Nubeqa (darolutamide)

What is Nubeqa?

Nubeqa is a brand-name prescription medication. It’s FDA-approved to treat a type of prostate cancer called nonmetastatic castration-resistant prostate cancer (nmCRPC).*

“Nonmetastatic” refers to cancer that hasn’t metastasized (spread) to other parts of the body from its original location. “Castration-resistant” means that reducing the level of testosterone in the body doesn’t stop this cancer. Testosterone is the main sex hormone in males.†

The active drug in Nubeqa is darolutamide. Nubeqa belongs to a group of medications known as androgen receptor inhibitors.

Nubeqa comes as tablets that you swallow. You’ll likely take the drug twice daily. Nubeqa is available in one strength: 300 milligrams (mg).

* To learn more about the uses of Nubeqa, see the “Nubeqa for prostate cancer” section below.
† Use of the terms “males” and “females” within this article refers to a person’s sex assigned at birth.

FDA approval

In 2019, the Food and Drug Administration (FDA) approved Nubeqa to treat nmCRPC.

Effectiveness

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

Nubeqa generic

Nubeqa 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.

The active drug in Nubeqa is darolutamide.

Nubeqa side effects

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

For more information about the possible side effects of Nubeqa, 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 Nubeqa, you can do so through MedWatch.

Mild side effects

Mild side effects of Nubeqa can include:

• weakness and fatigue (lack of energy)*
• pain in extremities (arms, legs, hands, or feet)*
• neutropenia (decreased level of white blood cells called neutrophils)*
• increased liver enzyme levels on blood tests
• rash
• nausea
• diarrhea

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.

To learn more about the mild side effects of Nubeqa, talk with your doctor or pharmacist. Or you can view Nubeqa’s Patient Information.

*For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Nubeqa 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:

• Pneumonia (a type of lung infection). Symptoms can include:
  • cough
  • coughing up greenish phlegm from your lungs
  • fever
  • shortness of breath
  • chest pain
• Hematuria (blood in the urine).*
• Heart problems, such as heart failure.†
• Urinary retention (not being able to fully empty your bladder).†
• Hypertension (high blood pressure).†
• Allergic reaction.†

* Bloody urine may also be a symptom of prostate cancer itself.
† 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 Nubeqa. It isn’t known how often allergic reaction may have occurred in clinical studies of Nubeqa.

Symptoms of a mild allergic reaction can include:

• skin 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 Nubeqa, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Heart problems

Heart problems are a possible side effect of Nubeqa. In a clinical trial of the drug, the types of heart problems reported fell into two categories:

• ischemic heart disease (also known as coronary heart disease)
• heart failure

Ischemic heart disease

With ischemic heart disease, the blood vessels that carry oxygen and blood to the heart become too narrow. This could result in serious health problems, such as heart attack.

The most common symptom of ischemic heart disease is angina. This is a type of chest pain that may cause a feeling of pressure or heaviness across the chest.

Heart failure

With heart failure, the heart doesn’t pump blood around the body well. As a result, the body’s cells don’t receive enough oxygen and nutrients from the blood.

Symptoms of heart failure can include:

• extreme fatigue
• shortness of breath
• dizziness
• heart palpitations (feeling of skipped or extra heartbeats)
• edema (fluid buildup) in your legs and feet

How often heart problems occurred

In a clinical trial, males took either Nubeqa or a placebo, which is a treatment with no active drug.

They also took a type of medication known as a gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. (A bilateral orchiectomy is surgical removal of the testicles). Both the GnRH analog and surgery reduce the level of testosterone produced in the body.

Here are the numbers and percentages of males who had heart problems in the trial:

If you notice any of the symptoms mentioned above while taking Nubeqa or have any concerns, talk with your doctor. They may be able to suggest ways to reduce your risk for heart problems.

Urinary retention

Urinary retention (not being able to fully empty your bladder) can occur with Nubeqa.

In a clinical trial, males took either Nubeqa or a placebo, which is a treatment with no active drug. They also took a type of medication known as a gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. (A bilateral orchiectomy is surgical removal of the testicles). Both the GnRH analog and surgery reduce the level of testosterone produced in the body.

Researchers found that the risk of urinary retention with Nubeqa wasn’t significantly higher than with a placebo.

Here are the numbers and percentages of males who had urinary retention in the trial:

Symptoms of urinary retention can include:

• trouble urinating
• needing to urinate often
• urinary incontinence (loss of bladder control)

If you notice any symptoms of urinary retention while using Nubeqa, be sure to talk with your doctor. They may be able to recommend ways to help ease this side effect.

Decreased white blood cell level

A possible side effect of Nubeqa is a decreased level of white blood cells called neutrophils. This condition is known as neutropenia. Neutrophils circulate around your blood and fight infection. If the neutrophil level remains low, there’s an increased risk of infection.

In a clinical study of Nubeqa, males took either Nubeqa or a placebo, which is a treatment with no active drug. They also took a type of medication known as a gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. (A bilateral orchiectomy is surgical removal of the testicles). Both the GnRH analog and surgery reduce the level of testosterone produced in the body.

In the group that took Nubeqa and either took a GnRH analog or had a bilateral orchiectomy:

• 20% of males had neutropenia
• 4% males had severe neutropenia

In the group that took a placebo and either took a GnRH analog or had a bilateral orchiectomy:

• 9% of males had neutropenia
• 0.6% males had severe neutropenia

To check your neutrophil level while you take Nubeqa, your doctor can order a blood test called a complete blood count. If you have any questions about your neutrophil level, talk with your doctor.

Weakness and fatigue

Weakness and fatigue (lack of energy) were common side effects that occurred in a clinical study of Nubeqa.

In the study, males took either Nubeqa or a placebo, which is a treatment with no active drug. They also took a type of medication known as a gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. (A bilateral orchiectomy is surgical removal of the testicles). Both the GnRH analog and surgery reduce the level of testosterone produced in the body.

Weakness and fatigue and occurred in:

• 16% of males who took Nubeqa and either took a GnRH analog or had a bilateral orchiectomy
• 11% of males who took a placebo and either took a GnRH analog or had a bilateral orchiectomy

If you have less energy and feel weaker than usual since starting Nubeqa treatment, talk with your doctor. They may be able to recommend ways to help ease these side effects.

High blood pressure

Hypertension (high blood pressure) has occurred with Nubeqa in a clinical trial.

In the trial, males took either Nubeqa or a placebo, which is a treatment with no active drug. They also took a type of medication known as a gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. (A bilateral orchiectomy is surgical removal of the testicles). Both the GnRH analog and surgery reduce the level of testosterone produced in the body.

Here are the numbers and percentages of males who had high blood pressure in the trial:

High blood pressure usually has no symptoms. Your doctor may discover it’s high when your pressure is measured during an office visit. In some cases, symptoms of high blood pressure can occur and include:

• headache
• vision changes
• dizziness

Your doctor will typically monitor your blood pressure during your Nubeqa treatment. If it becomes high, they may recommend lifestyle changes or medication to help reduce blood pressure.

Pain in extremities

Pain in extremities is a possible side effect of Nubeqa. It refers to pain in the hands, feet, arms, or legs.

In a clinical trial, males took either Nubeqa or a placebo, which is a treatment with no active drug. They also took a type of medication known as a gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. (A bilateral orchiectomy is surgical removal of the testicles). Both the GnRH analog and surgery reduce the level of testosterone produced in the body.

Pain in extremities occurred in:

• 5.8% of males who took Nubeqa and either took a GnRH analog or had a bilateral orchiectomy
• 3.2% of males who took a placebo and either took a GnRH analog or had a bilateral orchiectomy

No one who received Nubeqa in this study rated their extremity pain as severe.

If you have bothersome pain in your hands, feet, arms, or legs since starting Nubeqa treatment, talk with your doctor. They may be able to recommend ways to help relieve this side effect.

Nubeqa cost

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

Keep in mind that you may be able to get a 90-day supply of Nubeqa. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, talk with your doctor or your insurance company.

It’s important to note that you’ll have to get Nubeqa 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 Nubeqa, 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 Nubeqa, contact your insurance company.

Financial and insurance assistance

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

Bayer, the manufacturer of Nubeqa, offers a program called DUDE Access Services that may help lower the cost of this drug. For more information and to find out if you’re eligible for support, call 833-337-DUDE (833-337-3833) or visit the program website.

Mail-order pharmacies

Nubeqa may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Nubeqa, so there’s less concern about running out of the medication. If you’re interested in this option, talk with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Nubeqa is not 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.

Nubeqa for prostate cancer

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

Nubeqa is FDA-approved to treat a type of prostate cancer called nonmetastatic castration-resistant prostate cancer (nmCRPC).

“Nonmetastatic” refers to a cancer that hasn’t metastasized (spread) to other parts of the body from its original location. “Castration-resistant” means that reducing the level of testosterone in the body doesn’t stop this cancer. Testosterone is the main sex hormone in males.

With one exception, Nubeqa must be prescribed with another type of medication: a gonadotropin-releasing hormone (GnRH) analog. The one exception is if you’ve already had a bilateral orchiectomy, which is surgery to remove the testicles. In this situation, Nubeqa can be prescribed alone to treat nmCRPC. To learn more, see the “Nubeqa use with other drugs” section below.

Prostate cancer explained

Prostate cancer starts in the prostate gland, which is an organ located between the bladder and penis. Cancer causes cells to multiply out of control.

Nubeqa is used to treat nonmetastatic cancer, which is when the cancer has remained in the prostate gland. However, nonmetastatic prostate cancer can eventually become metastatic and grow outside of the prostate.

In some cases, decreasing the level of testosterone in the body can help treat prostate cancer. But the type of cancer Nubeqa treats is castration-resistant, so that treatment won’t help. (“Castration-resistant” means that reducing the level of testosterone in the body doesn’t stop this cancer.)

Early on, prostate cancer may not have any symptoms. It may be discovered in a blood test. But if you do have symptoms, they may include:

• needing to urinate often, usually during the night
• trouble starting and continuing to urinate
• blood in your semen or urine

In the advanced stages, symptoms of prostate cancer may include:

• feeling tired
• weight loss
• bone pain or fractures, often in the shoulders, hips, or thighs

Effectiveness for prostate cancer

In a clinical study of more than 1,500 males with nonmetastatic castration-resistant prostate cancer, Nubeqa was proven to be an effective treatment.

In the study, males took either Nubeqa or a placebo, which is a treatment with no active drug. They also took a type of medication known as a gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. (A bilateral orchiectomy is surgical removal of the testicles). Both the GnRH analog and surgery reduce the level of testosterone produced in the body.

Researchers measured how long before the prostate cancer progressed. In this case, the term “progressed” means that the cancer metastasized (spread to other areas of the body) or the person died from the cancer.

The results showed that males who took Nubeqa and had GnRH analog therapy or a bilateral orchiectomy:

• Lived 3.4 years without their cancer spreading. This was compared with 1.5 years for males who took a placebo and either took a GnRH analog or had a bilateral orchiectomy.
• Had a 31% lower risk for death compared to males who took a placebo and either took a GnRH analog or had a bilateral orchiectomy.

Nubeqa and children

Nubeqa isn’t approved for use in children. It isn’t known if Nubeqa is safe or effective in children.

Nubeqa use with other drugs

With one exception, Nubeqa must be used with another type of medication: a gonadotropin-releasing hormone (GnRH) analog. The one exception is if you’ve already had a bilateral orchiectomy, which is surgery to remove the testicles.* In this situation, Nubeqa can be used alone to treat nonmetastatic castration-resistant prostate cancer (nmCRPC).

Treatment with a GnRH analog may also be called GnRH analog therapy or androgen deprivation therapy. The GnRH analog helps prevent the body from making certain hormones. This includes blocking the production of testosterone, the main male hormone.

Some examples of GnRH analogs include:

• leuprolide (Lupron Depot)
• goserelin (Zoladex)
• triptorelin (Trelstar)
• histrelin (Vantas)

* The surgery permanently lowers the amount of testosterone in your body, so a GnRH treatment would not be needed.

Nubeqa dosage

The Nubeqa dosage your doctor prescribes may depend on other medical conditions you may have.

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

Nubeqa comes as a tablet that you swallow. It’s available in one strength: 300 milligrams (mg).

Dosage for prostate cancer

Nubeqa is used to treat nonmetastatic castration-resistant prostate cancer (nmCRPC). For details, see the “Nubeqa for prostate cancer” section above.

The recommended dosage of Nubeqa for nmCRPC is 1,200 mg per day. You’ll likely take two 300-mg tablets twice daily.

Your doctor may prescribe a lower dosage for you if you have certain kidney or liver problems. These problems include chronic kidney disease and hepatitis.

Dosage questions

Below are answers to some questions you may have about taking Nubeqa.

What if I miss a dose?

If you miss a dose of Nubeqa, take your dose as soon as you remember. Don’t double your next dose to make up for a missed dose.

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?

Nubeqa is meant to be used as a long-term treatment. If you and your doctor determine that Nubeqa is safe and effective for you, you’ll likely take it long term.

How Nubeqa works

Nubeqa is used to treat nonmetastatic castration-resistant prostate cancer (nmCRPC). This is a type of cancer that forms in the prostate gland (a part of the male reproductive system). Cancer cells are abnormal cells that usually grow very quickly and sometimes spread to other areas of the body.

nmCRPC is a kind of prostate cancer defined by two key features:

• It’s nonmetastatic, which means the cancer cells are located only in the prostate gland. The cancer hasn’t metastasized (spread) to other areas of the body.
• It’s castration-resistant. The word “castration” refers to a treatment or surgery that lowers the level of testosterone in the body. (Testosterone is the main sex hormone in males.) Medications or surgery to remove the testicles can reduce the level of testosterone. When a cancer is castration-resistant, reducing the level of testosterone in the body doesn’t stop the cancer.

Nonmetastatic prostate cancer can eventually become metastatic and grow outside of the prostate. The main goal of treatment for nmCRPC is to delay cancer spread to other areas of the body.

What Nubeqa does

The way a drug works is called its mechanism of action. The mechanism of action of Nubeqa is to block the effects of testosterone. Prostate cancer depends on testosterone to grow and spread. Nubeqa can help slow down how fast the cancer grows and help prevent it from spreading to other areas of the body.

How long does it take to work?

Nubeqa begins to work right away, but you may not notice any changes in your condition that quickly. Your doctor will order prostate-specific antigen (PSA) tests for you. PSA tests can check how well Nubeqa is treating your prostate cancer. A lower PSA level in the blood is a sign that the drug is working. To learn more about your PSA level, talk with your doctor.

Nubeqa and alcohol

There aren’t any known interactions between Nubeqa and alcohol. However, drinking too much alcohol can cause some of the same side effects of Nubeqa. (For more about Nubeqa side effects, see the “Nubeqa side effects” section above.)

Drinking alcohol with Nubeqa may raise your risk for certain side effects, such as:

• fatigue (lack of energy)
• nausea
• diarrhea

Also, over time, drinking too much alcohol can affect how well your liver works. Your liver is responsible for metabolizing (breaking down) medications and has many other important functions. If you have liver damage, it may not be safe for you to take Nubeqa. (To learn more, see the “Nubeqa precautions” section below).

If you drink alcohol, talk with your doctor about how much is safe for you to consume while you take Nubeqa.

Nubeqa interactions

Nubeqa can interact with many 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.

Nubeqa and other medications

Below are examples of medications that can interact with Nubeqa in different ways. This section doesn’t contain all possible drugs that may interact with Nubeqa.

Before taking Nubeqa, 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.

Nubeqa and drugs that can increase the level of Nubeqa

Certain medications can slow down how quickly your body metabolizes (breaks down) Nubeqa. If your system breaks down Nubeqa more slowly than usual, the level of Nubeqa in your body can increase. A higher level could raise your risk for side effects or make them more severe. For more information on side effects, see the “Nubeqa side effects” section above.

Examples of drugs that can increase the level of Nubeqa can include:

• certain antibiotics, such as:
  • clarithromycin (Biaxin)
  • telithromycin
• certain antifungals, such as:
  • itraconazole (Sporanox)
  • ketoconazole (Nizoral)
  • posaconazole (Noxafil)
• certain heart medications, such as:
  • conivaptan (Vaprisol)
  • diltiazem (Cardizem)
• certain HIV medications, such as:
  • cobicistat (Tybost)
  • indinavir (Crixivan)
  • ritonavir (Norvir)
  • saquinavir (Invirase)
• a hepatitis C drug called telaprevir (Incivek)

Before you start taking Nubeqa, talk with your doctor about any medications you’re taking. They can check whether any can increase the level of Nubeqa and adjust your treatment plan if needed.

Nubeqa and drugs that that can decrease the level of Nubeqa

Certain medications can speed up how quickly your body metabolizes (breaks down) Nubeqa. If your system breaks down Nubeqa more quickly than usual, the drug may be less effective in treating your prostate cancer.

Examples of drugs that can decrease the level of Nubeqa can include:

• bosentan (Tracleer)
• carbamazepine (Tegretol)
• dexamethasone (Decadron)
• efavirenz (Sustiva)
• etravirine (Intelence)
• modafinil (Provigil)
• rifampin

Before you start using Nubeqa, talk with your doctor about any medications you’re taking. They can see whether any can decrease the level of Nubeqa and adjust your treatment plan if needed.

Nubeqa and drugs whose levels can be increased by Nubeqa

Nubeqa may cause your body to metabolize (break down) certain drugs more slowly than usual. This may cause the levels of these other drugs to rise. Higher drug levels can increase the risk and severity of side effects.

Examples of drugs whose levels can be increased by Nubeqa can include:

• certain medications for high cholesterol, such as:
  • atorvastatin (Lipitor)
  • fluvastatin (Lescol)
  • rosuvastatin (Crestor)
  • simvastatin (Zocor)
• an anti-inflammatory medication called sulfasalazine

Before you start taking Nubeqa, talk with your doctor about any medications you’re taking. They can check whether Nubeqa can increase the levels of the drugs and adjust your treatment plan if needed.

Nubeqa and herbs and supplements

Some herbs or supplements may interact with Nubeqa. Be sure to check with your doctor or pharmacist before using any of these products while taking Nubeqa.

Nubeqa and St. John’s wort

St. John’s wort is an herb used in alternative medicine to treat depression, among other uses.

St. John’s wort can speed up how quickly your body metabolizes (breaks down) Nubeqa. If your system breaks down Nubeqa more quickly than usual, the drug may be less effective in treating your prostate cancer.

If you currently take St. John’s wort, talk with your doctor before you use Nubeqa. They may recommend that you stop taking St. John’s wort during Nubeqa treatment. Or they may suggest a treatment other than St. John’s wort.

Nubeqa and foods

Here’s some information on interactions between Nubeqa and grapefruit.

Nubeqa and grapefruit

You should avoid eating grapefruit and drinking grapefruit juice while receiving Nubeqa treatment. This is because consuming grapefruit can increase the level of Nubeqa in your body. With more Nubeqa in your system, the risk of side effects may increase. (For more about Nubeqa side effects, see the “Nubeqa side effects” section above.)

Alternatives to Nubeqa

Nubeqa is used to treat a type of prostate cancer called nonmetastatic castration-resistant prostate cancer (nmCRPC).

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

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when an FDA-approved drug is used for a purpose other than what it’s approved for.

Alternatives for prostate cancer

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

• apalutamide (Erleada)
• bicalutamide (Casodex)
• enzalutamide (Xtandi)

How to take Nubeqa

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

Nubeqa comes as tablet that you swallow.

When to take

You’ll likely take Nubeqa twice a day. You should take your dose around the same time each morning and evening, about every 12 hours.

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 Nubeqa with food

You should take Nubeqa with food.

Can Nubeqa be crushed, split, or chewed?

No, you should swallow each Nubeqa tablet whole.

Nubeqa and pregnancy

You shouldn’t take Nubeqa while pregnant or if you’re planning to become pregnant. The drug isn’t approved for use in females.

There haven’t been any human or animal studies on the use of Nubeqa during pregnancy. But based on how Nubeqa works, the drug could harm a fetus or cause miscarriage.

Nubeqa and fertility

Based on animal studies, Nubeqa could cause fertility problems in males. In this case, fertility is the ability to make someone pregnant.

After receiving high doses of Nubeqa for up to 39 weeks, some animals had a low sperm count. Also, the genitals of some male animals became smaller. However, animal studies don’t always predict how a drug will affect humans.

Nubeqa isn’t approved for use in females, so there are no human or animal studies to show how female fertility could be affected. In this situation, fertility is the ability to become pregnant.

If you have any concerns about Nubeqa’s effects on your fertility, talk with your doctor.

Nubeqa and birth control

You shouldn’t take Nubeqa while pregnant or if you’re planning to become pregnant. The drug isn’t approved for use in females. Based on how Nubeqa works, the drug could harm a fetus or cause miscarriage.

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 Nubeqa.

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

For females using Nubeqa

Nubeqa isn’t approved for use in females. Because of this, the drug manufacturer hasn’t given specific birth control recommendations for females.

For males using Nubeqa

If you’re male and your partner can become pregnant, you should use effective birth control while you take Nubeqa. You should keep using birth control for 1 week after stopping Nubeqa treatment. Condoms are an example of effective birth control.

Nubeqa and breastfeeding

You shouldn’t take Nubeqa if you’re breastfeeding. Nubeqa isn’t approved for use in females.

Nubeqa hasn’t been studied in regard to breastfeeding. Because of this, it isn’t known if the drug passes into breast milk or how it would affect a breastfed child.

Common questions about Nubeqa

Here are answers to some frequently asked questions about Nubeqa.

Is Nubeqa a chemotherapy drug?

No, Nubeqa isn’t a chemotherapy drug. Nubeqa is a type of medication called an androgen receptor inhibitor.

Chemotherapy drugs stop cancer cells from spreading and increasing in size. The drugs do this by halting their growth and killing cancer cells that are rapidly dividing.

Androgen receptor inhibitors work by blocking the effects of a hormone called testosterone. Testosterone can bind to receptors (attachment sites) on prostate cancer cells. This causes the cancer cells to grow and spread. Nubeqa works by blocking testosterone from binding to these receptors. This helps to stop the growth and spread of prostate cancer.

If you have more questions about Nubeqa, chemotherapy drugs, or other cancer treatments, talk with your doctor.

Will Nubeqa cure prostate cancer?

No, Nubeqa won’t cure prostate cancer. In fact, there’s no cure for prostate cancer. But Nubeqa should help slow down the possible spread of the cancer.

If you have other questions about Nubeqa, talk with your doctor.

Can I take Nubeqa if I have liver or kidney problems?

Yes, but your doctor may prescribe a lower dosage of Nubeqa. The dosage will depend on the condition of your kidneys or liver.

Your kidneys and liver help remove Nubeqa from your system. So if you have certain kidney or liver problems, your body may not be able to remove the drug as well as usual. Examples of these problems include chronic kidney disease and hepatitis.

Before you start taking Nubeqa, tell your doctor if you have any kidney or liver problems. Your doctor may order a blood test. This will check the function of your kidneys and liver to see whether it’s safe for you to take Nubeqa.

For more information, see the “Nubeqa precautions” section below. If you have other questions about whether Nubeqa is right for you, talk with your doctor.

Why do I have to take a gonadotropin-releasing hormone analog with Nubeqa?

In some cases, taking a type of drug known as a gonadotropin-releasing hormone (GnRH) analog with Nubeqa helps treat your prostate cancer better than with Nubeqa alone.

Nubeqa and GnRH analogs work in different ways to slow down cancer growth. Nubeqa blocks the effects of a hormone called testosterone. GnRH analogs tell the brain to stop making hormones that cause testosterone to be released from the testicles. Testosterone can cause prostate cancer to grow and spread.

You’ll need to take Nubeqa with a GnRH analog unless you’ve had a bilateral orchiectomy (surgical removal of the testicles). The surgery permanently lowers the amount of testosterone in your body, so a GnRH analog wouldn’t be needed.

For more information on Nubeqa and GnRH analogs, see the “Nubeqa use with other drugs” section above. You can also talk with your doctor.

Nubeqa precautions

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

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

Kidney problems and dialysis. If you’re receiving dialysis due to severe kidney failure, Nubeqa may not be safe for you to take. And if you have kidney problems, such as chronic kidney disease, but aren’t receiving dialysis, your doctor may lower your dose of Nubeqa. Kidney problems may make it harder for your body to effectively remove the drug from your system.

Talk with your doctor about any kidney problems you have. They can recommend the right treatment plan for you.

Liver problems. It isn’t known if Nubeqa is safe for you to use if you have severe liver problems. Liver problems may make it harder for your body to effectively remove the drug from your system.

If you have a problem with your liver, talk with your doctor. If you have moderate liver damage, your doctor may lower your dose of Nubeqa. They can also advise you on the best treatment plan for you.

Allergic reaction. If you’ve had an allergic reaction to Nubeqa or any of its ingredients, you shouldn’t take Nubeqa. Ask your doctor what other medications are better options for you.

Pregnancy. You shouldn’t take Nubeqa while pregnant or if you’re planning to become pregnant. The drug isn’t approved for use in females. For more information, see the “Nubeqa and pregnancy” section above.

Breastfeeding. You shouldn’t take Nubeqa if you’re breastfeeding. The drug isn’t approved for use in females. For more information, see the “Nubeqa and breastfeeding” section above.

Nubeqa overdose

Do not use more Nubeqa than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

Taking too much Nubeqa may be especially harmful if you’ve had severe kidney or liver problems in the past. These problems include chronic kidney disease and cirrhosis. For more information, talk with your doctor.

What to do in case you take too much Nubeqa

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.