Inlyta (Axitinib) - Oral

What Is Inlyta? 

Inlyta (axitinib) is an orally administered prescription medication that is used to treat renal cell carcinoma (RCC), also known as renal cell cancer. RCC begins in the cells of the kidneys. Inlyta treats RCC that has spread to other areas of the body (metastasized).

This medication is approved for adults aged 18 and older. It is either used alone or in combination with other cancer-fighting medications.

Inlyta is administered in the form of a tablet that is taken by mouth. It is in a class of medications called tyrosine kinase inhibitors (TKIs). These drugs are referred to as cancer blockers.

TKIs are used to restrain (inhibit) tyrosine kinases. They are also categorized as a kind of protein catalysts that speed chemical reactions in the body (enzymes). TKIs work by blocking the overly active enzymes inside cancer cells from growing and spreading.

Inlyta also works against the vascular endothelial growth factor (VEGF) pathway, which keeps cancer cells from being able to make blood vessels.

VEGF is a substance created by cells to stimulate the formation of blood vessels.

Inlyta is not available as a generic product; however, the active ingredient in the medication, axitinib, is available as a brand-name drug in the form of oral tablets.

Drug Facts

Generic Name: Axitinib
Brand Name: Inlyta
Drug Availability: Prescription
Administration Route: Oral
Therapeutic Classification: Antineoplastic agent
Available Generically: No
Controlled Substance: N/A
Active Ingredient: Axitinib
Dosage Form(s): Tablet

What Is Inlyta Used For?

The Food and Drug Administration (FDA) has approved Inlyta to treat RCC which has advanced and spread to areas of the body outside of the kidney.

Inlyta is a kinase inhibitor indicated for use:

  • In combination with avelumab for the first-line (initial) treatment of patients with RCC
  • In combination with pembrolizumab for the first-line treatment of patients with advanced RCC
  • As a single agent for the treatment of advanced RCC after the failure of one prior therapy that targets the entire body (systemic therapy)

Both avelumab and pembrolizumab are given as intravenous (IV) injections (immunotherapy infusions).

Additionally, Inlyta can be used alone in advanced RCC if another therapy has failed.

How to Take Inlyta

Inlyta should be taken twice a day, about 12 hours apart. The drug can be taken with or without food. However, you should avoid grapefruit and grapefruit juice when you are taking Inlyta. The tablets should be swallowed whole with a full glass of water.

Take Inlyta exactly as directed by your healthcare provider. Do not take more or less of it or take it more often than prescribed by your provider. Swallow the tablets whole with a glass of water. Do not split, chew, or crush them.

If you vomit after taking the medicine, do not take another dose. Continue your regular dosing schedule as prescribed.

You may start on a low dose and gradually increase it. Your dose will depend on how well the drug works for you and the severity of any side effects that you have.

Continue to take Inlyta even if you feel better. Do not stop taking it without consulting your healthcare provider first.

Storage

Store Inlyta in its original packaging at room temperature. Do not store in a bathroom or any other place susceptible to high levels of moisture. Keep it safely out of the reach of children or pets.

You are permitted to travel with this medication. Keep your medication in its original container from your pharmacy with your name on the label. If you have any questions about traveling with your medicine, ask your healthcare provider.

Do not keep unwanted or expired medications. Do not dispose of them in the toilet or throw them in the trash.

The best way to discard unwanted medication is through a medicine take-back program. Ask your pharmacist or contact your local waste disposal department to learn more about how to dispose of your medications properly.

How Long Does Inlyta Take to Work?

After two to three days, Inlyta will have reached a steady level in your bloodstream. However, it likely will be a few more months before your provider does internal imaging to see how well the drug is working.

What Are the Side Effects of Inlyta?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects while taking Inlyta, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

The most common side effects of taking Inlyta include:

Severe Side Effects

Inlyta has the potential to cause serious side effects. Call your healthcare provider right away if you experience anything severe.

Additionally, call 911 if you feel that your symptoms are life-threatening or if you’re having a medical emergency.

Serious side effects and their symptoms can include:

Long-Term Side Effects

If any of the severe side effects are not treated quickly, there is a potential for long-term complications, including:

Report Side Effects

Inlyta may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (1-800-332-1088).

Dosage: How Much Inlyta Should I Take?

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The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For kidney cancer (axitinib alone):
      • Adults—At first, 5 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.
    • For kidney cancer (axitinib with avelumab):
      • Adults—At first, 5 milligrams (mg) 2 times a day together with avelumab 800 mg every 2 weeks. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.
    • For kidney cancer (axitinib with pembrolizumab):
      • Adults—At first, 5 milligrams (mg) 2 times a day together with pembrolizumab 200 mg every 3 weeks. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.

Modifications

Here are some things you should know before you start Inlyta:

  • Dose adjustments might be needed if you have moderate to severe liver disease.
  • If any side effects from Inlyta are severe or if the side effects are no longer tolerable, the dose might be decreased to find a more sustainable amount that you can manage.
  • Inlyta can cause fetal harm when administered to a pregnant person. Talk to your healthcare provider if you plan on becoming pregnant or are currently pregnant, before use. They can discuss the potential risks associated with use during pregnancy with you.
  • There is limited data on the presence of axitinib in human milk and its subsequent effect on the breastfed infant. Since there is a potential for serious negative reactions in a breastfed infant from Inlyta, you should not breastfeed during treatment with Inlyuta and should avoid doing so for two weeks after you take your last dose.
  • Inlyta is not approved for children under the age of 18. Discuss alternative RCC treatments with your healthcare provider.

Missed Dose

If a dose of Inlyta is missed, it should be taken at the next scheduled time. Inlyta should never be "double dosed" to make up for a missed dose.

Overdose: What Happens If I Take Too Much Inlyta?

There is not one dose that defines an overdose of Inlyta. If you have taken too much Inlyta, contact your cancer care team right away.

Overdoses of Inlyta have caused life-threatening high blood pressure and uncontrollable internal bleeding. Seek immediate care if you think you may have overdosed on Inlyta.

What Happens If I Overdose on Inlyta?

If you think you or someone else may have overdosed on Inlyta, call your healthcare provider or the Poison Control Center (1-800-222-1222).

If someone collapses or isn't breathing after taking Inlyta, call 911 immediately.

Precautions

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If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for at least 1 week after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 1 week after the last dose. If you think you have become pregnant or your partner has become pregnant while using this medicine, tell your doctor right away.

Your blood pressure should be checked regularly during treatment with this medicine. The symptoms of high blood pressure include: blurred vision, dizziness, nervousness, headache, pounding in the ears, or a slow or fast heartbeat.

This medicine may cause serious heart and blood vessel problems (eg, blood clots). Call your doctor right away if you have chest pain or discomfort, numbness or weakness on one side of your body, pain or discomfort in your arms, jaw, back or neck, trouble talking, or vision changes.

If you are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of a heart problem (eg, left ventricular ejection fraction, heart failure) or your body keeping too much water.

Check with your doctor right away if you have severe stomach burning, cramps, or pains, bloody or black, tarry stools, trouble breathing, heartburn, indigestion, nausea, or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.

This medicine may increase your chance of bleeding and cause a delay in wound healing. To help with this problem, stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine at least 2 days before or 2 weeks after surgery.

This medicine may increase your chance of having a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Check with your doctor right away if you have headaches, seizures, extreme drowsiness, confusion, or problems with vision while you are using this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a serious skin problem called hand-foot syndrome. Check with your doctor right away if you have a skin rash or any redness, pain, swelling, or blisters on the palms of your hands or the soles of your feet.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

What Are Reasons I Shouldn’t Take Inlyta?

If any of the following apply to you, discuss alternative treatments with your provider. Adjustments to your treatment may need to be made.

Allergies: You should not take Inlyta if you are allergic to axitinib or any of the ingredients that Inlyta contains. Since it is a combinational drug, you also need to be aware of any allergy to avelumab or pembrolizumab.

Pregnancy/breastfeeding: People who are pregnant or want to become pregnant should talk with their healthcare provider before starting treatment. People who could potentially bear children should use protection against pregnancy while taking the medication as well as for one week after taking the last dose. This warning also applies to those who may breastfeed while taking Inlyta.

Hypertension: Blood pressure should be well controlled before starting Inlyta. The drug has the potential to lead to high levels of hypertension which can become dangerous.

Heart disease: People with a history of heart problems should discuss their health with their provider before beginning Inlyta. In one clinical study, heart failure was reported in 2% of people treated with axitinib, and there were two deaths.

Slowed wound healing: Compromised wound healing can occur in people being treated with VEGF inhibitors, such as Inlyta. You will need to stop taking it two days before you have surgery. Do not take Inlyta for at least two weeks after having major surgery and until sufficient wound healing has occurred.

What Other Medications Interact With Inlyta?

Several medications and foods should be avoided if you are taking Inlyta, as they have the potential to affect how much of the medication is absorbed into the bloodstream or how well it works to defeat cancer cells.

If any of the following must be taken, dose adjustments might be needed:

What Medications Are Similar?

The following is a list of medications that are traditionally prescribed to treat RCC which work similarly to Inlyta:

This is not a list of drugs that are recommended to take with Inlyta. You should not take these drugs together.

Frequently Asked Questions

  • What is Inlyta used for?

    Inlyta is used to treat advanced RCC, a type of cancer that starts in the kidney and spreads to other areas of the body.

  • How does Inlyta work?

    Cancer cells need blood vessels to provide them with oxygen and the nutrients that they need to grow, much like the healthy cells of the body do. Inlyta works by blocking the pathway that the cancer cells use to make blood vessels for themselves.

  • What are the side effects of Inlyta?

    Side effects associated with the use of Inlyta include:

    • Diarrhea
    • Nausea/vomiting
    • Hypertension
    • Bleeding
    • Redness to the palms or bottoms of the feet
    • Feeling tired
    • Decreased appetite
  • How to stop taking Inlyta?

    Inlyta should not be stopped without first talking to the healthcare provider who is treating you for cancer. If you’re experiencing side effects from the medication, tell your provider. A decrease in your dose might be needed.

How Can I Stay Healthy While Taking Inlyta?

If you’ve been prescribed Inlyta, take it at the dose that your healthcare provider has ordered. Take it at the correct time, typically about 12 hours apart.

If you’re experiencing any significant side effects, tell your cancer team. Your healthcare providers can help you manage these symptoms and may adjust your dose if necessary.

Never hesitate to ask your cancer care team if you have questions about anything related to this medication. 

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

6 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Pfizer. Inlyta (axitinib) prescribing information.

  2. Leukemia & Lymphoma Society. Tyrosine kinase inhibitor (TKI) therapy.

  3. National Library of Medicine, MedlinePlus. Axitinib.

  4. National Cancer Institute. VEGF.

  5. Fellner C. Launch of breakthrough therapies will reshape renal cell carcinoma market [published correction appears in P T. 2016;41(9):570]P T. 2016;41(8):523-525.

  6. Rini BI, Gruenwald V, Jonasch E, et al. Long-term duration of first-line axitinib treatment in advanced renal cell carcinomaTarget Oncol. 2017;12(3):333-340. doi:10.1007/s11523-017-0487-4

By Julie Scott, MSN, ANP-BC, AOCNP
Julie is an Adult Nurse Practitioner with oncology certification and a healthcare freelance writer with an interest in educating patients and the healthcare community.