Inlyta (axitinib)

What is Inlyta?

Inlyta is a brand-name prescription drug. It’s approved for use in certain adults with renal cell carcinoma (RCC), which is a type of kidney cancer. RCC can occur when cancer cells begin to multiply and spread in the kidney.

Specifically, Inlyta is approved for advanced RCC. This means the cancer can’t be surgically removed or it’s spread to other areas of your body. Inlyta can be used:

• with either avelumab (Bavencio) or pembrolizumab (Keytruda) as a first treatment for RCC
• on its own in people with advanced RCC who’ve already tried another treatment that didn’t work to treat their cancer

Drug details

The active drug in Inlyta is axitinib. It belongs to a group of medications called kinase inhibitors.

Inlyta comes as a tablet that’s taken by mouth. You’ll typically take this medication twice daily during your treatment.

Effectiveness

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

Inlyta generic

Inlyta 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.

Inlyta side effects

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

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

The side effects listed below include people who took Inlyta along with Bavencio or Keytruda. Therefore, some of the side effects listed may have been reported by people taking Inlyta and Bavencio or Inlyta and Keytruda.

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 Inlyta, you can do so through MedWatch.

Mild side effects

Mild side effects* of Inlyta can include:

• digestive problems, such as nausea, diarrhea, constipation, or vomiting†
• hair loss†
• fatigue (lack of energy)
• muscle or bone pain
• sores or swelling in your mouth
• palmar-plantar erythrodysesthesia (hand-foot syndrome)
• decreased appetite or weight loss
• rash
• cough
• trouble breathing
• abdominal (belly) pain
• headache
• trouble speaking
• protein in your urine

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

Serious side effects

Serious side effects from Inlyta aren’t common, but they can occur. Call your doctor right away if you experience any serious side effects. But 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:

• Changes in your thyroid gland. Symptoms can include:
  • feeling hot or cold
  • weight gain or weight loss
  • fatigue
• Liver damage. Symptoms can include:
  • nausea
  • abdominal pain
  • jaundice (yellowing of the skin or the whites of your eyes)
• Bleeding. Symptoms can include:
  • blood in your urine or stool
  • bruising easier than usual
  • coughing up blood or vomiting blood
• Blood clot. Symptoms can include:
  • pain in your chest, back, neck, or jaw
  • trouble breathing
  • headache
  • numbness or weakness, especially on one side
• Heart failure. Symptoms can include:
  • trouble breathing
  • swelling of your legs or ankles
  • fatigue
• Reversible posterior leukoencephalopathy syndrome (a brain condition). Symptoms can include:
  • headache
  • vision changes
  • seizures
• Gastrointestinal perforation (a tear in your stomach or intestine). Symptoms can include:
  • vomiting blood
  • blood in your stool
  • abdominal pain
• Allergic reaction.*
• Hypertension* (high blood pressure).

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

Side effect details

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

Hair loss

Inlyta may cause hair loss (also called alopecia) in some people. However, this side effect wasn’t common in clinical studies. To find out how often this side effect occurred in studies, see the drug’s prescribing information.

If you have concerns about hair loss during your Inlyta treatment, talk with your doctor or pharmacist. They may be able to recommend ways to reduce this side effect.

Digestive problems

Digestive problems, such as nausea, vomiting, constipation, and diarrhea, were some of the most common side effects that occurred with Inlyta use in clinical studies. To find out how often this side effect occurred in studies, see the drug’s prescribing information.

If you experience digestive problems during your Inlyta treatment, talk with your doctor. They may do tests to make sure Inlyta is the cause of your symptoms. In some cases, liver problems or other serious conditions (such as gastrointestinal perforation) can cause digestive problems.

If you have concerns about digestive problems with Inlyta, talk with your doctor or pharmacist. And if you experience nausea, vomiting, constipation, or diarrhea during your treatment, your doctor or pharmacist may be able to recommend ways to manage these side effects.

Hypertension

Hypertension (high blood pressure) was a very common side effect in clinical studies of Inlyta. In some cases, hypertension can be severe, leading to organ damage or a stroke. It’s important to treat high blood pressure before it can cause damage.

Of the people in clinical studies who had hypertension, this side effect typically occurred within the first month of treatment. To find out how often hypertension occurred in clinical studies, see the drug’s prescribing information.

Symptoms of high blood pressure include headache, chest pain, and trouble breathing. If you develop hypertension while taking Inlyta, your doctor will likely start you on a medication to lower your blood pressure. In most cases, you can continue your Inlyta treatment as long as your blood pressure is being well managed by the medication.

If you have a history of hypertension, your doctor will make sure your blood pressure is well managed with medication before you start taking Inlyta. To learn more, see the “Inlyta precautions” section below.

If you have questions about how Inlyta could affect your blood pressure, talk with your doctor or pharmacist.

Allergic reaction

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

• rash
• itchiness
• flushing (warmth, swelling, redness, or discoloration 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

It is not known how common allergic reactions were in clinical trials. If you have any additional questions about Inlyta and allergic reactions, be sure to ask your doctor or pharmacist.

Call your doctor right away if you have an allergic reaction to Inlyta, 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.

Inlyta use with other drugs

Inlyta may be used witheither pembrolizumab (Keytruda) or avelumab (Bavencio). For more information, see the sections below.

Inlyta use with Keytruda

Inlyta is approved for renal cell carcinoma (RCC) when used along with Keytruda. In this case, Inlyta and Keytruda can be used together as your first treatment for RCC. If you have any questions about using Keytruda with Inlyta, talk with your doctor.

Inlyta use with Bavencio

Inlyta is approved for RCC when used along with Bavencio. These drugs can be used together as your first RCC treatment. If you have any questions about using Bavencio with Inlyta, talk with your doctor.

Inlyta cost

As with all medications, the cost of Inlyta 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 Inlyta. 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 Inlyta, 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 Inlyta, contact your insurance company.

Financial and insurance assistance

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

Pfizer Inc., the manufacturer of Inlyta, offers a program called Pfizer Oncology together. For more information and to find out if you’re eligible for support, call 877-744-5675 or visit the program website.

Mail-order pharmacies

Inlyta 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 Inlyta, so there’s less concern about running out of the medication. If you’re interested in this option, check 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

Inlyta is a brand-name medication that’s 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.

Inlyta dosage

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

• the type and severity of the condition you’re using Inlyta to treat
• other medical conditions you may have
• other medications that you take

Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Inlyta comes as a tablet that’s taken by mouth. It’s available in strengths of 1 milligram (mg) and 5 mg.

Dosage for renal cell carcinoma

The Inlyta dosage for renal cell carcinoma is typically 5 mg taken twice daily. You should try to take your doses about 12 hours apart.

If you have other conditions, such as liver problems, your doctor may recommend a lower dose of Inlyta. Before using Inlyta, talk with your doctor about any other medical conditions you have. They can determine the right dose of Inlyta for you.

What if I miss a dose?

If you miss a dose of Inlyta or if you vomit up your dose, just skip your missed dose and take your next dose at its regular time. You shouldn’t take two doses at once 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 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?

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

How Inlyta works

Inlyta is FDA-approved for use in certain adults with renal cell carcinoma (RCC), a type of kidney cancer. (To learn more about who can use Inlyta, see the “Inlyta uses” section below.)

Inlyta belongs to a group of medications called kinase inhibitors. Inlyta’s mechanism of action, or how it works to treat your cancer, is by starving the tumor and not allowing it to grow any bigger.

Your body’s blood vessels supply the tumor with nutrients and blood so it can grow. Inlyta stops blood vessels from forming, which means your tumor can’t continue to grow without the nutrients or blood it needs.

How long does it take to work?

Inlyta will begin working a few hours after your first dose. However, because of how Inlyta works, it may take time before you notice the effects of Inlyta. You may notice that your symptoms of RCC are reduced or haven’t gotten worse.

Common questions about Inlyta

Here are answers to some frequently asked questions about Inlyta.

Is Inlyta a chemotherapy drug?

No, Inlyta isn’t a chemotherapy drug. Chemotherapy drugs work on your whole body to kill any cells that grow quickly. Although this helps kill cancer cells, it also kills many healthy cells in your body. This raises your risk for side effects from chemotherapy.

Inlyta, on the other hand, is a kinase inhibitor. It works by stopping blood vessels from forming. This can help prevent tumor growth and the further spread of your cancer. (To learn more, see the “How Inlyta works” section above.)

Can I take Inlyta if I’m going to have surgery?

If you have surgery scheduled, talk with your doctor ahead of time. Inlyta may decrease your body’s ability to heal wounds. If you’re having surgery, your doctor may recommend stopping Inlyta at least 2 days before your surgery. If you have unplanned surgery, and you’re able to communicate, let your healthcare team know you’re taking Inlyta.

Your doctor will also likely recommend not restarting the medication until at least 2 weeks after surgery, or until your wound has healed.

Your doctor can help determine the best time to stop and restart Inlyta if you’re having surgery.

Will Inlyta cure my kidney cancer?

No, Inlyta won’t cure your renal cell carcinoma (RCC). There currently isn’t a cure for RCC or any type of kidney cancer. However, Inlyta may stop your tumor from growing. Although Inlyta won’t cure your RCC, it may help you live longer without your cancer getting worse.

If you have questions about what to expect from your Inlyta treatment, talk with your doctor.

Inlyta and alcohol

There are no drug interactions between Inlyta and alcohol. However, your doctor may recommend that you limit the amount of alcohol you drink while using Inlyta. This is because Inlyta may cause damage to your liver. Alcohol can also cause liver damage, so drinking alcohol during your Inlyta treatment may raise your risk for liver damage.

If you drink alcohol, talk with your doctor about how much may be safe for you to drink during your Inlyta treatment.

Inlyta interactions

Inlyta 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 side effects or make them more severe.

Inlyta and other medications

Below is a list of medications that can interact with Inlyta. This list does not contain all drugs that may interact with Inlyta.

Before starting your Inlyta treatment, 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.

Specific medications or types of drugs that may interact with Inlyta include:

• Ketoconazole. Ketoconazole is sometimes used to treat fungal infections. Taking this drug with Inlyta may cause Inlyta to build up in your body. This can raise your risk for side effects from Inlyta. If you need to take ketoconazole and Inlyta, your doctor may prescribe a lower dose of Inlyta.
• Certain antibiotics. Some antibiotics may make Inlyta less effective. Examples of these antibiotics include:
  • rifampin (Rimactane, Rifadin)
  • rifabutin (Mycobutin)
  • rifapentine (Priftin)
• Dexamethasone (Hemady). Taking dexamethasone (a steroid) with Inlyta may cause Inlyta to be broken down more quickly in your body. This may make Inlyta less effective.
• Certain seizure drugs. Using Inlyta with some seizure medications may cause Inlyta to be broken down more quickly. This may make Inlyta less effective. Examples of these seizure drugs include:
  • phenytoin (Dilantin)
  • carbamazepine (Tegretol)
  • phenobarbital

If you have any questions about interactions between Inlyta and other medications you take, talk with your doctor or pharmacist.

Inlyta and herbs and supplements

Inlyta may interact with an herbal supplement called St. John’s wort. Using Inlyta with this supplement can cause Inlyta to be broken down more quickly in your body. This may make Inlyta less effective.

Your doctor may recommend that you don’t use St. John’s wort during your Inlyta treatment to avoid this interaction.

Inlyta and foods or beverages

Inlyta may interact with grapefruit or grapefruit juice. Consuming grapefruit or grapefruit juice during your Inlyta treatment may cause Inlyta to build up in your body. This can raise your risk for serious side effects.

Your doctor may recommend that you don’t consume grapefruit or grapefruit juice during your treatment to help avoid this interaction.

Inlyta uses

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

Inlyta for renal cell carcinoma

Inlyta is FDA-approved for use in certain adults with renal cell carcinoma (RCC), which is a type of kidney cancer.

Specifically, Inlyta is approved for advanced RCC. This means the cancer can’t be surgically removed or it’s spread to other areas of your body. Inlyta can be used:

• with either avelumab (Bavencio) or pembrolizumab (Keytruda) as a first treatment for RCC
• on its own in people with advanced RCC who’ve already tried another treatment that didn’t work to treat their cancer

RCC can occur when cancer cells begin to multiply and spread in the kidney. Symptoms of RCC may include blood in your urine, weight loss, or pain in your side.

Effectiveness for renal cell carcinoma

Clinical studies of Inlyta have shown that it’s an effective medication for advanced RCC. In fact, it’s recommended in treatment guidelines for RCC.

To learn more about how Inlyta performed in clinical studies, see the drug’s prescribing information.

Inlyta and children

Inlyta is only approved for use in adults. It’s not known if this medication may be a safe or effective treatment option for children.

How to take Inlyta

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

Inlyta is a tablet that’s taken by mouth.

When to take

Take your Inlyta dose twice per day, about 12 hours apart. You should take your dose of Inlyta with a glass of water.

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.

Taking Inlyta with food

You can take your dose of Inlyta with or without food. However, be sure to take your dose with a glass of water.

Can Inlyta be crushed, split, or chewed?

Inlyta shouldn’t be crushed, split, or chewed. You should swallow the tablet whole along with a glass of water.

Inlyta and pregnancy

Inlyta is not recommended if you’re pregnant or planning to become pregnant. Based on the way Inlyta works in your body, it can cause harm to a fetus.

No clinical studies of humans have looked at Inlyta use during pregnancy. Some animal studies, however, have shown that Inlyta may cause birth defects or miscarriage if taken during pregnancy.

Because of this risk, if you’re a female* who can become pregnant, your doctor will have you take a pregnancy test before you start treatment. You should use birth control during your treatment and for 1 week after your last dose. Also, males with female partners who can become pregnant should also use effective birth control during treatment and 1 week after the final dose. This is to prevent pregnancy while you’re taking Inlyta.

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

Inlyta and fertility

It’s possible that Inlyta may decrease fertility (the ability to conceive a child) in both males and females.

In males, Inlyta may decrease sperm count. In females, Inlyta may affect the hormones your body produces to support pregnancy. It may also cause changes to the uterus, such as the uterine tissue becoming smaller than it should be.

If you have questions about how Inlyta may affect your fertility, talk with your doctor before starting treatment.

Inlyta and birth control

Inlyta use is not recommended 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 Inlyta.

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

For females using Inlyta

If you’re a female* who could become pregnant, your doctor will have you take a pregnancy test before you start your Inlyta treatment. They’ll also recommend that you use birth control during your treatment and for 1 week after your last dose of Inlyta. This is to prevent pregnancy while you’re taking Inlyta.

For males using Inlyta

If you’re male* and have a partner who could become pregnant, you should use birth control while using Inlyta and for 1 week after your last dose.

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

Inlyta and breastfeeding

It’s not known whether Inlyta passes into breastmilk or if the drug causes any effects in a breastfed child. However, due to the possible risk of serious side effects from Inlyta in a breastfed child, you shouldn’t breastfeed during your treatment. You also shouldn’t breastfeed for at least 2 weeks after your last dose.

If you have any questions about breastfeeding and Inlyta, talk with your doctor or pharmacist.

Inlyta precautions

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

• Hypertension. Inlyta may cause hypertension that can be very serious or even fatal. If you have a history of high blood pressure, your doctor may check that it’s well managed before you start taking Inlyta. This is to prevent serious side effects from high blood pressure, such as organ damage or heart attack. Your doctor may also monitor your blood pressure throughout your treatment. If you have a history of high blood pressure, talk with your doctor before starting Inlyta.
• Hypothyroidism. Inlyta may cause hypothyroidism. If you already have a thyroid condition, Inlyta may make this condition worse. Your doctor will monitor your thyroid hormone throughout your Inlyta treatment. If you already have a thyroid condition, talk with your doctor before using Inlyta.
• Liver problems. Inlyta can cause liver damage. If you already have liver problems, Inlyta may make your condition worse. If you have liver problems, talk with your doctor before using Inlyta. Your doctor will order blood tests before you start Inlyta and throughout your treatment to monitor your liver health. If your liver condition is severe, your doctor may recommend a different treatment for you.
• Gastrointestinal perforation. Inlyta may raise your risk for gastrointestinal perforation. If you already have this condition or have had it in the past, Inlyta could raise your risk even more. If you have a history of gastrointestinal perforation or other health factors that raise your risk for this condition, your doctor may monitor you more closely during your Inlyta treatment. Before using Inlyta, talk with your doctor if you have a history of gastrointestinal perforation.
• Blood clots. Inlyta may raise your risk for a blood clot. If you’ve had a blood clot in the past, using Inlyta could raise your risk even more. If you have a history of blood clots, your doctor may monitor you more closely during your Inlyta treatment to watch for symptoms of a blood clot.
• Bleeding problems. Inlyta may raise your risk for bleeding. If you’ve had bleeding problems before, tell your doctor before taking Inlyta. Your doctor may monitor you more closely if you have a history of bleeding. Or they may also recommend a different medication to treat your condition.
• A wound that hasn’t healed. If you’ve recently had surgery or have a wound that hasn’t healed, tell your doctor before you start taking Inlyta. This is because Inlyta can lower your body’s ability to heal a wound, so any wounds you currently have may not heal properly. Your doctor may recommend waiting to start Inlyta until after your wound has healed.
• Heart failure. Inlyta may cause heart failure, which can sometimes be severe. If you already have heart failure, using Inlyta could make it worse. Your doctor may monitor your heart during your Inlyta treatment to make sure that your heart failure isn’t getting worse.
• Allergic reaction. If you’ve had an allergic reaction to Inlyta or any of its ingredients, you shouldn’t take Inlyta. Ask your doctor what other medications are better options for you.
• Pregnancy. Inlyta isn’t recommended if you’re pregnant or planning to become pregnant. For more information, see the “Inlyta and pregnancy” section above.
• Breastfeeding. You shouldn’t take Inlyta if you’re breastfeeding. For more information, see the “Inlyta and breastfeeding” section above.

Note: For more information about the possible side effects of Inlyta, see the “Inlyta side effects” section above.

Inlyta overdose

Using more than the recommended dosage of Inlyta can lead to serious side effects. Do not use more of this drug than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

• dizziness
• hypertension (high blood pressure)
• seizures
• bleeding, which can be very serious or lead to death

What to do in case of overdose

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.