Votrient (pazopanib)

What is Votrient?

Votrient is a brand-name prescription medication. It’s FDA-approved for use in adults to treat advanced forms of:

• Renal cell carcinoma, which is a type of kidney cancer.
• Soft tissue sarcoma,* which is cancer that develops in soft tissue such as muscles, tendons, nerves, or blood vessels. Votrient is approved to treat soft tissue sarcoma in people who’ve had chemotherapy for their sarcoma.

Cancer is described as “advanced” if it has spread from its original site to other parts of the body.

For more information, see the “Votrient uses” section below.

* Note: It’s not known if Votrient is effective for treating certain types of soft tissue sarcoma. These types are adipocytic sarcoma (cancer that develops in fat tissue) and gastrointestinal stromal tumors (cancer that develops in the stomach or intestines).

Drug details

Votrient contains the active ingredient pazopanib. It belongs to a drug class called tyrosine kinase inhibitors. (A drug class describes a group of medications that work in a similar way.)

Votrient is a targeted therapy for cancer. This means it “targets” and attacks certain proteins that are helping the cancer to grow and spread.

Votrient comes as an oral tablet. It’s available in one strength: 200 milligrams (mg).

Effectiveness

For information about the effectiveness of Votrient, see the “Votrient uses” section below.

Votrient generic or biosimilar

Votrient 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.

Votrient contains the active drug pazopanib.

Votrient side effects

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

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

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 Votrient, you can do so through MedWatch.

Mild side effects

Mild side effects* that have been reported with Votrient use include:

• diarrhea
• nausea and vomiting
• color changes of your skin and hair†
• fatigue (lack of energy)
• headache
• loss of appetite
• weight loss
• change in your sense of taste (may cause a sour, bitter, or metallic taste in your mouth)
• hair loss
• pain in your muscles or bones
• belly pain
• rash
• weakness

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

Serious side effects

Serious side effects from Votrient 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 that have been reported with Votrient use include:

• Bleeding problems. Symptoms can include:
  • bruising more easily than usual
  • bleeding, such as nosebleeds, bleeding gums, or bleeding that won’t stop
  • wounds that don’t heal
  • coughing up blood
  • blood in your stool, which may look red, black, or tar-like
  • blood in your urine, which may look pink or brown
  • sudden, severe headache
• Heart problems, such as slow heart rate, long QT syndrome (a type of abnormal heart rhythm), or heart failure. Symptoms vary by condition and can include:
  • shortness of breath
  • swollen ankles or feet
  • dizziness
  • fainting
  • a fluttering feeling in your chest
• Blood clot in an artery, which may cause a heart attack or stroke. Symptoms vary by location of the blood clot and can include:
  • chest pain that may spread to your arm, back, neck, or jaw
  • shortness of breath
  • dizziness
  • numbness or weakness on one side of your body, especially your face or arm
  • trouble speaking
• Blood clot in a vein, which may cause deep vein thrombosis or pulmonary embolism. Symptoms vary by location of the blood clot and can include:
  • pain, skin discoloration, or swelling in a leg or arm
  • sudden shortness of breath
  • chest pain
• Thrombotic microangiopathy (blood clots in small blood vessels, which can damage organs such as the kidneys or brain). Symptoms vary by location of the blood clots and can include:
  • bruising or bleeding more easily than usual
  • urinating less than usual
  • confusion
  • fatigue
• Gastrointestinal perforation (tear in your stomach or intestines) or fistula (abnormal connection between two parts of your intestines). Symptoms can include:
  • pain or swelling in your belly
  • vomiting blood
  • black or tar-like stools
• Lung problems, such as interstitial lung disease or pneumonitis (both of which can cause inflammation or scarring in your lungs). Symptoms can include:
  • cough
  • shortness of breath
• Posterior reversible encephalopathy syndrome, which causes swelling in your brain. Symptoms can include:
  • headache
  • confusion
  • trouble thinking or speaking
  • changes in vision, including loss of vision
  • seizures
• Hypothyroidism (underactive thyroid). Symptoms can include:
  • fatigue
  • weight gain
  • feeling cold
  • constipation
  • dry skin
• Tumor lysis syndrome (a condition that can occur when rapidly dying cancer cells release harmful chemicals into your blood). Symptoms can include:
  • urinating less than usual
  • muscle cramps or spasms
  • confusion
  • irregular heartbeat
  • seizures
• Infections. Symptoms can include:
  • fever
  • sore throat
  • cough
  • pain when urinating
  • red or swollen cuts or wounds
• Protein in your urine, which can be an early sign of kidney problems.
• Allergic reaction.*
• High blood pressure.*
• Liver damage.*†

* For more information about this side effect, see “Side effect details” below.
† Votrient has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Side effect details

Here’s some detail on certain side effects this drug may cause.

High blood pressure

Some people may have high blood pressure while taking Votrient. This was one of the most common side effects of Votrient seen in clinical studies. High blood pressure increases the risk of heart failure, heart attack, and stroke. To find out how often high blood pressure occurred in clinical studies, see Votrient’s prescribing information.

Your doctor will check your blood pressure before you start Votrient treatment to make sure the drug is safe for you to take. If you have high blood pressure, you’ll likely need to take medication to control it before you can start taking Votrient. High blood pressure doesn’t usually cause symptoms. So your doctor will monitor your blood pressure while you’re taking Votrient to make sure it’s still under control.

If you have high blood pressure while taking Votrient, your doctor may reduce your dosage or have you stop treatment for a while. They may also prescribe medication to help control your blood pressure. But if your blood pressure doesn’t improve or is very high, you may need to stop taking Votrient permanently.

On rare occasions, Votrient can cause a sudden, severe increase in blood pressure called a hypertensive crisis. This condition can be life threatening.

Symptoms of a hypertensive crisis can include:

• severe headache
• severe chest pain
• blurred vision
• nausea and vomiting
• shortness of breath
• confusion
• severe anxiety
• seizures
• loss of consciousness

If you have these symptoms while taking Votrient, call your doctor right away. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Liver damage

Votrient can sometimes cause liver damage that can lead, in rare cases, to severe or fatal liver problems, such as liver failure.* You may be more likely to have liver damage with Votrient if you’re older than age 65 years.

Liver damage can be spotted early with blood tests called liver function tests. These measure the levels of liver enzymes in your blood. Liver enzymes are proteins that help your liver carry out its usual functions. If blood tests show you have elevated liver enzymes, this means that cells in your liver are damaged.

In clinical studies, raised liver enzymes commonly occurred in people taking Votrient. But severe liver damage, liver failure, and death were rare. To find out how often these side effects occurred in clinical studies, see Votrient’s prescribing information.

Your doctor will check your liver function before you start Votrient to make sure the drug is safe for you to take. You’ll also have frequent blood tests to check your liver while you’re taking Votrient.

Although liver problems are usually detected in blood tests, they can sometimes cause symptoms as well. See your doctor right away if you have any symptoms of liver problems while taking Votrient. These may include:

• nausea and vomiting
• pain in the upper right part of your belly
• bruising more easily than usual
• dark-colored urine
• jaundice (yellowing of your skin or the whites of your eyes)
• loss of appetite

If you have liver problems while taking Votrient, your doctor may decrease your dosage or ask you to stop treatment for a while. This can allow your liver to recover. But if your liver doesn’t improve, or if you have severe liver problems, you may need to stop Votrient permanently.

* Votrient has a boxed warning for liver damage. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Color changes of your skin and hair

You may have changes in the color of your hair or skin while taking Votrient. These changes typically mean your skin or hair loses pigmentation and becomes lighter in color. Your hair may become white.

Skin and hair color changes were among the most common side effects reported with Votrient in clinical studies. To find out how often these side effects occurred in clinical studies, see the drug’s prescribing information.

Skin and hair color changes with Votrient aren’t harmful. But if you find them bothersome, talk with your doctor. They may be able to recommend ways to help manage these side effects. For example, you may be able to use natural hair dyes to color hair that’s turned white.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Votrient. Symptoms of a mild allergic reaction can include:

• rash
• itchiness
• flushing (warmth or redness/deepening of skin color for a brief time)

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 Votrient, 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.

Votrient cost

As with all medications, the cost of Votrient 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 Votrient. 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, check with your doctor or your insurance company.

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

Financial and insurance assistance

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

Novartis Pharmaceuticals Corporation, the manufacturer of Votrient, offers a copay card that may lower the cost of their drug. They also offer a program called Patient Assistance Now Oncology (PANO) that provides financial support.

For more information about the copay card, call 877-577-7756. And to find out if you’re eligible for support through PANO, call 800-282-7630. Or visit the manufacturer’s site to learn more about both options.

Generic or biosimilar version

Votrient 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.

Votrient dosage

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

• how well your liver works
• other medications you may take
• certain side effects you may have

The following information describes the dosage commonly used to treat renal cell carcinoma and soft tissue sarcoma. (Renal cell carcinoma is a type of kidney cancer. Soft tissue sarcoma is cancer in the soft tissue, such as the muscles, tendons, nerves, or blood vessels.)

But 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

Votrient comes as a tablet that you take by mouth. It’s available in one strength: 200 milligrams (mg).

Dosage for renal cell carcinoma or soft tissue sarcoma

The usual dosage of Votrient for both advanced renal cell carcinoma and advanced soft tissue carcinoma is the same. You’ll likely take 800 mg (four tablets) once per day.

What if I miss a dose?

If you miss a dose and it’s more than 12 hours until your next dose is due, take the missed dose. Then continue with your usual dosing schedule.

But if you miss a dose and it’s less than 12 hours until your next dose is due, skip the missed dose. Then continue with your usual dosing schedule.

Never take two doses together to make up for a missed dose.

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

Will I need to use this drug long term?

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

Common questions about Votrient

Here are answers to some frequently asked questions about Votrient.

What’s the success rate of Votrient treatment?

In clinical studies, Votrient was found to be effective at extending progression-free survival (PFS) in people with:

• renal cell carcinoma, which is a type of kidney cancer
• soft tissue sarcoma, which is cancer in soft tissue (such as muscles, tendons, nerves, and blood vessels)

PFS is the length of time that you live without the cancer growing or spreading further. To read about the success rates of Votrient in clinical studies, see Votrient’s prescribing information.

It’s important to note that everyone’s situation is different, and your results from Votrient may not be the same as those seen in clinical studies. How well Votrient works for you will depend on many factors. These include:

• the type of cancer you have
• the stage of your cancer when first diagnosed (a stage is an assessment of the location and amount of cancer in your body)
• how far the cancer has spread
• other treatments you may be having
• side effects you may have
• your overall health

You can talk with your doctor about what results you might expect from taking Votrient.

Will Votrient cure my cancer?

No, there is currently no cure for cancer. But taking Votrient may help delay the progression of your cancer.

A few people may have a complete response with Votrient. This means the cancer goes away completely. But a complete response doesn’t mean that the cancer is cured. Cancer can still come back after a complete response to treatment.

Talk with your doctor about what results you might expect from treatment with Votrient.

Do I need to follow a certain diet while I’m taking Votrient?

No, there’s no specific diet you need to follow while you’re taking Votrient. But if you have certain side effects from taking Votrient, making changes to your diet can sometimes help.

For example, loss of appetite can be helped by eating small meals often instead of having three main meals per day. This can help you keep up your strength and energy. Eating small amounts often can also help reduce nausea and vomiting. Other ways to help reduce nausea and vomiting include avoiding fatty, greasy, and spicy foods, and sipping water regularly throughout the day.

Diarrhea can be helped by avoiding foods that contain high amounts of fiber, such as raw fruits and vegetables. If you do get diarrhea, be sure to drink plenty of fluids.

The American Cancer Society offers general advice on how you can eat well while your cancer is being treated. By following a healthy diet, you can help your body function better. You may be able to cope with side effects better, too. But you should also ask your healthcare provider or dietitian for advice about the diet that’s best for you while you’re taking Votrient.

Keep in mind that you should avoid eating grapefruit and drinking grapefruit juice while you’re taking Votrient. Grapefruit can raise the level of Votrient in your blood, which can increase your risk for side effects from the drug.

Is Votrient used for ovarian cancer?

Yes, Votrient might be used off-label for ovarian cancer in certain cases. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the Food and Drug Administration (FDA).

Votrient isn’t FDA-approved for treating ovarian cancer. But pazopanib (the active drug in Votrient) is recommended as a treatment option for certain forms of ovarian cancer in guidelines from the National Comprehensive Cancer Network.

If you’re interested in taking Votrient for ovarian cancer, talk with your doctor.

Does Votrient shrink tumors?

It might. Votrient has been shown to slow the growth and spread of renal cell carcinoma and soft tissue sarcoma. (Renal cell carcinoma is a type of kidney cancer. Soft tissue sarcoma is cancer of the soft tissue, such as muscles, tendons, nerves, and blood vessels.) Votrient may also help shrink these types of tumors.

Talk with your doctor about what you can expect from Votrient treatment.

Can I have dental work done while I’m taking Votrient?

You may be able to, but it depends on the type of dental work you need.

It’s usually safe to have minor dental work while you’re taking Votrient. Procedures such as scaling (deep cleaning) and polishing are typically safe. But if you need dental surgery, you may need to stop taking Votrient 1 week before the surgery. This is because Votrient can cause delayed wound healing. It can also increase the risk of serious bleeding. Your doctor will tell you when to start taking Votrient again after you’ve had dental surgery.

Certain cancer treatments can cause a side effect called osteonecrosis of the jaw. This is a breakdown of the bone cells in your jaw. Although this condition is often triggered by dental work, Votrient is not known to cause this side effect.

If you need to have dental work done, be sure to talk with your doctor first. They can recommend whether dental work is safe for you or if you’ll need to stop taking Votrient for a while. And make sure to tell your dentist that you’re taking Votrient.

Votrient uses

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

Votrient for renal cell carcinoma

Votrient is a brand-name prescription medication. It’s FDA-approved for use in adults to treat advanced forms of renal cell carcinoma, a type of kidney cancer.

Cancer is described as “advanced” if it has spread from its original site to other parts of the body.

Symptoms of renal cell carcinoma may include:

• blood in your urine, which can make your urine pink
• pain in your side or lower back
• a lump in your side or lower back
• fatigue (lack of energy)
• loss of appetite
• loss of weight for no known reason

Advanced renal cell carcinoma may also have other symptoms, depending on where in your body the cancer has spread.

Effectiveness for renal cell carcinoma

Votrient has been found to be effective for treating advanced renal cell carcinoma. The drug is included as a treatment option for this type of cancer in guidelines from the National Comprehensive Cancer Network. For information on how well Votrient worked in clinical studies, see the drug’s prescribing information.

Votrient for soft tissue sarcoma

Votrient is a brand-name prescription medication. It’s FDA-approved to treat advanced soft tissue sarcoma in adults who’ve had chemotherapy for their cancer.

“Advanced” means that the cancer has spread from its original site to other parts of the body. Soft tissue carcinoma may spread to organs such as the lungs, liver, or brain. It can also spread to the bones and lymph nodes.

Soft tissue sarcoma is a rare type of cancer that develops in soft tissue.* This includes muscles, nerves, blood vessels, and deep skin tissue. It also includes fibrous tissue, such as ligaments and tendons. (Fibrous tissue is made of strong fibers that support and cushion bones and organs.) Soft tissue sarcoma can occur anywhere in the body, but it most commonly develops in the arms, legs, chest, or belly.

Symptoms of soft tissue sarcoma depend on where in the body the cancer started and where it has spread. A common symptom is a lump under the skin.

Effectiveness for soft tissue sarcoma

Votrient has been found to be effective for treating advanced soft tissue sarcoma. The drug is included as a treatment option for this type of cancer in guidelines from the National Comprehensive Cancer Network. For information on how effective Votrient was in clinical studies, see the drug’s prescribing information.

* Note: It’s not known if Votrient is effective for treating certain types of soft tissue sarcoma. These types are adipocytic sarcoma (cancer that develops in fat tissue) and gastrointestinal stromal tumors (cancer that develops in the stomach or intestines).

Votrient and children

It’s not known if Votrient is safe or effective for treating renal cell carcinoma (a type of kidney cancer) or soft tissue sarcoma in children. It’s not approved for use in children.

Votrient and alcohol

Votrient isn’t known to interact with alcohol. But if you have certain side effects with Votrient, drinking alcohol could make them worse. These include headache, diarrhea, and nausea.

Votrient can also cause liver damage,* which could be made worse by drinking alcohol.

If you drink alcohol, talk with your doctor about how much is safe for you to drink while you’re taking Votrient.

To read more about the side effects of Votrient, see the “Votrient side effects” section above.

* Votrient has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Votrient interactions

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

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

Votrient and other medications

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

Before taking Votrient, 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.

Types of drugs that can interact with Votrient include those listed below.

CYP3A4 inhibitors

CYP3A4 is an enzyme (protein) in your liver that helps your body break down certain drugs, including Votrient. Drugs that are CYP3A4 inhibitors can stop this enzyme from working properly. Taking Votrient with CYP3A4 inhibitors can raise your risk for having side effects with Votrient. Your doctor may prescribe a lower dose of Votrient if you need to take one of these drugs with Votrient. They may also recommend that you avoid certain medications while taking Votrient.

• CYP3A4 inhibitors you should not take with Votrient include:
  • certain antibiotics, such as:
    • erythromycin
  • certain antifungals, such as:
    • ketoconazole
    • itraconazole (Sporanox)
  • certain HIV medications, such as:
    • atazanavir (Reyataz)
    • cobicistat (Tybost)
    • darunavir (Prezista)
    • ritonavir (Norvir)
• CYP3A4 inhibitors you may be able to take with Votrient include:
  • certain antifungals, such as:
    • posaconazole (Noxafil)
    • voriconazole (Vfend)
  • the antidepressant nefazodone

CYP3A4 inducers

CYP3A4 is an enzyme (protein) in your liver that helps your body break down certain drugs, including Votrient. Drugs that are CYP3A4 inducers can make this enzyme more active. Taking Votrient with drugs that are strong CYP3A4 inducers can make Votrient less effective. Votrient is not usually recommended if you take one of these drugs. Examples of these drugs include:

• certain antimicrobials, such as:
  • rifabutin (Mycobutin)
  • rifampin (Rifadin)
  • rifapentine (Priftin)
• certain seizure medications, such as:
  • carbamazepine (Carbatrol, Equetro, Tegretol)
  • fosphenytoin (Cerebyx)
  • phenobarbital
  • phenytoin (Dilantin, Phenytek)

P-gp or BCRP inhibitors

P-gp and BCRP are proteins that transport certain drugs out of cells in your body. Taking Votrient with drugs that inhibit (block) these proteins can increase the risk of side effects with Votrient. Votrient is not usually recommended if you take one of these drugs. Examples of these drugs include:

• ranolazine (Ranexa)
• dronedarone (Multaq)
• verapamil (Verelan, Calan SR)
• cyclosporine (Gengraf, Neoral, Sandimmune)

Drugs that reduce stomach acid*

These drugs may be used to treat indigestion, heartburn, acid reflux, or stomach ulcers. Taking Votrient with these drugs can make Votrient less effective. They are not usually recommended with Votrient. Examples of these drugs include:

• proton pump inhibitors, such as:
  • esomeprazole (Nexium)
  • lansoprazole (Prevacid)
  • pantoprazole (Protonix)
• H2 antagonists, such as:
  • cimetidine (Tagamet)
• antacids, such as:
  • aluminium hydroxide, magnesium trisilicate (Gaviscon)
  • calcium carbonate, magnesium hydroxide, simethicone (Rolaids Advanced, Mylanta Tonight)
  • calcium carbonate (TUMS)

* If you need to take one of these drugs with Votrient, talk with your doctor or pharmacist. They can tell you whether you need to adjust your dosage of Votrient or if you need to take it separately from the other medications.

Drugs that cause long QT syndrome

Long QT syndrome is a type of abnormal heart rhythm. It may be a side effect of certain drugs, including Votrient. Taking Votrient with other drugs that can cause long QT syndrome can raise your risk for this side effect. Votrient is not usually recommended if you take one of these drugs. Examples of these drugs include:

• certain drugs to treat irregular heartbeats, such as:
  • amiodarone (Pacerone)
  • quinidine
  • sotalol (Sotylize, Betapace, Betapace AF, Sorine)
  • disopyramide (Norpace)
• certain antipsychotic drugs, such as:
  • pimozide
  • haloperidol
  • quetiapine (Seroquel, Seroquel XR)
  • ziprasidone (Geodon)
• certain antibiotics, such as:
  • moxifloxacin (Avelox)
  • clarithromycin

Simvastatin (Zocor)

Simvastatin is a drug used to treat high cholesterol. Taking Votrient with simvastatin can increase your risk for side effects affecting your liver.

Votrient and herbs and supplements

Taking St. John’s wort with Votrient may lower the level of Votrient in your body. You shouldn’t use St. John’s wort with Votrient, as it could make Votrient less effective.

Check with your doctor or pharmacist before using any other herbs or supplements while taking Votrient.

Votrient and foods

It’s important to note that you should avoid eating at least 1 hour before and 2 hours after taking Votrient. This is because taking Votrient with food lowers the level of the drug in your body, which may make it less effective.

While taking Votrient, you should also avoid eating grapefruit and drinking grapefruit juice. Grapefruit can raise the level of Votrient in your blood, which can increase your risk for the drug’s side effects.

How to take Votrient

You should take Votrient according to your doctor’s instructions.

When to take

Votrient should be taken once per day. You should take it at least 1 hour before or 2 hours after a meal.

You can take your daily dose at any time that fits best with your schedule. But you should try to always take it at the same time each day. Talk with your pharmacist if you have questions about when to take Votrient.

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

Taking Votrient with food

Votrient shouldn’t be taken with food. You should take your daily dose at least 1 hour before or 2 hours after a meal.

Can Votrient be crushed, split, or chewed?

No, Votrient should not be crushed, split, or chewed. You should swallow the tablets whole. Taking them with a drink will help make this easier. Talk with your doctor or pharmacist if you have trouble swallowing Votrient tablets whole.

How Votrient works

Votrient is used to treat advanced forms of renal cell carcinoma, which is a type of kidney cancer. It is also used to treat soft tissue sarcoma.

Soft tissue sarcoma is a rare type of cancer that develops in soft tissue. This includes muscles, nerves, blood vessels, and deep skin tissue. It also includes fibrous tissue, such as ligaments and tendons. (Fibrous tissue is made of strong fibers that support and cushion bones and organs.)

Advanced forms of these cancers have spread from their original site to other parts of the body.

What Votrient does

Votrient is a targeted therapy for cancer. This means it “targets” and attacks certain proteins that are helping the cancer to grow and spread.

Votrient belongs to a class of drugs called tyrosine kinase inhibitors. The medication blocks the action of several different enzymes called kinases. Enzymes are proteins that help chemical reactions happen inside cells. Votrient blocks kinases that are involved with certain sites on cells called vascular endothelial growth factor (VEGF) receptors.

VEGF receptors help tumors form new blood vessels. The blood vessels supply the tumor cells with oxygen and nutrients, helping the tumor to grow and spread. By blocking kinases associated with VEGF receptors, Votrient stops the tumor from forming new blood vessels.

Votrient also blocks certain other kinases that are involved in helping tumor cells grow and spread. By blocking these different kinases, Votrient helps slow the growth and spread of renal cell carcinoma and soft tissue sarcoma. Votrient can also block these kinases in healthy cells, which is why it may cause certain side effects. For example, Votrient can slow wound healing and increase the risk of bleeding.

Because of Votrient’s half-life,* these effects can last for about a week after you stop taking the drug. For this reason, you’ll need to stop taking Votrient about 1 week before planned surgery to avoid problems with bleeding or wound healing. To read more about the side effects of Votrient, see “Votrient side effects” above.

How long does it take to work?

Votrient starts working soon after you take your first dose. But you’re unlikely to notice it working. Your doctor may order various blood tests or scans throughout your treatment to check if the medication is working for you.

Votrient and pregnancy

Votrient isn’t safe to take during pregnancy. Although Votrient hasn’t been studied in pregnancy, based on how it works, it’s likely to harm the fetus if used during pregnancy. In animal studies, Votrient was found to cause birth defects and pregnancy loss.

If you’re able to become pregnant, you’ll need to have a pregnancy test before starting Votrient to make sure you’re not pregnant.

If you’re sexually active and you or your partner can become pregnant, you should use an effective form of birth control to help prevent pregnancy while taking Votrient. You should also continue using birth control for 2 weeks after completing treatment.

See the section below called “Votrient and birth control” for more details.

If you’re pregnant or planning to become pregnant, talk with your doctor. They’ll likely recommend a treatment other than Votrient.

Votrient and fertility

Votrient may reduce your fertility, which means it can affect your ability to have a child in the future. In animal studies, Votrient was found to reduce male and female fertility.

If you plan to have children in the future, talk with your doctor about the treatment options available to you.

Keep in mind that even though Votrient may reduce fertility, it’s still important to use birth control while you take this treatment. See the section below called “Votrient and birth control” for more details.

Votrient and birth control

Votrient isn’t 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 Votrient.

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

For females* using Votrient

If you are able to get pregnant, you should use an effective form of birth control while you take Votrient. You should also use it for 2 weeks after your last dose. Effective forms of birth control include the birth control pill, patch, or injection.

For males* using Votrient

If your partner could get pregnant, you should use condoms while you take Votrient. You should also use them for 2 weeks after you take your last dose. This guidance applies even if you’ve had a vasectomy. This is because in rare cases, vasectomies may not be effective.

* In this article, we use the terms “male” and “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.

Votrient and breastfeeding

It isn’t known if Votrient passes into breast milk. But if it does, it could cause serious side effects in a child who is breastfed.

You should not breastfeed while you’re taking Votrient or for 2 weeks after your last dose.

If you’re breastfeeding or planning to breastfeed, talk with your doctor about the best way to feed your child while you’re taking Votrient.

Votrient precautions

This drug comes with several precautions.

FDA warning: Liver damage

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

Votrient can sometimes cause severe or even fatal liver damage. You’ll have blood tests to check your liver before you start taking Votrient, then regularly throughout your treatment. If you have a problem with your liver, your doctor may reduce your Votrient dose or ask you to stop treatment for a while. If you have severe liver problems, you may need to stop Votrient permanently.

Symptoms of liver problems may include:

• nausea and vomiting
• pain in the upper right part of your belly
• bruising more easily than usual
• dark-colored urine
• jaundice (yellowing of your skin or the whites of your eyes)
• loss of appetite

Contact your doctor right away if you have any of these symptoms while taking Votrient.

Other precautions

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

• High blood pressure. Votrient can cause high blood pressure, which can raise your risk for heart problems and stroke. If you have high blood pressure, your doctor will likely prescribe medication to help control it before you start Votrient. Your doctor will monitor your blood pressure while you take Votrient. If your blood pressure increases, your doctor may lower your dose of Votrient or ask you to stop treatment for a while. They may also prescribe medication to help lower your blood pressure. If your blood pressure is very high or can’t be controlled, you may need to stop taking Votrient permanently.
• Heart problems, such as heart failure or long QT syndrome. Votrient can cause or worsen a type of abnormal heart rhythm called long QT syndrome. It can also cause or worsen heart failure. If you already have a heart problem, talk with your doctor about whether Votrient is right for you. You may need an electrocardiogram (EKG) before starting Votrient to make sure this drug is safe for you. You may also need extra monitoring, such as EKGs, while you take Votrient. Taking certain other medications with Votrient can also raise your risk for long QT syndrome. See the “Votrient interactions” section above for more information.
• Abnormal electrolyte levels. Votrient can sometimes cause a type of abnormal heart rhythm called long QT syndrome (see above). If you have low levels of electrolytes such as potassium or magnesium in your blood, this can raise your risk for this side effect. Your doctor will order blood tests to check your electrolytes before and during treatment with Votrient. If you have abnormal electrolyte levels, your doctor may prescribe medication to correct this.
• Past heart attack or stroke. Votrient can sometimes cause heart attack or stroke. These events can be life threatening. If you’ve had a heart attack or stroke in the past 6 months, talk with your doctor about whether Votrient is safe for you.
• Bleeding problems. Votrient can sometimes cause bleeding, including serious, life threatening bleeding in the lungs, stomach, intestines, or brain. If you’ve coughed up blood or had bleeding in your brain, stomach, or intestines in the past 6 months, talk with your doctor about whether Votrient is safe for you.
• Recent or planned surgery. Votrient can cause problems with wound healing. It can also increase the risk of serious bleeding. For these reasons, if you’ve recently had surgery, talk with your doctor about whether Votrient is safe for you. Votrient shouldn’t usually be started until at least 2 weeks after major surgery and until all wounds have healed. Your doctor will typically ask you to stop taking Votrient 1 week before planned surgery. Your doctor will tell you when to start taking Votrient again after you’ve had surgery.
• Hypothyroidism. Votrient can sometimes cause hypothyroidism (underactive thyroid). If you have hypothyroidism, talk with your doctor about whether Votrient is right for you. You’ll have blood tests to monitor your thyroid hormone levels while you take Votrient. Your doctor may adjust your dose of thyroid medication if needed.
• Allergic reaction. If you’ve had an allergic reaction to Votrient or any of its ingredients, you shouldn’t take Votrient. Ask your doctor what other medications are better options for you.
• Large tumor burden* or fast-spreading cancer. When rapidly dying cancer cells release harmful chemicals into your blood, it can cause a condition known as tumor lysis syndrome (TLS). Your risk for TLS may increase when you take Votrient if you have a large tumor burden or cancer that is spreading quickly. You may also have an increased risk for TLS if you have kidney problems or dehydration (water loss in the body). Your doctor will monitor you closely for TLS while you take Votrient.
• Pregnancy. Votrient is not safe to take during pregnancy. For more information, see the “Votrient and pregnancy” section above.
• Breastfeeding. You shouldn’t breastfeed while taking Votrient. For more information, see the “Votrient and breastfeeding” section above.

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

* Tumor burden refers to the number of cancer cells, the size of a tumor, or the amount of cancer in the body.

Votrient overdose

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

What to do in case you take too much Votrient

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 its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.