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INLYTA Side Effect Tips

Ways to help manage certain common side effects

Not all side effects are manageable. Dose interruptions and/or reductions may be needed during treatment with INLYTA. Be sure to talk to your healthcare professional about any side effects you experience and how they may be managed for you.

Common 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 RCC or other cancers.

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. INLYTA may cause your blood pressure to rise.

Your doctor should check your blood pressure regularly while you are being treated with INLYTA. If you develop blood pressure problems, your doctor may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA. Tell your doctor or nurse 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:

  • Take antihypertensive medications as prescribed
  • Recognize signs of potentially dangerous high blood pressure (eg, severe headache, shortness of breath, nosebleeds)
  • Follow healthy lifestyle choices: regular exercise, weight control, moderate alcohol consumption, sodium restriction

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

Diarrhea is more loose or watery stools/bowel movements than usual. If you have these symptoms, call your doctor or nurse. It is important for you and your doctor to try to manage diarrhea as soon as it begins.

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

  • Try yogurt containing probiotics
  • Eat foods containing soluble fiber
  • Eat small but frequent meals
  • Avoid spicy foods, fatty foods, caffeine, and fruit
  • Drink fluids, such as water, diluted cranberry juice, broth, or decaffeinated tea or coffee

Ask your doctor or nurse if you can be treated with over-the-counter medications.

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

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

  • Take short naps and breaks instead of long ones
  • Eat well and drink plenty of fluids
  • Take short walks or do light exercise, if you feel up to it
  • Do things that are relaxing, such as listening to music or reading
  • Stay as active as possible
  • Try to maintain normal work and social schedules

Ask your doctor if there are over-the-counter or prescription medications that may help you manage your condition.

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 even more vital to someone with cancer.

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

  • Eat several small meals a day—5 or 6 isn’t out of the question
  • When you are hungry, eat
  • Enjoy snacks and strive to make them nutritious. Find calories and protein in dried fruits, nuts, cheeses, and even milkshakes
  • For added protein and calories, it can be a good idea to add gravy, butter, or cheese to your favorite foods
  • Drink fluids between meals rather than filling up with them during meals
  • If you are too tired to cook, ask a friend or family member to make you something. You may be surprised how many people are willing to help you
  • If mouth pain causes you to eat less, consider avoiding spicy foods. Eat foods that are soft or use a straw for liquids
  • If taste changes cause you to eat less, try cold or frozen foods to minimize taste. Flavor foods with herbs, sugar, or sauces to maximize taste. And keep a clean and healthy mouth by brushing and flossing often
  • If an upset stomach causes you to eat less, avoid heavy meals, coffee, and alcohol; try sleeping in an upright position; and reduce stress with meditation, yoga, or music
  • A registered dietitian (RD) may have more ideas to offer you

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

It is best to call your doctor or nurse 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:

  • Avoid fatty, fried, spicy, or highly sweet foods
  • Eat bland foods and drink clear liquids
  • Eat smaller, more frequent meals
  • Reduce food aromas and other stimuli with strong odors. Eat food at room temperature to lessen the odor
  • Listen to soft music, watch a favorite television program, or enjoy the company of others while you eat

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, plain cornstarch 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.

Also called dysphonia (dis-phone-ee-uh), this is when you have a weak, rough, or harsh voice.

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

  • Drink plenty of water and avoid irritants (eg, dust, smoke, alcohol, industrial chemicals)
  • Give your voice a break—write things down
  • Avoid voice strain through shouting or whispering

Skin conditions, such as rash, redness, or itching or peeling of the skin are other side effects you may have. You may notice dryness, thickening, calluses, or cracking of the skin on the palms of your hands and soles of your feet. This is called hand-foot syndrome. Some patients may have blisters or a rash. Tell your doctor or nurse 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:

  • Wear loose cotton clothes
  • Use sunscreen
  • Clean hands and feet with lukewarm water and gently pat dry
  • Apply creams containing lanolin or urea to the hands and feet liberally and often
  • Avoid tight-fitting shoes and jewelry or rubbing pressure on the hands and feet
  • Do not shave off blisters

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 doctor. He or she may recommend any of the following:

  • Drinking more fluids
  • Taking a stool softener
  • Changing your dose of INLYTA
  • Adding fiber to your diet
  • Increasing physical activity
  • Getting an enema

Make note of all your side effects and how you’re feeling
Be sure to pay attention to all your side effects. They can be important signs that let you and your doctor know what is happening in your body.

Before starting INLYTA, tell your doctor how you are feeling and about any side effects you have had from other medicines and treatments. As you start taking INLYTA, let your doctor know if you notice any side effects or a change in how you feel. Also tell your doctor if you notice any side effects that are not listed here. Based on your experience, your doctor may change your dose or stop treatment with INLYTA.

Side effects in the clinical trial
In a head-to-head clinical trial, 9% of patients taking INLYTA had to stop treatment because of side effects. This is compared with 13% of those taking Nexavar.

In all, 61% of people taking INLYTA stopped treatment compared with 71% taking Nexavar. The most common reasons for stopping treatment in both groups included:

  • Disease progression
  • Side effects

Also, 55% of people taking INLYTA required dose changes or a delay of treatment due to side effects. This is compared with 62% taking Nexavar.

Scroll for Important Safety Information and Indication

IMPORTANT SAFETY INFORMATION

What is INLYTA?

INLYTA is a prescription medicine used to treat advanced kidney cancer (advanced renal cell carcinoma or RCC) when one prior drug treatment for this disease has not worked.

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

What should I tell my doctor before taking INLYTA?

Before you take INLYTA, tell your doctor 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 failure
  • have an unhealed wound
  • plan to have surgery. You should stop taking INLYTA at least 24 hours before planned surgery
  • have any other medical conditions

For females, tell your doctor if you:

  • are pregnant or plan to become pregnant. Taking INLYTA during pregnancy can cause the death of an unborn baby or birth defects. You should not become pregnant while taking INLYTA. Talk to your doctor if you are pregnant or plan to become pregnant
  • are able to become pregnant. You should use effective birth control during your treatment with INLYTA. Talk to your doctor about birth control methods to prevent pregnancy while you are taking INLYTA
  • are breastfeeding or plan to breastfeed. It is not known if INLYTA passes into your breast milk. You and your doctor should decide if you will take INLYTA or breastfeed. You should not do both

For males:

  • use effective birth control during your treatment with INLYTA. Talk to your doctor about birth control methods
  • if your female partner becomes pregnant while you are taking INLYTA, tell your doctor right away

Tell your doctor 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.

Especially tell your doctor if you take:

  • dexamethasone
  • bosentan
  • modafinil
  • St. John’s wort (Hypericum perforatum)
  • Medicine for:

    • asthma
    • tuberculosis
    • seizures
    • bacterial infections
    • fungal infections
    • depression
    • HIV or AIDS

Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. If you are taking any medicines for the conditions listed above, your doctor might need to prescribe a different medicine or your dose of INLYTA may need to be changed. Talk with your doctor before you start taking any new medicine.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take INLYTA?

  • Take INLYTA exactly as prescribed by your doctor
  • Your doctor may change your dose if needed
  • INLYTA can be taken with or without food
  • Take INLYTA 2 times a day about 12 hours apart
  • Swallow INLYTA tablets whole with a glass of water
  • Your doctor should check your blood pressure regularly during treatment with INLYTA
  • If you vomit or miss a dose of INLYTA, take your next dose at your regular time. Do not take two doses at the same time
  • If you take too much INLYTA, call your doctor or go to the nearest hospital emergency room right away

What should I avoid while taking INLYTA?

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

What are the possible side effects of INLYTA?

INLYTA may cause serious side effects, including:

  • High blood pressure (hypertension). Your doctor should check your blood pressure regularly during treatment with INLYTA. If you develop blood pressure problems, your doctor may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA
  • Problem with 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 doctor 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 doctor 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 doctor should check 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 doctor 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 (abdominal) pain or stomach pain that does not go away
    • vomit blood
    • red or black stools
  • Thyroid gland problems. Your doctor should do blood tests to check your thyroid gland function before and during your treatment with INLYTA. Tell your doctor 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
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen while taking INLYTA. Call your doctor right away if you get:


    • headache
    • seizures
    • weakness
    • confusion
    • high blood pressure
    • blindness or change in vision
    • problems thinking
  • - Increased protein in your urine. Your doctor should check your urine for protein before and during your treatment with INLYTA. If you develop protein in your urine, your doctor may decrease your dose of INLYTA or stop your treatment

  • - Change in liver function. Your doctor should do blood tests before and during your treatment with INLYTA to check your liver function

The most common side effects of INLYTA include:

  • diarrhea (frequent or loose bowel movements)
  • high blood pressure
  • tiredness or feeling weak
  • decreased appetite
  • nausea
  • hoarseness
  • rash, redness, itching, or peeling of your skin on your hands or feet
  • decreased weight
  • vomiting
  • constipation

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of INLYTA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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