Provenge is a brand-name prescription medication. It’s approved by the Food and Drug Administration (FDA) to treat metastatic, castration-resistant prostate cancer in adult males.* Provenge may be used to treat your prostate cancer if it’s causing few to no symptoms.

Metastatic means that the cancer has spread beyond the prostate to other parts of your body. Having castration-resistant cancer means that therapy to reduce levels of testosterone (a hormone) in your body isn’t effective in treating it.

* Use of the term “male” within this article refers to a person’s sex assigned at birth.

Drug details

Provenge comes as a liquid. It’s given as an intravenous (IV) infusion, which is an injection into your vein over a period of time. Provenge infusions typically last for about 1 hour.

Provenge contains the active drug sipuleucel-T. It belongs to a drug class called immunotherapies. (A drug class is a group of medications that work in a similar way.)

Immunotherapies such as sipuleucel-T help your immune system work better against cancer cells. (Your immune system helps protect your body from abnormal cells such as germs and cancer cells.)

Provenge is different from other immunotherapies because it uses your own immune cells to make a personalized dose. For more information, see the “How Provenge works” section below.

Effectiveness

For information about the effectiveness of Provenge, see the “Provenge for prostate cancer” section below.

Provenge is available only as a brand-name medication. It’s a biologic drug that’s not currently available in generic or biosimilar form.

Generic drugs are exact copies of a brand-name drug that’s made from chemicals. Biologic drugs, on the other hand, are made using living cells. It’s not possible for drug companies to produce exact copies of these drugs.

A biosimilar drug is a very similar version of the parent brand-name biologic drug. But it’s not identical. Biosimilar drugs are made to treat the same conditions as their parent drug. They’re considered to be as safe and effective as the parent drug. Like generic drugs, biosimilars tend to cost less than brand-name drugs.

Provenge contains the active drug sipuleucel-T.

As with all medications, the cost of Provenge can vary. To find current prices for Provenge in your area, check out WellRx.com.

The cost you find on WellRx.com is what you may pay without insurance. 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 can only get Provenge through the manufacturer, Dendreon. This is because Provenge is a special type of drug made from your own cells. Each dose of Provenge is made for you and can only be given to you. Dendreon will mail your Provenge doses to your infusion center before each appointment.

Before approving coverage for Provenge, 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 Provenge, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Provenge, or if you need help understanding your insurance coverage, help may be available.

Dendreon Pharmaceuticals LLC, the manufacturer of Provenge, offers a program called Dendreon ON Call. This program offers ways to help lower the cost of Provenge treatment. For more information and to find out if you’re eligible for support, call 877-336-3736 or visit the program website.

Biosimilar version

Provenge isn’t available in a biosimilar form. A biosimilar drug is a very similar version of the parent brand-name biologic drug. But it’s not identical. Biosimilar drugs are made to treat the same conditions as their parent drug. They’re considered to be as safe and effective as the parent drug. Like generic drugs, biosimilars tend to cost less than brand-name drugs.

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

For more information about the possible side effects of Provenge, 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’d like to notify the FDA about a side effect you’ve had with Provenge, you can do so through MedWatch.

Mild side effects

Mild side effects* of Provenge can include:

  • back pain
  • chills
  • constipation
  • diarrhea
  • fatigue† (lack of energy)
  • fever
  • headache
  • joint pain
  • nausea
  • numbness or tingling in your arms, legs, hands, or feet

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 Provenge. To learn about other mild side effects, talk with your doctor or pharmacist or view Provenge’s patient brochure.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Provenge 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 you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Thromboembolism (a type of blood clot), such as pulmonary embolism or deep vein thrombosis. Symptoms vary but may include:
    • discoloration of your arm or leg
    • pain, warmth, and swelling in your arm or leg
    • chest pain that worsens with deep breaths
  • Stroke. Symptoms can include:
    • trouble speaking
    • loss of vision in one eye
    • numbness or weakness on one side of the body
  • Heart attack. Symptoms can include
    • chest pain or discomfort
    • shortness of breath
    • dizziness or fainting
    • feeling weak
  • Allergic reaction.*
  • Infusion reactions.*

* For more information about this side effect, see “Side effect details” 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 Provenge. It isn’t known how often allergic reaction may have occurred in studies.

Symptoms of a mild allergic reaction can include:

  • rash
  • itchiness
  • flushing (warmth, swelling, or 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 an allergic reaction to Provenge, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Infusion reactions

Some people may experience infusion reactions while using Provenge.

Infusion reactions may occur during or shortly after you receive a drug by intravenous (IV) infusion. (With IV infusions, the drug is slowly injected into a vein over a certain period of time.)

In clinical studies, 71.2% of people who received Provenge experienced an infusion reaction. It isn’t known how many people who received a placebo (a treatment with no active drug) experienced infusion reactions.

In the studies, the most common infusion reactions reported in people taking Provenge were:

  • chills
  • fatigue (lack of energy)
  • fever

Other types of infusion reactions that may occur with Provenge include:

If you experience an infusion reaction while receiving Provenge, your doctor will stop or slow your infusion. They’ll also provide any necessary treatment for your reaction. Then, they’ll decide whether it’s safe for you to continue with your Provenge treatment.

To lower your risk for infusion reactions, your doctor may give you certain medications before your infusion. For more information, see the “Provenge use with other drugs” section below.

Chills

Chills are a common side effect of Provenge. In clinical studies:

  • 53.1% of people who received Provenge had chills, including 2.2% of people who had chills that were considered serious
  • 10.9% of people who received a placebo (a treatment with no active drug) had chills, and no one receiving a placebo had chills that were considered serious

Chills are a type of infusion reaction. (To learn more, see “Infusion reactions” directly above.) If you experience chills while receiving a Provenge dose, your doctor will stop or slow your Provenge infusion. They may give you a one-time dose of acetaminophen (Tylenol) to help with this side effect. Then, they’ll decide whether it’s safe for you to continue your Provenge treatment.

To lower your risk for infusion reactions, your doctor may give you certain medications before your infusion. For more information, see the “Provenge use with other drugs” section below.

Fatigue

Some people may experience fatigue (lack of energy) while using Provenge.

In clinical studies:

  • 41.1% of people who received Provenge experienced fatigue, including 1% of people with fatigue that was considered serious
  • 34.7% of people who received a placebo had chills, including 1.3% of people with fatigue that was considered serious

Fatigue can be a type of infusion reaction. (To learn more, see the “Infusion reactions” section above.) If you experience fatigue while receiving Provenge, your doctor will stop or slow your Provenge infusion. Then, they’ll decide whether it’s safe for you to continue your Provenge treatment.

To lower your risk for infusion reactions, your doctor may give you certain medications before your infusion. To learn more, see the “Provenge use with other drugs” section below.

The Food and Drug Administration (FDA) approves prescription drugs such as Provenge to treat certain conditions. Provenge may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Provenge is approved for use in adult males with metastatic, castration-resistant* prostate cancer. Provenge may be used to treat prostate cancer if your cancer is causing few to no symptoms.

Symptoms of metastatic prostate cancer may include:

  • trouble urinating
  • pain while urinating
  • pain in the back or neck
  • swelling or weakness in your legs

Cancer cells are abnormal cells that typically grow quickly and can spread to other areas in the body. Prostate cancer occurs in the prostate gland (part of the male reproductive system.)

Provenge works by helping your immune system work better against cancer cells. (Your immune system helps protect your body from abnormal cells such as germs and cancer cells.)

* Metastatic means that the cancer has spread beyond the prostate to other parts of your body. Having castration-resistant cancer means that therapy to reduce levels of testosterone (a hormone) in your body isn’t effective in treating it.

Effectiveness for prostate cancer

Clinical studies have shown Provenge to be effective for treating metastatic, castration-resistant prostate cancer in adult males.

In one study, adults with prostate cancer were randomly given either Provenge or a placebo (a treatment with no active drug). Researchers wanted to see how Provenge compared with a placebo at improving overall survival. (Overall survival measures how many people in a study are still alive at a certain point during the study.)

The study found that:

  • about half of the people who received Provenge were still alive after 25.8 months of treatment
  • about half of the people who received a placebo were still alive after 21.7 months of treatment

It’s important to note that your results from using Provenge may vary from those seen in clinical studies.

The American Urological Association and National Comprehensive Cancer Network both recommend Provenge for certain males with this type of prostate cancer.

Provenge and children

Provenge isn’t approved for use in children. This is because the drug has only been studied in adults.

About 30 minutes before starting your Provenge infusion, your doctor will likely give you two other medications. This is to help prevent infusion reactions, which are side effects that may occur during or shortly after you receive a drug by intravenous (IV) infusion. (With IV infusions, the drug is slowly injected into a vein over a certain period of time.)

In clinical studies, 71.2% of people who received Provenge experienced an infusion reaction. It isn’t known how many people who received a placebo (a treatment with no active drug) experienced infusion reactions.

The medications you’re most likely to receive before your Provenge infusion are acetaminophen (Tylenol) and an antihistamine, usually diphenhydramine (Benadryl).

As well as giving you these medications, your doctor will monitor you for side effects during and after your Provenge infusion.

If you have questions about medications that may be used with Provenge, talk with your doctor.

Provenge has Food and Drug Administration (FDA) approval for use in adult males with metastatic, castration-resistant* prostate cancer. Provenge may be used to treat your prostate cancer if it’s causing few to no symptoms.

Cancer cells are abnormal cells that typically grow quickly and can spread to other areas in the body. Prostate cancer occurs in the prostate gland (a part of the male reproductive system).

* Metastatic means that the cancer has spread beyond the prostate to other parts of your body. Having castration-resistant cancer means that therapy to reduce levels of testosterone (a hormone) in your body isn’t effective in treating it.

What Provenge does

Provenge contains the active drug sipuleucel-T. It belongs to a drug class called immunotherapies. (A drug class is a group of medications that work in a similar way.)

Immunotherapies such as sipuleucel-T help your immune system work better against cancer cells. (The way a drug works is also called its mechanism of action.)

Provenge is different from other immunotherapies because it uses your own immune cells to make a personalized dose.

About 3 days before each of your Provenge infusions, you’ll have your immune cells collected at a blood center. This collection procedure is called leukapheresis, and it lasts for about 2 to 4 hours. During leukapheresis, your blood passes through a machine that collects your immune cells and returns the rest of your blood to your body.

These collected cells are sent to a manufacturing center. There, your cells are mixed with a certain protein that prepares them to work against your prostate cancer.

After your customized dose of Provenge has been prepared, it’s mailed to your doctor’s office or infusion center.

How long does it take to work?

Provenge begins working as soon as you receive your infusion. But you aren’t likely to notice Provenge working in your body. This is because Provenge may not improve your symptoms as it works against your cancer.

Clinical studies didn’t look at how soon people’s symptoms may have improved while taking Provenge. If you have questions about how long Provenge takes to work, or what types of results you can expect, talk with your doctor.

Provenge comes as a liquid. It’s given as an intravenous (IV) infusion. (With IV infusions, the drug is slowly injected into a vein over a certain period of time.) Provenge infusions typically last for about 1 hour.

After the infusion, your doctor will monitor you for 30 minutes to check for any side effects.

Collecting your immune cells

About 3 days before each of your Provenge infusions, you’ll have your immune cells collected. This is because Provenge uses your own immune cells to make a personalized dose. This collection procedure is called leukapheresis, and it lasts for about 2 to 4 hours. During leukapheresis, your blood passes through a machine that collects your immune cells and returns the rest of your blood to your body.

During your leukapheresis appointment, you may experience chills, fever, or tingling in your hands and feet. To help prepare for your leukapheresis appointment and lower your risk for these side effects, see these tips from Provenge’s manufacturer (scroll down to “Step 1. Cell collection”).

After your leukapheresis appointment, these collected cells are sent to the manufacturer. There, your cells are modified to help them work better against your prostate cancer. After your customized dose of Provenge has been prepared, it’s mailed to your doctor’s office or infusion center.

The day you undergo leukapheresis is considered day 1 of your Provenge treatment. On day 3 or 4, you’ll go to your doctor’s office or an infusion center to receive your Provenge dose.

When is Provenge given?

For treating metastatic, castration-resistant prostate cancer, it’s typical to receive three doses of Provenge. Each dose is given about 2 weeks apart.

It’s important to keep your appointments for your Provenge infusions. If you miss your appointment, call your doctor’s office right away to reschedule. To help make sure you don’t miss your appointment, try setting a reminder on your phone.

When is Provenge treatment started?

You’ll receive your first dose of Provenge about 3 days after your first leukapheresis appointment.

If you have questions about when you’ll start treatment, talk with your doctor.

Other drugs are available that can treat prostate cancer. Some may be a better fit for you than others. If you’re interested in finding an alternative to Provenge, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here may be used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is used for a purpose other than what it’s approved for.

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

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

Ingredients

Provenge contains the active drug sipuleucel-T, which is a type of immunotherapy.

Xtandi contains the active drug enzalutamide. This belongs to a drug class called androgen receptor inhibitors. (A drug class is a group of medications that work in a similar way.)

Uses

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

  • Both Provenge and Xtandi are FDA-approved to treat:
  • Xtandi is also FDA-approved to treat:
    • non-metastatic, castration-resistant prostate cancer
    • metastatic, castration-sensitive prostate cancer

* Metastatic means that the cancer has spread beyond the prostate to other parts of your body. Having castration-resistant cancer means that therapy to reduce levels of testosterone (a hormone) in your body isn’t effective in treating it.

Drug forms and administration

Provenge comes as a liquid. It’s given as an intravenous (IV) infusion, which is an injection into your vein over a period of time. Provenge infusions typically last for about 1 hour.

Xtandi comes as capsules that you take by mouth once per day.

Side effects and risks

Provenge and Xtandi have some similar side effects and others that vary. 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 either Provenge or Xtandi, as well as mild side effects that both drugs may share.

  • Can occur with Provenge:
    • chills
    • fever
    • nausea
  • Can occur with Xtandi:
    • feeling weak
    • flushing (warmth, swelling, or redness in your skin)
    • loss of appetite
  • Can occur with both Provenge and Xtandi:
    • back pain
    • constipation
    • diarrhea
    • headache
    • joint pain

Serious side effects

These lists contain examples of serious side effects that can occur with either Provenge or Xtandi, as well as serious side effects that both drugs may share.

Effectiveness

Provenge and Xtandi have different FDA-approved uses, but they’re both used to treat metastatic, castration-resistant prostate cancer.

These drugs haven’t been directly compared in clinical studies. But studies have found both Provenge and Xtandi to be effective for treating this type of prostate cancer.

The American Urological Association and National Comprehensive Cancer Network both recommend Provenge and Xtandi as treatment options for certain males with this type of prostate cancer.

Costs

According to estimates on WellRx.com, Provenge costs significantly more than Xtandi. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Provenge and Xtandi are both brand-name drugs. There are currently no generic forms of Xtandi or biosimilar forms of Provenge.

A generic drug is an exact copy of the active drug in a brand-name medication that’s made from chemicals. Biosimilars are drugs that are based on biologic drugs, which are made from parts of living organisms. Brand-name medications usually cost more than generics or biosimilars.

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

Ingredients

Provenge contains the active drug sipuleucel-T. Zytiga contains the active drug abiraterone acetate.

Uses

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

  • Both Provenge and Zytiga are FDA-approved to treat:
  • Zytiga is also FDA-approved to treat:
    • high-risk, castration-sensitive metastatic prostate cancer

* Metastatic means that the cancer has spread beyond the prostate to other parts of your body. Having castration-resistant cancer means that therapy to reduce levels of testosterone (a hormone) in your body isn’t effective in treating it.

Drug forms and administration

Provenge comes as a liquid. It’s given as an intravenous (IV) infusion, which is an injection into your vein over a period of time.

Zytiga comes as tablets that you take by mouth once daily. It’s taken along with a corticosteroid called prednisone to help reduce the risk of certain side effects.

Side effects and risks

Provenge and Zytiga have some similar side effects and others that vary. 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 either Provenge or Zytiga, as well as mild side effects that both drugs may share.

  • Can occur with Provenge:
    • back pain
    • chills
    • constipation
    • fever
  • Can occur with Zytiga:
    • cough
    • swelling in your hands, feet, or legs
    • flushing (warmth, swelling, or redness in your skin)
    • rash
  • Can occur with both Provenge and Zytiga:
    • diarrhea
    • headache
    • joint pain
    • nausea

Serious side effects

These lists contain examples of serious side effects that can occur with either Provenge or Zytiga, as well as serious side effects that both drugs may share.

Effectiveness

Provenge and Zytiga have different FDA-approved uses, but they’re both used to treat metastatic, castration-resistant prostate cancer.

These drugs haven’t been directly compared in clinical studies. But studies have found both Provenge and Zytiga to be effective for treating this type of prostate cancer.

Both the American Urological Association and National Comprehensive Cancer Network recommend Provenge and Zytiga as treatment options for certain males with this type of prostate cancer.

Costs

According to estimates on WellRx.com, Provenge costs significantly more than Zytiga. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Provenge and Zytiga are both brand-name drugs. Zytiga is also available as a generic drug called abiraterone acetate. But there isn’t a biosimilar form of Provenge.

A generic drug is an exact copy of the active drug in a brand-name medication that’s made from chemicals. Biosimilars are drugs that are based on biologic drugs, which are made from parts of living organisms. Brand-name medications usually cost more than generics or biosimilars.

The following information describes dosages that are commonly used or recommended.

Drug forms and strengths

Provenge comes as a liquid. It’s given as an intravenous (IV) infusion, which is an injection into your vein over a period of time. Provenge infusions typically last for about 1 hour.

Provenge contains the active drug sipuleucel-T. It belongs to a drug class called immunotherapies. (A drug class is a group of medications that work in a similar way.)

Immunotherapies such as sipuleucel-T help your immune system work better against cancer cells. (Your immune system helps protect your body from abnormal cells such as germs and cancer cells.)

Provenge is different from other immunotherapies because it uses your own immune cells to make a personalized dose. For more information, see the “How Provenge works” section above.

Dosage for prostate cancer

For treating prostate cancer, the recommended dosage of Provenge is three separate infusions, each given about 2 weeks apart.

What if I miss a dose?

It’s important to keep your appointments for your three Provenge infusions. If you miss any of these appointments, you’ll need to undergo another leukapheresis procedure. Then, you’ll have to wait for the manufacturer to create and ship your dose, which may delay your treatment.

To help make sure you don’t miss a dose, try setting a reminder on your phone or marking the appointments on your calendar.

Will I need to use this drug long term?

No, Provenge isn’t meant to be used as a long-term treatment. If your doctor decides that Provenge is right for you, you’ll receive three infusions of the drug for your total course of treatment.

Here are answers to some frequently asked questions about Provenge.

Is there an average life expectancy with Provenge treatment?

As with other cancer treatments, life expectancy with Provenge can vary depending on your cancer and other health factors.

In a clinical study, researchers looked at how Provenge compared with a placebo at improving overall survival. (Overall survival measures how many people in a study are still alive at a certain point during the study.)

The study found that:

  • about half of the people who received Provenge were still alive after 25.8 months of treatment
  • about half of the people who received a placebo were still alive after 21.7 months of treatment

It’s important to note that your results from using Provenge may vary from those seen in clinical studies. If you have questions about life expectancy with Provenge, talk with your doctor.

Is Provenge chemotherapy?

No, Provenge isn’t chemotherapy. Chemotherapy drugs kill cells in your body that grow rapidly. Cancer cells are usually fast-growing cells, so chemotherapy affects these cells. But certain healthy cells (such as hair cells) can also be fast growing. Chemotherapy can also affect these healthy cells, which raises your risk for side effects.

Provenge contains the active drug sipuleucel-T. It belongs to a drug class called immunotherapies. (A drug class is a group of medications that work in a similar way.)

Immunotherapies such as sipuleucel-T help your immune system work better against cancer cells. (Your immune system helps protect your body from abnormal cells such as germs and cancer cells.)

Provenge works differently from chemotherapy, and even from other immunotherapies. It uses your own immune cells to make a personalized dose. For more information, see the “How Provenge works” section above.

Does Provenge cure prostate cancer?

No, Provenge isn’t a cure for prostate cancer. There currently isn’t a cure for prostate cancer. But Provenge may help you live longer with prostate cancer.

In a clinical study:

  • about half of the people who received Provenge were still alive after 25.8 months of treatment
  • about half of the people who received a placebo were still alive after 21.7 months of treatment

For more information, see “Effectiveness” under the “Provenge for prostate cancer” section above.

It’s important to note that your results from using Provenge may vary from those seen in clinical studies.

Why is Provenge considered a personalized treatment?

Provenge is considered a personalized treatment because it’s made from your own immune cells.

About 3 days before each of your Provenge infusions, you’ll have your immune cells collected. This collection procedure is called leukapheresis. During leukapheresis, your blood passes through a machine that collects your immune cells and returns the rest of your blood to your body.

These collected cells are sent to the manufacturer. There, your cells are modified to help them better fight your prostate cancer.

For more information, see the “How Provenge works” section above.

Can Provenge be used in people of any race?

Possibly. But there currently aren’t enough data to know whether Provenge is safe and effective for people of all races.

In clinical studies of the drug:

  • 90.6% of people in the trial identified as Caucasian
  • 5.8% of people identified as African American
  • 3.7% of people identified as “Other”

Because so few non-Caucasian people were included in the study, more research is needed to know whether Provenge can be used safely in people of all races.

If you have questions about whether Provenge is right for you, talk with your doctor. They’ll work to find the best treatment for your prostate cancer.

There aren’t any known interactions between Provenge and alcohol. But drinking alcohol while taking Provenge could raise your risk for certain side effects, such as:

If you drink alcohol, talk with your doctor about much is safe for you to drink during your Provenge treatment.

There are no known interactions between Provenge and other medications. In addition, there aren’t any known interactions with any supplements or foods.

But talk with your doctor and pharmacist before you begin treatment with Provenge. 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.

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.

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

Provenge isn’t intended for use by females,* and it hasn’t been studied in females. Because of this, it shouldn’t be taken by females who are pregnant or may become pregnant.

If you have questions, talk with your doctor.

* Use of the term “female” within this article refers to a person’s sex assigned at birth.

It’s not known if Provenge is safe to take during pregnancy. 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 Provenge.

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

Provenge isn’t intended for use by females,* and it hasn’t been studied in females. Because of this, it shouldn’t be taken by females who are breastfeeding. It also isn’t known whether Provenge passes into breast milk and whether it can cause side effects in a breastfed child.

If you have questions about Provenge and breastfeeding, talk with your doctor.

* Use of the term “female” within this article refers to a person’s sex assigned at birth.

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

  • Heart problems. Provenge may not be right for you if you’ve had heart problems. Provenge infusions may cause certain side effects, such as high or low blood pressure, a fast heart rate, fainting, and blood clots. People with a history of heart problems may be at higher risk for these side effects. They may also be more likely to experience serious side effects. Before using Provenge, tell your doctor about any history of heart problems you may have.
  • Breathing or lung problems. You may not be able to take Provenge if you have breathing or lung problems. Provenge infusions may cause shortness of breath, bronchospasm, and low oxygen levels. People with a history of breathing or lung problems may be at higher risk for these side effects. They may also be more likely to experience serious side effects. Tell your doctor about any history of breathing or lung problems before you begin treatment with Provenge.
  • History of stroke. In clinical studies, people taking Provenge had strokes more often than people who received a placebo. But it’s not known if Provenge was the cause of these strokes. Before starting Provenge, tell your doctor if you’ve ever had a stroke.
  • Allergic reaction. If you’ve had an allergic reaction to Provenge or any of its ingredients, you shouldn’t take the drug. Ask your doctor about other medications that may be better options for you.
  • Pregnancy. Provenge shouldn’t be used during pregnancy. For more information, see the “Provenge and pregnancy” section above.
  • Breastfeeding. Provenge isn’t intended for use while breastfeeding. For more information, see the “Provenge and breastfeeding” section above.

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

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