Tips to help manage certain side effects

The tips in this section are based on published general guidelines for managing certain side effects that are common among patients with advanced kidney cancer (advanced RCC) or other cancers. You can find a list of possible serious side effects in the Important Safety Information.

Studies show that treatment can have both benefits and risks. Keep in mind that while taking INLYTA, whether alone or in combination with pembrolizumab, side effects are expected. Not all side effects are manageable. Dose interruptions and/or reductions may be needed during treatment with INLYTA, pembrolizumab, or both. Be sure to pay attention to all your side effects. They can be important signs that let you and your healthcare provider know what is happening in your body.

Before starting INLYTA, tell your healthcare provider how you are feeling and about any side effects you have had from other medications and treatments. As you start taking INLYTA, let your healthcare provider know if you notice any side effects or a change in how you feel. Also tell your healthcare provider if you notice any side effects that are not listed below.

High blood pressure

INLYTA may cause your blood pressure to rise. In the clinical trial, hypertension occurred as early as 4 days into treatment. On average, this increase was seen within the first month of treatment.

Your healthcare provider should check your blood pressure regularly while you are being treated with INLYTA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA. Tell your healthcare provider if you have high blood pressure or a history of heart disease.

If you have high blood pressure, your healthcare provider’s recommendations may include:

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Monitoring severe headaches, shortness of breath, or nosebleeds

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Exercising regularly, controlling your weight, or limiting alcohol and sodium consumption

If you are already being treated for high blood pressure, your healthcare provider may change your blood pressure medicine when you start taking INLYTA. Your healthcare provider may also ask you to track your blood pressure regularly. Follow the advice of your healthcare provider—talk to them if you have any questions or concerns.

Diarrhea

Diarrhea is defined as 3 or more loose or watery stools/bowel movements in 1 day. If you have these symptoms, call your healthcare provider. It is important for you and your healthcare provider to try to manage diarrhea as soon as it begins.

If you experience diarrhea, your healthcare provider’s recommendations may include:

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Trying yogurt containing probiotics

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Avoiding spicy foods, fatty foods, caffeine, and fruit

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Eating small, frequent meals and foods containing soluble fiber

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Drinking fluids, such as water, diluted cranberry juice, or broth

Ask your healthcare provider if you can be treated with over-the-counter medications or prescriptions.

Tiredness or feeling weak

While you are taking INLYTA, you may feel tired or weak. Call your healthcare provider if you have these symptoms.

If tiredness or feeling weak is a recurring problem, your healthcare provider’s recommendations may include:

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Taking short naps and breaks instead of long ones

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Staying as active as possible

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Eating well and drinking plenty of fluids

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Trying to maintain normal work and social schedules

Ask your healthcare provider if there are over-the-counter or prescription medicines that may help you manage your condition.

Decreased appetite or weight

During treatment, you may have less desire to eat. But maintaining good nutrition and a healthy weight are important to your overall health. Protein and calories are especially vital to someone with cancer.

If you have decreased appetite, you can discuss the following diet ideas with your healthcare provider:

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Eating several small meals a day, including nutritious snacks that are high in calories and protein

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If taste changes cause you to eat less, try cold or frozen foods to minimize taste

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Drinking fluids between meals rather than filling up with beverages during meals

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Consulting with a registered dietitian (RD) for more ideas

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Flavoring foods with herbs, sugar, or sauces to maximize taste

Ask your healthcare provider if there are over-the-counter or prescription medicines that may help you manage your condition.

Nausea or vomiting 

It is best to call your healthcare provider at the first sign of nausea or vomiting. This is especially important if these symptoms keep you from taking your oral medications or keeping them down. Your healthcare provider may prescribe a medicine for these symptoms.

If you experience nausea or vomiting, your healthcare provider’s recommendations may include:

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Eating smaller, more frequent meals

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Eating bland foods at room temperature and drinking clear liquids

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Avoiding fatty, fried, spicy, or highly sweet foods

If you vomit, start with small amounts of water, broth, or other clear liquids when you are ready to eat again. If that stays down, then try soft foods. Some examples include gelatin, pudding, yogurt, strained soup, or strained cooked cereal. Slowly work up to eating solid food. Make sure that you do not eat any food that you are allergic to.

Hoarseness

Also called dysphonia, this is when you have a weak, rough, or harsh voice. 

If you have trouble speaking, your healthcare provider’s recommendations may include:

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Writing things down to give your voice a break

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Remembering to avoid shouting or whispering

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Drinking plenty of water and avoiding irritants (eg, dust, smoke, alcohol, industrial chemicals)

Skin conditions

Skin conditions, such as rash, redness, itching, or peeling of the skin are other side effects that may occur. You may notice dryness, thickening, calluses, blisters, or cracking of the skin on the palms of your hands and soles of your feet. This is called hand-foot syndrome. Tell your healthcare provider if you start to develop skin problems. He or she may give you specific treatments, which may include lotions, moisturizers, or pain medicines.

To help manage the effects of hand-foot syndrome, your healthcare provider’s recommendations may include:

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Wearing loose, cotton clothes

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Avoiding tight-fitting shoes and jewelry that rub or chafe the hands and feet

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Cleaning hands and feet with lukewarm water and gently patting dry

Constipation

Some patients taking INLYTA experience constipation. This has the potential to become a serious side effect. Left untreated, constipation can cause a blockage in your intestines, leading to dehydration and even internal damage.

If you experience constipation, speak to your healthcare provider. He or she may recommend any of the following:

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Drinking more fluids

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Increasing physical activity

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Taking a stool softener

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Changing your dose of INLYTA

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Adding fiber to your diet

Before starting INLYTA, tell your healthcare provider how you are feeling and about any side effects you have had from other medications and treatments. As you start INLYTA, let your healthcare provider know if you notice any side effects or a change in how you feel. Also tell your healthcare provider if you notice any side effects that are not listed in the Important Safety Information.

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Learn how INLYTA may work.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

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Before taking INLYTA, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure
  • have thyroid problems
  • have liver problems
  • have a history of blood clots in your veins or arteries (types of blood vessels), including stroke, heart attack, or change in vision
  • have any bleeding problems
  • have a history of heart problems, including heart failure
  • have an unhealed wound
  • plan to have surgery or have had a recent surgery. You should stop taking INLYTA for at least 2 days before planned surgery

For females, tell your healthcare provider if you:

  • are pregnant or plan to become pregnant. Taking INLYTA during pregnancy can harm your unborn baby. You should not become pregnant during treatment with INLYTA.
  • are able to become pregnant. You should have a pregnancy test before you start treatment with INLYTA. Use effective birth control during treatment and for 1 week after your last dose of INLYTA. Talk to your healthcare provider about birth control methods that you can use to prevent pregnancy during this time.
  • are breastfeeding or plan to breastfeed. It is not known if INLYTA passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after your last dose of INLYTA.

For males with female partners who are able to become pregnant:

  • use effective birth control during treatment and for 1 week after your last dose of INLYTA.
  • if your female partner becomes pregnant during your treatment with INLYTA, tell your healthcare provider right away.

INLYTA may cause fertility problems in males and females, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INLYTA and certain other medicines can affect each other causing serious side effects.

Talk with your healthcare provider before you start taking any new medicine. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Do not drink grapefruit juice or eat grapefruit. Grapefruit may increase the amount of INLYTA in your blood.

INLYTA may cause serious side effects, including:

  • High blood pressure (hypertension).High blood pressure is common with INLYTA and may sometimes be severe. Your healthcare provider should check your blood pressure regularly during treatment with INLYTA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA
  • Blood clots in your veins or arteries. INLYTA can cause blood clots which can be serious, and sometimes lead to death. Get emergency help and call your healthcare provider if you get any of the following symptoms:
    • chest pain or pressure
    • pain in your arms, back, neck or jaw
    • shortness of breath
    • numbness or weakness on one side of your body
    • trouble talking
    • headache
    • vision changes
  • Bleeding. INLYTA can cause bleeding which can be serious, and sometimes lead to death. Call your healthcare provider right away or get medical help if you develop any of the following signs or symptoms:
    • unexpected bleeding or bleeding that lasts a long time, such as:
      • unusual bleeding from the gums
      • menstrual bleeding or vaginal bleeding that is heavier than normal
      • bleeding that is severe or you cannot control
      • pink or brown urine
      • red or black stools (looks like tar)
      • bruises that happen without a known cause or get larger
      • cough up blood or blood clots
      • vomit blood or your vomit looks like “coffee grounds”
    • unexpected pain, swelling, or joint pain
    • headaches, feeling dizzy or weak
  • Heart failure. Your healthcare provider should check you for signs or symptoms of heart failure regularly during treatment with INLYTA. Heart failure can be serious and can sometimes lead to death. Tell your healthcare provider if you have any of the following symptoms during your treatment with INLYTA:
    • tiredness
    • swelling of your stomach-area (abdomen), legs or ankles
    • shortness of breath
    • protruding neck veins
  • Tear in your stomach or intestinal wall (perforation). A tear in your stomach or intestinal wall can be serious and can sometimes lead to death. Get medical help right away if you get the following symptoms:
    • severe stomach-area (abdominal) pain or stomach-area pain that does not go away
    • vomit blood
    • red or black stools
  • Thyroid gland problems. Your healthcare provider should do blood tests to check your thyroid gland function before and during your treatment with INLYTA. Tell your healthcare provider if you have any of the following symptoms during your treatment with INLYTA:
    • tiredness that worsens or that does not go away
    • feeling hot or cold
    • your voice deepens
    • weight gain or weight loss
    • hair loss
    • muscle cramps and aches
  • Risk of wound healing problems. Wounds may not heal properly during INLYTA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with INLYTA.
    • You should stop taking INLYTA at least 2 days before planned surgery
    • Your healthcare provider should tell you when you may start taking INLYTA again after surgery
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen during treatment with INLYTA. Call your healthcare provider right away if you get:
    • headache
    • seizures
    • weakness
    • confusion
    • high blood pressure
    • blindness or change in vision
    • problems thinking
  • Protein in your urine. Your healthcare provider should check your urine for protein before and during your treatment with INLYTA. If you develop protein in your urine, your healthcare provider may decrease your dose of INLYTA or stop your treatment.
  • Liver problems. Your healthcare provider will do blood tests before and during your treatment with INLYTA. Your healthcare provider may delay or stop your treatment with INLYTA if you develop severe liver problems.
    Tell your healthcare provider right away if you have any of the following symptoms:
    • yellowing of your skin or the whites of your eyes
    • severe nausea or vomiting
    • pain on the right side of your stomach area (abdomen)
    • dark urine (tea colored)
    • bleeding or bruising more easily than normal

The most common side effects of INLYTA with pembrolizumab include:

    • diarrhea
    • feeling tired or weak
    • high blood pressure
    • liver problems
    • low levels of thyroid hormone
    • decreased appetite
    • rash, redness, itching or peeling of your skin on your hands and feet
    • nausea
    • mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina
    • hoarseness
    • rash
    • cough
    • constipation

Important information: If your healthcare provider prescribes INLYTA for you to be taken with pembrolizumab, also read the Medication Guide for pembrolizumab.

The most common side effects of INLYTA when used alone include:

  • diarrhea
  • high blood pressure
  • feeling tired or weak
  • decreased appetite
  • nausea
  • hoarseness
  • rash, redness, itching or peeling of your skin on your hands and feet
  • decreased weight
  • vomiting
  • constipation

These are not all of the possible side effects of INLYTA. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information and Patient Information, which includes a complete discussion of the risks of INLYTA.

INDICATIONS

INLYTA is a prescription medicine used to treat kidney cancer that has spread or cannot be removed by surgery (advanced renal cell carcinoma or RCC):

  • in combination with pembrolizumab as your first treatment
  • alone when 1 prior drug treatment regimen for your RCC has not worked

It is not known if INLYTA is safe and effective in children.

INDICATIONS

INLYTA is a prescription medicine used to treat kidney cancer that has spread or cannot be removed by surgery (advanced renal cell carcinoma or RCC):

It is not known if INLYTA is safe and effective in children.

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Tumor

A mass of cancer cells.

Hypertension

A disease of the arteries (commonly called high blood pressure).

Lymph node

Located throughout the body, lymph nodes filter lymph fluid. They store special cells that can trap cancer cells or bacteria that are traveling through the body in the lymph.

Kidney

One of a pair of organs that removes waste products from the blood. In the process, they make urine to help carry waste products out of the body. One is on the left side of the abdomen. The other is on the right side.

INDICATIONS

INLYTA (axitinib) is a prescription medicine used to treat kidney cancer that has spread or cannot be removed by surgery (advanced renal cell carcinoma or RCC): 

  • in combination with pembrolizumab as your first treatment  
  • alone when 1 prior drug treatment regimen for your RCC has not worked

It is not known if INLYTA is safe and effective in children.

Metastatic

Cancer that has spread from one part of the body to another through the lymphatic system or bloodstream.