Padcev is a brand-name prescription medication. It’s FDA-approved to treat locally advanced or metastatic urothelial cancer in adults. For this use, it’s given to adults who’ve received specific treatments for this condition in the past.

Urothelial cancer is a type of bladder cancer that affects the lining of your bladder and urinary tract. The term “locally advanced” means the cancer has grown through your bladder wall or spread to nearby lymph nodes only. And “metastatic” means the cancer has spread to other parts of your body.

Padcev should only be used in adults who have received both of the following treatments for urothelial cancer:

  • a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor
  • neoadjuvant* or adjuvant* chemotherapy that’s made from platinum

For examples of these types of treatments, see the “Padcev for bladder or urinary cancer” section below.

* Adjuvant treatment is therapy given after surgery, to treat tumor cells that are still in the body. Neoadjuvant treatment is therapy used to shrink a tumor before surgery is done.

Drug details

Padcev contains the active ingredient enfortumab vedotin-ejfv. This ingredient is an antibody-drug conjugate (ADC), meaning it consists of an antibody* that’s linked to an active drug. Padcev’s antibody carries the active chemotherapy drug. And the chemotherapy drug works to destroy urothelial cancer cells.

Padcev comes as a powder that’s mixed with water to form a solution. The solution is given by your healthcare provider as an intravenous (IV) infusion. An IV infusion means that the drug is injected into your vein, typically in your arm, over a period of time.

* An antibody is an immune system protein.

FDA approval

Padcev was approved by the FDA in 2019. It’s important to note that the drug received accelerated approval from the FDA.

Typically, drugs receive approval from the FDA after many clinical studies have been completed. But in special circumstances (as with Padcev), a drug may receive approval before all of the studies have been done.

Accelerated approval is granted for certain drugs used to treat conditions that don’t have many effective treatment options. For example, if you’ve had certain past treatments for locally advanced or metastatic urothelial cancer, there aren’t many effective treatment options for your condition.

When a drug receives accelerated approval, it’s generally expected that the drug’s final clinical studies will be completed within a specific amount of time, and final approval of the drug will be granted.

Effectiveness

For information about the effectiveness of Padcev, see the “Padcev for bladder or urinary cancer” section below.

Padcev contains the active drug enfortumab vedotin-ejfv. It’s 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.

Padcev can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Padcev. These lists do not include all possible side effects.

For more information about the possible side effects of Padcev, 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 they have approved. If you would like to notify the FDA about a side effect you’ve had with Padcev, you can do so through MedWatch.

Mild side effects

Mild side effects of Padcev can include*:

Talk with your doctor or pharmacist about ways to manage side effects during Padcev treatment. If you have side effects that become severe or don’t go away, let your doctor know.

* This is a partial list of mild side effects from Padcev. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Padcev’s patient information.
† This side effect is discussed in detail in the “Side effects details” section below.

Serious side effects

Serious side effects from Padcev can occur. Call your doctor right away if you have serious side effects. Or call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

If you think you’re having serious side effects while receiving doses of Padcev, tell a healthcare provider right away.

Serious side effects of Padcev, which are explained below in “Side effect details,” can include:

Note: In some cases, serious side effects were fatal. In clinical studies, 3.2% of people died due to side effects from Padcev. These side effects included acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis. For more information, see Padcev’s prescribing information.

Side effect details

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

Note: In the clinical trials of Padcev described in this section, people taking Padcev were not compared with people taking a placebo. (A placebo is a treatment with no active drug.) So, it isn’t known how many people in these trials may have had certain side effects while taking a placebo.

It’s important to note that your results from taking Padcev may vary from those seen in clinical studies. If you have questions about whether Padcev is right for you, talk with your doctor.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Padcev. However, it’s not known how many people taking Padcev during clinical studies may have had an allergic reaction to the drug.

Symptoms of a mild allergic reaction can include:

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

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

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

Call your doctor right away if you have an allergic reaction to Padcev, as the reaction could become severe. Make sure to call 911 or your local emergency number if you’re having trouble breathing or symptoms that feel life threatening, or if you think you’re having a medical emergency.

Severe skin reactions

It’s possible to experience severe skin reactions while using Padcev. Symptoms of a severe skin reaction can include:

  • a red rash occurring in skin folds
  • a rash with large, raised, fluid-filled blisters
  • exfoliative dermatitis (extreme reddening of the skin that causes itchiness and pain and leads to peeling)

In clinical trials, 54% of people taking Padcev had skin reactions. And severe skin reactions occurred in 10% of people taking the drug. Half of the people who had a severe skin reaction developed the reaction at least about 24 days after receiving a dose of Padcev.

Extravasation

Extravasation is a type of skin reaction that may occur with Padcev. In clinical trials of the drug, 1.3% of people had extravasation.

Extravasation occurs when a drug given by intravenous (IV) infusion leaks out of your vein and into the tissues around your infusion site. (With an IV infusion, the drug is injected into your vein, over a period of time.)

This reaction may occur right after an infusion of Padcev. Or, it may occur days later. Symptoms at the infusion site may include:

  • discomfort
  • itchiness
  • redness
  • swelling

Sometimes, symptoms of extravasation may develop or get worse 2 to 7 days after you have an infusion. But generally, symptoms resolve within 1 to 4 weeks.

If you have any symptoms of extravasation, contact your doctor right away. Or seek medical care at your closest emergency room or urgent care center right away.

Peripheral neuropathy

It’s possible to experience peripheral neuropathy while using Padcev. Peripheral neuropathy is a nerve problem that causes numbness or tingling in your hands or feet. It may also cause muscle weakness.

In clinical trials, 49% of people taking Padcev had peripheral neuropathy. After receiving a dose of Padcev, symptoms of peripheral neuropathy took anywhere from 8 days to more than 9 months to develop. In about 50% of people, symptoms had developed by 3.8 months (about 114 days) after starting Padcev treatment. Among the people who had peripheral neuropathy in trials:

  • 2% of people had peripheral neuropathy that was serious. This means their symptoms were intolerable, or they had significant loss of motor function, or both. (Motor function refers to using large muscle groups to do things such as walk and maintain your balance.)
  • 6% of people stopped taking Padcev due to peripheral neuropathy. Of this group of people, after they stopped taking the drug:
    • 19% had their peripheral neuropathy go away completely
    • 26% had their peripheral neuropathy at least partially improve

Your doctor will monitor you for peripheral neuropathy during Padcev treatment. If you have symptoms of this condition, tell your doctor right away. They may consider decreasing your dosage or pausing your treatment to see if your symptoms go away or improve.

If your doctor determines that your symptoms are serious, they’ll likely stop your Padcev treatment and recommend a different treatment for your condition.

Decreased appetite

Decreased appetite can occur with Padcev treatment. With decreased appetite, you don’t want to eat as much as usual. In clinical trials, this was a common side effect of Padcev. In fact, 52% of people receiving Padcev had a decreased appetite.

If your appetite is decreased while taking Padcev and this is bothersome to you, talk with your doctor. They’ll help determine the best way to manage this side effect and treat your condition.

Hair loss

Some people may experience alopecia (hair loss) while taking Padcev. In a clinical trial, 50% of people taking the drug had hair loss.

Hair loss is a common concern of people having cancer treatment. If you have hair loss that bothers you while you’re taking Padcev, talk with your doctor. They can help determine how to manage this side effect and treat your condition. And keep in mind that this side effect may go away on its own after you finish treatment with Padcev.

Eye problems

Eye problems are a possible side effect of Padcev. In clinical trials, 46% of people taking Padcev had some type of eye problem, including:

In about 50% of the people who had eye problems in clinical trials, their symptoms had developed by 1.9 months (about 57 days) after starting Padcev.

If you have blurry vision, dry eyes, or other eye problems while taking Padcev, contact your doctor right away. They’ll likely refer you to an ophthalmologist for an eye exam, especially if your symptoms don’t go away.

To treat eye symptoms, your doctor may recommend eye drops or a topical steroid (a steroid cream or ointment that’s applied to the eye). Your doctor may also lower your Padcev dosage, or have you take a drug other than Padcev.

High blood sugar level

Padcev may cause hyperglycemia (high blood sugar levels). And in rare cases, hyperglycemia can be life threatening. In one clinical trial, 8% of people developed high blood sugar that required hospitalization or that was fatal. It isn’t known exactly how many people in this trial had an increase in their blood sugar level, however.

Hyperglycemia can occur whether or not you have diabetes, as it did in this clinical trial.* The trial also found that people with a higher body mass index (BMI) were more likely to have high blood sugar. And people with diabetes may have a higher risk for hyperglycemia, especially serious hyperglycemia.

Symptoms of high blood sugar can include:

  • abdominal (belly) pain
  • blurry vision
  • confusion
  • breath that smells fruity
  • feeling more thirsty than usual
  • loss of appetite
  • nausea
  • needing to urinate more frequently than usual
  • vomiting

If you have symptoms of high blood sugar, contact your doctor right away. If your blood sugar is above 250 mg/dL†, your doctor will likely pause your Padcev treatment to see whether your blood sugar levels improve.

* Diabetes causes problems with how the body processes blood sugar. Only people who either didn’t have diabetes, or had mild or well-managed diabetes, participated in this trial.
† Blood sugar is measured in milligrams per deciliter (mg/dL). This refers to the amount of glucose (sugar) per unit of blood.

Diabetic ketoacidosis

Rarely, high blood sugar can lead to a serious condition called diabetic ketoacidosis (DKA).

DKA happens when cells in the body don’t get enough sugar to meet their energy needs. So the body begins to convert fat cells into energy, instead of converting sugar into energy. This creates chemicals called ketones in your blood. If too many ketones build up, your blood can become too acidic. Over time, this can cause symptoms of DKA, which can become dangerous.

DKA most often occurs in people who have diabetes. However, in a clinical trial involving people who either didn’t have diabetes or had diabetes that was mild or well managed, DKA developed in both groups of people. But it isn’t known exactly how many people in the trial had this side effect.

Symptoms of DKA can include:

If you think you might be having symptoms of DKA, contact your doctor or seek medical attention right away. DKA is a life threatening medical emergency that requires immediate treatment.

The Food and Drug Administration (FDA) approves prescription drugs such as Padcev to treat certain conditions. Padcev may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is used for a purpose other than what it’s approved for.

Padcev is FDA-approved to treat locally advanced or metastatic urothelial cancer in certain adults. Urothelial cancer, also called urothelial carcinoma, is a type of bladder cancer. It starts in your urothelial cells, which are found in the lining of your bladder and urinary tract. The urinary tract includes the parts of the body that help produce and drain urine.

The term “locally advanced” means the cancer has grown through your bladder wall or spread to nearby lymph nodes only. And “metastatic” means the cancer has spread to other parts of your body.

Padcev is only approved for use in adults who’ve received both of the following treatments for urothelial cancer:

  • a programmed death receptor-1 (PD-1) or programmed death-ligand 1 inhibitor (PD-L1), such as:
    • avelumab (Bavencio)
    • cemiplimab (Libtayo)
  • adjuvant or neoadjuvant treatment* with chemotherapy made from platinum, such as:
    • carboplatin
    • cisplatin
    • oxaliplatin (Eloxatin)

* Adjuvant treatment is therapy given after surgery to treat tumor cells that are still in the body. Neoadjuvant treatment is therapy used to shrink a tumor before surgery is done.

Effectiveness for bladder and urinary tract cancer

Clinical studies of Padcev’s effectiveness in treating locally advanced or metastatic urothelial cancer are ongoing at this time. It isn’t yet known whether Padcev improves overall survival in people with these types of cancer.

It also isn’t known yet whether Padcev increases the length of time that some people live without their cancer progressing (getting worse). This length of time is called progression-free survival. (For more information about ongoing clinical studies of Padcev, see the “What is Padcev?” section above.)

In one clinical study, 125 adults with locally advanced or metastatic urothelial cancer were given Padcev.* The study showed that 44% of people had their cancer respond to Padcev. Specifically:

  • 12% of people had a complete response to treatment. This means that certain tests no longer detected cancer in their body. But a complete response doesn’t necessarily mean that the cancer is cured. It’s possible for cancer to return after it’s had a complete response to a treatment.
  • 32% of people had a partial response to treatment. This means their tumor shrank in size, but it didn’t go away completely.
  • Half of people whose tumor responded to treatment maintained their response for just over 7.5 months. This means their tests continued to show either a complete or partial response for this period of time.

It’s important to note that treatment results can vary from person to person. And keep in mind that Padcev received accelerated approval for its approved uses.

Typically, drugs receive FDA approval after many clinical studies have been completed. But in special circumstances, as with Padcev, a drug may receive approval before all of the studies have been done. (For more information, see the “What is Padcev?” section above.)

* The people in this clinical study had previously received treatment with a PD-1 or PD-L1 inhibitor, and with chemotherapy made from platinum. In this study, no other treatments were compared with Padcev treatment.

Padcev and children

Padcev isn’t approved for use in children. The drug’s safety and effectiveness haven’t been studied in children. It’s only approved for use in people ages 18 years and older.

As with all medications, the cost of Padcev can vary. To find current prices for Padcev 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 and your location.

It‘s important to note that your doctor or healthcare provider will order Padcev for you. And you’ll receive doses of the drug in a medical facility. You won’t pick up this medication from a traditional pharmacy or administer it to yourself.

Before approving coverage for Padcev, 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 prior authorization for Padcev coverage, contact your insurance company.

Financial and insurance assistance

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

Astellas Pharma US, Inc. and Seattle Genetics, Inc., the manufacturers of Padcev, offer a program called Padcev Support Solutions. Through this program, you can find assistance in understanding your insurance coverage for Padcev. And you can learn about ways to lower the cost of Padcev.

For more information and to find out if you’re eligible for support, call 888-402-0627 or visit the program website.

Generic or biosimilar version

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

A biologic drug is made from living cells, while other drugs are made from chemicals. Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication.

Biologics, on the other hand, can’t be copied exactly. Therefore, instead of a generic, biologics have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe.

Like generics, biosimilars are often less expensive compared with brand-name medications.

Padcev is approved to treat locally advanced* or metastatic** urothelial cancer† in certain adults.‡ Urothelial cancer is a type of bladder cancer that affects the lining of your bladder and urinary tract. (For more information and symptoms, see the “Padcev for bladder or urinary tract cancer” section above.)

* The term “locally advanced” means the cancer has spread through your bladder wall or into local lymph nodes only.
** The term “metastatic” means the cancer has spread to other parts of your body.
† Urothelial cancer is a type of bladder cancer that affects the lining of your bladder and urinary tract.
‡ Padcev is only approved for use in adults who’ve received specific treatments for this condition in the past.

How cancer occurs

Cancer occurs when cells in your body grow and multiply uncontrollably due to a change in the cells’ genes. (Cells that multiply are making more cells.) Usually, your immune system can use proteins called antibodies to destroy these cancer cells before they grow too large.

However, some cancer cells can develop certain additional genetic changes that help the cells avoid your immune system. Being able to avoid the immune system makes the cancer cells more likely to grow and spread.

What Padcev does

Padcev contains the active ingredient enfortumab vedotin-ejfv. This active ingredient is an antibody-drug conjugate (ADC). This means it consists of active drug molecules that are linked to an antibody. (An antibody is an immune system protein.)

The antibody and active chemotherapy drug in Padcev work together to destroy urothelial cancer cells. Specifically:

  • The antibody binds (attaches) to a certain receptor (attachment site) called Nectin-4. This receptor is found on urothelial cancer cells.
  • Then the chemotherapy drug can enter and destroy the cancer cell. This chemotherapy drug is called monomethyl aurstatin E (MMAE).

How long does it take to work?

Padcev begins working as you soon as you receive a dose of the drug. You likely won’t “feel” the drug working, however. This is because of how the drug works over time to treat urothelial cancer.

In one clinical study, 44% of people had their cancer respond to Padcev. A “response” means their tumor either partially or completely went away. Also, half of people whose tumor responded to treatment maintained their response for just over 7.5 months. This means that certain tests continued to show either a complete or partial response over this period of time.

It’s important to note that treatment results can vary from person to person. If you have questions about what to expect from Padcev treatment, talk with your doctor. And for more information about Padcev’s effectiveness, see the “Padcev for bladder or urinary cancer” section above.

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

  • your body weight in kilograms (kg)
  • any side effects you have while taking the drug

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

Padcev contains the active ingredient enfortumab vedotin-ejfv. It comes as a powder that your healthcare provider will mix with water to form a solution. The solution is then given by your healthcare provider as an intravenous (IV) infusion. An IV infusion means that the drug is injected into your vein, typically in your arm, over a period of time.

Padcev powder comes in vials and is available in two strengths: 20 milligrams (mg) and 30 mg. When the powder is mixed with water, the resulting solution has a strength of 10 mg of Padcev per milliliter (mL).

Dosage for bladder and urinary tract cancer

Padcev is approved to treat locally advanced* or metastatic** urothelial cancer† in certain adults‡. For this use, the recommended Padcev dose is 1.25 mg/kg. But for people who weigh 100 kg (220 pounds) or more, the maximum dose of Padcev is 125 mg per infusion.

Padcev infusions are given in cycles. Each Padcev cycle lasts for 28 days. You’ll receive an infusion on days 1, 8, and 15 of your 28-day cycle.

For example, if a person weighing 70 kg (154 pounds) is prescribed a Padcev dose of 1.25 mg/kg, their dose would be 87.5 mg. They would receive this dose on days 1, 8, and 15 of every 28-day Padcev cycle their doctor prescribes.

Your doctor will determine how many cycles of Padcev infusions you should have. How many cycles you’ll have may be based on how effectively the drug treats your condition. Or your doctor may stop your treatment if you have side effects that you consider unacceptable.

* The term “locally advanced” means the cancer has spread through your bladder wall or into local lymph nodes only.
** The term “metastatic” means the cancer has spread to other parts of your body.
† Urothelial cancer is a type of bladder cancer that affects the lining of your bladder and urinary tract.
‡ Padcev is only approved for use in adults who’ve received specific treatments for this condition in the past.

What if I miss a dose?

If you miss an appointment to get your Padcev dose, contact your doctor right away. They’ll provide instructions about how to proceed and when you should get your next dose.

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

Will I need to use this drug long term?

It depends. Padcev is given for varying lengths of time depending on how your body responds to the drug. Padcev is meant to be used for as long as it effectively treats your condition or until you have side effects from the drug that you find intolerable.

Based on your side effects and how well the drug is working for you, your doctor will determine how many treatment cycles of Padcev you should have.

A healthcare provider administers Padcev. It’s given as an intravenous (IV) infusion. An IV infusion means that the drug is injected into your vein, typically in your arm, over a period of time.

Padcev infusions usually take about 30 minutes. A healthcare provider will give you this infusion at your doctor’s office or at a clinic.

When to take

Padcev infusions are given over periods of time called cycles. Each Padcev cycle lasts for 28 days. You’ll receive an infusion on days 1, 8, and 15 of your 28-day cycle.

Your doctor will determine how many cycles of Padcev infusions you should have. How many cycles you’ll have may be based on how effectively the drug treats your condition. Or your doctor may stop your treatment if you have side effects that you consider unacceptable.

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

Other drugs are available that can treat locally advanced* or metastatic** urothelial cancer†. Some of these drugs may be a better fit for you than others. If you’re interested in finding an alternative to Padcev, 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 use is when a drug that’s approved to treat one condition is used to treat a different condition.

Examples of other drugs that may be used to treat locally advanced or metastatic urothelial cancer include:

  • atezolizumab (Tecentriq)
  • avelumab (Bavencio)
  • durvalumab (Imfinzi)
  • nivolumab (Opdivo)
  • pembrolizumab (Keytruda)
  • platinum-based chemotherapy, such as cisplatin or oxaliplatin
  • taxane-based chemotherapy, such as docetaxel or paclitaxel

* The term “locally advanced” means the cancer has spread through your bladder wall or into local lymph nodes only.
** The term “metastatic” means the cancer has spread to other parts of your body.
† Urothelial cancer is a type of bladder cancer that affects the lining of your bladder and urinary tract.

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

Ingredients

Padcev contains the active drug enfortumab vedotin-ejfv. It belongs to a class of medications called antibody-drug conjugates (ADCs). A medication class is a group of drugs that work in similar ways.

On the other hand, Keytruda contains the active drug pembrolizumab. It belongs to a class of medications called PD-1 inhibitors.

Uses

Both Padcev and Keytruda are approved by the Food and Drug Administration (FDA) to treat locally advanced* or metastatic** urothelial cancer† in adults.

However, unlike Padcev, people who haven’t received chemotherapy and have certain types of tumors may still receive Keytruda. Padcev, on the other hand, is only approved for use in adults who’ve received specific treatments for this condition in the past.

In addition, Keytruda is also approved to treat:

* The term “locally advanced” means the cancer has spread through your bladder wall or into local lymph nodes only.
** The term “metastatic” means the cancer has spread to other parts of your body.
† Urothelial cancer is a type of bladder cancer that affects the lining of your bladder and urinary tract.

Drug forms and administration

Both Padcev and Keytruda come as a powder that’s mixed with water to form a solution. The solution is given by a healthcare provider as an intravenous (IV) infusion. An IV infusion means that the drug is injected into your vein, typically in your arm, over a period of time.

Both Padcev and Keytruda infusions typically last about 30 minutes.

Side effects and risks

Padcev and Keytruda 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, as well as mild side effects that both drugs may share.

Serious side effects

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

  • Can occur with Padcev:
    • eye problems
  • Can occur with Keytruda:
    • colitis (inflammation in your colon) caused by an immune system reaction
    • hepatitis (inflammation in your liver) caused by an immune system reaction
    • infusion reactions (an immune system reaction shortly after receiving a drug infusion)
    • nephritis (inflammation in your kidneys) caused by an immune system reaction
  • Can occur with both Padcev and Keytruda:
    • severe skin reactions

Effectiveness

Padcev and Keytruda are both used to treat locally advanced or metastatic urothelial cancer in adults.

These drugs haven’t been directly compared in clinical studies, but studies have found both Padcev and Keytruda to be effective for treating locally advanced and metastatic urothelial cancer.

Costs

According to estimates on WellRx.com, Padcev generally costs more than Keytruda. The actual price you’ll pay for either drug depends on:

  • your insurance plan
  • your location
  • the number of treatment cycles you receive, which can vary based on the condition either drug is used to treat

Padcev and Keytruda are only available as brand-name medications. There are no generic forms of Padcev or Keytruda at this time.

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

There aren’t any known interactions between Padcev and alcohol. However, drinking alcohol can make certain side effects of Padcev worse. These side effects may include:

For more information about other possible side effects, see the “Padcev side effects” section above.

If you drink alcohol, talk with your doctor. They can recommend whether there’s an amount of alcohol that’s safe for you to drink while you’re taking Padcev.

Padcev can interact with some other drugs and treatments.

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

Padcev and other medications

Below are examples of medications that can interact with Padcev. This section does not contain all drugs that may interact with Padcev.

Before taking Padcev, 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.

Padcev and strong CYP3A4 inhibitors

CYP3A4 is an enzyme (a type of protein). It helps your body metabolize (break down) drugs. Strong CYP3A4 inhibitors are drugs that work to inhibit (slow down) the activity of the CYP3A4 enzyme. So taking these medications with Padcev can slow down your body’s breakdown of Padcev.

Taking a strong CYP3A4 inhibitor drug with Padcev can increase the levels of Padcev in your body. This can also increase your risk for side effects from Padcev, or make your side effects more severe. (For more information about side effects, see the “Padcev side effects” section above.)

Examples of strong CYP3A4 inhibitors include:

  • certain antibiotics such as clarithromycin or erythromycin
  • antifungals such as ketoconazole and itraconazole (Sporanox)
  • antivirals such as ritonavir, saquinavir, or tipranavir

Talk with your doctor before taking Padcev if you’re taking any strong CYP3A4 inhibitors. If your doctor determines that Padcev is safe for you, they’ll likely monitor you more closely than usual for any side effects while you’re taking both drugs. Or they may decide to have you try a different medication.

Padcev and herbs and supplements

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

Padcev and foods

You should avoid eating grapefruit or drinking grapefruit juice while taking Padcev. Grapefruit can slow down the way your body normally metabolizes (breaks down) Padcev, which can increase your risk for side effects from the drug.

If you have questions about eating certain foods while you’re taking Padcev, talk with your doctor.

Padcev treatment shouldn’t be given during pregnancy. Although, animal studies don’t always predict what will happen in people, studies of pregnant animals showed that Padcev may cause harm to a developing fetus.

There aren’t any studies of Padcev use in humans during pregnancy. However, animal studies showed that Padcev caused harm to the pregnant female, birth defects in offspring, and miscarriage (loss of pregnancy). Doses given in animal studies were similar to those that are used in humans.

If you’re pregnant or planning to become pregnant, talk with your doctor. If you’re receiving Padcev and you become pregnant or think you may be pregnant, contact your doctor right away.

Padcev and fertility

Padcev may cause fertility problems (trouble getting someone pregnant) in males. In animal studies, the drug caused side effects such as reduced testicular weight and abnormal sperm production.

Doses of Padcev given in animal studies were considered similar to those recommended for humans (1.25 mg/kg). However, animal studies don’t always predict what will happen in people.

If you have questions about Padcev’s effect on fertility, talk with your doctor.

Padcev treatment shouldn’t be given 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 receiving Padcev.

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

For women taking Padcev

If you’re able to become pregnant, your doctor will have you take a pregnancy test before you start Padcev treatment. You should also use an effective method of birth control while taking the drug and for at least 2 months after your last dose.

For men taking Padcev

If you’re a man and your partner can become pregnant, you should use an effective method of birth control while taking Padcev. You should continue to use this birth control method for 4 months after your last dose. This is because Padcev can cause harm to a developing fetus if your partner becomes pregnant during or just after your treatment.

Padcev shouldn’t be taken while breastfeeding.

There aren’t any studies of Padcev use in humans while breastfeeding. And it isn’t known whether the drug can pass into human breast milk. However, there’s a risk of serious side effects in a child who’s breastfed and is exposed to Padcev.

Due to this risk, the drug’s manufacturer recommends that you don’t breastfeed during Padcev treatment. The manufacturer also recommends waiting at least 3 weeks after your last Padcev dose before breastfeeding your child.

If you have questions about taking Padcev while breastfeeding, talk with your doctor.

Here are answers to some frequently asked questions about Padcev.

Is Padcev a chemotherapy drug?

Padcev isn’t a traditional chemotherapy drug, but it does contain a chemotherapy drug.

Traditional chemotherapy drugs work by directly killing cells in the body that are multiplying rapidly, including cancer cells.

On the other hand, Padcev is an antibody-drug conjugate (ADC). It contains a chemotherapy agent called monomethyl aurstatin E (MMAE). MMAE is linked to an antibody (a type of protein). This antibody can attach to a certain protein (called Nectin-4) that’s found on urothelial cancer cells. (Urothelial cancer is a type of bladder cancer that affects the lining of your bladder and urinary tract.)

Then the MMAE can enter cancer cells and kill them.

Will Padcev cure my condition?

No, unfortunately, Padcev won’t cure your condition. There’s currently no known cure for urothelial cancer, which Padcev is used to treat. However, Padcev may help lengthen the amount of time you live without your cancer getting worse.

In one clinical study, 12% of people had a complete response to Padcev treatment. This means tests no longer detected cancer in their body. But a complete response doesn’t necessarily mean that the cancer is cured.

It’s possible for cancer to return after a complete response to a treatment. It’s also important to note that your results from taking Padcev may vary from those seen in clinical studies.

Talk with your doctor if you have questions about what to expect from Padcev treatment. And for more information about Padcev’s effectiveness, see the “Padcev for bladder or urinary cancer” section above.

If I have diabetes, can I take Padcev?

Maybe. If you have diabetes, you may be able to take Padcev if your doctor determines that the drug is safe for you.

But keep in mind that Padcev may cause hyperglycemia (high blood sugar levels) in some people.

In a clinical trial, 8% of people had serious increases in their blood sugar level while taking Padcev. It isn’t known exactly how many people in this trial had an increase in their blood sugar level, however.* (For more information about high blood sugar in this clinical trial and possible symptoms of hyperglycemia, see the “Padcev side effects” section above.)

If you have diabetes and your doctor determines that Padcev is safe for you to take, your doctor may have you monitor you blood sugar more often than usual. Your blood sugar level will likely be checked on the day of your infusions, too. If your blood sugar is above 250 mg/dL, your doctor will likely pause your Padcev treatment to see whether your blood sugar levels improve.

If you have questions about whether it’s safe for you to take Padcev due to diabetes or other medical conditions you have, talk with your doctor. And if you develop symptoms of hyperglycemia while taking Padcev, call your doctor right away.

* Only people who either didn’t have diabetes, or had mild or controlled diabetes, participated in this trial.

Is Padcev safe for older people to use?

Yes, in general, Padcev is safe for older adults to take.

There aren’t any known differences in how safe or effective Padcev is for treating urothelial cancer in older people, compared with younger people. (Urothelial cancer is a type of bladder cancer that affects the lining of your bladder and urinary tract.)

In clinical studies of Padcev, 60% of people were 65 years or older. And 26% of people in trials were 75 years or older.

If you have questions about whether Padcev is safe for you to take based on your age, talk with your doctor.

Will I need to have lab tests done while I’m taking Padcev?

Probably. There aren’t any lab tests specific to Padcev that you’ll need to have done while taking the drug. But your doctor may recommend lab tests during Padcev treatment to monitor how your body responds to the drug.

Also, if you’re at risk for high blood sugar or if you have diabetes, your doctor may have you monitor your blood sugar more often than usual during Padcev treatment. For more information about tests you may have done during Padcev treatment, talk with your doctor.

Can I take Padcev if I have liver damage?

Maybe. But it depends on the severity of your liver damage.

People with mild liver damage may be able to take Padcev. But, the drug shouldn’t be used in people who have moderate or severe liver damage. Although Padcev hasn’t been studied in these groups of people, drugs similar to Padcev have caused severe side effects in people with moderate to severe liver damage.

Talk with your doctor if you have questions about whether your liver is healthy enough for you to take Padcev.

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

  • Diabetes. Padcev may cause hyperglycemia (high blood sugar levels). The drug can cause this side effect in people with or without diabetes. But people with diabetes may have a higher risk for developing hyperglycemia and a higher risk for serious hyperglycemia. Be sure to tell your doctor if you have diabetes before starting treatment with Padcev. Your doctor can determine whether Padcev is safe for you.
  • Liver damage. Padcev isn’t safe for use in people who have moderate or severe liver damage. Drugs similar to Padcev have caused serious side effects when used in people who have moderate or severe liver damage. Before taking Padcev, tell your doctor about any liver damage you may have.
  • Peripheral neuropathy. Peripheral neuropathy (nerve damage in your arms and legs) is a possible side effect of Padcev. If you’re currently experiencing symptoms of peripheral neuropathy, starting Padcev could make the condition worse. These symptoms include numbness or tingling in your hands or feet. Be sure to tell your doctor if you have peripheral neuropathy before taking Padcev.
  • Allergic reaction. If you’ve had an allergic reaction to Padcev or any of its ingredients, you shouldn’t take Padcev. Ask your doctor what other medications might be better options for you.
  • Pregnancy. Padcev shouldn’t be used during pregnancy. For more information, see the “Padcev and pregnancy” section above.
  • Breastfeeding. Padcev shouldn’t be taken while breastfeeding. For more information, see the “Padcev and breastfeeding” section above.

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

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

Indications

Padcev was granted accelerated approval in 2019 by the Food and Drug Administration (FDA). The drug may be used in adults who have urothelial cancer that’s either locally advanced or metastatic, and who have had past treatment with both:

  • a programmed death receptor-1 (pd-1) inhibitor or programmed death-ligand 1 (pd-l1) inhibitor, and
  • platinum-containing chemotherapy, in the adjuvant/neoadjuvant, locally advanced, or metastatic setting

Administration

Padcev should be given by intravenous infusion only. Padcev should not be mixed or administered with any other drug.

Padcev is available in two different strengths: 20 milligram (mg) and 30 mg. It comes as a white powder in single-use vials.

Padcev powder must be reconstituted with sterile water for injection (SWFI). The reconstituted solution may be diluted in a bag of normal saline, 5% dextrose for injection, or lactated ringer’s. Infuse Padcev through an IV line over 30 minutes.

Padcev is a cytotoxic drug requiring special handling and disposal procedures. Follow Occupational Safety and Health Administration (OSHA) guidelines for handling of hazardous drugs.

Mechanism of action

Padcev contains the active drug enfortumab vedotin-ejfv, which belongs to a class of medications called antibody-drug conjugates (ADCs). The IgG antibody targets Nectin-4, which is found on the surface of urothelial cancer cells. It delivers monomethyl aurstatin E (MMAE) molecules, a microtubule-disrupting chemotherapy drug that induces apoptosis in cancer cells.

Pharmacokinetics and metabolism

Peak MMAE levels are reached about two days following infusion. Steady-state for both the ADC and MMAE are reached after completion of one treatment cycle. The antibody component of Padcev has an elimination half-life of just under 3.5 days, while MMAE has an elimination half-life just under 2.5 days.

MMAE is primarily metabolized by CYP3A4.

Contraindications

There are no known contraindications to Padcev.

Storage

If reconstituted solution isn’t immediately used, store vials for up to 4 hours in the refrigerator at a temperature of 36°F to 46°F (2°C to 8°C). Do not freeze this solution.

If not used immediately, store prepared infusion bags for up to 8 hours in the refrigerator at a temperature of 36°F to 46°F (2°C to 8°C). Do not freeze this solution.

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.