchers used an overall response rate to determine if the medications were working to treat MM. The overall response rate was the percentage of people who had either fewer and less severe symptoms of MM or no symptoms after taking Pomalyst.

The results showed the following overall response rates:

  • 7.4% of people who took Pomalyst alone
  • 23.5% to 29.2% of people who took Pomalyst with low-dose dexamethasone

Because of such differences in overall response rates, the Food and Drug Administration (FDA) approved Pomalyst to be used along with dexamethasone.

Blood thinners

Pomalyst may increase your risk for developing a blood clot if you take the drug for MM. In fact, Pomalyst has a boxed warning for blood clots. A boxed warning is the most serious warning from the FDA. (For more information, see “Blood clots” in the “Pomalyst side effects” section above.)

In general, having cancer can put you at a higher risk for a blood clot compared with people who don’t have cancer. And there are certain cancers, such as MM, that naturally carry an even greater risk of blood clots than other cancers.

To reduce your risk for blood clots during your Pomalyst treatment, your doctor may have you take medication such as a blood thinner.

Your doctor may recommend a blood thinner if you already have a conditions that may increase your risk for blood clots. These include:

For more information on these conditions and Pomalyst, see the “Pomalyst precautions” section below.

Pomalyst can interact with several other medications. It can also interact with certain supplements as well as certain foods.

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

Pomalyst and other medications

Below are medications that can interact with Pomalyst. This section doesn’t contain all drugs that may interact with Pomalyst.

Before taking Pomalyst, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Pomalyst and CYP1A2 inhibitors

Pomalyst is broken down in your body by an enzyme in your liver called CYP1A2. (An enzyme is a protein that aids chemical changes in your body.) Other drugs may block this action, which means your body won’t be able to get rid of Pomalyst as quickly as usual. This can cause you to have too much Pomalyst in your body, which increases your risk for side effects. (For information on side effects, see the “Pomalyst side effects” section above.)

Examples of medications that are CYP1A2 inhibitors are ciprofloxacin (Cipro) and fluvoxamine (Luvox).

You should avoid taking Pomalyst with any medications that are CYP1A2 inhibitors. If you must take Pomalyst with a CYP1A2 inhibitor, your doctor may decrease your dose of Pomalyst to help prevent side effects.

Before you start taking Pomalyst, tell your doctor about any medications you’re taking. They’ll be able to determine if there are any drug interactions between the drugs and Pomalyst.

Pomalyst and pembrolizumab

The use of Pomalyst and dexamethasone along with pembrolizumab (Keytruda) can increase the risk of death. The use of these medications together isn’t recommended.

Before you start Pomalyst treatment, tell your doctor if you’re taking pembrolizumab. If you are, they’ll likely recommend a different medication for you.

Pomalyst and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Pomalyst. However, you should still check with your doctor or pharmacist before using any of these products while taking Pomalyst.

Pomalyst and foods

There aren’t any foods that have been specifically reported to interact with Pomalyst. If you have any questions about eating certain foods with Pomalyst, talk with your doctor.

As with all medications, the cost of Pomalyst can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you’ll have to get Pomalyst at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Pomalyst, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Pomalyst, contact your insurance company.

Financial and insurance assistance

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

Celgene Corporation, the manufacturer of Pomalyst, offers the Celgene Commercial Co-pay Program and Celgene Patient Assistance Program. For more information and to find out if you’re eligible for support, call 800-931-8691 or visit the drug’s website.

Generic version

Pomalyst isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

You may wonder how Pomalyst compares with other medications that are prescribed for similar uses. Here we look at how Pomalyst and Revlimid are alike and different.

Ingredients

The active ingredient in Pomalyst is pomalidomide. The active ingredient in Revlimid is lenalidomide.

Uses

Here’s a list of conditions that the Food and Drug Administration (FDA) has approved Pomalyst and Revlimid to treat.

* For this purpose, Pomalyst is approved for use in people who have tried at least two other treatments, including lenalidomide (Revlimid) and a proteasome inhibitor. The MM must have gotten worse while using these drugs or within 60 days of stopping their use.
† Based on early clinical trials, Pomalyst was granted accelerated approval from the FDA for this use. When more clinical trials have been done on Pomalyst and KS, the FDA may give the drug full approval. To learn more, see “FDA approval” in the “What is Pomalyst?” section above.

Drug forms and administration

Pomalyst and Revlimid both come as capsules that you swallow. Either drug is typically taken once a day.

Side effects and risks

Pomalyst and Revlimid are both used to treat MM. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects. However, Pomalyst and Revlimid are also used for other types of cancer. For those uses, side effects may differ from those listed below.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, or with both Pomalyst and Revlimid (when taken individually).

Serious side effects

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

*Pomalyst has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. For more information on blood clots, see “Blood clots” in the “Pomalyst side effects” section above. For more information on birth defects, see the “Pomalyst and pregnancy” section below.)
† Revlimid has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA.

Effectiveness

Pomalyst and Revlimid have different FDA-approved uses, but they’re both used to treat MM.

These drugs haven’t been directly compared in clinical studies, but studies have found both Pomalyst and Revlimid to be effective for treating MM.

In some cases, people with MM will first take Revlimid. If their MM gets worse while taking the drug or within 60 days of stopping treatment, they may be switched to Pomalyst.

Pomalyst is approved to be used only in people who have tried at least two other treatments, including lenalidomide (Revlimid) and a proteasome inhibitor. The MM must have gotten worse while using these drugs or within 60 days of stopping their use.

Costs

Pomalyst generally costs more than Revlimid. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

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

Like Revlimid (above), the drug Doxil has uses similar to those of Pomalyst. Here’s a comparison of how Pomalyst and Doxil are alike and different.

Ingredients

The active ingredient in Pomalyst is pomalidomide. The active ingredient in Doxil is doxorubicin liposomal.

Uses

Here’s some information on the uses of Pomalyst and Doxil.

Uses of Pomalyst

The Food and Drug Administration (FDA) has approved Pomalyst to treat the following in certain situations:

For details on Pomalyst’s uses in treating these conditions, see the “Pomalyst for the multiple myeloma” and “Other uses for Pomalyst” sections above.

* Based on early clinical trials, Pomalyst was granted accelerated approval from the FDA for this use. When more clinical trials have been done on Pomalyst and KS, the FDA may give the drug full approval. To learn more, see “FDA approval” in the “What is Pomalyst?” section above.

Uses of Doxil

The FDA has approved Doxil to treat the following in certain situations:

* For this purpose, Doxil is used with bortezomib (Velcade). You must have already tried at least one other medication, but it wasn’t successful in treating MM. You must also not have previously used bortezomib.
† For this purpose, you must have already tried chemotherapy, but it wasn’t successful in treating KS, or you aren’t able to take chemotherapy drugs.

Drug forms and administration

Pomalyst comes as a capsule that you swallow. You’ll likely take it once a day.

Doxil comes as a suspension (a liquid mixture) and is given an intravenous infusion. An infusion is an injection into a vein that’s given over a period of time. Doxil infusions are typically given once every 3 to 4 weeks.

Side effects and risks

Pomalyst and Doxil both treat MM and KS. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, or with both Pomalyst and Doxil (when taken individually).

Serious side effects

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

* Pomalyst has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. For more information on blood clots, see “Blood clots” in the “Pomalyst side effects” section above. For more information on birth defects, see the “Pomalyst and pregnancy” section below.)
† Doxil has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA.

Effectiveness

Pomalyst and Doxil have different FDA-approved uses, but they’re both used to treat certain people with multiple myeloma and Kaposi sarcoma.

These drugs haven’t been directly compared in clinical studies, but studies have found both Pomalyst and Doxil to be effective for treating multiple myeloma and Kaposi sarcoma.

Costs

Costs of Pomalyst and Doxil may vary depending on your treatment plan. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

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

Pomalyst is approved to treat multiple myeloma (MM) and Kaposi sarcoma (KS) in certain situations.

MM is a type of type of cancer that affects blood cells called plasma cells. These plasma cells are created in bone marrow.

KS is a kind of cancer that causes growths to occur under the skin, in the mouth, or in other areas of the body. KS occurs only in people who have a virus called human herpesvirus-8. However, most people who have this virus won’t develop KS.

Cancer occurs when cells grow out of control. With both MM and KS, the cell growth leads to the formation of tumors (masses of cancerous tissue).

Pomalyst works in multiple ways to fight your cancer. First, it boosts your immune system (your body’s defense against infection). This helps your body recognize the cancer cells as threats and fight them. Pomalyst also actively finds and kills cancer cells. In addition, the drug decreases the reproduction level of new cancer cells. Pomalyst does this by blocking the blood supply that cancer cells need to grow.

How long does it take to work?

Pomalyst will begin working after your first dose. However, you may not notice effects of treatment right away. This is because it may take time for your cancer to improve enough where you notice a decrease in your symptoms.

You shouldn’t take Pomalyst while pregnant or if you’re planning to become pregnant. Pomalyst is similar to a drug called thalidomide, which can frequently cause severe birth defects. These birth defects can often be life threatening to the fetus.

In fact, Pomalyst has a boxed warning for birth defects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). The warning alerts doctors and patients about drug effects that may be dangerous.

Birth defects that occurred in children whose mothers took Pomalyst included missing or shortened limbs, heart defects, and eye problems.

REMS program

Because of the possible risks of taking Pomalyst during pregnancy, you, your doctor, and the pharmacy where you get Pomalyst must be enrolled in a program called REMS. It stands for Risk Evaluation and Mitigation Strategy. This program requires you to follow birth control guidelines to prevent pregnancy.

You should avoid becoming pregnant:

  • 4 weeks before starting Pomalyst treatment
  • while taking the drug
  • at least 4 weeks after stopping treatment with Pomalyst

Pregnancy tests

Your doctor will give you pregnancy tests before and throughout your Pomalyst treatment.

Before you can start using Pomalyst, you’ll need to take two pregnancy tests that must be negative. You’ll have the first test within 10 to 14 days of starting treatment. You’ll have the second one within 24 hours before you start taking Pomalyst.

During your treatment with Pomalyst, you’ll need to take pregnancy tests each week during the first month. After that, you’ll take a pregnancy test each month. If you have an irregular period, your doctor may recommend a pregnancy test every 2 weeks. If you miss your period or have any changes in bleeding, your doctor will give you another pregnancy test to rule out pregnancy.

For information on how to avoid becoming pregnant, see the “Pomalyst and birth control” section below.

Pregnancy registry

If you become pregnant while you’re taking Pomalyst, your doctor may recommend that you report the pregnancy to the Pomalyst pregnancy registry.

The purpose of a pregnancy registry is to collect information on people who have taken Pomalyst while pregnant. The registry looks at what side effects occurred. The registry also looks at how the pregnancy happened because you’re required to use two forms of birth control while taking the drug.

The pregnancy should be reported to an FDA program called MedWatch by completing an online report or calling 800-FDA-1088 (800-332-1088). It should also be reported to the drug manufacturer, Celgene Corporation, at 888-423-5436.

Blood donation

You shouldn’t donate blood while you’re taking Pomalyst. If the donated blood is given to someone who’s pregnant, it could harm the developing fetus.

Pomalyst and fertility

Studies of Pomalyst in humans haven’t showed that the drug affects fertility (the ability to make a person pregnant or the ability to become pregnant). In animal studies, however, female animals given Pomalyst had an increased risk of miscarriage. Fertility in male animals wasn’t affected by the drug. Keep in mind that animal studies don’t always predict what will occur in humans.

If you’re planning to become pregnant in the future, talk with your doctor about whether Pomalyst is the right choice for you.

Talking with your doctor

If you do become pregnant while you’re taking Pomalyst, tell your doctor right away. They’ll likely recommend that you stop Pomalyst treatment.

You shouldn’t take Pomalyst while pregnant or if you’re planning to become pregnant. In fact, Pomalyst has a boxed warning for birth defects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). The warning alerts doctors and patients about drug effects that may be dangerous.

For women using Pomalyst

If you can become pregnant, you should avoid becoming pregnant:

  • 4 weeks before starting Pomalyst treatment
  • while taking the drug
  • at least 4 weeks after stopping treatment with Pomalyst

If you can become pregnant, you’ll need to either abstain from sex with male partners or use two forms of effective birth control while taking Pomalyst.

One form of birth control must be very reliable. Examples include an intrauterine device (IUD), hormonal contraception (such as the patch, injection, pill, or ring), and tubal ligation. The second form of birth control should be a condom, diaphragm, or cervical cap. You should use birth control even if you have a history of infertility.

You should use birth control:

  • 4 weeks before starting Pomalyst treatment
  • while taking the drug
  • at least 4 weeks after stopping treatment with Pomalyst

For men using Pomalyst

Pomalyst is present in the semen of men who take Pomalyst. During sex, the drug could pass from a man to a person who could become pregnant.

If you’re a man taking Pomalyst, you should use a condom any time you have sex with someone who can become pregnant. You should also use condoms for at least 4 weeks after stopping Pomalyst treatment.

You should use condoms even if you’ve had a vasectomy.

Note: You shouldn’t donate sperm while taking Pomalyst.

Talking with your doctor

If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Pomalyst.

For more information about taking Pomalyst during pregnancy, see the “Pomalyst and pregnancy” section above.

You shouldn’t breastfeed while you’re taking Pomalyst. This is because it’s not known if Pomalyst is present in human breast milk or if the drug has a harmful effect on a breastfed child.

In animal studies, Pomalyst was present in the milk of animals given the drug while pregnant. However, animal studies don’t always show what will happen in humans.

If you’re breastfeeding or plan to breastfeed, talk with your doctor before taking Pomalyst. They can suggest treatments other than Pomalyst, or recommend other healthy ways to feed your child.

Here are answers to some frequently asked questions about Pomalyst.

Does Pomalyst cause hair loss?

No, hair loss isn’t a side effect that was seen in clinical trials of people taking Pomalyst.

Pomalyst is a chemotherapy drug, and chemotherapy drugs sometimes cause you to lose your hair. But Pomalyst shouldn’t cause hair loss.

If you’re taking Pomalyst for multiple myeloma, you’ll also take dexamethasone. Your hair may become thinner than usual because of the dexamethasone.

If you’re concerned about thinning hair while taking Pomalyst, talk with your doctor. They may be able to recommend ways to help.

What is the safest way to handle Pomalyst?

The safest way to handle Pomalyst is to keep the capsules intact. You shouldn’t open, crush, or chew them.

If the capsule does open and the contents get on your skin, wash the area right away with soap and water. It’s important to avoid touching your eyes and face after coming into contact with a broken capsule. If the contents of a Pomalyst capsule get in nose or eyes, flush them with water.

If you have any questions about how to handle Pomalyst, talk with your doctor or pharmacist.

Is Pomalyst chemotherapy?

Yes, Pomalyst is a chemotherapy drug. It’s used for types of cancer called multiple myeloma and Kaposi sarcoma in certain situations. Chemotherapy drugs work to kill cancer cells that are multiplying and stop them from growing.

Can I use Pomalyst if I smoke?

Possibly. Whether or not you can take Pomalyst may depend on how often you smoke and other risk factors that you may have.

Pomalyst can affect your lungs and cause trouble breathing, shortness of breath, and cough. Smoking can make these side effects worse.

Pomalyst can also cause a serious condition called tumor lysis syndrome. If you have high blood pressure or other heart problems, smoking and using Pomalyst can worsen the side effects of tumor lysis syndrome.

Pomalyst is broken down in your body by a protein in your liver called CYP1A2. Smoking causes this protein to work faster than normal, which causes Pomalyst to break down more quickly than usual. This means you may not have enough of the drug in your body for it to work properly, and it may not treat your cancer.

In addition, smoking can increase your risk for developing a blood clot. Pomalyst can also raise the risk for blood clots if you take the drug for multiple myeloma.* Having HIV and taking HIV medications also increases your risk for blood clots. If you smoke while taking Pomalyst, the risk may be even higher. If possible, try to smoke less or quit smoking during your Pomalyst treatment.

If you smoke, talk with your doctor before you start taking Pomalyst. They can advise you on whether you can keep smoking during treatment and recommend ways to stop smoking.

* Pomalyst has a boxed warning for blood clots. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information on blood clots, see “Blood clots” in the “Pomalyst side effects” section above.

Do I need to adjust my Pomalyst schedule when I have hemodialysis?

You may need to adjust your Pomalyst schedule. On days when you have hemodialysis, you should take your dose of Pomalyst after you finish hemodialysis.

Hemodialysis filters your blood through a machine, and during the process, Pomalyst is removed from your blood. If you take your Pomalyst dose before hemodialysis, the medication won’t stay in your blood and be able to treat your cancer.

If you’re taking Pomalyst and have questions about when to time your doses, talk with your doctor. If you haven’t started Pomalyst treatment and are getting hemodialysis, ask your doctor if Pomalyst is the right choice for you.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Birth defects

You shouldn’t take Pomalyst if you’re pregnant. Pomalyst is similar to a drug called thalidomide, which can frequently cause severe birth defects. These birth defects can often be life threatening to a fetus. If you can become pregnant, your doctor will make sure you’re not pregnant before you start taking Pomalyst. You’ll also need to use two forms of birth control.

Because of the possible risks during pregnancy, you, your doctor, and the pharmacy where you get Pomalyst must all be enrolled in a program called REMS. It stands for Risk Evaluation and Mitigation Strategy. For more information, see the “Pomalyst and pregnancy” and “Pomalyst and birth control” sections above.

Blood clots

Pomalyst can increase the risk for blood clots if you take the drug for multiple myeloma. These blood clots include deep vein thrombosis (DVT) and pulmonary embolism (PE). DVTs occur in the legs, and PEs occur in the lungs. Pomalyst can also lead to blood clots in the brain, which can cause a stroke, or clots in the heart, which can cause a heart attack. During your Pomalyst treatment, your doctor may have you take a medication to help prevent blood clots.

Other precautions

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

  • Smoking. Smoking may make Pomalyst less effective in treating your cancer. Smoking may also increase your risk for developing a blood clot, which can be very serious. If you smoke, be sure to talk with your doctor before taking Pomalyst. They may want you to smoke less or quit smoking during treatment. (To learn more, see “Can use Pomalyst if I smoke?” in the “Common questions about Pomalyst” section above.)
  • Liver problems. Pomalyst is broken down by proteins in your liver. If your liver isn’t working properly, the drug may build up to a dangerous level in your body. Pomalyst may also cause liver problems, such as liver failure, to occur. If you already have liver problems, taking Pomalyst may make these issues worse. Before taking Pomalyst, talk with your doctor about any liver problems you have. They can advise you on whether the drug is still an option for you.
  • Kidney problems and hemodialysis. Pomalyst is typically removed from the blood during hemodialysis. If you have kidney problems and are getting hemodialysis, talk with your doctor before taking Pomalyst. They can let you know if the medication is a good choice for you and when to take your dose of Pomalyst. (To learn more, see “Do I need to adjust my Pomalyst schedule when I have hemodialysis?” in the “Common questions about Pomalyst” section above.)
  • History of blood clots. Pomalyst may increase the risk of blood clots if you take the drug for MM. If you’ve had blood clots in the past and take Pomalyst for MM, the risk is increased further. Before you take Pomalyst, tell your doctor if you have a history of blood clots. They may recommend that you take a blood thinner to help prevent clots during your treatment.(For more about blood clots, see “Blood clots” in the “Pomalyst side effects” section above.)
  • High blood pressure. Having high blood pressure may increase your risk for blood clots. Pomalyst may also increase the risk for blood clots if you take the drug for MM. If you have high blood pressure and take Pomalyst for MM, the risk is increased further. Before you take Pomalyst, tell your doctor if you have high blood pressure. They may recommend that you take a blood thinner to help prevent clots during your treatment. (For more about blood clots, see “Blood clots” in the “Pomalyst side effects” section above.)
  • High cholesterol. Having high cholesterol may increase your risk for blood clots. Pomalyst may also increase the risk for blood clots if you take the drug for MM. If you have high cholesterol and take Pomalyst for MM, the risk is increased further. Before you take Pomalyst, tell your doctor if you have high cholesterol. They may recommend that you take a blood thinner to help prevent clots during your treatment. (For more about blood clots, see “Blood clots” in the “Pomalyst side effects” section above.)
  • Allergic reaction. If you’ve had an allergic reaction to Pomalyst or any of its ingredients, you shouldn’t take Pomalyst. Ask your doctor what other medications are better options for you.
  • Pregnancy. You shouldn’t take Pomalyst if you’re pregnant. For more information, see the “Pomalyst and pregnancy” section above.
  • Breastfeeding. You shouldn’t breastfeed while you’re taking Pomalyst. It’s not known if the drug is safe to use while breastfeeding. For more information, see the “Pomalyst and breastfeeding” section above.

Note: For more information about the potential negative effects of Pomalyst, see the “Pomalyst side effects” section above.

Using more than the recommended dosage of Pomalyst can lead to serious side effects.

Do not use more Pomalyst than your doctor recommends. It’s not known what symptoms you may experience if you take too much Pomalyst.

What to do in case you take too much Pomalyst

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Pomalyst from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

You should store Pomalyst capsules at room temperature (68°F to 77°F/20°C to 25°C) in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms. In some cases, for a short period of time, you can keep Pomalyst at 59°F to 86°F (15°C to 30°C).

Disposal

If you no longer need to take Pomalyst and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

Pomalyst is considered to be a medication that may be hazardous. Because of this, you may be able to return any unused capsules to your doctor’s office or to the drug manufacturer. This allows them to dispose of Pomalyst properly. Talk with your doctor if you have questions about how to dispose of leftover Pomalyst.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

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

Indications

Pomalyst is indicated for use in adults with:

  • Multiple myeloma (MM) who have tried at least two treatments, including lenalidomide (Revlimid) and a proteasome inhibitor, and still had progression of disease during or within 60 days of stopping treatment with these medications. In this case, Pomalyst will be used along with dexamethasone.
  • AIDS-related Kaposi sarcoma (KS) after trying and failing highly active antiretroviral therapy.
  • KS who are HIV-negative.

Administration

Pomalyst is a tablet that is taken orally, usually on days 1 through 21 of a 28-day cycle. It should be administered until the disease worsens.

Mechanism of action

Pomalyst is a thalidomide derivative that works in multiple ways to treat cancer. The drug blocks angiogenesis and cancer cell growth, essentially starving off growing cancer cells. Pomalyst also is an immunomodulatory drug. In addition, it is an antineoplastic drug, which blocks the reproduction of cancer cells.

Pomalyst also works to block reproduction and kill lenalidomide-resistant MM. In addition, Pomalyst also stimulates the immune system, causing an increase in cell-mediated immunity via T-cells and natural killer cells. This also causes a decreased level of inflammatory cytokines, which normally contribute to the cancer growth.

Pharmacokinetics and metabolism

After a dose of Pomalyst, plasma concentrations of the drug are at their maximum at about 2 to 3 hours post-dose. It has a volume of distribution between 62 liters (L) and 138 L once the medication has reached steady state. Pomalyst is between 12% and 44% protein-bound. It is a substrate of the plasma membrane protein p-glycoprotein.

The medication is mainly metabolized hepatically, via CYP1A2 and CYP3A4. Pomalyst is cleared at a rate of between 7 L to 10 L per hour. It has a half-life of about 7.5 hours in patients with MM or KS.

The drug is mainly (73%) eliminated through urination, and 15% is eliminated through the fecal route.

Contraindications

Pomalyst is contraindicated in patients who are:

  • pregnant
  • have an allergy to Pomalyst or any of the ingredients in the drug

Storage

Pomalyst capsules should be stored at room temperature (68°F to 77°F/20°C to 25°C) in a tightly sealed container away from light and moisture. Brief deviations are allowed at 59°F to 86°F (15°C to 30°C).

Pomalyst capsules are considered hazardous. They should not be opened, crushed, or chewed. If the capsule does open up and gets onto the skin, wash the area right away with soap and water. If Pomalyst capsule contents enter the nose or eyes, they should be flushed with water.

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.

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